Federal Ministry of Health

Ethiopia

Tuberculosis, Leprosy and

TB/HIV Prevention and Control
Programme

Manual
Fourth Edition

2008
 TABLE OF CONTENTS

CONTENT Page
FOREWORD .............................................................................. X

ACKNOWLEDGEMENT ..................................................XI

LIST OF ABBREVIATIONS ...........................................XV

1. INTRODUCTION ...................................................................... 1

2. THE GLOBAL AND NATIONAL BURDEN OF

TUBERCULOSIS AND LEPROSY................................................. 2
2.1 GLOBAL BURDEN OF TUBERCULOSIS ................................................ 3
2.2 NATIONAL BURDEN OF TUBERCULOSIS: ........................................... 3
2.3 GLOBAL BURDEN OF LEPROSY ......................................................... 5
2.4 NATIONAL BURDEN OF LEPROSY ...................................................... 6
3. PRINCIPLES OF TB AND LEPROSY CONTROL .............. 8
3.1 GLOBAL STRATEGY TO PREVENT AND CONTROL TB ....................... 8
3.2 THE STOP TB STRATEGY: .................................................................. 9
3.3 GLOBAL PLAN TO STOP TB 2006-2015 ......................................... 10
3.4 GLOBAL STRATEGY FOR FURTHER REDUCING THE LEPROSY
BURDEN AND SUSTAINING LEPROSY CONTROL ACTIVITIES ...................... 11
4. TB AND LEPROSY CONTROL PROGRAMME IN
ETHIOPIA........................................................................................ 12
4.1 GENERAL OBJECTIVES OF TLCP (TUBERCULOSIS AND LEPROSY
CONTROL PROGRAM)................................................................................. 12
4.2 SPECIFIC OBJECTIVES OF TLCP ..................................................... 12
4.3 BASIC STRATEGIES IN REACHING THE OBJECTIVES ......................... 13
4.4 ORGANIZATIONAL STRUCTURE AND FUNCTIONS............................ 14
5. TUBERCULOSIS ..................................................................... 18
5.1 DEFINITION .................................................................................... 18
5.2 TRANSMISSION AND PATHOGENESIS .............................................. 18
5.3 NATURAL HISTORY ........................................................................ 19
5.4 CASE DETECTION, CASE FINDING.................................................. 21
5.4.1 Objectives..................................................................................... 21
5.4.2 Case finding strategies:................................................................ 22
5.5 IDENTIFICATION OF SUSPECTS ........................................................ 22
5.6 DIAGNOSTIC METHODS .................................................................. 25

ii
 5.6.1 Microscopic examination of sputum smears ......................... 25
5.6.2 Radiological examination ..................................................... 27
5.6.3 Culture................................................................................... 27
5.6.4 Histo-pathological examination............................................ 28
5.7 GENERAL DEFINITIONS................................................................... 29
5.8 CLASSIFICATION OF TUBERCULOSIS CASES .................................... 29
5.9 DEFINITION OF TYPE OF CASES ....................................................... 31
5.10 SERIOUSNESS OF ILLNESS:.............................................................. 32
5.11 TREATMENT OF TB ........................................................................ 33
5.11.1 Drugs used for the chemotherapy of TB ............................... 33
5.11.2 Phases of chemotherapy........................................................ 34
5.11.3 Patient categories and treatment regimens........................... 35
5.11.4 Treatment regimen for Category I and III: ........................... 37
5.11.5 Treatment regimen for Category II [Retreatment regimen] . 39
5.11.6 Side effects............................................................................. 39
5.11.7 Anti-TB drug treatment in special situations ........................ 41
5.11.8 Indications for hospitalization .............................................. 44
5.12 FOLLOW-UP DURING TREATMENT .................................................. 44
5.12.1 Follow-up during the initial phase of treatment ................... 45
5.12.2 Follow up during the continuation phase of treatment......... 45
5.12.3 How to improve treatment compliance ................................. 46
5.13 DEFINITIONS OF TREATMENT OUTCOME......................................... 53

6 TUBERCULOSIS IN CHILDREN .............................. 53

6.1 PRIMARY PULMONARY TUBERCULOSIS .......................................... 54
6.2 ACUTE DISSEMINATED TUBERCULOSIS .......................................... 56
6.3 POST-PRIMARY PULMONARY TUBERCULOSIS ................................. 57
6.4 EXTRA-PULMONARY TUBERCULOSIS IN CHILDREN ........................ 58
6.5 DIAGNOSIS OF PAEDIATRIC TB ...................................................... 59
6.5.1 Contact with a TB case ......................................................... 61
6.5.2 Sputum microscopy ............................................................... 61
6.5.3 Chest radiography................................................................. 61
6.5.4 Tuberculin Skin Test (TST or Mantoux Test) ........................ 62
6.5.5 Lumbar puncture for TB meningitis...................................... 62
6.5.6 Diagnosis of Tuberculosis in HIV-positive children............. 63
6.6 TREATMENT OF TUBERCULOSIS IN CHILDREN ................................ 64
6.7 ADMINISTERING TREATMENT AND ENSURING ADHERENCE ............ 70
6.8 FOLLOW UP.................................................................................... 70
6.9 ADVERSE REACTIONS TO TB DRUGS IN CHILDREN ......................... 71
7 TB/HIV COLLABORATIVE ACTIVITIES ......................... 72
7.1 IMPACT OF HIV ON TUBERCULOSIS ............................................... 72
7.2 IMPACT OF TUBERCULOSIS ON HIV ............................................... 73
7.3 DIAGNOSIS OF TB IN HIV-POSITIVE PATIENTS .............................. 74
7.4 PREVENTION AND MANAGEMENT OF TB AMONG PLHI ................ 77

iii
 7.4.1 Isoniazid Preventive Therapy (IPT) ...................................... 77
7.4.2 Co-trimoxazole Preventive Therapy (CPT) .......................... 78
7.4.3 Treatment of TB in PLHIV .................................................... 78
7.4.4 Anti-TB Treatment and Anti-Retroviral Therapy (ART) ....... 78
8 DRUG-RESISTANT TB AND MULTI-DRUG RESISTANT
TB
…………………………………………...……………………..8
0
8.1 MDR-TB OR MULTI DRUG RESISTANT TUBERCULOSIS ................ 81
8.2 EXTENSIVELY DRUG-RESISTANT TUBERCULOSIS (XDR-TB) ....... 82
8.3 TREATMENT OF MDR-TB.............................................................. 82
8.4 FOLLOW-UP OF MDR TB PATIENTS............................................... 85
9 PREVENTION OF TB............................................................. 85
9.1 MAIN GROUPS AT RISK ................................................................... 86
9.2 MEASURES OF PREVENTION ........................................................... 87
10 LEPROSY ................................................................................. 92
10.1 EPIDEMIOLOGY............................................................................... 92
10.2 CASE-FINDING ................................................................................ 93
10.3 DIAGNOSTIC METHODS .................................................................. 94
10.4 CASE DEFINITIONS ....................................................................... 108
10.5 SIGNS OF ACTIVE LEPROSY: ......................................................... 108
10.6 CHEMOTHERAPY .......................................................................... 108
10.6.1 PB-MDT regimen ................................................................ 110
10.6.2 MB-MDT regimen ............................................................... 110
10.6.3 Phases of chemotherapy...................................................... 111
10.7 TREATMENT OF SPECIAL CASES ................................................... 114
10.8 ADVERSE EFFECTS OF MDT......................................................... 114
10.9 FOLLOW-UP DURING TREATMENT ................................................ 115
10.10 RETRIEVAL OF ABSENTEES ........................................................... 118
10.11 DEFINITIONS OF TREATMENT OUTCOMES ..................................... 118
10.12 COMPLICATIONS OF LEPROSY AND THEIR MANAGEMENT ............. 119
10.13 PREVENTION OF LEPROSY ............................................................. 128
10.14 RELAPSE ....................................................................................... 128
11 COMMUNITY PARTICIPATION IN TBL CONTROL... 130
11.1 OBJECTIVES ................................................................................. 130
11.2 PROGRAM IMPLEMENTERS OF COMMUNITY-BASED CARE ............ 130
11.3 IMPLEMENTATION OF COMMUNITY BASED CARE .......................... 132

12 PUBLIC-PRIVATE MIX (PPM) IN TB CARE .................. 135

12.1 RATIONALE FOR PPM IN ETHIOPIA ................................................ 136
12.2 EXPERIENCE OF PPM ETHIOPIA...................................................... 137

iv
 12.3 A STEP BY STEP APPROACH FOR SCALIN UP PPM DOTS .................. 137
13 ADVOCACY COMMUNICATION AND SOCIAL
MOBILIZATION (ACSM) ........................................................... 140
13.1 ACSM FOR PATIENTS AND SERVICE PROVIDERS ............................ 140
13.1.1 What a patient should know at the diagnosis of TB, TB/HIV
and leprosy .......................................................................................... 142
13.2 THE TB/HIV CO-EPIDEMIC ............................................................. 144
13.3 LEPROSY PATIENT WHEN RELEASED FROM TREATMENT (RFT) ..... 144
13.3.1 Education in self-care for patients with disability of eye,
hand or foot ......................................................................................... 145
13.3.2 Care of the hands ................................................................ 145
13.3.3 Care of the skin and feet...................................................... 146
13.3.4 Care of the eyes................................................................... 146
13.4 THE PATIENT AND THE COMMUNITY ............................................. 146
13.4.1 The patient and family members ......................................... 146
13.4.2 The community .................................................................... 148
14 RECORDING AND REPORTING IN TB, LEPROSY AND
TB/HIV............................................................................................ 149
14.1 INTRODUCTION............................................................................. 149
14.2 REGISTERS, RECORDS AND REPORTS ............................................ 149
14.2.1 Tuberculosis and TB/HIV.................................................... 149
14.2.2 Leprosy................................................................................ 150
14.2.3 Forms and registers used for both TB and Leprosy............ 151
15 SUPPORTIVE SUPERVISION AND REVIEW MEETINGS155
15.1 LEVELS OF SUPERVISION .............................................................. 155
15.1.1 Health facility level ............................................................. 155
15.1.2 Woreda (District) level........................................................ 156
15.1.3 Zonal level........................................................................... 157
15.1.4 Regional level...................................................................... 157
15.1.5 Central level ........................................................................ 158
15.2 SUPERVISION CHECKLIST AND REPORTS ....................................... 159
15.3 REVIEW MEETINGS ....................................................................... 159
16 SUPPLIES AND LOGISTICS............................................... 161
16.1 PROCUREMENT, STORAGE, DISTRIBUTION AND USE OF DRUGS &
CONSUMPTION REPORTING ....................................................................... 161
16.1.1 Procurement........................................................................ 161
16.1.2 Storage and Distribution..................................................... 162
16.1.3 Rational use of drugs .......................................................... 163
16.1.4 Drug Consumption Reporting ............................................. 163
16.1.5 Records and forms............................................................... 164
16.1.6 IEC/BCC materials ............................................................. 165

v
 16.1.7 Supply of formats and registers........................................... 165
16.2 RESPONSABILITIES ....................................................................... 165
16.3 QUALITY CHECK AND QUALITY CONTROL .................................... 166

LIST OF TABLES AND FIGURES

TABLES
TABLE 1: EIGHT-YEAR OVERVIEW OF TB CASE
NOTIFICATION IN ETHIOPIA, 1999-2007 (1992-1999 E.C);
TB DATA, TLCT, FMOH …..………………………………… 4
TABLE 2: TEN-YEAR OVERVIEW OF LEPROSY CASE
NOTIFICATION, 1997/98 – 2006/07 (1990 – 1999 EC)
(SOURCE: ANNUAL LEPROSY DATA TLCT, FMOH)……………7
TABLE 3: OVERVIEW OF ACTIVE AND LATENT TB………. 19
TABLE 4: SYMPTOMS OF PTB AND EPTB …………………… 24
TABLE 5: TREATMENT CATEGORY BY TYPE OF PATIENT 35
TABLE 6: DOSAGE OF CATEGORY I AND III REGIMENS:
2ERHZ/6EH……………………………………………….. ………. 36
TABLE 7. DOSAGE FOR CATEGORY II REGIMEN:2
S(ERHZ) / (ERHZ) / 5E3(RH)3 ….…………………..… ……….. 38
TABLE 8. SYMPTOM-BASED APPROACH TO MANAGEMENT
OF DRUG SIDE-EFFECTS. ……………………………………… 39
TABLE 9: MANAGEMENT OF PATIENTS INITIALLY SMEAR
POSITIVE, WHO INTERRUPTED TB TREATMENT
FOR LESS THAN 8 CONSECUTIVE WEEKS…………………. 49
TABLE 10: RECOMMENDED DOSES OF PAEDIATRIC
TREATMENT……………………………………………………… 66
TABLE 11. DIFFERENTIATION BETWEEN EARLY AND
LATE STAGES OF HIV-INFECTION ………………… 75
TABLE 12: CAUSES OF INADEQUATE ANTI-
TUBERCULOSIS TREATMENT………………………………… 80

vi
TABLE 13: ADVERSE EFFECTS OF MDT DRUGS………….. 113
TABLE 14: DIFFERENTIATION BETWEEN RELAPSE
AND REACTIONS……………………………………………….. 128
TABLE 15. RECOMMENDED STOCKS OF DRUGS AND
SUPPLIES AT DIFFERENT LEVELS OF THE HEALTH SYSTEM….. 161

FIGURES
FIGURE 1: NOTIFIED CASES OF TB IN THE LAST EIGHT
YEARS, 1992-1999 E.C. (TBL DATA, TLCT, FMOH)….………. 4
FIGURE 2: LEPROSY CASE NOTIFICATION, 1997/98-2006/07
(1990-1999 EC)………………………………………………………. 7
FIGURE 3. FLOW CHART FOR FOLLOW-UP OF NEW
SMEAR- POSITIVE PULMONARY TB PATIENTS…………... .. 48
FIGURE 4: SITES WHERE NERVES CAN BE FELT……….. 96
FIGURE 5: FLOWCHART FOR DIAGNOSIS AND
CLASSIFICATION OF LEPROSY……….………………………. 106

vii
ANNEXES:

ANNEX 1: DUTIES AND RESPONSIBILITIES OF THE

DIFFERENT LEVELS IN THE HEALTH SYSTEM ……….166
ANNEX 2: ORGANOGRAM OF TLCP……………………….169
ANNEX 3: DIAGNOSTIC ALGORITHMS FOR
PULMONARY TB AND EXTRA PULMONARY TB……… 170
ANNEX 4: MANAGEMENT OF ENLARGED
LYMPHONODES……………………………………………... 175
ANNEX 5: MANAGEMENT OF LEPROSY RELATED
COMPLICATIONS ………………………………………….. 176
ANNEX 6: TLCP SUPERVISION CHECKLIST
……………..178
ANNEX 7: DRUG ORDER
FORM……………………………..189
ANNEX 8: TLCP RECORDING AND REPORTING
FORMS …………………………………………………………..191
ANNEX 8.1: AFB LABORATORY REGISTER & REQUEST
FORM ……………………………………………………………
191
ANNEX 8.2: TB UNIT REGISTER HMIS V2…………… 193
ANNEX 8.3: INSTRUCTIONS FOR TB-DOTS
REGISTRATION AT HEALTH CENTER / CLINIC /
HOSPITAL………………………………………………. 195
ANNEX 8 .4: TUBERCULOSIS REFERRAL AND TRANSFER
FORM ………………………………………………………. 199
ANNEX 8.5: QUARTERLY REPORT ON TUBERCULOSIS
CASE-INDING………………………………………… …. 200
ANNEX 8.6: HMIS LEPROSY REGISTER …………… 202

viii
ANNEX 8.7: INSTRUCTIONS FOR LEPROSY
REGISTRATION AT HEALTH CENTER / CLINIC /
HOSPITAL ………………………………… 204
ANNEX 8.8: LEPROSY RECORDS & FORMS… 207
ANNEX 8.9: LEPROSY QUARTERLY REPORTING
FORMS……………………………………………… 212
ANNEX 8.10: TB& LEPROSY ID CARDS ……… 214
ANNEX 8.11: TB AND LEPROSY QUARTERLY
ACTIVITY REPORTING FORMS …………………. 216
ANNEX 8.12: HMIS TB, LEPROSY AND TB/HIV
QUARTERLY REPORTING FORM …………….. 218

ix
FOREWORD
Tuberculosis and leprosy are chronic infectious diseases affecting
thousands of people in Ethiopia every year. The prevention and
control as well as eventual elimination of these two ancient
scourges of mankind require concerted effort by all.

Tuberculosis is a major cause of morbidity and mortality in

Ethiopia. Ethiopia belongs to the list of countries most affected.
Compounded with HIV/AIDS, TB has become a formidable
threat to the country. The burden of TB in Ethiopia is estimated at
168 new smear-positive cases per 100,000 population according
to the World Health Organization global TB report 2008. Efforts
made to identify and treat those cases are far below satisfactory.
This will further worsen our situation until the trend is reversed.

Successful fight against TB calls for implementation of Tb/HIV

collaboration which is basically enabling all people living with
HIV/AIDS benefit from packages of TB diagnosis and care and
enabling all TB suspects benefit from packages of Provider
Initiated HIV Counseling, Testing and subsequent services.

Leprosy is a major cause of disability for people affected by it. If

left untreated leprosy will continue to be a significant problem for
decades to come even the elimination target (a prevalence rate of
patients on treatment below 1 per 10,000 population) has been
reached at country level a couple of years ago. It is wise to note
that new leprosy cases will continue to occur, and will need to be
detected at an early stage of the disease and enrolled to regular
and complete treatment with multi drug therapy (MDT).
Significant proportion of patients coming to health facilities show
disability at diagnosis and many will be at risk of developing
(further) disability after diagnosis. This indicates the need for
aggressive Advocacy, Communication and Social Mobilization
(ACSM) to ensure that patients come at an earlier stage and
complete treatment without accompanying disability.

x
The prevention and control effort against TB and Leprosy has
been since 1994. This fourth edition of TBL and TB/HIV manual
is a revised version and an outcome of efforts to accommodate all
the latest developments in TB, Leprosy and TB/HIV worlds in
line with the Stop TB Strategy for TB and TB/HIV collaborative
activities, as well as the global strategy for further reducing the
leprosy burden and sustaining leprosy control activities for
leprosy. This manual will serve the purpose of a tour guide in the
fight against TB, Leprosy and TB/HIV to all stakeholders in
general and frontline health workers in particular. It is with great
pleasure that I recommend this fourth edition to be your
companion day-in day-out.

Dr. Zerihun Tadesse, MD MPH

Head, Diseases Prevention and Control, Federal Ministry of
Health

ACKNOWLEDGEMENT

xi
The Tuberculosis and Leprosy Disease Prevention and Control
Team is congratulated for successful revision of this manual. The
revision was possible due to kind support from the various
departments of the Federal Ministry of Health, Regional Health
Bureaus, World Health Organization (WHO), the German
Leprosy and Tuberculosis Relief Association (GLRA), Center for
Diseases Prevention and Control (CDC) and its partners (in
country American Universities), Family Health International
(FHI) and all others who have contributed to the revision process.

The valuable contribution of experts listed below is worth special

mention.

Ato Bekele Chaka ------------------------------Team leader, TLCT

Ato Desalegne G/Yesus -----------------------Benshangul Gumuz
Ato Fasil Tsegaye ----------------------------GF consultant, TLCT
Ato Ferede Mosisa ------------CDC team leader, Gambella RHB
Ato Gadissa Lemecha -----------------HMIS team leader, FMOH
Ato Tadele Kebede ------------------------------------Expert,
TLCT
Ato Wassie Shiferaw -------------------------TBL expert, SNNPR
Ato Wessagnu Zewde ----------------HLM expert,
HEEC/FMOH
Dr. Beniam Feleke ---------------------------------Advisor, CDC-E
Dr. Dawit Assefa ------------------PPM-DOTS consultant, TLCT
Dr. Diriba Agegnehu -------------------------TB/HIV NPO, WHO
Dr. Eshetu Gezahegne ----------------S. Technical officer, FHI-E
Dr. Eshetu Kebede ------------------------------TB expert, ALERT
Dr. Ezra Shimelis ---------------------TB/HIV Advisor, CU-
ICAP
Dr. Fekadeselassie Mikru ---------------Medical Advisor, GLRA
Dr. Getachew W/Agegne ------------TB/HIV Advisor,
FHAPCO
Dr. Getenet Amere ---------------------------------Dire Dawa RHB
Dr. Marina Tadolini ---------------------------------WHO APO/TB
Dr. Mohamed Absenos -----Research focal person, St. Peter’s
H
Dr. Retta Ayele ---------------------------TB/HIV Advisor, UCSD

xii
Dr. Thierry Comolet ----------------------------------WHO
MO/TB
Dr. Wubaye Walelegne --------------------TB/HIV Advisor, JHU
Sr. Genet Yosef --------------------------------RTLC, Addis
Ababa
W/o Tsegemariam Teklu ----------------TBL expert, Tigray
RHB

The revision of this manual was accomplished through the

generous financial support of the World Health Organization
(WHO), which covered the cost of the revision process and
printing.

Bekele Chaka, MPH

TB and Leprosy Prevention and Control Team Leader
FMOH-Ethiopia

xiii
xiv
LIST OF ABBREVIATIONS
AAU Addis Ababa University
ACSM Advocacy, Communication and Social Mobilization
AIDS Acquired Immunodeficiency Syndrome
ANC Antenatal Care
ARI Annual Risk of Infection
ART Anti-Retroviral Treatment
CBOs Community Based Organizations
CDC-E Centers for Disease Control and prevention,
Ethiopia
CO Central Office
CPT Cotrimoxazole Preventive Treatment
CRL Central Reference Laboratory
CU-ICAP-E Columbia University-International Center for AIDS
Care and Treatment Programs-Ethiopia
DACA Drug Administration and Control Authority
DOTS Directly Observed Treatment, Short-Course
DPCD Diseases Prevention and Control Department
DST Drug Sensitivity Test
EC Ethiopian Calendar
EHNRI Ethiopian Health and Nutrition Research Institute
EPTB Extra-pulmonary Tuberculosis
EQA External Quality Assurance
FBOs Faith Based Organizations
FHI-E Family Health International, Ethiopia
FMOH Federal Ministry of Health
FY Financial or Fiscal Year
GC Gregorian Calendar
GF Global Fund
GFATM Global Fund to Fight AIDS, TB and Malaria
GLRA German Leprosy and TB Relief Association
HAART Highly Active Anti Retroviral Treatment
HAPCO HIV/AIDS Prevention and Control Office

xv
HBCs High Burden Countries
HC Health Center
HCT HIV Counseling and Testing
HESP Health Extension Service Package
HEWs Health Extension Workers
HF Health Facility
HIV Human Immunodeficiency Virus
HMIS Health Management Information System
HPPD Health Programmes Provisional Department
HQ Head Quarter
HS Health Station
HSDP Health Sector Development Programme
HSEP Health Service Extension Programme
HW Health Worker
IEC Information, Education and Communication
IEC/BCC Information, Education and
Communication/Behavior Change Communication
IP Infection Prevention
IPT Isoniazid Preventive Therapy
IR Infection risk
IRIS Immune Reconstitution Inflammatory Syndrome
ISTC International Standards for Tuberculosis Care
I-TECH-E International Training and Education Center for
HIV, Ethiopia
JHU-E John Hopkins University, Ethiopia
LMIS Logistic Management Information System
M&E Monitoring and Evaluation
MB Multi-Bacillary
MDGs Millennium Development Goals
MDR-TB Multi-Drug Resistant TB
MDT Multi-Drug Therapy
MOH Ministry of Health
MSH-E Management Sciences for Health, Ethiopia

xvi
NGOs Non-Governmental Organizations
NTCP National Tuberculosis Control Programme
NTLCP National Tuberculosis & Leprosy Control
Programme
OI Opportunistic Infection
PB Pauci-Bacillary
PHCU Primary Health Care Unit
PIHCT Provider Initiated HIV Counseling and Testing
PLHIV People Living With HIV/AIDS
PMTCT Prevention of Mother-to-child transmission of HIV
PPD Planning and Programming Department
PPM Public-Private Mix
PTB Pulmonary Tuberculosis
QC Quality Control
RHB Regional Health Bureau
RNE Royal Netherland Embassy
RRL Referral Regional Laboratory
RTLC Regional TB and Leprosy Control Coordinator
SCC Short Course Chemotherapy
SNNPR Southern Nations Nationalities and Peoples Region
SOPs Standard Operation Procedures
SSA Sub Saharan Africa
TB Tuberculosis
TB/HIV TB and HIV Co-infection
TBL Tuberculosis & Leprosy
TLCP TB and Leprosy Prevention and Control Programme
TLCT TB and Leprosy Prevention and Control Team
UCSD-E University of California San Diego, Ethiopia
UNAIDS The joint United Nations Programme on HIV/AIDS
USAID United States Agency for International
Development
VCT Voluntary Counseling and Testing

xvii
WCDC Woreda Communicable Diseases Control
Coordinator
WHO World Health Organization
XDR-TB Extensively Drug Resistant Tuberculosis
ZCDC Zonal Communicable Diseases Control Coordinator

xviii
 1. INTRODUCTION
Tuberculosis and Leprosy have been recognized as major public
health problems in Ethiopia more than half a century ago. The
effort to control tuberculosis began in the early 1960s with the
establishment of TB centres and sanatoriums in three major urban
areas in the country. In 1976, in order to address effectively the
TB challenge, the Central Office (CO) of the National
Tuberculosis Control Programme (NTCP) was established.
An organized leprosy control programme was established within
the Ministry of Health (MOH) in 1956 and a detailed policy was
issued in 1969. Leprosy control was strongly supported by the
German Leprosy Relief Association (GLRA). The programme
was rather vertical and well funded and has scored notable
achievements in reducing the prevalence of the disease, especially
after the introduction of Multiple Drug Therapy (MDT) in 1983.
However, the annual new case detection did not show comparable
decline.
Global efforts to control TB were strengthened in 1991, when a
World Health Assembly resolution recognized TB as a major
global public health problem. Two targets for TB control were
established as part of this resolution – 70% of case detection rate
and 85% of cure rate by the year 2000, which means that at least
the 70% of new smear positive cases should be detected and at
least the 85% of these cases should be treated. These two targets
were embedded within the DOTS strategy launched by WHO in
1994, and subsequently endorsed by the WHO STOP TB Strategy
in 2006. Ethiopia, implementing the DOTS and STOP TB
Strategy, adopted the global targets for TB control.
In 1992 a standardized TB prevention and control programme,
incorporating Directly Observed Treatment, Short Course
(DOTS), was started as a pilot in Arsi and Bale zone, Oromia
Region. The DOTS strategy has been subsequently scaled up in
the country and implemented at national level. Currently the
DOTS geographic coverage reaches 90%, whereas the Health
Facility coverage is 75%.
In view of the achievements made by combined tuberculosis and
leprosy control programmes in other countries, including those in
sub-Saharan Africa, it was decided in 1994 to combine the two
1
programmes in Ethiopia into the National Tuberculosis & Leprosy
Control programme (NTLCP) under the co-ordination and
technical leadership of the CO.
In June 2000 the previous Epidemiology/AIDS Department of the
MOH was re-structured and named Disease Prevention and
Control Department (DPCD). The TB and Leprosy Control
Programme was subsequently accommodated within this
Department, together with Malaria and other Vector-Borne
Diseases Prevention and Control Team, Integrated Diseases
Surveillance and Response Team, other Communicable and Non-
Communicable Diseases Prevention and Control Team. The
former CO was then named Tuberculosis and Leprosy Control
Team (TLCT).
The leprosy component of the combined TB and Leprosy control
program has been fully integrated into the general health services
by the end of 2001. Integration means that TB and leprosy
prevention and control activities became the responsibility of the
general health service.
This Manual contains the technical and managerial aspects of TB,
TB/HIV and Leprosy control activities in Ethiopia. This revised
version of the Manual was developed in the framework of the new
Stop TB Strategy, with significant updating of diagnostic and
clinical management criteria of TB and is including all aspects of
TB Control, including TB/HIV, Multi-Drug Resistant-TB and
Public-Private Mix (PPM)-DOTS. Regarding Leprosy, the manual
has been significantly updated; in line with the global strategy for
further reducing the leprosy burden and sustaining leprosy control
activities (2006 – 2010) as well as the operational guideline for
the implementation of the global strategy.
This manual is primarily intended for general health workers who
are responsible for the diagnosis and treatment of both diseases,
for program coordinators at different levels of the health system
and development partners in the health sector. Furthermore, it is
an important reference material for academic and research
institutions.
2. THE GLOBAL and NATIONAL BURDEN OF
TUBERCULOSIS AND LEPROSY

2
 2.1 Global burden of tuberculosis

TB is a major public health problem throughout the world.

According to the WHO Global Report 2007, one-third of the
world’s population is estimated to be infected with tubercle bacilli
and hence at risk of developing active disease. Globally, in 2005,
the annual incidence of TB, expressed as the number of new TB
cases, was about 8.8 million people (7.4 million of these in Asia
and sub-Saharan Africa), and the annual number of deaths due to
TB was 1.6 million, including 195,000 patients infected with
HIV. In developing countries, TB comprises 25% of all avoidable
adult deaths. It is estimated that nearly one million (11%) of the
total TB cases are children less than 15 years of age.
The 22 High Burden Countries (HBCs) account for approximately
80% of the estimated number of new TB cases (all forms) arising
worldwide each year. These countries are the focus of intensified
efforts in DOTS expansion. The HBCs are not necessarily those
with the highest incidence rates per capita; many of the latter are
medium-sized African countries with high rates of TB/HIV co-
infection.
Recent evidences tend to demonstrate that TB prevalence and TB
death rates are globally decreasing after having reached a peak.
Since 2005, the TB incidence rate is in decline in all six WHO
regions. However, the TB case-load continues to grow in Africa,
and Eastern Europe.
2.2 National burden of tuberculosis:
According to the 2007 WHO estimates, the incidence of TB of all
forms and smear positive TB stand at 341 and 152 per 100,000
population, respectively. The prevalence and mortality of
Tuberculosis of all forms is estimated to be 546 and 73 per
100,000 population respectively. In the year 2006/7 Ethiopia
registered 129,743 cases of TB. According to latest estimates,
Ethiopia stands 7th in the list of High Burden Countries for TB.
Table 1: Eight-year overview of TB case notification in Ethiopia,
1999-2007 (1992-1999 E.C); TB Data, TLCT, FMOH

3
 Case
notification Trea
rate per tme
100,000 nt
Total Smear succ
Year Smear population
New % Negativ % EPTB % ess
(G.C.) Positive Sme
Cases e rate
ar All
Posi forms
tive
1999/ 83,334 26,459 32 30,333 36 26,542 31 42 131
2000
2000/01 90,729 32,423 36 28,994 32 29,312 32 50 139
2001/02 105,250 35,915 34 32,197 31 37,138 35 53 157
2002/03 108,488 37,014 34 32,656 30 38,818 36 54 157
2003/04 121,026 41,430 34 37,119 31 42,477 35 59 173
2004/05 123,090 38,800 31 40,269 33 44,021 36 53 169 81%
2005/06 120,163 36,674 31 40,234 33 43,255 36 49 160 78%
2006/07 126,809 38,040 30 43,500 34 45,269 36 49 164 85%

Figure 1: Notified cases of TB in the last eight years, 1992-1999 E.C.

(TBL Data, TLCT, FMOH)

According to the MOH hospital statistics data, tuberculosis is the

leading cause of morbidity, the third cause of hospital admission
(after deliveries and malaria), and the second cause of death in
Ethiopia, after malaria.
Tuberculosis is an obstacle to socio-economic development; 75%
of people affected by TB are within the economically productive
age group of 15-54 years.
4
The HIV epidemic worsened the TB situation by:
• Accelerating the progression from primary infection to
disease;
• Increasing the reactivation rate of TB;
• Increasing the re-infection rate.

It is estimated that 50 to 60% of HIV infected people will develop

TB disease in their lifetime in contrast with HIV negative persons,
whose lifetime risk is only 10%.

Seroprevalence of HIV among adult TB patients is 11% according

to WHO report 2007, and 31% according to more recent national
data from 1999 EC (2006/07).
Another challenge to TB control in Ethiopia is the emergence of
multi-drug resistant TB (MDR-TB). The data from DST survey
conducted in the country between 2003 and 2006 shows that
levels of MDR-TB are: 1,6% and 11,8% in new cases and re-
treatment cases of TB patients, respectively. However, these
figures translate into large absolute number of MDR-TB cases,
who can transmit drug resistant strains to others, especially in
overcrowding condition, high prevalence of HIV and
malnutrition. For these reasons, this emerging problem calls for
serious consideration and urgent action.
The incidence of TB in children is less compared to adults, but
they are likely to suffer from more serious forms of TB and may
die if not treated properly.
2.3 Global burden of leprosy
The WHO elimination strategy (elimination of leprosy is defined
as reducing the registered prevalence of leprosy to less than 1 per
10,000 inhabitants), based on the widespread implementation of
multi-drug therapy (MDT), has led to a dramatic reduction of the
prevalence of registered leprosy. The impact of MDT on the
prevalence of leprosy is due to the greatly reduced duration of
treatment. The global registered prevalence of leprosy at the
beginning of 2007 stood at 224,717 cases, while the number of
new cases detected during 2006 was 259,017. During 2006, the
5
number of new cases detected fell globally by more than 40,019
cases (13.4%) when compared with 2005. Since 1985, prevalence
of leprosy has been reduced globally by more than 90% and over
14.5 million patients have been cured through multidrug therapy
(MDT).
2.4 National burden of leprosy
The national registered prevalence of leprosy at the end of June
2007 is 4,611, while the number of new cases detected during
2006/07 (1999 EC) is 4,187. The prevalence rate of registered
cases of leprosy, therefore, stood at 0.6 per 10,000 inhabitants at
the end of June 2007. However, the registered prevalence varies
considerably from region to region. The proportion of children
and disability grade 2 among newly detected cases during
2006/07 (1999 EC) is 7% and 10% respectively.
Table 2 below illustrates trend in leprosy new case detection in
Ethiopia over the past five years.

6
Table 2: Ten-year overview of Leprosy case notification, 1997/98 –
2006/07 (1990 – 1999 EC) (Source: Annual leprosy data TLCT,
FMOH)

New cases
Year
Prevalence Child Grade II MB
(G.C.) New
rate disability proportion
cases
(%) (%) (%)
1997/98 7,764 4,457 6 16 74
1998/99 5,585 4,643 7 12 79
1999/00 5,233 4,732 6 13 81
2000/01 5,081 4,584 7 13 84
2001/02 5,580 4,940 6 15 86
2002/03 5,852 5,193 6 15 88
2003/04 5,364 4,787 7 14 88
2004/05 5,277 4,698 7 13 88
2005/06 4,646 4,092 8 11 75
2006/07 4,611 4,187 7 10 93

7
 3. PRINCIPLES OF TB AND LEPROSY CONTROL

3.1 Global Strategy to prevent and control TB

In 1994, WHO launched the Directly Observed Treatment, Short-
course (DOTS) Strategy, which is the brand name of the
internationally recommended strategy for TB control. The DOTS
strategy ensures that infectious TB patients are identified and
cured using standardized drug combination. The five key
components of DOTS strategy are:
1. Government commitment to ensure sustained and
comprehensive TB control activities, increase human and
financial resources and make TB control a nationwide
priority;
2. Case detection by sputum smear microscopy among
symptomatic patients self reporting to health facilities;
3. Standardized short-course chemotherapy using regimens of
six to eight months, for all diagnosed cases of tuberculosis
under proper case-management conditions, including direct
observation of treatment;
4. Regular, uninterrupted supply of all essential anti-tuberculosis
drugs and laboratory supplies;
5. Standardized recording and reporting system that allows
assessment of case finding and treatment result for each
patient and of the tuberculosis control programme
performance overall.
One of the most important components of DOTS is the direct
observation of treatment, which means that a health worker must
watch the patient taking each dose. Direct observation of
treatment is important to:
· Ensure that patients take the correct treatment regularly;
· Notice rapidly when a patient misses a dose, find out why, and
solve the problem;
· Monitor any problem that the patient may experience with the
disease, the treatment or other condition.
The DOTS framework has subsequently been expanded and
implemented in 182 countries. It has helped countries to improve
national TB control programmes (NTPs) and make major

8
progress in TB control. By 2005, more than 26 million patients
had been notified in DOTS programmes worldwide, and 10.8
million new smear-positive cases were registered for treatment by
DOTS programmes between 1994 and 2004. In 2005, nearly 5
million TB patients were notified under DOTS.
DOTS programmes detected an estimated 53% of all new cases
and 60% of new smear-positive cases in 2005. The detection rate
achieved by DOTS programmes, of both smear-positive and all
new TB cases, has accelerated sharply since 2000. However, the
increase in the smear-positive case detection rate under DOTS is
slowing: the increment between 2004 (54%) and 2005 (60%) was
6%, which is less than in the two preceding yearly intervals. In
2005 the point estimate of 60% smear-positive case detection rate
by DOTS programmes is below the 70% target.
At present, cure rate among cases registered under DOTS is
globally 77%, and a further 7% completed treatment (no
laboratory confirmation of cure), giving a reported, overall
treatment success rate of 84%, i.e. 1% below the 85% target set
for the 2004 cohort. However, out of all patients treated under
DOTS, 10% had no reported outcome. A total of 496 719 patients
were reported to have been re-treated under DOTS in 2004. While
some patients remained on treatment, the re-treatment success rate
by the end of 2005 was 73%.
3.2 The STOP TB Strategy:

The STOP TB Strategy was launched by WHO in 2006. It

comprises of the following elements:
1. Pursue quality DOTS expansion and enhancement,
improving case-finding and cure through an effective
patient-centred approach to reach all patients, especially
the poor.
2. Address TB/HIV, MDR-TB and other challenges, by
scaling up TB/HIV joint activities, DOTS-Plus, and other
relevant approaches.
3. Contribute to health system strengthening by
collaborating with other health programmes and general

9
 services, for example in mobilizing the necessary human
and financial resources for implementation and impact
evaluation, and in sharing and applying achievements of
TB control.
4. Involve all care providers, public, nongovernmental and
private, by scaling up approaches based on a public-
private mix, to ensure adherence to the International
Standards for TB Care.
5. Engage people with TB and affected communities to
demand, and contribute to, effective care. This will
involve scaling up community TB care; creating demand
through context specific advocacy, communication and
social mobilization; and supporting development of a
patients’ charter for the TB community.
6. Enable and promote research for the development of new
drugs, diagnostics and vaccines. Research will also be
needed to improve programme performance.

The new Stop TB Strategy acknowledges the need to provide care

to all TB patients, whether drug susceptible or drug-resistant
bacilli cause their disease.
3.3 Global Plan to Stop TB 2006-2015
The Global Plan for 2006-2015 fully adopts the WHO-
recommended Stop TB Strategy; its implementation over a 10-
year duration should bring the following achievements:
• Expansion of equitable access for all to quality TB
diagnosis and treatment.
• About 50 million people will be treated for TB under the
Stop TB Strategy, including about 800 000 patients with
MDR-TB, and about 3 million patients who have both TB
and HIV will be enrolled on antiretroviral therapy (ART).
• Some 14 million lives will be saved from 2006 to 2015.
• The first new TB drug for 40 years will be introduced in
2010, with a new short TB regimen (1-2 months) soon
after 2015.
• By 2010, diagnostic tests at the point of care will allow
rapid, sensitive and inexpensive detection of active TB.

10
 By 2012, a diagnostic toolbox will accurately identify
people with latent TB infection and those at high risk of
progression to disease.
• By 2015, a new, safe, effective and affordable vaccine
will be available with potential for a significant impact on
TB control in later years.
3.4 Global Strategy for Further Reducing the Leprosy
Burden and Sustaining Leprosy Control Activities
The main principles of leprosy control, based on timely detection
of new cases and their treatment with effective chemotherapy in
the form of multi drug therapy, will not change over the coming
years. The emphasis will remain on providing patient care that is
equitably distributed, affordable and easily accessible.
The main elements of the strategy are as follows:
! Sustain leprosy control activities in all endemic areas of
the country
! Use case detection as the main indicator to monitor
progress
! Ensure high-quality diagnosis, case management,
recording and reporting
! Strengthen routine and referral services
! Discontinue the approach by campaign
! Develop tools and procedures that are home/community-
based, integrated and locally appropriate for the
prevention of disabilities/impairments and for the
provision of rehabilitation services.
! Promote operational researches in order to improve
implementation of a sustainable strategy.
! Encourage supportive working arrangements with partners
at all levels.
This strategy will require endorsement and commitment from
everyone working towards the common goal of controlling
leprosy, to ensure that the physical and social burden of the
disease continues to decline throughout the world.

11
 4. TB AND LEPROSY CONTROL PROGRAMME IN
ETHIOPIA
4.1 General objectives of TLCP (Tuberculosis and
Leprosy Control Program)
The general objectives of TB and Leprosy control are to:
1. Interrupt transmission of the infections;
2. Reduce morbidity, mortality and disability;
3. Prevent emergence and spread of drug resistance;
4. Reduce burden of TB among people living with HIV;
5. Reduce HIV burden among TB patients.
4.2 Specific objectives of TLCP
1. Expand and strengthen the access to high quality DOTS in
order to meet the Stop TB Partnership targets for TB
Control: to identify at least 70% of people with infectious
TB (under the DOTS strategy), and to cure at least 85% of
these patients.
2. Expand and strengthen high quality leprosy prevention,
control and care that is equitably distributed, affordable
and easily accessible, in order to meet the targets for
leprosy control: to reduce the proportion of disability
grade 2 among new leprosy cases to less than 5% by
identifying new cases as early as possible as well as
achieving and maintaining MDT completion rate to at
least 90%.
3. To address adequately TB/HIV, by strengthening the
collaboration between TB and HIV Prevention and
Control Programmes at all levels, in order to reduce
burden of TB among People Living with HIV (PLWH)
and to reduce the burden of HIV and AIDS among TB
patients
4. Reduce the burden of TB, Leprosy and TB/HIV among
more vulnerable communities

12
 5. Ensure community participation in the promotive and
preventive activities for TB, leprosy and TB/HIV, in order
to empower people with TB and Leprosy and
communities.
6. Enable and promote program-based operational researches
4.3 Basic strategies in reaching the objectives
In order to reach the national objectives and targets, the TB and
Leprosy Control Program of Ethiopia is aligned with the globally
recommended Stop TB Strategy and Global Strategy for Leprosy
Prevention and Control.The basic strategies are:
1. Early case detection
2. Adequate chemotherapy
3. Provision of comprehensive & standard patient care
4. Enhanced case management
5. Accurate Monitoring and Evaluation (M & E) of program
performance
6. Community participation
The most efficient method for preventing transmission is
identification (through early case detection and diagnosis) and the
cure of the most potent sources of infection: pulmonary
tuberculosis patients excreting tubercle bacilli.
The targets of an effective TBL Control Programme are:
• To achieve and maintain detection of at least 70% of new
sputum smear-positive TB cases;
• To achieve and maintain a cure rate of at least 85% among
these patients (through DOTS);
• To reduce the proportion of grade 2 disability among new
leprosy cases to less than 5%.
• To achieve and maintain a treatment completion rate of
leprosy to at least 90%.
These strategies are cost effective for the individual patients, their
families and the community at large. Therefore, establishment of
early case finding and adequate chemotherapy with a standardized
combination of drugs (SCC for TB and MDT for leprosy),

13
remains top priority to cure the patient, interrupt transmission of
infection and prevent death and complications caused by both
diseases.
4.4 Organizational structure and functions
Disease prevention and control measures that serve the needs of
people must be carried out throughout the whole country and the
services including laboratory should be placed as close as possible
to the community. In Ethiopian context, the only way to apply this
is to incorporate the programmes into the existing general health
services.
Within this integrated health system, the TLCP relies on
supervisory staff at National, Regional, Zonal, Sub-cities, City
Administration and Woreda levels, staff equipped with expertise
and skills on TB, TB/HIV and Leprosy.
The functions of TB and leprosy control can be classified as
community, patient-and programme-management activities:
a. Community management activities (mainly carried out by
Health Extension Workers and community
volunteers/promoters):
Activity TB Leprosy TB/HIV
collaboration
Education of the community Yes Yes Yes
Identification of suspects Yes Yes Yes
Referral of suspects to health Yes Yes Yes
facilities
Support for adherence to Yes Yes Yes
treatment
Retrieval of absentees Yes Yes Yes
Contact tracing Yes Yes Yes

14
b. Patient management activities (mainly carried out by General
Health Workers at the health facility level) are:
Activity TB Leprosy TB/HIV
collaboration
Case detection Yes Yes Yes
Contact examination Yes Yes Yes
Case holding Yes Yes Yes
Patient education Yes Yes Yes
Infection control Yes Yes Yes
Prevention of disability + +++++ +
Rehabilitation + +++++ +
HIV Counselling and + - +
Testing
Cotrimoxazole Preventive Yes for Yes if HIV Yes if HIV pos
Therapy HIV pos pos
Linkage for HIV chronic Yes if Yes if HIV Yes if HIV pos
care & treatment HIV pos pos
Isoniazide Preventive Yes for - Yes for HIV- pos
Therapy high risk clients, after
contacts ruling out active
(children TB
below 5
years)
Recording and reporting Yes Yes Yes

c. Programme management activities (carried out by

specialized units of TLCP) are:
Activity TB Leprosy TB/HIV
collaboration
Planning Yes Yes Yes
Guideline development Yes Yes Yes
& developing strategic
policy directives
Training Yes Yes Yes
Co-ordination Yes Yes Yes
Advocacy, Yes Yes Yes
Communication &
Social Mobilization
(ACSM)

15
Monitoring and Yes Yes Yes
evaluation (supportive
supervision, review
meetings,
epidemiological
surveillance)
Data collection and Yes Yes Yes
analysis
Drugs and supplies Yes Yes Yes
management
Establishment of quality Yes - Yes
assured laboratory
services
Resource mobilization Yes Yes Yes
Operational research Yes Yes Yes

The success of TB and Leprosy Prevention and Control

Programme entirely depends on integrity of the structure, which is
made of the different levels in the health system. Details of duties
and responsibilities of the different levels (National, Regional,
City Administration, Zonal, Sub-cities, Woreda, Health facility
level and laboratories) are described under annex I.

16
17
 5. TUBERCULOSIS
5.1 Definition
Tuberculosis (TB) is an infectious diseases caused by
Mycobacterium tuberculosis, a rod-shaped bacillus called “acid-
fast” due to its staining characteristics in laboratory. Occasionally
the disease can also be caused by Mycobacterium bovis and
Mycobacterium africanum.
The bacilli usually enter the body by inhalation (breathing). They
may spread from the initial location in the lungs to other parts of
the body via the blood stream, the lymphatic system, via the
airways or by direct extension to other organs. Tuberculosis is
broadly classified into:

Pulmonary TB (PTB): accounts for 85 % of all TB cases, and

it is further classified in:

a. Smear-positive PTB: comprises 75 – 80% of PTB

cases, worldwide
b. Smear-negative PTB: comprises 20 – 25% of PTB
cases, worldwide

Extra-pulmonary TB (EPTB): it is the result of the spread of

tuberculosis to other organs, most commonly pleura, lymph
nodes, spine, joints, genitor-urinary tract, nervous system or
abdomen and it represents 14% of all TB cases in the world and
12% of all TB in HBC.
5.2 Transmission and pathogenesis
Tuberculosis is most commonly transmitted by inhalation of
infected droplet nuclei (very small and light drops), which are
discharged in the air when somebody with untreated sputum-
positive pulmonary TB coughs or sneezes. Persons living in the
same household, or who otherwise are in frequent and close
contact with an infectious patient have the greatest risk of being
exposed to the bacilli. In addition, consumption of raw milk
containing M.bovis is a possible way of getting infected by TB,

18
though it is much less frequent.
TB affects individuals of all ages and both sexes. There are,
however, groups, which are more vulnerable to develop the
disease:
Poverty, malnutrition and over-crowded living conditions have
been known for decades to increase the risk of developing the
disease. HIV infection has been identified as a major risk factor
for developing tuberculosis.
The age group mainly affected is between 15 and 54 years, and
this leads to grave socio-economic consequences in a country
with a very high prevalence of the disease.
5.3 Natural history
In the great majority (90-95%) of persons infected with M.
Tuberculosis the immunological defence either kills the inhaled or
ingested bacilli or perhaps more often, keeps them suppressed
(silent focus) causing latent M. Tuberculosis infection.
Only about 5-10% of such infected persons (primary infection)
develop active disease.
Active TB disease arises from progression of the primary lesion
as a continuous process within a year or so after infection, or from
endogenous reactivation of latent foci, which remained dormant
since the initial infection or exogenous re-infection. Post primary
TB usually affects the lungs (more than 85%) but can involve any
part of the body.
If untreated, TB leads to deaths within 2-3 years in at least half
the patients. Without treatment, about 20 to 25% would have
natural healing and 25 to 30% would remain chronically ill, thus
continuing to spread the disease in the community.

Table 3: Overview of active and latent TB

19
20
 5.4 Case Detection, Case Finding

Detection of the most infectious cases of tuberculosis – sputum

smear-positive pulmonary cases –is an essential component of the
control of tuberculosis; it’s case finding.
5.4.1 Objectives
Basically the objectives of case finding are:
1. To cut the chain of transmission;
2. To start the treatment early, with better outcome.
The first objective of case finding is to identify the source of
infection in the community, that is, individuals who are
discharging large number of tubercle bacilli. Treatment of those
infectious patients rapidly renders them non infectious, thereby
cutting the chain of TB transmission.

The identification of TB suspects (cough for more than 2 weeks)

and screening them by examination of sputum smears allows
discovering those who are transmitting tuberculosis.

The second objective of case detection is to minimize the delay in

initiating treatment, thereby increasing the possibility of cure.
Successful treatment of these patients has a rapid effect on
tuberculosis prevalence, mortality and transmission.
Community education should be provided so that people are made
aware that persistent cough is abnormal, informed where health
services are available, and convinced to consult a health provider
promptly for sputum smear examination.
Systematic identification of adults with persistent cough among
outpatients in general health facilities can detect a large
proportion of sources of tuberculosis infection and identify
infectious patients who are at risk to the community and to other
patients and staff.
Contacts of smear-positive tuberculosis patients are at high risk of

21
getting infection and developing tuberculosis, thus justifying
active case detection in these individuals. Examination of
contacts, particularly of contacts of sputum smear-positive
patients, is therefore recommended to identify and treat additional
tuberculosis cases and to provide preventive treatment to those at
highest risk, such as children and people infected with HIV.
Among residents of institutions with a high risk of tuberculosis
transmission (prisons, shelters for homeless, hospitals), evaluation
for cough on admission and periodic assessment are useful to
detect and treat sources of infection.
The regular screening for TB among HIV-positive clients, at
every stage of the disease, is one key TB/HIV collaborative
activity, with the aim to reduce the burden of TB in PLWH.
5.4.2 Case finding strategies:
1. Identification of suspects among patients who present on
their own initiative at health facilities or in the
community;
2. Proper diagnosis through examination of sputum of
patients with symptoms suggestive of TB;

3. Promotion of awareness in the community, amongst the

medical staff and the Community workers regarding
respiratory symptoms, notably persistent cough for 2
weeks or more, and the need to obtain and examine 3
sputum specimens for the diagnosis of TB;
4. Contact screening: examination of household contacts of
smear-positive TB patients; irrespective of the duration of
cough;
5. Intensified TB screening in high-risk groups.

5.5 Identification of suspects

Health extension workers and community volunteers can perform

the identification of suspects at the health facility, or at
community level. Once a suspect is identified, he/she should be
immediately referred to health facility providing DOTS service

22
for examination and treatment.
All patients have to be interviewed and examined for signs and
symptoms described below.
The TB suspects can be roughly divided in:
• Pulmonary TB (PTB) suspects;
• Extra-pulmonary TB (EPTB) suspects.

Pulmonary TB:

A person is a suspect of Pulmonary Tuberculosis when

presenting with
persistent cough for two weeks or more

Cough is usually with expectoration, with or without blood

stained sputum and can be accompanied by one or more of the
following symptoms:
• Weight loss;
• Chest pain;
• Shortness of breath;
• Intermittent fever;
• Night sweats;
• Loss of appetite;
• Fatigue and malaise.

Every adult patient with respiratory symptoms attending the

health facility must be asked about symptoms suggestive of
tuberculosis, with particular attention to cough persisting for 2
weeks or more.
A patient is most likely to be suffering from PTB if, in addition to
one or more of the above symptoms, he/she is a/has a/lives in
close contact with contact of a PTB+ patient or/and if she/he is
HIV+.
Moreover, any person who for any other medical reasons has got
a chest x-ray examination and whose chest x-ray findings are
suggestive of PTB must be dealt with as a TB-suspect.
Extra-pulmonary TB

23
The signs and symptoms of Extrapulmonary Tuberculosis
(EPTB) depend mainly on the organ(s) involved.

The most common forms and their respective presentations are:

Tuberculous lymphadenitis
• Slowly developing and painless enlargement of lymph nodes,
followed by matting and eventual drainage of pus. See
appendix VI.
Tuberculous pleurisy
• Pain while breathing in, dull lower chest pain, intermittent
cough, breathlessness on exertion.
TB of bones and/or joints
• Localized pain and/or swelling, discharge of pus, muscle
weakness, paralysis, stiffness of joints.
Intestinal TB
• Loss of appetite and weight, abdominal pain, diarrhoea or
constipation, mass in the abdomen, fluid in the abdominal
cavity (ascites).
Tuberculous meningitis
• Headache, fever, vomiting, neck stiffness and mental
confusion of insidious onset

Whenever a person presents with signs and symptoms suggestive

of EPTB, he/she should be referred to a health center or a hospital
where there is a clinician and better diagnostic facility.

Table 4: symptoms of PTB and EPTB

24
 5.6 Diagnostic methods
All suspects of any form of TB must be examined according to
the standardized diagnostic procedures of which the microscopic
examination of sputum is the most important and reliable. By rank
of importance the diagnostic methods to confirm/exclude TB are:
• Microscopic examination of sputum smears
• Radiological investigation
• AFB culture
• Histo-pathology
5.6.1 Microscopic examination of sputum smears
Sputum microscopy is the most efficient way of identifying
sources of tuberculosis infection, and the primary tool for
diagnosing TB; it is easy to perform at the peripheral laboratories,
not expensive and specific. It can be used for diagnosis,
monitoring and defining cure. Therefore, this is the key diagnostic
tool used for case detection.
Three sputum specimens must be collected and examined in two
consecutive days (spot-early morning-spot). Detailed
information on the method of sputum collection is given in annex
IV.

Every individual suspected of having tuberculosis must have an

examination of 3 sputum smears, to determine whether or not they
have infectious tuberculosis.

According to the latest recommendation by WHO and the national

AFB microscopy laboratory manual, the result of the sputum

25
smear should be indicated as follows:

Examination finding Result as Laborator No. of

recorded y result fields
examined

No AFB in 100 oil Negative NEG 100

immersion fields

1 to 9 AFB in 100 oil Positive 1-9 (Scanty) 100

immersion fields

10-99 AFB in100 oil Positive (+) 100

immersion fields

1-10 AFB per oil Positive (++) 50

immersion field

> 10 AFB per oil Positive (+++) 20

immersion field

PTB+ is confirmed when at least 2 out of three smear results

are positive for AFB.

PTB + is also confirmed when one sputum specimen is positive

for AFB in addition to radiographic abnormalities consistent
with active PTB (see flowchart: annex III).
Only one positive smear result in HIV-negative patients does not
justify starting TB treatment since errors, made during the
handling of the specimen, can never be excluded.

In HIV-positive patients (or in presence of a strong clinical

suspicion of HIV-infection), only one positive smear result is
necessary to make diagnosis of smear-positive pulmonary TB.

The laboratory should keep all positive and negative slides (in
separate boxes for positive and negative slides) to facilitate the
Quality Assurance procedures according to the “AFB smear
microscopy and external quality assurance Manual”.

26
The sputum specimen collection procedures, the guidelines for
sputum smear examination and quality assurance are provided in
the National TB and Leprosy Laboratory Manual, edition 2007.
5.6.2 Radiological examination
For the diagnosis of pulmonary TB, X-ray is sensitive but less
specific, because abnormalities identified on a chest X-ray
suggestive of TB may also be caused by a variety of other
conditions.

Suggestive X-ray findings are:

• Upper lobe infiltrates (bi-lateral or uni-lateral right).
• Cavitation (with a thick wall >2mm).
• Patchy, nodular shadows around the cavity.
No shadow is typical for TB, and 40% patients diagnosed as
having TB by X-Ray alone may not have active TB disease. Some
individuals, in fact, who had TB in the past that has been cured
(and therefore do not require treatment) may still have a chest X-
ray suggestive of active TB.
Chest radiography is useful for differential diagnosis of
pulmonary disease among patients with negative sputum smears,
miliary and childhood TB, when interpreted in conjunction with
presenting signs and symptoms.
Readings of chest X- rays should, whenever possible, be made by
a radiologist or an experienced physician.
Only bacteriology provides proof of TB

Remember: Chest X-ray is supportive to microscopy!

It is a major error to omit sputum examination and
diagnose TB
based on X-ray findings alone!

5.6.3 Culture

The probability of finding acid-fast bacilli (AFB) in sputum

specimens by smear microscopy is directly related to the

27
concentration of bacilli in the sputum. In comparison,
mycobacterial culture can detect far lower numbers of TB bacilli.
Moreover, the culture makes it possible to identify the
mycobacterial species on the basis of biochemical and other
properties.
Culture of Mycobacterium tuberculosis bacilli is very sensitive
and specific but is expensive, as it is a complex and sophisticated
tool, which requires a specialized laboratory set-up; culture results
are available only after several weeks. Culture with Drug
Sensitivity Testing (DST) is even longer. If available, culture can
be used for diagnosis or confirmation of the diagnosis of TB in
patients with PTB- and EPTB but it is not recommended routinely
as a primary diagnostic method.
Beside surveillance purpose, culture with sensitivity testing
(DST) is valuable for diagnosis and management of drug-resistant
TB: treatment failure, poor response to correct treatment, re-
treatment, and chronic cases.
The National Reference Laboratory for TB in Ethiopia is the
EHNRI Institute, Addis Ababa, and culture facilities should be
scaled up to main Regional Reference laboratories in the coming
years, according to the national plan for the laboratory
strengthening.
5.6.4 Histo-pathological examination
Pathology can play a complementary role in confirming the
diagnosis of EPTB, such as tubercular lymphadenitis.
Multiplication of tubercle bacilli in any site of the human body
causes a specific type of inflammation, with formation of
characteristic granuloma that can be found on histological
examination. Samples can be taken from the following:
" Fine needle aspiration of the lymph nodes: affected peripheral
lymph nodes, particularly cervical nodes, can be aspirated.
" Effusions of the serous membranes can be aspirated.
However, the liquid aspirated is much less useful for
diagnosis than histology and culture of a pleural (membrane)
biopsy specimen.

28
" Tissue biopsy (serous membranes, skin, endometrium,
bronchial, pleural, gastric or liver tissue), can be taken, with or
without surgery; surgical intervention can be performed to
confirm diagnosis of TB by sampling of a deep or superficial
lymph node, a bone fragment or part of an organ.
" Post mortem; after death from an unknown cause, tissue
samples taken at autopsy can be analyzed.

Due to the scarcity of facilities for histo-pathological services,

this procedure is not routinely practiced in Ethiopia.

5.7 General definitions

Tuberculosis suspect:
A person who presents with symptoms and/or signs suggestive of
tuberculosis, in particular cough for two weeks or more.
Case finding:
The act of identifying active tuberculosis cases through sputum
examination, among TB suspect attending a health facility.
Case of tuberculosis:
A patient in whom tuberculosis has been bacteriologically
confirmed, or has been diagnosed by an experienced medical
officer
A proven case of tuberculosis:
A patient with two sputum smears or culture positive for
Mycobacterium tuberculosis (one sputum positive is enough for
HIV positive patients).

5.8 Classification of tuberculosis cases

Cases are classified according to the site of the lesions as either

pulmonary or extra-pulmonary.
Pulmonary (PTB) cases are further classified as either:
• Sputum smear-positive;
• Sputum smear-negative (which include smear result
unknown).

29
Extrapulmonary (EPTB) cases are classified according to the
site affected:
• Lymph node;
• Central Nervous System CNS;
• Pericardial;
• Pleural;
• Other
a. Smear-positive pulmonary TB (PTB+)
A patient with at least two initial sputum smear examinations
positive for AFB by direct microscopy,
Or
A patient with one initial smear examination positive for AFB by
direct microscopy and culture positive,
Or
A patient with one initial smear examination positive for AFB by
direct microscope and radiographic abnormalities consistent with
active TB as determined by a clinician.
b. Smear-negative pulmonary TB (PTB-)
A patient having symptoms suggestive of TB with at least 3 initial
smear examinations negative for AFB by direct microscopy, and
1. No response to a course of broad-spectrum antibiotics, and
2. Again three negative smear examinations by direct microscopy,
and
3. Radiological abnormalities consistent with pulmonary
tuberculosis, and
4. Decision by a clinician to treat with a full course of anti-
tuberculosis
Or
A patient whose diagnosis is based on culture positive for M.
tuberculosis but three initial smear examinations negative by direct
microscopy
c. Extra-pulmonary TB (EPTB)
TB in organs other than the lungs, proven by one culture-positive
specimen from an extra-pulmonary site or histo-pathological
evidence from a biopsy,
Or
TB based on strong clinical evidence consistent with active EPTB
and the decision by a physician to treat with a full course of anti-TB
therapy.

30
Any patient with both sputum smear positive pulmonary TB
(PTB+) and Extra-pulmonary TB (EPTB), should be
classified as PTB+.
Cases of TB pleurisy and TB mediastinal lymphadenopathy,
without lesions in the lung, should be classified as EPTB,
provided the sputum smears are negative.
5.9 Definition of type of cases
A case of TB is a patient in whom tuberculosis has been
confirmed bacteriologically or diagnosed by a clinician.

New case (N):

A patient who never had treatment for TB, or has been on
previous anti-TB treatment for less than four weeks.
Relapse (R):
A patient declared cured or treatment completed of any form of
TB in the past, but who reports back to the health service and is
now found to be AFB smear-positive or culture positive.
Treatment Failure (F):
A patient who, while on treatment, is smear-positive at the end of
the fifth month or later, after commencing. Treatment failure also
includes a patient who was initially sputum smear-negative but
who becomes smear-positive during treatment.
Return after default (D):
A patient previously recorded as defaulted from treatment and
returns to the health facility with smear-positive sputum.
Transfer out (T):
A patient who started treatment in one treatment unit and is
transferred to another treatment unit to continue treatment.
Chronic (C):
A TB patient who remains smear-positive after completing a re-
treatment regimen.

31
Other (O):
A patient who does not fit in any of the above mentioned
categories (e.g., a PTB smear negative who returns after treatment
interruption).

5.10 Seriousness of illness:

The severity of the illness depends on the bacillary load, the
extent and the anatomical site of the disease and the background
condition of the patient. The involvement of an anatomical site
helps in classifying if the disease is severe, depending on whether
it is life threatening or has high risk of developing subsequent
severe handicap or both. The following forms of extrapulmonary
TB and smear negative pulmonary TB are classified as “seriously
ill”.

Extra-pulmonary TB Smear-negative pulmonary

classified as “seriously ill” TB classified as “seriously ill”
• Meningitis • Miliary TB
• Pericarditis • Extensive parenchymal
• Peritonitis infiltration (bilateral
• Bilateral or extensive involvement or > 50%)
pleural effusion • Co-infection with HIV
• Spinal TB with • cavitary disease
neurological involvement • All forms of paediatric
• Intestinal sputum smear-negative
• Genito-urinary • Concomitant diabetes
• Co-infection with HIV mellitus, chronic steroid
• All forms of paediatric use, other severe diseases
EPTB other than lymph
node TB and unilateral
pleural effusion
• Concomitant diabetes
mellitus, chronic steroid
use, other severe diseases

Patients with the following symptoms should be referred urgently

to hospital for proper management:

32
• Coughing up blood.
• Increasing breathlessness.
• Suddenly increasing chest pain.
• Progressively deteriorating general condition.

5.11 Treatment of TB

The main objectives of anti-TB treatment are to:

1. Cure the patient of TB (by rapidly eliminating most of the
bacilli);
2. Prevent death from active TB or its late effects;
3. Prevent relapse of TB (by eliminating the dormant
bacilli);
4. Prevent the development of drug resistance (by using a
combination of drugs);
5. Decrease TB transmission to others.
Chemotherapy is considered to be adequate when it:
! Rapidly and substantially reduces the number of actively
multiplying bacteria.
! Cures patients.
! Prevents relapse of the disease
! Prevents the development of resistance to the drugs.
The requirements for adequate chemotherapy are:
! An appropriate combination of drugs.
! Prescribed in the correct dosage.
! Taken regularly by the patient.
! For a sufficient period of time.
5.11.1 Drugs used for the chemotherapy of TB
The drugs used for TB treatment are safe and effective if properly
used.
The following drugs are used as first line treatment of TB in
Ethiopia:
# Rifampicin(R);
# Ethambutol (E);

33
 # Isoniazid (H);
# Pyrazinamide (Z);
# Streptomycin (S).
The drugs available in fixed dose combination (FDC) are:

! Rifampicin, Isoniazid, Pyrazinamide and Ethambutol

(RHZE 150/75/400/275 mg);
! Rifampicin and Isoniazid (RH 150/75 mg);
! Ethambutol and Isoniazid (EH 400/150 mg).
The drugs available as single drugs are:
• Ethambutol 400 mg;
• Isoniazid 150 mg and 300 mg;
• Streptomycin sulphate vials, 1 g;
Streptomycin is administered by injection while the other drugs
are to be taken orally.

All the drugs should be taken together as a single, daily dose,

preferably on an empty stomach.

5.11.2 Phases of chemotherapy

The treatment of TB has two phases:
Intensive (initial) phase
This phase consists of three or more drugs for the first 8 weeks for
new cases, and 12 weeks for re-treatment cases. It renders the
patient non-infectious by rapidly reducing the load of bacilli in
the sputum, usually within 2-3 weeks (except in case of drug
resistance).
During the intensive phase, the drugs must be collected daily by
the patient and must be swallowed under the direct observation of
a health worker. Sundays only can be skipped.

34
Continuation phase
This phase immediately follows the intensive phase and is
important to ensure cure or completion of treatment. It is
necessary in order to avoid relapse after completion of treatment.
This phase requires at least two drugs, to be taken for 4 - 6
months.
During the continuation phase, the drugs must be collected every
month and self-administered by the patient, except for re-
treatment cases and for regimens containing Rifampicin.
5.11.3 Patient categories and treatment regimens

In order to establish treatment priorities, WHO recommends that

tuberculosis patients should be classified into four categories:
Category I: consists mainly of new, smear-positive tuberculosis
cases, but includes new smear-negative cases with extensive
parenchymal lesions, and new cases with severe extrapulmonary
tuberculosis (disseminated, meningeal, pericardial, peritoneal,
bilateral pleural, spinal, intestinal and genito-urinary). A new case
is defined as a patient who has never previously been treated for
tuberculosis or who has received treatment for less than one
month.
Category II: smear-positive cases who have already received
treatment for at least one month in the past and who need to
receive re-treatment. Among these patients three groups can be
distinguished in:
“Relapses” – patients who have been treated and declared cured, but
whose smear examinations are once again positive.
“Failures” – patients whose smear examinations have remained
positive or have once again become positive five or more months
after starting treatment.
“Return after interruption” – patients who return to the health centre
smear-positive after interrupting treatment for more than two
consecutive months.
Category III: new cases of smear-negative pulmonary or
extrapulmonary tuberculosis (excluding those with severe forms,

35
included in Category I) who have never previously been treated
for as much as one month in the past.
Category IV: chronic cases defined as smear-positive cases of
pulmonary tuberculosis who have previously received a
supervised re-treatment regimen.

Table 5: Treatment Category by Type of Patient

Category Type of patient
of
treatment
I New sputum smear-positive
Seriously ill1 new sputum smear-negative
Seriously ill1 new EPTB
Others
II Sputum smear-positive Relapse
Sputum smear-positive Failure
Sputum smear-positive Return after default
PTB- patients who become smear positive after 2
months of treatment (case definition = other).
Return after default from re-treatment (only once
retreatment again).
Relapses after retreatment (only once retreatment
again).
III New sputum smear-negative, not seriously ill
New EPTB, not seriously ill
IV Chronic and MDR-TB cases (still sputum positive
after supervised retreatment)
1 ‘Seriously ill’ includes:
! Life threatening disease = acute disseminated miliary TB, TB
meningitis or TB peritonitis.
! Risk of severe disability = spinal TB, TB pericarditis, bilateral TB
pleural effusion, renal TB.
! Extensive X-ray lesions without cavitation in immuno-
compromised patients, e.g., diabetics, HIV-positives, or patients
with other concomitant disease.

36
 5.11.4 Treatment regimen for Category I and III:

Patients belonging to category I and III will be treated with

the same regimen, which is 2ERHZ/ 6EH.

This regimen consists of 8 weeks treatment with Ethambutol,

Rifampicin, Isoniazid and Pyrazinamide during the intensive
phase, followed by six ‘months’ (1 ‘month’ = 4 weeks) with
Ethambutol and Isoniazid: 2ERHZ/6EH.

Table 6. Dosage of category I and III regimens: 2ERHZ/6EH

Regimen Initial phase (2 Continuation phase
months) (6 months)
2 (HRZE) daily 6 (EH) daily
H 75 mg + H 150 mg +
R 150 mg + E 400 mg
Z 400 mg +
Patients weight E 275 mg
Number of tablets
20-29 1! 1
30-39 Kg 2 1!
40-54 Kg 3 2
55-70 Kg 4 3
Over 70 Kg 5 3

Special consideration for Extra-pulmonary TB:

# Pericardial tuberculosis
For patients with pericardial tuberculosis, a 8-month regimen is
recommended. Corticosteroids (prednisolone) are recommended
as adjunctive therapy for tuberculous pericarditis, daily during the
first 11 weeks of antituberculosis therapy.
For adults the prednisone dose is 60 mg/day (or the equivalent
dose of prednisolone) given for 4 weeks, followed by 30 mg/day
for 4 weeks, 15 mg/day for 2 weeks, and finally 5 mg/day for
week 11 (the final week). Children should be treated with doses
proportionate to their weight, beginning with about 1 mg/kg body

37
weight and decreasing the dose as described for adults.
# Pleural tuberculosis
A 8-month regimen is also recommended for treating pleural
tuberculosis. A number of studies have examined the role of
corticosteroid therapy for tuberculous pleural effusions, but
prednisone (or prednisolone) administration did not reduce the
development of residual pleural thickening.
Tuberculous empyema, a chronic, active infection of the pleural
space containing a large number of tubercle bacilli, usually occurs
when a cavity ruptures into the pleural space. Treatment consists
of drainage (often requiring a surgical procedure) and antiTB
drugs. Surgery, when needed, should be undertaken by
experienced thoracic surgeons. The optimum duration of
treatment for this unusual form of tuberculosis has not been
established.
# Tuberculous meningitis
Before the advent of effective antituberculosis chemotherapy,
tuberculous meningitis was uniformly fatal. Tuberculous
meningitis remains a potentially devastating disease that is
associated with a high mortality and sequelae, despite prompt
initiation of adequate chemotherapy. HIV-infected patients appear
to be at increased risk of developing tuberculous meningitis but
the clinical features and outcomes of the disease are similar to
those in patients without HIV infection. Patients presenting with
more severe brain impairment such as drowsiness, neurological
signs, or coma have a greater risk of neurological sequelae and a
higher mortality.
Chemotherapy should be initiated with RHZE in an initial 2-
month phase. After 2 months of four-drug therapy for meningitis
caused by susceptible strains, Z and E may be discontinued, and
RH continued for an additional 7 to 10 months. Repeated lumbar
punctures should be considered to monitor changes in CSF cell
count, glucose, and protein, especially in the early course of
therapy.
Adjunctive corticosteroid therapy with dexamethasone is
recommended for all patients, particularly those with a decreased

38
level of consciousness, with tuberculous meningitis. The
recommended regimen is dexamethasone in an initial dose of 8
mg/day for children weighing less than 25 kg and 12 mg/day for
children weighing 25 kg or more and for adults. The initial dose is
given for 3 weeks and then decreased gradually during the
following 3 weeks.
5.11.5 Treatment regimen for Category II
[Retreatment regimen]
This regimen is to be prescribed for patients previously treated for
more than one month with TB drugs and who are still smear
positive. The treatment regimen for this category is:
2 S(ERHZ) / 1(ERHZ) / 5 E3 (RH)3.

Table 7 Dosage for Category II regimen: 2 S(ERHZ) /

1(ERHZ) / 5E3(RH)3
Regimen Initial phase (3 months) Continuation phase (5
months)
2 (HRZE)S/1(HRZE) daily 5 (RH)3E3
(three times per week)
H 75 mg + S (vials, (H 75 mg +
R 150 mg + IM) R 150 mg) +
Z 400 mg + 1g E 400 mg
Patients E 275 mg
weight
20-29 1! ! 1!+1
30-39 Kg 2 ! 2+1!
40-54 Kg 3 " 3+2
55-70 Kg 4 1g 4+3
Over 70 Kg 5 1g 5 +3

! Streptomycin should not be included in the re-treatment for

pregnant women.
! For patients over 60 years of age, the dose of streptomycin is 0.75
gm.
! Throughout the duration of re-treatment, including the continuation
phase, the drugs must be taken under the direct observation of a
health worker.

5.11.6 Side effects

39
Serious side effects are rare. The possible side effects of the drugs
and the management of these side effects are listed Table 8.
Table 8. Symptom-based approach to management of drug side
effects.
Side-effects Drugs Management
Anorexia, nausea, Rifampicin Give tablets with
a. Minor small meals or as last
abdominal pain
Pyrazinamide thing at night

[Continue Joint pains Pyrazinamide Aspirin

anti TB Burning sensation Isoniazid Pyridoxine 100mg
drugs] in feet daily
Orange/red urine Rifampicin Reassurance
Itching, skin Streptomycin; Stop and replace with
reaction Rifampicin or ethambutol;
b. Major
isoniazid Stop, then reintroduce
with desensitization1
Deafness Streptomycin Stop streptomycin and
[Stop replace with
responsible Ethambutol
drug(s)] Dizziness Streptomycin Stop streptomycin and
(vertigo, replace with
imbalance and Ethambutol
nystagmus)
Jaundice; Most anti-TB Stop all anti-TB drugs
hepatitis drugs and refer
Vomiting and Most anti-TB Stop all anti-TB drugs
confusion drugs and refer
Visual Ethambutol Stop Ethambutol and
impairment refer
Shock, purpura Stop Rifampicin and
and acute renal Rifampicin refer
failure

Management of cutaneous reaction

1
Desentization: If a skin reaction developes, all anti-tuberculosis
drugs must be stopped. Once the reaction has resolved, anti-TB
drugs are reintroduced. The idea of desensitization is to start with
a small dose of drugs: if a reaction occurs, it will be less severe
than the reaction to a full dose. The dose is gradually increased

40
over three days. There is no evidence that this process gives rise
to drug resistance. It may be necessary to extend the treatment
regimen. This prolongs the total time of TB treatment, but
decreases the risk of relapse.

Management of drug-induced hepatitis

Most anti-TB drugs can damage the liver. Isoniazid, pyrazinamide

and rifampicin are most commonly responsible, ethambutol
rarely. When a patient develops hepatitis during TB treatment, the
cause may be the TB treatment or something else. It is important
to rule out other possible causes before deciding that the hepatitis
is drug induced.

If the diagnosis is drug-induced hepatitis, the anti-TB drugs

should be stopped. The drugs must be withheld until liver
function test have reverted to normal. Sometimes it is not possible
to perform liver function test; in these situations, it is advisable to
wait an extra 2 weeks after the jaundice has disappeared before
recommencing TB treatment. Asymptomatic jaundice without
evidence of hepatitis is probably due to rifampicin.

Once drug-induced hepatitis has resolved, the same drugs are

reintroduced. However, if the hepatitis produced clinical jaundice,
it is advisable to avoid pyrazinamide. The suggested regimen in
such patients is a 2-month initial phase of daily streptomycin,
isoniazid and ethambutol, followed by a 10-month continuation
phase of isoniazid and ethambutol (2 SHE/10EH).

A severely ill TB patient with drug-induced hepatitis may die

without antituberculosis drugs. In this case, the patient should be
treated with two of the least hepatotoxic drugs, streptomycin and
ethambutol. After the hepatitis has resolved, usual TB treatment
should be restarted.

5.11.7 Anti-TB drug treatment in special situations

• Pregnancy

41
Most anti-TB drugs are safe for use in pregnancy with the
exception of streptomycin. Therefore ask women patients whether
they are or may be pregnant: Do not give streptomycin to a
pregnant woman as it can cause permanent deafness in the baby.
Pregnant women who have TB must be treated, but their drug
regimen does not include streptomycin and ethambutol is use
instead of streptomycin.
• Oral contraception
Rifampicin interacts with oral contraceptive medications with a
risk of decreased protection against pregnancy. While receiving
treatment with rifampicin, a woman who takes the oral
contraceptive pill may choose between the following two options:
(1) after consulting with a clinician, she could take an oral
contraceptive pill containing a higher dose of estrogen (50 µg).
(2) Alternatively, she could use another form of contraception.
• Breastfeeding
A breastfeeding woman who has TB can be treated with the
regimen appropriate for her disease classification and previous
treatment. The mother and baby should stay together and the baby
should continue to breastfeed in the normal way. Give the infant a
course of preventive therapy (isoniazid) for a minimum of six
months, after ruling out active TB. When preventive therapy is
completed, give the infant BCG if not yet immunized.
• HIV patients on antiretrovirals
TB patients with HIV infection or HIV/AIDS may experience a
temporary worsening of symptoms and signs after beginning TB
treatment. In TB patients infected with HIV, treatment with
antiretrovirals (ARV) may interact with treatment of TB,
reducing the efficacy of antiretrovirals and of anti-TB drugs and
increasing the risk of drug toxicity. In patients with HIV-
related TB, the priority is to treat TB. Options are to defer
antiretroviral treatment until TB treatment is completed; defer
until completing the initial phase and use H +E in the
continuation phase; or use antiretrovirals that are less likely to
interact with anti-TB drugs. Detailed management of co-infected

42
patients is provided in the Manual “TB/HIV implementation
guidelines, Edition 2008” and in the TB Care with TB-HIV co-
infection; IMAI module, 2008.

Patients infected with HIV respond equally well to TB treatment

as those without HIV infection. However, they are more likely to
die during the course of treatment, usually from causes other than
TB.
Because of the association between TB and HIV infection, great
care must be taken to prevent the spread of both infections. When
injections have to be given, every health worker should strictly
adhere to the universal precaution for safe injection, using a new
disposable syringe and needle for each injection to each patient.
Used needles and syringes should be disposed safely.

One syringe and one needle for one injection for one
patient! "
"
"
• Treatment of patients with TB and leprosy
"
Patients suffering from both TB "and leprosy require appropriate
anti-TB chemotherapy in addition " to the standard MDT.
Rifampicin will be common to both" regimens and it must be given
in the doses required for TB. Once the anti-TB course is
completed, the patient should continue his anti-leprosy treatment
(or the other way round).
• Treatment of patients with renal failure
Avoid Streptomycin and Ethambutol; therefore the recommended
regimen is 2RHZ/4RH.

• Treatment of patients with (previously known) liver disease

Most anti-TB drugs can cause liver damage. Do not give
Pyrazinamide because this is the most hepatotoxic anti-TB drug.
Isoniazid and Rifampicin plus one or two non-hepatotoxic drugs
such as Streptomycin and Ethambutol, can be used for a total
treatment duration of eight months. Hence for TB patients with
liver disease, recommended regimens are 2SERH/6RH, 9 RE or

43
2SEH/10EH.

5.11.8 Indications for hospitalization

In the majority of cases it is not necessary to hospitalize

tuberculosis patients, either to achieve cure, or to avoid infecting the
patient's family. Only a few days after beginning adequate treatment
tuberculosis patients are no longer infectious, provided that their
bacilli are susceptible to the major medications used in their
treatment; if members of their families are infected they may have
been infected before the patient began treatment.

This is why tuberculosis patients need to be hospitalized only in the

following situations:
• Severe deterioration of the patient's general state, making
outpatient treatment difficult or impossible;
• Tuberculosis-related complications: massive haemoptysis,
pneumothorax;
• Complications associated with treatment: major side-effects
such as jaundice, purpura or severe allergic skin reaction;
• Severe concomitant disease necessitating hospital care and
specific surveillance, such as unstable or complicated
diabetes, kidney failure, or stomach ulcer.
The period of hospitalization varies depending on the cause; it often
lasts less than 2 weeks, and the patient can be discharged as soon as
the reasons for hospitalization have resolved.

5.12 Follow-up during treatment

The organization of TB clinics must facilitate (1) the
implementation of directly observed treatment (DOT) at least
during the initial phase and (2) the adherence of patients to their
treatment until cure.
Tuberculosis can be cured only if the anti-TB drugs are taken
regularly. The choice of the place of treatment depends on two
factors: the state of the patient, and the ability of the health staff
to provide treatment to patients.

44
 5.12.1 Follow-up during the initial phase of treatment
During the initial phase of treatment, which always contains
rifampicin, the patient must take the drugs in front of the health
worker who is responsible for verifying that the patient swallows
all of the prescribed drugs every day.
• If the patient lives, or can be housed, near a TB clinic, he or
she must attend every morning to take the drugs.
• If the patient lives near a health post with staff that are
trained and acknowledged to be capable by the TB clinic
coordinator, treatment can be delivered by this health post staff;
the follow-up of the patient must continue to be done by the TB
clinic, and health post staff must be closely supervised. More
information on this issue can be found in the Community
DOTS chapter of this Manual.
• If directly observed treatment cannot be provided on an
out-patient basis, or if the condition of the patient requires it,
the patient should be hospitalized during the whole of the
initial phase of treatment, but this is quite costly.

5.12.2 Follow up during the continuation phase of

treatment
The continuation phase of the treatment of TB can be “self-
administered”: in that case a supply of drugs in fixed-dose
combination is given to the patient at fixed regular intervals, and the
patient is given the responsibility to take the drugs correctly every
day. The recommended interval between visits for drug supply is
not more than one month, and must be set jointly by the health
worker and the patient, depending on the ease of access to the health
center and the adherence requirements.
Whatever facility is providing drugs during the continuation phase,
all TB patients must be clearly advised to go the TB clinic where
they are registered, for clinical check and bacteriological tests, at
defined stages and at the end of their treatment. During these follow
up visits, efficiency and outcome of treatment is monitored, drug
tolerance is assessed and sputum is taken for microscopic
examination for PTB+ patients. Follow up laboratory tests is
necessary in order for cure to be confirmed and the patient's final
status to be correctly recorded.

45
For tuberculosis patients who are in a precarious situation
(homeless) and those who are drug addicts, alcoholics or who
have mental problems, the organization of follow-up must aim at
reducing the lack of compliance common in these population
groups: for example, a fully supervised intermittent treatment can
be selected if it is thought that the patient will comply with it
more easily, and health staff should try to make themselves more
available to these patients.

In order to avoid the emergence of strains that are multi drug

resistant (MDR: resistant to both to isoniazid and rifampicin),
all rifampicin-containing treatment should be taken under the
direct observation of a health worker.

5.12.3 How to improve treatment compliance

The organization of anti-TB treatment is the key to a programme's

success. The uninterrupted availability of drugs and rigorous
organization of treatment delivery will ensure patients'
compliance with treatment. In order to improve the compliance of
the patient, it is necessary to:

" Enhance patients' access to the health services

For every patient, the treatment center is the TB clinic where the
patient is registered and that is in charge of laboratory and
treatment follow up and recording. It must be the more convenient
place for the patient: usually it is the facility closest to the
patient’s home. It may differ from the place where diagnostic of
TB was made.
Whatever regimen is given and wherever it is given, treatment
must be monitored during follow-up visits. For all follow up
visits, arrangement should be made so that patients do not wait
long and get discouraged.

" Communicate with the patient

During all phases of treatment, the patient and family members

(in the case of children) have to be educated on the importance of

46
regularly taking the prescribed medications during the prescribed
duration –even if they may feel better- the risks linked to default
from treatment, and the major side-effects of the drugs and the
need to report whenever side-effects occur.

Health education is an ongoing process that allows health staff

and other patients to inform patients about their illness and its
treatment, to motivate patients, and to respond to any questions
that might be asked by patients and their families. It should aid in
creating an immediate relationship with the patient. For more
information refer to the ACSM chapter in this Manual.

" Organize treatment follow-up and schedule regular

appointments

These dates are scheduled from the beginning of treatment.

New smear-positive cases (2nd, 5th and 7th months)
Laboratory follow up
As a routine, all sputum-positive patient on TB treatment must
have one sputum specimen examined at the end of the 2nd, 5th and
7th ‘month’. Dates and results of direct sputum examinations
should be entered in the Unit TB Register.
! If the direct smear is negative at the end of 2nd month, the
continuation phase can be started.
! If the smear is positive at the end of the 2nd month of intensive
phase, the intensive daily treatment should be continued for
additional 4 weeks with ERHZ. After these additional 4
weeks of intensive treatment the continuation phase should be
started without an additional sputum examination.
! In the continuation phase of treatment, if the smear result at
the end of 5th month of treatment is negative, the patient
should continue with the same treatment. If the smear result is
positive at the end of 5th month or more after the start of
chemotherapy, sputum smear examination should be repeated.
If the second sputum smear result is positive, the patient is
declared as treatment failure. The patient should be registered
as treatment failure and started with re-treatment regimen (Cat
II).

47
! The sputum is examined again at the end of 7th month or
during the last month. If the result is negative the patient will
be provided with the last 4-week dose and is declared cured
(if at least one previous sputum examination, either at the 2nd
or 5th month was negative). If the result is positive in 2
smears at 5 or 7 months, the patient is a treatment failure and
must start the re-treatment regimen.
! If for whatever reason after 7 months of treatment, the final
sputum examination cannot be done and the sputum result at
5th month was negative or not done, the patient should be
declared treatment completed.

48
Figure 3. Flow chart for follow-up of new smear-positive
pulmonary TB patients

New smear positive

month week patient

Start intensive
0 0 phase

Pos
Start Neg Smear at end (2x) Give 1 more
continuation of 2nd month month
2 8
phase intensive
phase

Start
3 12 continuation
phase

Continue Neg Smear at Pos (2x) Treatment

continuation end of 5th Failure (needs
5 20 phase month re-treatment)

Treatment
Provide final Smear at Pos
Neg (2x) Failure (needs
7 28 4 weeks of end retreatment)
treatment of 7th month

8 32 Cured

Compliance follow-up
! The total duration of treatment for short course regimen is
8 months (32 weeks) or 6 months (24 weeks) for children
who receive RH in the continuation phase. If a patient
misses some treatment during the continuation phase, the
number of doses missed should be added on at the end, so
that the complete course of treatment is given.

49
 ! A patient who does not collect drugs for a period of 8
consecutive weeks or more (after vigorous attempts to
trace him/her have failed) will be declared default. For
management of smear-positive cases, who present after
interrupting treatment for less than 8 consecutive weeks,
see table 8.
Table 9: Management of patients initially smear positive, who
interrupted TB treatment for less than 8 consecutive weeks

Duration of
treatment Duration of Smear
before interruption result at Treatment
interruption return
< 2 consecutive weeks No smear Continue the same
< 4 weeks treatment.
2 - 8 consecutive No smear Re-start the same
weeks treatment.
Negative Continue the same
< 2 consecutive weeks treatment.
Positive Start re-treatment
regimen.
4 - 8 weeks
Negative One-month extra
2 - 8 consecutive intensive phase.
weeks
Positive Start re-treatment
regimen.
Negative Continue the same
> 8weeks < 8 consecutive weeks treatment.
Positive Start re-treatment
regimen.

• Patients who interrupted treatment for more than 8 consecutive

weeks are recorded as default. A patient who returns after default
and who is PTB+ should be registered in a new cohort as “return
after default” and should be treated with the re-treatment regimen.

Smear-negative pulmonary and extra-pulmonary cases

The treatment of PTB- is followed up by monitoring the clinical
progresses and the regularity of drug collection.
• Any PTB- patient, whose condition has not improved or gets
worse by the end of the intensive phase should be assessed by a

50
 physician and two specimens of sputum should be examined. If
one smear is positive, two other specimens should be examined.
• If out of these, one more is positive, the patient has PTB+ and has
to start a full course of the re-treatment regimen. This group of
patients are registered under the category = ‘failure’.
• If the condition of the patient deteriorates while the sputum
remains negative, X-ray is advisable to aid the diagnosis. If
findings on X-ray are consistent with active TB (exclusion of lung
cancer, pneumonia, etc.), the initial anti-TB treatment may be
repeated this group of patients are registered under the category =
‘others’.
Any PTB- patient, who interrupted the treatment for more than 8
consecutive weeks (defaulting) and returns for continuation of
treatment should be assessed by an experienced medical officer
and two specimens of sputum should be examined. Out of these
smears, if one or more is positive, the patient has PTB+ and must
start a full course of the re-treatment regimen (case definition =
return after default). If the smears remain negative, the patient
should be treated with the original regimen (case definition =
‘other’).
A patient who returns after default and who is PTB- (as proven by
deterioration of the X-ray not due to other diseases) should be
registered in a new cohort as “other” and be treated with a full
course of the original regimen.
Any EPTB patient, who interrupted the treatment for more than 8
consecutive weeks (defaulting) and who returns for continuation
of treatment should be assessed by an experienced medical
officer. If the condition remains the same or gets worse the patient
should be treated with the full course original regimen.
Re-treatment cases
The sputum is examined at the end of the intensive phase of 12
weeks.
• If the result of the sputum is negative, the continuation phase is
started.
• If the sputum is positive at the end of 12 weeks, the intensive
phase of 4 drugs (ERHZ) daily will be continued for other 4

51
 weeks. Thereafter, the continuation phase is started, without an
additional sputum examination. For these patients, possible MDR
TB must be considered and sputum culture with Drug Sensitivity
Testing (DST) should be carried out in a reference laboratory.
The possible outcomes of treatment are the same as for the new
smear-positive cases.
• If the patient is found still smear-positive at the end of 5th month
of treatment in 2 different specimens, the patient is declared as
treatment failure and should be assessed for MDR-TB (with
culture and DST whenever available).
The decision about the next treatment will be taken according to
the specific MDR-TB national guidelines.

" Trace any patients who defaults (retrieval of absentees)

If, during the intensive phase, a patient has not attended on the
appointed clinic day and fails to report for 2 days thereafter, or if
the patient fails to report for 1 week during the continuation phase
of treatment, he/she has to be considered as an absentee and
should be retrieved.
In case of absenteeism the following measures are suggested:
a. Inquire from fellow patients as to why the patient has failed to
collect his/her drugs and ask them to contact and advise the
absentee if and when this is possible.
b. Notify the contact person, recorded in the register, through
available means and request his/her assistance to encouraging
the patient to return for treatment.
c. Communicate with health extension worker or community
volunteer to retrieve the patient.
d. Send out messages through health workers who may travel to
the patient’s village for outreach health programmes like EPI.
e. Visit the home of the patient.
All available means need to be put into action when a patient
misses a scheduled visit but the methods of tracing patients differ
from one centre to the next: it can be done by telephone, home
visits, or even visits by a neighbour being treated at the same
centre. The longer the absence, the less likelihood there is of
finding the patient.

52
When the patient is found, further care and treatment is based on the
duration of treatment already received and the patient's
bacteriological status.

5.13 Definitions of treatment outcome

Cured:
A initially smear-positive patient who is sputum smear-negative at, or
one ‘month’ prior to, the completion of treatment and on at least one
previous occasion (usually at the end of the 2nd or 5th month).

Treatment completed:
A patient who completed treatment but for whom smear results are not
available at 7th month or one month prior to the completion of treatment.

Treatment failure:
A patient who remains or becomes again smear-positive at the end of 5
“month” or later during treatment. Or a patient who was PTB-negative
at the beginning and turned out smear-positive at the end of the
intensive phase.

Died:
A patient who dies for any reason during the course of treatment.

Defaulter:
A patient who has been on treatment for at least 4 weeks and whose
treatment was interrupted for 8 or more consecutive weeks.

Transfer out:
A patient who started treatment and has been transferred to another
reporting unit and for whom the treatment outcome is not known at the
time of evaluation of treatment results.

Treatment success:
The sum of patients who are declared “cured” and those who have
“completed” treatment.

6 TUBERCULOSIS IN CHILDREN

Most children exposed to an infectious adult in their close

environment (the household), may acquire tuberculosis infection.
This exposure leads to the development of a primary lesion in the

53
lungs with spread to the regional lymph node(s). In the majority
of cases, the resultant immunity will contain the disease process at
this stage. Progression to TB disease occurs more commonly in
children under 5 years of age and in immuno-compromised HIV-
infected children/post measles/malnourished, etc.

Children at greater risk of developing TB are:

• Children who are contacts of a newly diagnosed
smear-positive case
• Children less than 5 years of age
• HIV-infected children
• Severely malnourished children.

Tuberculosis disease presents in children in various clinical

forms:
o primary pulmonary tuberculosis;
o acute disseminated tuberculosis: meningitis and miliary
tuberculosis;
o post-primary pulmonary tuberculosis;
o extra-pulmonary tuberculosis.

6.1 Primary pulmonary tuberculosis

Primary pulmonary tuberculosis occurs most often in children less
than 5 years of age.
• Primary infection is asymptomatic in the majority of
cases, and goes unnoticed. This is termed infection and must
be distinguished from disease.
• In 10% of cases primary infection has clinical
manifestations and presents with certain symptoms and
radiographic abnormalities.
- Generalized symptoms are often minor: slight fever, loss of
weight, apathy and listlessness can attract the attention of
the parents. Sometimes the symptoms are more obvious
(e.g. a high fever of 39–40 °C and profound lethargy), and
alert the parents to the fact that something is wrong.
- Mucocutaneous manifestations, although infrequent, are

54
 highly characteristic:
Erythema nodosum appears in the form of painful nodules
(lumps) under the skin in two to three bursts: on the shins
(legs), sometimes on the back of the arms and rarely on the
front,. They are painful, red, raised lesions that may turn
purple and take on the appearance of a bruise.
Phlyctenular conjunctivitis begins with generalized pain
and irritation in one eye accompanied by watering and
photophobia. On examination, grey or yellow lesions can be
observed where the cornea joins the white of the eye; a
number of blood vessels enter the lesions, giving an
appearance of vascular engorgement of the conjunctiva.
Each lesion persists for about a week, then disappears, to be
replaced by others. In severe cases the cornea may ulcerate.

The course of primary tuberculosis is usually benign, with or

without treatment, and most children recover completely without
sequelae. They may, however, subsequently develop active
tuberculosis (reactivate) after a period of quiescence.

Local complications of primary tuberculosis, while unusual,

are well recognized:
Fistulation of the lymph node into the bronchi: the lymph node
swells and erodes into the bronchus. This can be a serious event
for small infants, where the caseous material can create acute
bronchial obstruction; in older children it usually causes cough;
The formation of a primary tuberculous cavity at the site of
infiltration is a more unusual complication.
In both cases the child is usually incapable of producing sputum,
but if a sample of bronchial or gastric aspiration is obtained, acid-
fast bacilli can be recovered from smear microscopy.

Delayed local complications can occur. Without treatment,

lymphadenopathy can compress a lobar or segmental bronchus,
creating breathing difficulties. Bronchiectasis may develop in the
poorly ventilated area of the lung, creating bronchial
superinfections and repeated episodes of haemoptysis. The most
characteristic feature of this type of sequelae is “hilar disease” or

55
“right middle lobe syndrome” seen on X ray.

6.2 Acute disseminated tuberculosis

These are early complications of primary infection (within 2–10
months). Caused by the dissemination of bacilli from the primary
infection through the bloodstream, they can occur at all ages, but
do so most often in very young children (<2 years of age),
particularly if they have not been vaccinated with BCG. They are
very serious, and are often fatal if diagnosed late.

# Tuberculous (TB) meningitis

Clinical signs of tuberculous meningitis are often initially unclear

in children, particularly under 5 years. It may start simply with a
lack of interest in playing, irritation, headache or vomiting. Later
on, changes in state of consciousness, strabismus, and possibly
neck rigidity indicate signs of meningeal tuberculosis. The
diagnosis is obvious at a later stage, with the infant in foetal
position, photophobia and extreme neck rigidity; in the final stage
the child is in a coma, prostrate and stiff-legged. When the disease
progresses to such an advanced stage, there is almost no chance of
cure; even if the child survives, major neurological sequelae are
expected, such as paralysis, deafness or blindness.

# Acute miliary tuberculosis

This is a disseminated form of TB ; it can occurs within the first
weeks after primary infection and is also common in late
HIV/AIDS disease. It’s often accompanied with TB meningitis. It
is a severe condition with high fever at 39–40°C, confusion,
vomiting. There are respiratory abnormalities: dyspnoea, cyanosis
and occasional respiratory distress and characteristic spoted
shadows on X Ray. Unlike typhoid fever, there is no
splenomegaly, and the pulse is elevated. In HIV-infected child it
may be difficult to differentiate from lymphocytic interstitial
pneumonia (LIP). The diagnosis rests on strong clinical suspicion
and treatment must be started urgently, once other causes of
childhood acute febrile miliary disease have been ruled out (such
as viral illness or staphylococcal infection). If treatment is
delayed, the prognosis may be badly affected.

56
 6.3 Post-primary pulmonary tuberculosis
This type of tuberculosis, a delayed result of primary infection,
usually occurs in adults but may appear in children (especially
older children and adolescents), particularly in the presence of
malnutrition.

Symptoms of childhood TB
Children with TB develop chronic symptoms in most cases,
although TB may be a more acute disease in the presence of HIV
infection. The commonest symptoms are:
• Chronic cough: chronic cough is a persistent cough, present
for more than three weeks (21 days) and that is not improving.
• Fever: fever of greater than 380C for 14 days after common
causes like malaria, pneumonia have been excluded.
• Weight loss: documented weight loss or failure to gain
weight, even after being treated in a nutritional rehabilitation
program.
Signs of childhood TB
• The clinical picture of Pulmonary TB is similar to that of
pulmonary tuberculosis in the adult
Additional signs are suggestive of EPTB:
• Physical signs highly suggestive of tuberculosis:
– Gibbus (angulation of the spine), especially of recent
onset
– Non-painful enlarged cervical lymphadenopathy with
fistula formation
• Physical signs requiring investigation for TB:
– Meningitis not responding to treatment with antibiotics,
with sub-acute onset
– Pleural effusion or pericardial effusion
– Distended abdomen with ascites
– Non-painful enlarged joints

Unlike the acute forms, where treatment must be given promptly,

this type of tuberculosis does not represent an emergency, and the

57
physician can take the time to exclude the other definitive
diagnoses, particularly acute respiratory infections, before
proceeding to treatment.

6.4 Extra-pulmonary tuberculosis in children

In children, the most common EPTB are:

o Tuberculous lymphadenitis from far the most common

form.

o Tuberculosis of the spine or joints is the second most

common form of childhood EPTB, and may occur within
the first few years following primary infection.
o Tuberculosis of the serous membranes: TB pleurisy and
peritonitis are rare in small children, although frequent in
adolescents. Peritonitis with ascites is relatively more
common, particularly in girls aged 10–14 years and
localized forms can cause sterility due to obstruction of
the fallopian tubes.

58
 6.5 Diagnosis of Paediatric TB

Criteria for the diagnosis of childhood tuberculosis

Categories Supportive evidence Diagnostic

confirmation
Primary Mediastinal Positive sputum
pulmonary lymphadenopathy with culture (rare, only if
tuberculosis or without infiltration there is fistulization
TS-positive of the
lymphadenitis into
the bronchi)
Post-primary Pulmonary infiltration AFB on smear and
pulmonary affecting upper zones culture of
tuberculosis with cavities sputa/gastric
aspiration
Tuberculous Meningeal syndrome, Positive CSF
meningitis strabismus, sometimes culture
miliary pattern and
choroid tubercles
Clear CSF: high protein
levels and lymphocytosis
Miliary General deterioration Culture (pleural
tuberculosis Typical miliary image on fluid, CSF, etc.) or
X Ray biopsy of another
Signs of dissemination lesion (liver, pleura,
(tubercles, meningitis) etc.)
Other X-ray and clinical signs Positive culture (of
tuberculosis TST positive sero-fibrinous
Cytochemical effusion or pus)
examination of effusions Tissue biopsy
(high protein level and (culture and
lymphocytosis) histology)

Tuberculosis in children is difficult to diagnose, even pulmonary

59
TB; children rarely produce sputum, whereas laboratory is the
cornerstone of diagnosis in adults.
For older children capable of expectorating, sputum samples
should be collected as for adults. For all other children, gastric
aspiration may be performed to get adequate material for smear
examination.

The diagnosis of childhood TB therefore makes use of a

systematic approach where a number of clinical signs are
interpreted and it depends on careful evaluation of all the
available evidences. A clinical diagnosis of childhood TB is
possible in the majority of cases. There are two key factors in
diagnosing tuberculosis in children (1) identification of an
infectious adult close to the child, especially in the family, and (2)
loss of weight or failure to thrive.

In most children, TB presents with symptoms of chronic

disease after they have been in contact with an infectious
source TB case.

To make the diagnosis of childhood TB with a fair degree of

accuracy the following tests are useful: tuberculin skin test (TST),
chest radiograph, sputum smear microscopy and HIV testing.
These tests, coupled with the history of contact with a smear-
positive case and the presence of symptoms suggestive of TB, are
used to make the diagnosis.
Recommended approach to diagnose TB in children
1. Careful history (including history of TB contact and
symptoms consistent with TB)
2. Clinical examination (including growth assessment)
3. Tuberculin skin test (if available)
4. Bacteriological confirmation whenever possible
5. Investigations relevant for suspected pulmonary TB
(Chest X-Ray) and extra-pulmonary TB (lumbar puncture,
etc.)
6. HIV testing

60
 6.5.1 Contact with a TB case
A close contact is defined as living in the same household or
being in frequent contact with a person (e.g. caregiver) who is
smear-positive TB. Patients who are sputum smear-negative but
culture positive are also infectious, but to a lesser degree.
6.5.2 Sputum microscopy
Sputum is difficult to obtain from young children and most
children are sputum smear-negative. However, in children who
are able to produce sputum, it is worth doing smear microscopy
(and culture where available). In older children and adolescents
and in children with severe disease, sputum smears are more often
positive for AFB. Gastric aspiration or sputum induction are more
elaborate methods to detect TB bacilli.
6.5.3 Chest radiography
Chest radiography is useful for the diagnosis of TB in children. In
the majority of cases the chest X-ray shows abnormalities
suggestive of TB. The commonest picture of active TB is that of
persistent pulmonary abnormalities together with enlarged
mediastinal lymph nodes. Patients with persistent pulmonary
abnormalities who do not improve after a course of antibiotics
should be investigated for TB. Chest radiographs should
preferably be read by a radiologist or an experienced physician.
The radiological signs of primary pulmonary tuberculosis are
characteristic:
- Typical primary complex, the most frequent manifestation,
consists of a small area of infiltration at any location in the
lung parenchyma, accompanied by unilateral mediastinal
lymphadenopathy. The infiltration nodular shadow is usually
small (3 to 10 mm in diameter) and is sometimes surrounded
by a lighter shadow with irregular edges. On lateral X-ray,
mediastinal lymphadenopathy appears as a rounded or oval
latero-tracheal or hilar shadow. In some cases, isolated
mediastinal lymphadenopathy may occur without any visible
changes in the pulmonary parenchyma.
- Occasionally, primary infection lesions may present as

61
 segmental (or lobar) consolidation associated with
mediastinal lymphadenopathy. This is shadowing of a
discrete area (usually right middle lobe, or lingula on the
left), with clear margins and no bronchial markings, caused
by compression.

Adolescent patients with TB have chest radiographic changes

which are similar to adult patients with large pleural effusions and
apical infiltrates with cavity formation being the most common
forms of presentation. A miliary pattern of shadowing in non
HIV-infected children is highly suggestive of TB.

When a child presents with acute febrile illness with miliary

X-ray images, treatment for tuberculosis should be given
unless there is evidence of a viral or staphylococcal infection.
This is particularly the case if the child has not been BGC-
vaccinated and/or if there has been contact with a case of
pulmonary tuberculosis.

6.5.4 Tuberculin Skin Test (TST or Mantoux Test)

Tuberculin test, when available, may be useful as an additional tool
for diagnosing paediatric TB, in whom a positive test is more likely
to reflect recent infection with TB and indicates a higher risk of
developing TB disease.
6.5.5 Lumbar puncture for TB meningitis:

Lumbar puncture is the key investigation in TB meningitis

where CSF is clear or opalescent, pressure is elevated, with plenty
of lymphocytes, and the glucose level is low. Protein is elevated
(0.6–2 g/l): the higher the level, the worse the prognosis.

Bacteriological examination of CSF (microscopy and especially

culture), preferably of three different samples collected after
lumbar puncture, will aid in identifying tubercle bacilli in the
majority of cases. Treatment must be instituted immediately if the
disease is strongly suspected, without waiting for the final results
of the CSF culture.

62
Differential diagnosis to consider for meningitis with clear CSF in
children are: (i) inadequately treated bacterial meningitis, (ii)
meningococcal meningitis (iii) viral meningitis and (iv) meningeal
reactions during the course of other infections in children.

If the evidence of tuberculosis is not sufficiently convincing, it is

still wise to begin treatment for tuberculosis unless there is other
evidence to confirm another cause of meningitis.

High protein levels with an elevated lymphocyte count in a

clear cerebrospinal fluid is sufficient evidence to begin
treatment for tuberculosis, especially in a child less than 5
years of age who has not been BCG-vaccinated and/or who is
in contact with a case of pulmonary tuberculosis.

6.5.6 Diagnosis of Tuberculosis in HIV-positive

children
As in adults, PTB is the most common manifestation of TB in
HIV-positive children. The diagnosis of PTB in children under 4
years old has always been difficult, and HIV infection further
compounds this diagnostic challenge.
The approach to diagnosing TB in HIV-infected children is
essentially the same as for HIV-uninfected children, i.e. the
presence of three or more of the following should strongly
suggest the diagnosis of TB:
· chronic symptoms suggestive of TB
· physical signs highly suggestive of TB
· a positive TST (diameter of induration >5 mm, as the
child is HIV-infected)
· CXR suggestive of TB.
Many children who present with chronic symptoms suggestive of
TB may not have been tested for HIV infection. In high HIV
prevalence settings (and in all settings where HIV infection in a
child is suspected), children and their families should be offered
HIV counseling and testing as part of routine TB management.

63
Because it is often difficult to distinguish HIV-related pulmonary
disease from pulmonary TB, childhood pulmonary TB is probably
over-diagnosed in many areas. Classification of childhood TB is
similar to that of adult TB.
Drug-resistant TB
TB in children may be drug-resistant as drug-sensitive. Drug-
resistant TB is a laboratory diagnosis. However, drug-resistant TB
should be suspected if any of the features below are present.

1. Features in the source case suggestive of drug-resistant TB:

• Contact with a known case of drug-resistant TB
• Remains sputum smear-positive after 3 months of
treatment
• History of previously treated TB
• History of treatment interruption
2. Features of a child suspected of having drug-resistant TB:
• Contact with a known case of drug-resistant TB
• Not responding to the anti-TB regimen
• Recurrence of TB after adherence to treatment

6.6 Treatment of tuberculosis in children

The lesions of primary tuberculosis have a smaller number of M.
tuberculosis organisms than those of adult-type pulmonary
tuberculosis. Thus, treatment failure, relapse, and development of
secondary resistance are less common among children. Children
with pulmonary TB usually have low bacterial load, as cavitating
disease is relatively rare. On the other hand, children more often
develop extra-pulmonary TB (EPTB). Very severe and
disseminated TB (e.g. miliary TB and TB meningitis) is found in
the young (<3 years old) child.
Because tuberculosis in infants and children younger than 4 years
of age is more likely to disseminate, treatment should be started
as soon as the diagnosis is made.
Children and adolescents with adult-type pulmonary tuberculosis
should be treated with the four-drug initial phase regimen. Three

64
times weekly therapy is not recommended for children.
Pyridoxine is recommended for infants, children, and adolescents
who are being treated with INH and who have nutritional
deficiencies, symptomatic HIV infection, or who are
breastfeeding.
DOT should be used for all children with tuberculosis. Even when
drugs are given under DOT, tolerance of the medications must be
monitored closely. Parents should not be relied on to supervise
DOT.
In general, extra-pulmonary tuberculosis in children can be
treated with the same regimens as pulmonary disease. Exceptions
are the disseminated TB disease, and meningitis, for which the
recommended duration is 9 to 12 months.

65
 TB TB cases Regimena
diagnostic
Intensive Continu
category
phase ation
phase
I New smear-positive 2HRZE 4RH
pulmonary TB
New smear-negative
pulmonary TB with extensive
parenchymal involvement
Severe forms of
extrapulmonary TB (other
than TB meningitis)
Severe concomitant HIV
disease
I TB meningitis 2HRZSb 4HR
II Previously treated smear- 2HRZES/ 5HRE
positive pulmonary TB: 1HRZE
Relapse
Treatment after interruption
Treatment failure
III New smear-negative 2HRZc 4RH
pulmonary TB (other than in
category I)
Less severe forms of
extrapulmonary TB
IV Chronic and MDR-TB Specially designed
standardized or
individualized
regimens

a
Direct observation of drug administration is recommended during
the initial phase of treatment and whenever the continuation phase
contains rifampicin
b
In comparison with the treatment regimen for patients in
diagnostic category I, streptomycin replaces ethambutol in the

66
treatment of TB meningitis.
c
In comparison with the treatment regimen for patients in
diagnostic category I, ethambutol may be omitted during the
initial phase of treatment for patients with non-cavitary, smear-
negative pulmonary TB who are known to be HIV-negative,
patients known to be infected with fully drug-susceptible bacilli
and young children with primary TB.
Table 10: Recommended doses of paediatric treatment:
Drug Recommended dose
Daily Three times weekly
Dose and Maximu Dose and Maximu
range m (mg) range m (mg)
(mg/Kg (mg/Kg
body body
weight) weight)
Isoniazid 5 (4-6) 300 10 (8-12) -
Rifampicin 10 (8-12) 600 10 (8-12) 600
Pyrazinamide 25 (20-30) - 35 (30-40 -
Ethambutol 20 (15-25) - 30 (25-35) -
Streptomycin 15 (12-18) - 15 (12-18) -

The recommended dose of Ethambutol is higher in children (20

mg/Kg) than in adults (15 mg/Kg), because the pharmacokinetics
is different. Although ethambutol was frequently omitted from
treatment regimens for children in the past, due in part to
concerns about the difficulty of monitoring for toxicity
(particularly for optic neuritis) in young children, a literature
review indicates that it is safe in children at a dose of 20 mg/Kg
[range 15-25 mg/Kg/daily].
Streptomycin should be avoided when possible in children
because the injections are painful and irreversible auditory nerve
damage may occur. The use of Streptomycin in children is mainly
reserved for the first 2 months of treatment of TB meningitis.
Management of TB meningitis and miliary TB

67
TB meningitis and miliary TB are more common in young
children and are associated with high rates of death and disability,
particularly if the diagnosis is delayed. It is therefore important to
consider these diagnoses in young children as early as possible,
especially in children who have a history of contact with an adult
with infectious TB.
Children with TB meningitis or miliary TB should be
hospitalized, preferably for at least the first 2 months. Due to
different degrees of drug penetration into the central nervous
system, some experts recommend modifying the standard anti-TB
treatment regimen for children with meningitis, as follows.
Selected regimens for treatment of TB meningitis in children
• 2HRZS/4HR
• 2HRZ(S or Eth)/7–10HR
Corticosteroids (usually prednisone) are recommended for all
children with TB meningitis in a dosage of 2 mg/kg daily for 4
weeks. The dose should then be gradually reduced (tapered) over
1–2 weeks before stopping. The dosage of prednisone can be
increased to 4 mg/kg daily (maximum 60 mg/day) in the case of
seriously ill children because rifampicin will decrease
corticosteroid concentrations, but higher doses carry a risk of
greater immune suppression.
Children with TB meningitis are at high risk of long-term
disability and therefore benefit from specialist care, where this is
available.
Management of TB in HIV-infected children
Most current international guidelines recommend that TB in HIV-
infected children should be treated with a 6-month regimen as in
HIV-uninfected children. Where possible, HIV-infected children
should be treated with rifampicin for the entire treatment duration,
as higher relapse rates among HIV-infected adults have been
found when ethambutol is used in the continuation phase. Most
children with TB, including those who are HIV-infected, have a
good response to the 6-month regimen. Possible causes for

68
failure, such as non-compliance with therapy, poor drug
absorption, drug resistance and alternative diagnoses should be
investigated in children who are not improving on anti-TB
treatment. As in children not infected with HIV, a trial of anti-TB
treatment is not recommended in HIV-infected children. A
decision to treat any child for TB should be carefully considered,
and once this is done, the child should receive a full course of
treatment.
Cotrimoxazole prophylaxis
Daily cotrimoxazole prophylaxis (20 mg trimethoprim (TMP) +
100 mg sulfamethoxazole (SMX) if under 6 months of age; 40 mg
TMP + 200 mg SMX if aged under 5 years; 80 mg TMP + 400mg
SMX if 5 years or older) prolongs survival in HIV-infected
children and reduces the incidence of respiratory infections and
hospitalization. All HIV-infected children with advanced
immunosuppression should be started on cotrimoxazole.
Antiretroviral therapy
HIV-infected children benefit from treatment of HIV with ART.
In HIV-infected children with confirmed or presumptive TB,
however, the initiation of anti-TB treatment is the priority.
Treatment of TB in HIV-infected children on ART or who are
planned to start on ART needs careful consideration, especially
rifampicin, and some of the non-nucleoside reverse transcriptase
inhibitors and protease inhibitors cause clinically significant drug
interactions. Furthermore, the adverse events of the anti-TB drugs
and the antiretroviral drugs are similar and can cause confusion as
to which drugs need to be stopped.
The clinical and immunological condition of the HIV-infected
child should guide the decision whether to:
· start ART treatment soon (2–8 weeks) after the start of anti-TB
treatment;
· delay ART until after completion of the initial phase of anti-TB
treatment;
· delay start of ART until anti-TB treatment is completed.
Where possible, the initiation of ART should be deferred for at
least 2–8 weeks in children starting anti-TB treatment who have
not yet started ART.

69
 6.7 Administering treatment and ensuring adherence

Many children with TB can be managed on ambulatory basis.

Conditions that necessitate hospitalization include:
a) TB meningitis or miliary TB, preferably for the first 2 months
of anti-TB treatment;
b) Any child with respiratory distress;
c) Spinal TB;
d) Severe adverse events, such as hepatotoxicity;
6.8 Follow Up
Each child should be assessed (i) 2 weeks after treatment
initiation, (ii) at the end of the intensive phase and (iii) every 2
months until treatment completion. At a minimum assessment
should include symptom assessment, an assessment of adherence,
inquiry about any adverse events, and weight measurement.
Medication dosages should be adjusted for weight gain. A follow-
up sputum smear microscopy at 2 months should be obtained for
any child who was smear-positive at diagnosis.
Because of the difficulties in isolating M. tuberculosis from
children, bacteriological examinations are less useful in
evaluating the response to treatment and clinical and radiographic
examinations are of relatively greater importance. However, hilar
adenopathy may require 2 to 3 years to resolve. Thus, a persisting
abnormality on chest radiographs is not necessarily a criterion for
continuing therapy.
A child who is not responding to TB treatment should be referred
for further assessment and management. Recognition of treatment
failure or relapse in a child is subject to the same difficulties as
making a diagnosis. Thus, clinical and radiographic worsening
may not be accompanied by positive AFB smears or
mycobacterial cultures. A decision to modify the drug regimen
should not be made without due consideration, but must be based
on sound clinical grounds.

70
 6.9 Adverse reactions to TB drugs in children

Adverse events are less common in children than in adults. The

most common adverse reaction is the development of
hepatotoxicity, which can be caused by Isoniazid, Rifampicin or
Pyrazinamide. Serum liver enzyme levels should not be
monitored routinely, as an induction of liver enzymes (<5 times
normal values) is not an indication to stop treatment. However,
the occurrence of liver tenderness, hepatomegaly, or jaundice
should lead to investigation of serum liver enzyme levels and the
immediate interruption of all potentially hepatotoxic drugs.
Patients should be screened for other causes of hepatitis, and no
attempt should be made to reintroduce these drugs until liver
functions have normalized. An expert should be involved in the
further management of such cases.
Isoniazid may cause symptomatic pyridoxine deficiency,
particularly in severely malnourished children. Supplemental
pyridoxine (5-10 mg/day) is recommended in malnourished
children and in HIV-infected children.

71
7 TB/HIV COLLABORATIVE ACTIVITIES

7.1 Impact of HIV on Tuberculosis

The Human Immunodeficiency Virus (HIV) pandemic presents a
massive challenge to the control of tuberculosis (TB). The
synergy between TB and HIV/AIDS is strong: in high HIV
prevalence populations, TB is a leading cause of morbidity and
mortality, and HIV is fuelling the tuberculosis epidemic in
Ethiopia. This unprecedented scale of the epidemic of HIV-
related tuberculosis demands concerted and urgent action.
HIV increases susceptibility to infection with M. tuberculosis, the
risk of progression to TB disease, and the incidence and
prevalence of TB. It also increases the likelihood of re-infections
and relapses of TB.
Mechanisms in the development of HIV-associated TB:
• Re-activation of latent TB infection (acquired prior to HIV
infection).
• Rapid progression to disease, following recent TB
infection.
• Re-infection with another strain of M. tuberculosis

HIV has a number of impacts on prevention and control of TB,

including:
• Increased number of patients developing side-effects from
anti-TB drugs
• Worsened stigma and discrimination
• Increased workload of health care providers that can
compromise quality of service
• Depletion of resources.
It has also been found that latent TB-infection in HIV-positive
persons reactivates at a rate of 10% per year (as opposed to 5%-
10% over a lifetime for HIV-negative persons). HIV-positive
persons are prone to re-infection with new strains of TB from the
community and drug resistance may occur more frequently.

72
Health care workers should strongly recommend and routinely
offer HIV TESTING for all TB patient and TB suspects, after
providing them with adequate information on the benefits of HIV
testing.

7.2 Impact of Tuberculosis on HIV

• TB is the leading cause of illness and death among
PLHIV;
• TB increases the occurrence of other opportunistic
infections;
• TB hastens the rate of HIV progression;
• TB influences ART in various ways: drug-drug
interactions, side effects and Immuno Reconstitution
Inflammatory Syndrome;
• Late TB diagnosis contributes to increased death rates in
PLHIV.
Ethiopia is one of the highly affected countries by the TB/HIV co-
epidemic. The WHO Global Report 2008 estimates that in
Ethiopia 40% of TB patients tested for HIV are HIV positive,
while routine data from 1999 EFY (2006/7) estimates that 31% of
TB patients are HIV positive.

The dual epidemics have a number of impacts on the health

sector. They increase TB and HIV burden, demand for care and
worsen the situation of the already overstretched health care
delivery system in the country. Hence, they deplete resources,
worsen stress and aggravate attrition of health workers at service
delivery points. Therefore Tuberculosis and HIV Prevention and
Control Programmes share mutual concerns: prevention of HIV is
a priority for tuberculosis control and prevention and care of TB
are priority concern for HIV/AIDS prevention and control
programme.
The expanded scope of the new strategy for tuberculosis control
in high HIV prevalence population comprises
a) Interventions against TB (intensified case-finding,
treatment and Isoniazide Preventive Therapy - IPT)
and
b) Interventions against HIV (and therefore indirectly

73
 against tuberculosis), e.g. safe sexual practice, STI
treatment, Co-trimoxazole Preventive Therapy (CPT)
and Anti-Retroviral Treatment (ART).
WHO recommends twelve main collaborative activities between
TB and HIV/AIDS control programmes.
A. Establish the mechanisms for collaboration
A.1 Set up a coordinating body for TB/HIV activities at all levels
A.2 Conduct surveillance of HIV prevalence among tuberculosis
patients
A.3 Carry out joint TB/HIV planning
A.4 Conduct monitoring and evaluation
B. Decrease the burden of tuberculosis in people living with
HIV
B.1 Establish intensified tuberculosis case-finding
B.2 Introduce Isoniazid preventive therapy
B.3 Ensure tuberculosis infection control in health care and
congregate settings
C. Decrease the burden of HIV in tuberculosis patients
C.1 Provide HIV testing and counseling
C.2 Introduce HIV prevention methods
C.3 Introduce co-trimoxazole preventive therapy
C.4 Ensure HIV/AIDS care and support
C.5 Introduce antiretroviral therapy
NB: For details on the collaborative activities refer to TB/HIV
implementation guideline, MOH, 2008

7.3 Diagnosis of TB in HIV-positive patients

In the early stages of HIV infection, when immunity is only
partially compromised, the features are more typical of
tuberculosis, commonly with upper lobe cavitation, and the
disease resembles that seen in HIV- negative TB patients. As
immune deficiency advances, HIV-infected patients present with
atypical pulmonary disease, resembling primary tuberculosis or
extrapulmonary (like pleurisy) and disseminated (miliary)
disease, commonly with hilar adenopathy and lower lobe
infection. In the advanced stages there is a tendency to develop
smear-negative TB.

74
Pulmonary tuberculosis is the most common manifestation of
tuberculosis in adults infected with HIV. Tuberculosis occurs at
various stages of HIV infection, with the clinical pattern
correlating with the patient’s immune status and could broadly be
classified as early and late presentation.
From the clinical point of view, the clinical features in pulmonary
TB are generally similar in HIV-infected and HIV-negative
patients. However, cough and haemoptysis are reported less
frequently by HIV-infected patients.
Most of HIV-infected pulmonary TB patients are sputum smear-
positive, however the proportion of smear-negative patients is
much greater in HIV-infected than in HIV-negative TB patients.
HIV-infected, smear-positive patients also tend to excrete
significantly fewer bacilli in sputum than HIV-negative patients.
This can lead to AFB being missed if not enough fields are
examined by microscopy.

Sputum smear remains the cornerstone to confirm the

diagnosis of pulmonary TB, including in HIV-positive
patients.
It also helps identifying infectious patients so that
transmission can be stopped.

TB and the chest X-ray in HIV-positive patients

If the sputum-smear remains negative, a chest X-ray can be of

additional value in the diagnosis. However, the appearance of the
X-ray may not be typical for TB.
HIV-infected patients with relatively well-preserved immune
function will often show typical radiological features.
As immunosuppression worsens, however, chest radiographs
more often show atypical features such as pulmonary infiltrates
affecting the lower lobe rather than the upper lobes and
intrathoracic lymphadenopathy, In addition, TB tends to be
disseminated with absence of cavitation.
There are many other lung conditions in HIV-positive patients

75
 that are indistinguishable from TB on the chest X-ray!
Therefore the flow chart for the diagnosis of TB should be
followed strictly in case of negative sputum smears (annex III).
Diagnosis of TB in the HIV-infected therefore requires a high
index of suspicion. The following table summarizes differences in
presentation between early and late stages of HIV-infection:
Table 11. Differentiation between early and late stages of HIV-
infection
Stage of HIV-infection
TB & HIV
Late stage / clinical AIDS
Early stage
Clinical Cough > 2 weeks • Dry cough, not
picture Productive sputum productive
• Upper lobe • Lower lobe infiltrates,
infiltrates no cavitation
X-ray • Cavitation • Often mediastinal
appearance lymphadenopathy and/or
• Nodular or
patchy pleural effusion
shadows • Sometimes miliary or
interstitial pneumonia
Sputum • Often positive • Often negative (< 50%)
smear (>80%)

The main manifestations of EPTB in HIV-infected patients are

lymphadenopathy, pleural effusion, pericardial effusion, and
miliary TUB.. Presentation of EPTB in HIV-infected patients is
generally not different from that in HIV-negative patients.
However, HIV-related TB lymphadenopathy can occasionally be
acute and resemble an acute pyogenic bacterial infection. The
definitive diagnosis of EPTB is often difficult because of the
scarcity of diagnostic facilities. Diagnosis can be made with fine
needle aspiration, (pathology), and examination of direct smears
from the cut surface.
In TB meningitis, the CSF can be completely normal in HIV-
infected patients. Disseminated TB can be extremely difficult to
diagnose. Pericardial TB is not rare and may be diagnosed

76
presumptively from the characteristic balloon-shaped appearance
of the cardiac shadow on chest radiography.

TB CLASSIFICATION in HIV-POSITIVE PATIENTS

(according the revised case definition from WHO 2006)

Smear-positive pulmonary tuberculosis

! One sputum smear examination positive for Acid Fast Bacilli
(AFB) by direct microscopy, and
! Laboratory confirmation of HIV infection or
! Strong clinical evidence of HIV infection
Smear-negative pulmonary tuberculosis
! At least two sputum specimens negative for AFB and
! Radiographical abnormalities consistent with active
tuberculosis and
! Laboratory confirmation of HIV infection or
! Strong clinical evidence of HIV infection and
! Decision by a clinician to treat with a full course of anti-
tuberculosis chemotherapy
OR
! A patients with AFB smear-negative sputum which is culture-
positive for Mycobacterium tuberculosis
Extra-pulmonary tuberculosis
! One specimen from an extra-pulmonary site culture-positive
for Mycobacterium tuberculosis or smear-positive for AFB
OR
! Histological or strong clinical evidence consistent with active
extra-pulmonary tuberculosis and
! Laboratory confirmation of HIV infection or
! Strong clinical evidence of HIV infection and
! Decision by a clinician to treat with a full course of anti-
tuberculosis chemotherapy

7.4 Prevention and Management of TB among PLHI

7.4.1 Isoniazid Preventive Therapy (IPT)
TB disease is one of the major opportunistic infections that cause
death among PLHIV. All newly-identified HIV-infected adults
and children should be screened for TB symptoms (prolonged

77
cough # 2 weeks), followed by sputum smear microscopy and in
some cases chest radiography. After ruling out active TB, IPT
should be considered for PLHIV in order to protect them from
developing TB disease (for details see TB/HIV Implementation
Guideline).
Where HIV prevalence is high among cases with smear positive
PTB, children of index cases may be at risk of both TB and HIV.
It is important to know HIV status of children (if not, consider
HIV testing). If the child contact is HIV- positive and otherwise
well, then consider IPT for all ages including those 5 years and
older. IPT must not be given to any child, who has active or
possible TB (for details see TB/HIV Implementation Guideline).
7.4.2 Co-trimoxazole Preventive Therapy (CPT)
It is well-documented that administration of CPT decreased
morbidity and mortality among HIV-infected TB patients. Co-
trimoxazole is standard of care for this category of patients and is
given to HIV-positive TB patients (for details see the TB/HIV
Implementation Guideline).
7.4.3 Treatment of TB in PLHIV
The treatment of TB in PLHIV is essentially the same as in HIV-
negative patients. It is well tolerated and in general the outcome
of treatment is good, particularly in patients in the early course of
HIV infection. TB treatment must therefore be commenced
without delay in PLWH. However, due in part to HIV-related
complications, predominantly in the first months of TB treatment,
death occurs more commonly in HIV-positive than in HIV-
negative TB patients, with a higher risk of death in the late stage
of HIV infection. These complications can be decreased to a
large extent by prescribing Cotrimoxazole (2 tablets or one double
strength tablet daily) to all HIV-positive TB patients irrespective
of the stage of HIV infection. When available, ART substantially
decreases the risk of death in HIV-infected TB patients. For more
detail refer to TB Care with TB-HIV co-infection; IMAI module.
7.4.4 Anti-TB Treatment and Anti-Retroviral
Therapy (ART)

78
Anti-TB treatment and ART together give rise to a number of
potential problems, such as drug interactions, increased risk of
adverse effects and increased frequency of “Immune
Reconstitution Inflammatory Syndrome” (IRIS).

Management of co-infected patients is detailed in the “TB Care

with TB-HIV co-infection; IMAI module”. Possible options for
ART in patients with TB include:
• Delayed start of ART after completion of TB treatment.
• Delayed start of ART after completion of the initial phase of
TB treatment and, then, use Ethambutol and Isoniazid in the
continuation phase.
• Treatment of TB with a Rifampicin-containing regimen as
indicated in national ART guideline.

79
8 DRUG-RESISTANT TB AND MULTI-DRUG
RESISTANT TB
Like for all infectious diseases, the bacilli responsible for TB may
be, or become, resistant to antibiotics. TB bacilli are naturally,
spontaneously, resistant to penicillins or cotrimoxazole for
instance. They may also become resistant to anti-TB drugs,
possibly any anti-TB drug.
When a patient has TB with TB strain/bacilli that are not sensitive
anymore to a given antibiotic (for instance INH), these bacilli will
not be affected by this drug, and therefore using this antibiotic for
this patient will not help him. It will furthermore tend to select
resistant strains, because they can grow in the presence of INH,
whether sensitive strains will not. This is actually the reason why
TB patients must always be treated with a combination of drugs.
Therefore resistance to TB drug(s) usually occurs as a
consequence of an inadequate treatment, be it irregular, too short
or too weak. It develops because a patient is treated incorrectly or
is not able to adhere to the treatment regimen. In both cases, the
patient has not been receiving a strong enough dosage of the drug
over a long enough period of time to kill the bacilli, so the
organism are given time to develop resistance to anti-TB drugs. A
good TB control program–especially with regard to patient follow
up and adherence- will not generate much resistance. Resistance
is man made, most of the time. Mostly people who have already
received TB treatment –specially sub optimal care- have resistant
TB bacilli.
Once it is created, resistant TB can be transmitted like any other
TB. It is estimated that the average MDR-TB patient infects up to
20 other people in her/his lifetime Some people who have never
been previously treated for TB may get resistant bacilli.
Resistance to anti-TB drug can only be confirmed by a reference
laboratory by Drug Sensitivity Testing (DST):
# Mono-resistant TB: TB in patients whose infecting
isolates of M.tuberculosis are confirmed to be resistant in
vitro to one first-line anti-TB drug.

80
 # Poly-resistant TB: TB in patients whose infecting isolates
are resistant in vitro to more than one first-line drug, other
than Isoniazid and Rifampicin
# Multi-drug resistant TB (MDR): is active TB involving
M.Tuberculosis organism that are resistant to at least both
Isoniazid and Rifampicin, the two most powerful anti-TB
agents. A MDR-TB strain can be resistant to more than
these two antibiotics and in most cases it is resistant to
other first-line drugs.
# Extensive-drug resistant TB (XDR): is defined as
resistance to at least Rifampicin and Isoniazid, in addition
to any Fluoroquinolone, and to at least one of the three
following injectable drugs used in anti-TB treatment:
Capreomycin, kanamycin and Amikacin.
Table 12: Causes of Inadequate anti-tuberculosis treatment

8.1 MDR-TB or Multi Drug Resistant Tuberculosis

In Ethiopia, according to a national survey (2003-2006), it is
estimated that MDR-TB represents about 1,6 % of new TB cases
(never treated previously) and 11,8% of re-treatment cases.
Treatment of MDR-TB is more complicated and longer than
treatment of TB with no resistance. It is important to treat MDR-
TB patients both to prevent their death and to limit the
dissemination of drug-resistant TB in the community.
Good history taking is essential when people present with TB
symptoms to determine previous TB treatment, its length and the

81
drugs used. In addition, during history taking the patient may
reveal contact with someone who suffered from drug-resistant
disease.
The diagnosis of MDR TB is made only by reference laboratories
performing culture of TB strains, with additional testing of anti
TB drug sensitivity (DST: drug sensitivity testing). It requires a
specimen of fresh sputum and the final result takes 2 to 3 months
to be on hand with common techniques. The test will gradually be
available in Regional and National Reference laboratories in
Ethiopia.
The main indications for TB culture and DST in search for MDR-
TB are:
• Retreated cases who fail to respond to category II
regimen.
• Chronic cases.
• New cases that are contact cases of known or suspected
MDR cases.
• Unclear treatment failure with good compliance .
Specific guidelines for MDR case detection and indication for
DST in Ethiopia will soon be developed and circulated.
8.2 Extensively Drug-Resistant Tuberculosis (XDR-TB)
Extensively Drug-Resistant Tuberculosis (XDR-TB) is a rare type
of MDR-TB. XDR-TB is defined as resistance to Rifampicin and
Isoniazid (which is the definition of MDR-TB), in addition to any
Fluoroquinolone, and at least one of the three following injectable
drugs used in anti-TB treatment: Capreomycin, Kanamycin and
Amikacin.
Because XDR-TB is resistant to first – and second line drugs,
patients are left with very few efficient treatment options.
However, it can be identified early, can be treated and cured in
some cases under proper TB control conditions. Successful
treatment outcomes depend on the extent of the drug resistance,
the severity of the disease and the immune response of the patient.
In many XDR cases there is no efficient treatment available.
8.3 Treatment of MDR-TB

82
 The best measure regarding TB MDR is to prevent its
occurrence
The prevention of MDR can only be achieved through proper TB
case detection, rational diagnosis, standard treatment and, most of
all, successful follow up and high adherence of patients.. Clearly
an efficient DOTS program is the best weapon against MDR.
There are not enough second line options to cope with widespread
surge of MDR and XDR TB
For established and proven MDR, anti-TB drugs efficient for
MDR (Second line TB drugs) will gradually be accessible in
Ethiopia. It is however of crucial importance that this “last
chance” second line drugs are used in a very rational way to
maintain their effectiveness. If they are not properly used,
resistance will extend to these second line drugs. Every health
worker has to be aware that, beyond these second line TB drugs,
there is no other option left, and the presence of untreatable
communicable TB in the community would be a serious threat for
all, especially health workers.
When MDR-TB is confirmed by culture and sensitivity testing, or
is suspected based on the patient’s history, a specific treatment
regimen has to be given: Patients with MDR TB mustn’t be
treated only with usual TB drugs and standard regimens (I, II or
III): this would simply generate more resistance to TB drugs
(because at least 2 major ant-Tb drugs are already useless in those
cases).
The treatment is complex, very long and expensive; severe side
effects are quite common and success rate is lower than with
common TB (non MDR).
MDR-TB patients should be treated with a combination of second
line drugs and, if advisable, fist line TB drugs that still have
proven efficacy. Regimens should consist of drugs with either
certain, or almost certain, effectiveness.
The treatment should be standardized or individually adjusted on
the basis of result of Drug Sensitivity Testing. Since susceptibility
to all TB drugs cannot be assessed routinely, and as
comprehensive result may not be available before several weeks,

83
five or six drugs are recommended initially. The first phase,
which injectable drug, should be a minimum of 6 months and
initial treatment may be extended if the patient does not convert
both smear and culture. The entire treatment period is 18-24
months after smear and culture conversion.
Classification of Anti-TB drugs
Grouping Drugs (abbreviations)
Group 1 – Isoniazid (H), rifampicin (R),
First-line oral ethambutol (E), pyrazinamide (Z)
antituberculosis
agents
Group 2 – Streptomycin (S); Kanamycin (Km);
Injectable Amikacin (Am); Capreomycin (Cm);
antituberculosis Viomycin (Vi)
agents
Group 3 – Ciprofloxacin (Cfx); Ofloxacin (Ofx);
Fluoroquinolones Levofloxacin (Lfx); Moxifloxacin
(Mfx); Gatifloxacin (Gfx)

Group 4 – Ethionamide (Eto); Protionamide

Oral bacteriostatic (Pto);
second-line agents Cycloserine (Cs); Terizidone (Trd);
P-aminosalicylic acid (PAS);
Thioacetazone (Th)

Group 5 – Clofazimine;
Antituberculosis amoxicillin/clavulanate;
agents with unclear clarythromicyn; linezolid
efficacy (not
recommended by
WHO for routine use
in MDR-TB patients)

84
 8.4 Follow-up of MDR TB patients
Ideally second line treatment for MDR-TB patients should be
directly observed for the full course of treatment, and patients
closely monitored at least until they become non-infectious. MDR
treatment centers facilities should be adequately equipped for
infection control.
Patients with MDR-TB take more tablets and receive more
injections for a longer period of time, may experience more
adverse effects and require increased support to continue
treatment and/or to monitor adverse effects. Detecting and
controlling adverse effects in a timely manner promotes
adherence and prevents default to treatment.
The Ministry of Health, backed by the international community,
has decided to start providing treatment for MDR TB patients at a
TB Specialized Center in Addis Ababa, with particularly trained
staff and reinforced infection control measures. For the coming
years only this selected specialized Centre will be equipped for
MDR cases management. The Ministry of Health will issue case
finding and treatment guidelines that must be strictly followed by
every health worker and clinician.

9 PREVENTION OF TB

85
The best measure for primary prevention of tuberculosis is the
treatment of infectious cases. The disease being transmitted only
by –coughing- TB patients to other contact(s).
Primary prevention can also be promoted through good public
health practice to reduce the transmission of infection in
institutions by adequate ventilation and isolation of infectious
patients.
Prevention of TB also includes two measures: BCG vaccination
and prescription of Isoniazid chemoprophylaxis for groups at risk.

9.1 Main groups at risk

“Groups at risk” are population groups whose risk of contracting
tuberculosis is 5–10 times higher than that of the general population,
either because they have a greater risk of being infected, or because
they have a greater likelihood of progressing to disease once
infected. They include:

1. Groups most exposed to sources of infection

• The family circle of index cases

Subjects living in contact with smear-positive cases have a risk that
is directly proportional to their contact with the patient. The greatest
risk is observed in individuals who live in the same household as a
smear-positive pulmonary tuberculosis case.

• Health institutions
Individuals present in health facilities at the same time as untreated
or drug-resistant tuberculosis patients, and health personnel working
in tuberculosis services or in bacteriology laboratories handling
sputum, are more exposed to sources of infection than the general
population.

2. Groups with lowered immunity

This group mainly consists of individuals who are HIV-positive

or who have AIDS. Other diseases (such as silicosis, lymphoma
and diabetes) and immunosuppressive treatment provoke a
lowering of immunity that is much less significant. Drug

86
dependence and alcoholism favour reduction in immunitary
defences.

3. Underprivileged and marginalized groups

Individuals in precarious situations, those who are homeless, and

those who live in poor areas of big cities and prisoners often
experience overcrowded living conditions that increase the
intensity of exposure to tubercle bacilli excreted when someone in
the environment has tuberculosis. HIV infection may also be
higher in underprivileged population groups.

4. Individuals with extensive sequelae from untreated

tuberculosis

These individuals have a higher risk of recurrence of tuberculosis

through reactivation of bacilli that have remained latent after their
disease has become quiescent. This is principally the case if they
have had inadequate or no treatment for their previous episode of
tuberculosis.

9.2 Measures of prevention

$ Treatment of smear-positive pulmonary tuberculosis

Detection and treatment of sources of infection are still the best

methods of tuberculosis prevention. To improve this means of
prevention, it is essential to improve access to health care for the
population in general and for groups at risk in particular. It is also
important for health practitioners to maintain a high level of
awareness regarding tuberculosis.
Every effort must be made to improve the accessibility of care for
these population groups, by:
! Providing free timely tuberculosis care and treatment;
! Decentralizing health services to make them more
accessible for marginalized groups, in the poorest urban
and rural areas, in prisons, etc.

$ Treatment of latent tuberculosis infection (preventive

87
chemotherapy)

Treatment of latent tuberculosis infection (preventive

chemotherapy) prevents disease from appearing in infected
individuals. It is targeted mainly at contacts aged less than 5 years
living in the same household as a newly identified case of
pulmonary tuberculosis. Depending on the situation, preventive
chemotherapy may be extended to other groups at risk. The regimen
consists of isoniazid given at doses of 5 mg/kg for 6 months.
Contacts of pulmonary TB case
• Children in contact with a pulmonary tuberculosis
case
All children in contact with a pulmonary TB case should undergo
clinical examination, and those identified as tuberculosis suspects
should undergo further testing. Children diagnosed with
tuberculosis should receive a full course of preventive treatment;
all other children aged under 5 years who have been exposed to a
smear-positive case should receive treatment for latent TB
infection whether or not they have been BCG-vaccinated.
• Adult contacts
All adults who have been in contact with a pulmonary
tuberculosis case should be examined, and tuberculosis suspects
should be asked for three sputum samples for bacteriological
examination.
Systematic case-finding among contacts beyond individuals living
in the same household is not feasible. This is why it is preferable to
educate the entire population about tuberculosis symptoms and to
improve access to health care.

HIV-infected individuals
Controlled clinical trials have confirmed the efficacy of
preventive chemotherapy in HIV-infected individuals in lowering
the risk of active TB. More details are provided in the chapter
regarding TB/HIV.

$ Infection Prevention: Measures that reduce the risk of

88
transmission of TB infection in health facilities

Smear-positive cases are virtually no longer infectious 2 weeks

after starting treatment, provided they are not MDR TB. Where
patients are multidrug-resistant, they have a high risk of infecting
those around them and, where this is likely to occur, very careful
precautions must be taken to isolate such patients from those at
risk of becoming infected by contact with them.

Simple measures that should be taken in order to avoid the spread

of TB infection include:
! treat the majority of TB patients on an outpatient basis as soon
as they are diagnosed;
! increase the ventilation of rooms where tuberculosis patients
are hospitalized and let as much sun into them as possible;
UV light are also useful in that regard.
! avoid, as much as possible, all contact between tuberculosis
patients and those patients who are known or suspected to be
HIV-positive or have AIDS; they should never be hospitalized
in the same wards.
! Ensure there is adequate ventilation in laboratories collecting
and handling sputum, or undertaking culture of
Mycobacterium tuberculosis, and in areas where patients
cough, such as bronchoscopy suites. When sputum specimens
are collected, it is best to ask all patients to produce the
specimen in the open air.
$ BCG vaccination
BCG vaccine consists of bacilli whose virulence has been
attenuated. When these bacilli are injected into the body, the
development of protective immunity is stimulated, and the
person's means of defence is increased without causing disease.

BCG should be administered:

At birth, on the same day as the BCG vaccination is given, the

newborn should be given a dose of oral polio vaccine;

89
After 2 months, the first vaccination against diphtheria, pertussis,
tetanus and poliomyelitis can be given at the same time as BCG;
After 9 months, BCG vaccination can be given at the same time
as the measles vaccine.

It is unusual for complications to occur if the vaccination is given

correctly. In about one in 1000 children lymphadenopathy may
develop in the axilla or inside the elbow, which may become
fluctuant and fistulize. Treatment consists of an incision to drain
the node, and application of dry dressings until scarring. It will
heal within several days or weeks.

If the infant has –symptomatic- AIDS, BCG is contraindicated;

however, infants who are HIV-positive should be BCG-
vaccinated, as the risk of tuberculosis in such infants is greater
than the risk of complications from the vaccine. Infants born to
HIV-positive mothers should also be vaccinated, unless they
present symptoms of AIDS.

BCG vaccination does not protect children from Mycobacterium

tuberculosis infection, but from its immediate consequences. It is
now agreed that BCG gives protection against the acute severe
forms of tuberculosis in childhood: disseminated disease and
TB meningitis.

The protective effect of BCG lasts for 10 to 15 years, but

revaccination has no proven benefit. To reduce the number of
infectious cases, it is much more important to give adequate
treatment to all patients who constitute sources of infection, i.e.
cases of smear-positive tuberculosis.

90
 PREVENTION OF TB
Among the various methods of preventing tuberculosis, the most
effective is the identification and effective treatment of patients
with infectious pulmonary tuberculosis.

It is important to pay careful attention to adequate ventilation in

institutions where TB patients may be encountered, in order to
prevent infection of those in contact with them. Isolation of
infectious TB patients (especially where there is an increased
possibility that the patient may have multidrug-resistant TB) is
important to prevent infection.

Treatment of latent TB infection with Isoniazid (IPT) has limited,

individual indications, and applies above all to children aged
under 5 years living in close contact with smear positive TB
patient and to people living with HIV in whom active TB is ruled
out.

BCG vaccination is of proven efficacy in protecting small

children against severe, acute forms of tuberculosis.

91
10 LEPROSY

10.1 EPIDEMIOLOGY
Definition
Leprosy is a chronic infectious disease caused by Mycobacterium
Leprae. It usually affects the skin and peripheral nerves.

Source of infection
Untreated Multi-bacillary leprosy patients discharging bacilli are
the main source of infection.
Route of transmission
Route of transmission is uncertain. However, transmission of
infection through air-borne spread of droplets containing the
bacilli expelled by untreated infectious persons and inhaled by
healthy persons is believed to be the most important route of
transmission. Persons living in the same household or who
otherwise are in frequent contact with an infectious person have
the greatest risk of being exposed to the bacilli.
Population affected
Leprosy affects persons in all age groups and both sexes. The age
group mainly affected is between 15 and 45 years. Factors related
to poverty increase the risk of developing the disease.
Natural evolution
Under normal circumstances, only a very small proportion (less
than 5%) of all individuals who are infected by the leprosy bacilli
will develop the disease during their lifetime. In the majority of
people, the immunological defence kills all the bacilli. The
disease has a long incubation period, ranging from 3 to 5 years,
but it may vary from 6 months to more than 20 years. If not
treated, leprosy can cause severe disability, mainly as a result of
peripheral nerve damage.
Association of Leprosy with HIV
Research conducted in various countries showed that there is no
strong association between these two diseases.

92
 10.2 CASE-FINDING
Case-finding means the detection of active cases of leprosy by
examination of suspects attending health facilities.
A case of leprosy is a person with clinical signs of leprosy, who
requires chemotherapy. A leprosy patient who has completed a
full course of chemotherapy should no longer be regarded as a
case of leprosy, even if sequelae of leprosy such as skin lesions,
disability and/or disfiguration remain.
Leprosy is diagnosed by finding at least one of the cardinal signs
of leprosy.

The cardinal signs of leprosy are:

1. Definite loss of sensation in a pale

(hypopigmented) or reddish skin lesion.
2. Thickened or enlarged peripheral nerve, with loss
of sensation and/or weaknesses of the muscles
supplied by that nerve.
3. The presence of acid-fast bacilli in a slit skin
smear.
The main aim of case-finding is to:
! To identify the sources of infection in the community, that
is, individuals who are discharging large number of
leprosy bacilli. Treatment of those infectious patients
rapidly renders them non infectious, thereby interrupting
the chain of transmission.
! Diagnose and cure leprosy cases before irreversible nerve
damage has occurred
! Minimizes the delay in initiating treatment, thereby
increasing the possibility of cure before irreversible nerve
damage ensues

There are two methods of case detection:

a) Passive case-finding
! Self reporting.
! Examination of contacts brought to health facilities by

93
 the patients.
b) Active case-finding
! Contact tracing.
! Institutional survey (school, prison, military camps).
! Population (mass) survey e.g. Leprosy Elimination
Campaign (LEC), Special Action Project for
Elimination of Leprosy (SAPEL).
However, active case detection is not recommended, except in
remote areas where health infrastructures are inadequate.
The following activities are implemented for case-finding:
! Physical examination: “cotton wool test“of hypo-
pigmented skin lesion for all self-presenting persons
with symptoms suggestive of leprosy.
! Examination of all household contacts of newly
detected patients (annex XII).
! Examination of a skin smear by direct microscopy for
the presence of AFB: mostly for doubtful cases or cases
difficult to diagnose.

Leprosy should be suspected in people with any of the following

symptoms or signs:
! Pale or reddish patches on the skin (the most common sign
of leprosy).
! Loss, or decrease, of sensation in the skin patch.
! Numbness or tingling of the hands and/or feet.
! Weakness of the hands, feet or eyelids.
! Painful and/or tender nerves.
! Burning sensation in the skin.
! Swellings or lumps in the face and earlobes.
! Painless wounds or burns on the hands or feet.

A person is likely to be suffering from leprosy if, in addition to

one or more of the above signs and symptoms, he/she is contact of
a patient with MB leprosy.
10.3 Diagnostic methods
Over 95% of leprosy cases can be diagnosed on clinical grounds.

94
Laboratory is indicated for confirmation of doubtful cases and
patient’s classification.
Clinical

A. History taking
The following information must be obtained from the patient and
recorded on the Patient Record Card:
! General information on the patient: name, sex, age, complete
address, distance from home to the clinic (in km and travel
time) and occupation.
! Main complaints and duration of signs
! History of previous leprosy treatment
! Contact information: other leprosy patients in the household
and/or family
B. Physical examination
Physical examination includes:
1. Examination of the skin:
! The patient is asked to remove all garments.
! Examination must always be carried out with adequate light
(preferably natural light) and sufficient privacy for the patient
to feel at ease.
! Examination must be carried out systematically to ensure that
no important signs are missed. First the head, then neck,
shoulders, arms, trunk, buttocks and legs.
! First the front side of the body and then the backside.
The skin should be examined for:
! Presence of skin lesions (patches or nodules).
! Presence of loss of sensation in the skin lesions
(patches)
! Number of skin lesions

95
 Leprosy skin patches Testing for sensation on the skin patch

Sensation of the skin lesions is tested with a wisp of cotton-wool

as follows:
! Roll the end of a wisp of cotton wool into a fine point.
! Explain to the patient the purpose of the test and what is
expected from him.
! Touch the skin with the fine point of the cotton wool until it
bends.
! After the explanation a trial test is done by touching the patient
on normal skin with the patient’s eyes open so that he/she
can exactly see what is done. Continue until the patient has
shown that he/she understands the purpose of the test.
! Then do the testing with the patient’s eyes closed. First test on
normal skin. When he/she points correctly, test in the skin
patches, while touching normal skin now and then. Watch
at every touch that the patient keeps his/her eyes closed.

A patient points accurately to areas of normal skin, but

sometimes points away from where the skin in a patch is
tested. This is called misreference, and shows diminished
sensation in the patch. If this is consistent during
repeated testing of a patch, it is a cardinal sign and thus
a diagnosis of leprosy is made.

2. Examination of the nerves:

2.1 Nerve palpation

! Palpate the nerves starting from the head and going to the
feet.
! The following nerves are to be examined in leprosy.
However, the two most commonly affected are the ulnar
and peroneal nerves. Hence, these two nerves are
commonly enlarged and can be felt quite easily.

96
 Figure 4: Sites where nerves can be felt

Palpating the nerves

! Peripheral nerves are

examined for:
! Enlargement or
thickening
! Tenderness
! When palpating a nerve
always use 2 or 3 fingers.
! The nerve should be rolled
over the surface of the
underlying bone.
! The left and right side must
always be compared.

Error!

Palpating the Ulnar

nerves

Palpating the Ulnar nerve Palpating the Peroneal nerve

2.2 Nerve function testing

The functions of the following peripheral nerve fibres are

97
examined:
! Motor nerve fibres by Voluntary Muscle Testing (VMT)
! Sensory nerve fibres by Sensory Testing (ST)
! Autonomic nerve fibres by checking for dryness of
palms and soles

2.2.1. Voluntary Muscle Testing (VMT)

Muscle strength is measured with VMT. The strength should be
graded as Strong (S), Weak (W) or Paralyzed (P). Test the muscle
strength of eyes, hands and feet as follows:
Voluntary muscle testing (VMT) of the eyes
Eye closure:
Ask the patient to close his eyes lightly as in sleep. Observe
whether or not the closure is complete. Inability to fully close the
eye is called lagophthalmos (paralysis “labeled as P” of the eyelid
muscles). If there is lagophthalmos, measure the lid gap. If the
patient is able to fully close his/her eyes, then ask the patient to
close his eyes firmly while you gently check for strength and
grade the strength as weak (W) or strong (S).

Lid gap measuring procedures

1. Explain the procedure to the

patient
2. Ask the patient to close his/her
eyes lightly, as in sleep.
3. Measure and record any gap in
mm as illustrated on the right
side.
4. If closure is normal, record: “0
mm.”

98
Voluntary Muscle testing (VMT) of hands and feet:
VMT of hands and feet should be done as shown below.

1. A check of range of movement to see whether normal,

reduced or absent due to muscle paralysis (in the table
below, black arrows show movement required).
2. If movement is normal, test for resistance. Press gently
whilst asking the patient to maintain the position, resisting
the pressure as strongly as possible.
3. Then press gradually more firmly and judge whether
resistance is strong or weak. (White arrows show where
resistance is applied)
4. Always compare the right hand or foot with the left

a. Is movement full? b. Is resistance full?

Little finger in...a test of Nerve function
ulnar Patient tries to hold a
card between ring-
Hold these 3
and little fingers.
fingers straight
Assessor pulls card
gently.

Straight Thumb up…a test Median nerve function

of
Patient moves Assessor resists at
thumb base fully side of thumb
out and across (not at front or
back)

Wrist up….…a test of Nerve function

radial
Foot up ….a test of Nerve function
peroneal

99
2.2.2. Sensation testing (ST)
Test the sensation of eyes, hands and feet as follows:
Sensation of the eyes (cornea):
Observe the patient's blink when talking to him/her. If the blink is
normal, corneal sensation will be normal and there is no need for
testing sensation. If there is no blink, the eye is at risk. Look at the
illustration below to see how corneal sensation test is done.

1. The health worker should wash

hands before testing, then make a
point out of a wisp of cotton wool
and explain the test to the patient.

2. The patient should look to the

opposite side and upwards.

3. The assessor should:

• Stand behind the patient.
• Approach from the side.
• Touch the edge of the cornea.
• Observe the reaction.

4. Record on the Patient Record

Card:
• If sensation is normal,
write Yes
• If sensation is absent,
write No

Sensation of palms and soles:

ST on palms and soles should be done with a ball-point pen. The
tests are done on ten standard points.
Hand and foot mapping, including sensation test (ST)

100
 1. Explain the test to the 2. Compare sensation of the little
patient. Rehearse it with the finger with that of the thumb and
patient. Then test. A book sensation of one hand with the
should be held before the other, to see if there is difference.
eyes, so the patient cannot Compare findings with those shown
see. on any earlier records.
3. Support the patient’s hand or 4. Record:
foot so that fingers/toes are If the patient feels, !
well supported to prevent
joint movement during the If not, X
test.

5. Mark any wounds ( ),

open crack ( ) clawing of
digits (c) and bone loss or
absorption ( ) on the Patient
Record Card or VMT/ST
Form.

6. Dent the patient’s skin by

1 - 2 mm at dot sites using a
ball-point pen - asking the
patient to point to the exact
site whenever he/she feels.
The stimuli should be
irregular in timing and
placing.

7. Look for any CHANGE. Make sure

that the change is real and not due to
inaccuracies in testing.

3. Examination of eyes, hands and feet for disabilities

101
 Examination of the eye
% Visual Acuity:
Vision of both eyes of the patient should be tested according to
the demonstration below and should be recorded on the Patient
Record Card.
• Test vision with good light
falling on the assessor.
• Ask the patient to cover one eye,
then count the number of
fingers that the assessor holds up.
• Test at 6 meters. If the patient
cannot see at 6 meters, re-test
at 3 meters.
• Record the findings
% Other eye problems/complications:

Look for: Injury of cornea and loss of vision due to incomplete

blink and/or eye closure.
Examination of hands and feet
Patients should also be examined for the following complications,
which result from nerve damage:
• Skin cracks on palms and soles with sensation loss.
• Wounds on palms and soles with sensation loss.
• Clawed fingers and toes.
• Foot drop.
• Wrist drop.
• Shortening and scarring in fingers and toes with sensation
loss.

4. Disability grading.
Every new case of leprosy must be assessed for disability and
assigned a Disability Grade, which shows the condition of the

102
patient at diagnosis. The grade is 0, 1 or 2. Each eye, each hand
and each foot is given its own grade, so the person actually has
six grades, but the highest grade given is used as the disability
status for that patient.
Disabilities should be graded as follows:
Eyes
Grade 0: No disability found. This means there is no eye
problem due to leprosy, no loss of vision.
Grade 1: The eyes are not given a grade of 1.
Grade 2: Visible damage or disability is noted. This
includes the inability to close the eye fully
(lagopthalmos) or obvious redness of the eye
(typically caused by a corneal ulcer or uveitis).
Visual impairment or blindness (vision less than
6/60 or inability to count fingers at 6 meters) also
gives a disability grade of 2.
Hands and feet
Grade 0: No disability found. This means there is no loss of
sensation or visible deformity or damage.
.
Grade 1: Loss of sensation has been noted in the palm of
the hand or sole of the foot, but no visible
deformity or damage.
Grade 2: Visible deformity or damage present. This
includes wounds and ulcers as well as deformity
such as a foot drop or a claw hand.
C. Laboratory
1. Microscopic examination of skin smears
Bacteriological examination of a skin smear is done for doubtful
cases to confirm the diagnosis and/ or classification of leprosy.
Only one slide, with smears taken from 2 sites must be collected
and examined. The slit skin smear examination procedure is
provided by the National TB and Leprosy Laboratory Manual,

103
Edition 2007. One positive smear result is enough for diagnostic
and justifies starting MB treatment.
2. Histo-pathological examination
Biopsies may sometimes play a role in the confirmation of the
diagnosis or classification of leprosy, however, this is not yet
practiced in Ethiopia.
D. Differential diagnoses of leprosy
Without careful examination, leprosy can easily be mistaken for a
number of skin diseases. Likewise, some skin diseases can be
mistaken for leprosy. If patients are examined carefully, mistakes
in diagnosis should not occur as none of the cardinal signs of
leprosy are found in the common skin diseases. The differential
diagnoses of leprosy are listed below.
! Tinea versicolor. The lesions are hypopigmented, but without
loss of sensation. They often itch. When an anti-fungal
ointment is applied they usually clear up within 6 weeks.
! Ringworm. The lesions are well-defined areas of hypo-
pigmentation with white scales and without loss of sensation.
They usually clear up within 6 weeks when an anti-fungal
ointment is applied.
! Vitiligo. There are usually completely white areas of skin.
The skin texture is normal and there is no loss of sensation.
! Birthmarks. Lightly or deeply pigmented areas of different
sizes, which are present since birth or shortly after birth and
do not change.
! Psoriasis. Raised areas with white fatty scales, which itch and
bleed easily on scratching (pin point bleeding). There is no
loss of sensation.
! Molluscum contagiosum. Nodular lesions with a depression
in the centre. Firm squeezing results in the appearance of a
creamy substance.
! Onchocerciasis (in endemic areas). Hypopigmented macules
are often one of the manifestations. There is itching and no
loss of sensation. In a later stage there are mottled lesions, in
particular on the loins and shins. Previous complaints of
itching exclude leprosy.
! Cutaneous leishmaniasis (Nodular lesions in endemic

104
 areas). To differentiate with MB leprosy, skin smears
should be examined as Leishman bodies are found, no
AFB are seen.
! Post kala-azar cutaneous leishmaniasis (in endemic
areas). Nodular, papular lesions and diffuse infiltrates,
usually located on the face. These may occur one or more
years after treatment of visceral leishmaniasis. Skin
smears are negative for AFB.
! Neurofibromatosis. Multiple soft nodules, rarely on the
earlobes. Skin smears are negative for AFB.
! Syphilis. Secondary syphilis presents with a considerable
variety of lesions, e.g. papular and nodular lesions. Skin
smears are negative for AFB. Positive serology for
treponematosis.
! Kaposi's sarcoma. In HIV positive patients Kaposi's
sarcoma often presents with nodules on the face and ear
lobes. There are often lesions within the mouth and the
throat, which may bleed. Skin smears are negative for
AFB.

In children two common dermatological conditions that should be

differentiated from leprosy are:
! Pityriasis alba. The lesions are often restricted to the face
making differentiation from leprosy difficult since loss of
sensation in the face is not easy to demonstrate. The
lesions subside spontaneously, leaving hypopigmented
macules and at the same time new lesions may appear at
other sites.
! Nutritional deficiencies. Usually over the cheek, single
or multiple, ill-defined, hypopigmented patches with other
features of vitamin deficiencies such as glossitis,
stomatitis. The patches will clear after the administration
of vitamins.
E. Disease classification
For the choice of the MDT regimen, patients should be classified
into either the PB or MB group. If there is doubt about the
classification, the patient should be classified as MB and treated
accordingly.

105
Patients should be classified according to:
! The number of leprosy skin lesions.
! The result of the skin smear examination
1. Multibacillary (MB) leprosy:
! Six or more skin lesions.
! Less than six skin lesions, which have a positive slit skin
smear result.
2. Paucibacillary (PB) leprosy
! One to five leprosy skin lesions.
3. Pure neural leprosy
These are patients, who do not have any skin lesion, but who have
clearly thickened nerves with or without signs of nerve damage.
! Patients with pure neural leprosy should be reported and
treated as a PB case if only one nerve is affected and the
nerve biopsy smear result is negative.
! If two or more nerves are affected, or the nerve biopsy
smear is positive, the patient should be reported and
treated as an MB case.

106
 Figure 5: Flowchart for Diagnosis and Classification of
Leprosy

Skin patch Major nerve trunks

Test the skin patches for sensation Palpate the nerves

(use cotton wool)

No Doubtful Definite Thickened/Tender

sensory sensory sensory loss nerve(s)
loss loss With or without
sensory/motor deficit

Review after
6 months
Not
Leprosy
LEPROSY

Classifying Leprosy 1 to 5 skin patches or 6 or more skin

(Clinically) 1 thickened/tender patches or more than
nerve trunk 1 thickened/tender
nerve trunk

Types of Pauci-Bacillary Multi-Bacillary

Leprosy Leprosy (PB) Leprosy (MB)

Classifying Leprosy Skin Smear negative

(bacteriologically) Skin Smear positive

107
 10.4 Case definitions
New case (N):
A patient with MB or PB leprosy who has never received
treatment for leprosy before.
Relapse after MDT (R):
A patient declared "treatment completed" after a full course of
MDT, but who reports back to the health service and is found to
have active leprosy (see section 3.2.6) of the same classification
as the original classification.
N.B. A patient who has MB disease after being treated as a PB
case is a mis-classification and is defined as ‘other’.
Return after default (D):
An MB patient who returns for treatment, after having missed
more than 3 four-weekly doses of MDT.
Transfer in (T):
A patient started treatment in one health institution and moved to
another health institution to continue treatment. The result of
treatment of all such cases should be reported back to the original
health institution where the patient was notified.
Other (O):
Any leprosy patient requiring chemotherapy who does not fit in
any of the above mentioned categories, including patients who
relapse after treatment with dapsone monotherapy in the past.
10.5 Signs of active leprosy:
! Previous lesions becoming more erythematous or
reddish.
! Previous lesions becoming more raised.
! Appearance of new skin lesions.
! Raised Bacteriological Index (BI) or Morphological
Index (MI)

10.6 CHEMOTHERAPY

108
Leprosy is treated with Multi Drug Therapy (MDT). MDT is the
use of a combination of two or three anti-leprosy drugs to treat
leprosy:
Transmission of leprosy is interrupted after the very first dose of
MDT. In other words, patients are no longer infectious to others
after being administered the first dose of the treatment regimen.
There are virtually no relapses, i.e. no recurrences of the disease
after treatment is completed.
No resistance of the bacillus to MDT has been detected
PB patients treated with MDT are cured within six months.
MB patients treated with MDT are cured within 12 months.
The objective of the treatment is to:
! Cure leprosy by rapidly eliminating the bacilli
! Prevent the emergence of drug resistance
! Prevent relapse
! Prevent disability
MDT is very safe, effective and available free of charge in all
treatment centers. easy to apply in the field.
DRUG REGIMENS
MDT drugs
! Rifampicin (R) 150mg, 300mg
! Clofazimine (C) 50mg, 100mg
! Dapsone (DDS) 50mg, 100mg

Rifampicin is given once a month. No toxic effects have been

reported in the case of monthly administration. The urine may be
coloured slightly reddish for a few hours after its intake; this
should be explained to the patient while starting MDT.
Clofazimine is most active when administered daily. The drug is
well tolerated and virtually non-toxic in the dosage used for
MDT. The drug causes brownish black discoloration and dryness
of skin. However, this disappears within few months after
stopping treatment. This should be explained to patients starting
MDT regimen for MB leprosy.

109
Dapsone. This drug is very safe in the dosage used in MDT and
side effects are rare. The main side effect is allergic reaction,
causing itchy skin rashes and exfoliative dermatitis. Patients
known to be allergic to any of the sulpha drugs should not be
given dapsone.
Except for children below 10 years, the drugs are provided in
blister calendar packs, each pack containing four weeks (one
month) supply.
The appropriate dose for children under 10 years of age can be
decided on the basis of body weight. [Rifampicin: 10 mg per
kilogram body weight, clofazimine: 1 mg per kilogram per body
weight daily and 6 mg per kilogram monthly, dapsone: 2 mg per
kilogram body weight daily. The standard child blister pack may
be broken up so that the appropriate dose is given to children
under ten years of age. Clofazimine can be spaced out as
required.]
There are two types of MDT regimens. The Paucibacillary (PB)-
MDT and Multibacillary (MB)-MDT:
10.6.1 PB-MDT regimen
This regimen consists of Rifampicin and Dapsone for a total
duration of 6 months. It is to be prescribed to all cases classified
as Paucibacillary (PB) leprosy.

Child < 10
Drugs 10 – 14 years ! 15 years
years
300 mg 450 mg 600 mg
Rifampicin
monthly monthly monthly
25 mg 100 mg
Dapsone 50 mg daily
daily daily
For adults the standard regimen is: Rifampicin: 600 mg once a month;
Dapsone: 100 mg daily Duration= six months

10.6.2 MB-MDT regimen

This regimen consists of Rifampicin, Dapsone and Clofazimine,
for 12-month duration. It is to be prescribed to all cases classified

110
as Multibacillary (MB) leprosy.

Child < 10
Drugs 10 – 14 years ! 15 years
years
300 mg 450 mg 600 mg
Rifampicin
monthly monthly monthly
100 mg 150 mg 300 mg
Clofazimine
monthly monthly monthly
50 mg twice a 50 mg every 50 mg
Clofazimine
week other day daily
100 mg
Dapsone 25 mg daily 50 mg daily
daily

For adults the standard regimen is: Rifampicin: 600 mg once a

month, Dapsone: 100 mg daily Clofazimine: 300 mg once a
month and 50 mg daily Duration= 12 months.

10.6.3 Phases of chemotherapy

MDT regimens consist of two phases:
1. Supervised: drugs are administered under the direct
observation by the health worker on fixed clinic days at four
weekly intervals.

2. Unsupervised: drugs are self administered by the patient.

The drugs are to be taken orally and should be taken in a single

dose on an empty stomach if not two hours after meal

111
MDT blister packs for adults

MDT blister packs dren

112
113
 10.7 Treatment of special cases
Treatment during pregnancy and breast-feeding
The standard MDT regimens are safe, both for the mother and the
child and therefore should be continued during pregnancy and
breast-feeding.
Treatment for patients also infected with HIV
Patients infected with HIV usually respond equally well to
leprosy treatment as those without HIV infection.
Treatment for patients with Leprosy and TB
Patients suffering from both TB and leprosy require standard TB
treatment in addition to the standard MDT. Hence, skip the
monthly dose of rifampicin in the leprosy MDT regimen. Once
the TB treatment is completed, the patient should continue his/her
MDT, or the other way round.
10.8 Adverse effects of MDT
MDT is remarkably safe and serious adverse effects are very rare.

Table 13: Adverse effects of MDT Drugs

Side-effects Drug (s) Action
Minor Itching and skin rash Rifampicin Reassurance
Loss of appetite, Give drugs with
nausea and abdominal Rifampicin food
pain
Orange/red urine,
faeces, saliva and Rifampicin Reassurance
sputum
Brown discoloration
of skin lesions and
Clofazimine Reassurance
pigmentation of the
conjunctiva
Dryness and ichthiosis Apply Vaseline
Clofazimine
of skin ointment
Insomnia Dapsone Give the drug in

114
 the morning
Give iron and
Anaemia Dapsone
folic acid
Rifampicine Stop treatment
Jaundice
Dapsone and refer
Itching of the skin and Stop treatment
Dapsone
skin rash and refer
Major Stop treatment
Shock, purpura and Rifampicin and refer
renal failure
Dapsone & Stop treatment
Allergy, urticuria
Rifampicin and refer

10.9 Follow-up during treatment

MDT must be delivered as close to the patient's home as possible.
The treatment should be given on fixed clinic days. Adequate
time should be allocated to the patients and long queue should be
avoided. Patients who cannot attend on the fixed clinic day should
be allowed to collect drugs on any of the subsequent days or the
drugs should be given through family member or treatment should
be brought to the patient's home if necessary.
During all phases of treatment, the patient has to be educated on
the importance of regularly taking the prescribed medications, the
major side-effects of the drugs and signs and symptoms of
reactions/neuritis and on the need to report immediately to the
nearby treatment center whenever these occur.
During MDT, monitoring nerve function (with VMT and ST of
the eyes, hands and feet) is extremely important as a tool to detect
nerve function impairment early and to prevent the occurrence of
disability.
MB cases
MB patients should complete 12 four-weekly doses of MDT
within a maximum period of 15 months.
! After completion of the 12 doses of MDT, the patient
should be released from treatment (RFT) and recorded as
treatment completed.
! If a patient misses some treatment, the number of doses
missed should be added on at the end, so that the complete

115
 course of treatment is given. A patient who has missed
more than 3 four-weekly doses of MDT in total should be
recorded as default.
! If an MB patient recorded as a default report at a clinic, a
second course of MDT should be started, after the
importance of regular treatment is discussed with the
patient.
! Patients who restart treatment must be entered into a new
treatment cohort, which is currently open for intake. They
should be re-registered as return after default with a new
registration number. The previous number should be
recorded in the column ‘remarks’. This implies that such
patients have been included in two different cohorts, the
first one being the cohort in which they did not
successfully complete their treatment, the second one
being the cohort whose intake period includes the point at
which they started their second MDT course.
! After completion of the second course of MDT, the
patient should be declared treatment completed.
! Patients who fail to complete the second course of MDT
should not be given a third chance. These patients should
be recorded as default immediately after they have missed
the 4th four weekly doses of MDT. They should be told to
report immediately as soon as signs of active disease
return (section 3.2.6).

MB patients should be declared cured at the time they collect the

12th four-weekly dose of the drugs
PB cases
PB patients should complete 6 four-weekly doses of MDT within
a maximum period of nine months.
! After completion of the 6 doses of MDT the patient
should be released from treatment (RFT) and recorded as
treatment completed.
! Patients who have missed more than 3 four-weekly doses
of MDT in total should be recorded as default.
! If they return to the clinic again, they should not be given
a second course of MDT unless they are found to have
signs of active disease.

116
 PB patients should be declared cured at the time they collect
the 6th four-weekly doses of drugs.
Examinations during treatment
Examination of eyes, hands and feet (including VMT-ST) should
be performed:
! At any time if the patient complains of loss of sensation
and/or change in muscle strength or problem with vision.
! Routinely every month as long as the patient is on MDT.
! Just before release from treatment.

Nerve function assessment at the end of treatment should be

compared with that at the beginning of treatment. This includes
comparing disability grades and VMT-ST status at the beginning
and completion of treatment. The assessment should be scored as
improved (I), same (S) or deteriorated (D) and recorded in the
patient record card and unit leprosy register.
Treatment for patients living in inaccessible areas
Some patients who live in geographically inaccessible areas or
whose lifestyle does not permit regular visits to the health facility
(e.g. pastoralists) or who cannot attend clinics at certain times
(e.g. rainy season) should be given a sufficient supply of MDT
blisters to cover their period of absence. It is, in exceptional cases,
even acceptable to give a full course supply of MDT blisters to
these patients, but the involvement of a formal or informal
community leader or community health worker in the monitoring
of drug intake should always be sought; patients should be
strongly advised to report to the nearest health facility if they
develop any complication.

117
 10.10 Retrieval of absentees
If a patient has neither attended the fixed clinic day nor during the
two weeks thereafter, he/she has to be considered as an absentee
and should be retrieved. The following measures are suggested:
a. Inquire from fellow patients as to why the patient has
failed to collect his/her drugs and ask them to contact and
advise the absentee.
b. Notify the contact person, recorded in the register,
through available means and request his/her assistance to
encourage the patient to return for treatment.
c. Send out messages through health workers who may
travel to the patient’s village for outreach health
programmes like EPI.
d. Communicate with the health extension worker or
community volunteers to assist in retrieving the patient.
e. Visit the home of the patient.
The above measures can be taken either in combination or
separately and all efforts must be exerted to ensure the
continuation of treatment.
10.11 Definitions of treatment outcomes
Treatment completed:
! A patient who has completed a full course of MDT within
the prescribed period.
Died:
! A patient who dies of any cause during the course of
MDT.
Default:
! A patient who has failed to collect more than three
(consecutive or cumulative) four-weekly (monthly) doses
of MDT.
Transfer out:
! A patient who has started treatment and has been
transferred to another health institution and for whom the

118
 treatment outcome is not known at the time of evaluation
of the results of treatment.
Care after release from treatment (RFT)
Ex-leprosy patients should be advised to visit or report to the
near-by health facility whenever they have complaints. Care to
this group includes:
! Management of neuritis.
! Provision of protective foot wears.
! Provision of vaseline ointment.
! Basic medications such as analgesics, antibiotics, eye
ointments etc.
These are provided to the patients free of charge if and only if
they are made available by the control programme. When this is
not the case, patients should be encouraged to buy by themselves.
All these care activities should be recorded in the RFT register
and some of them (like neuritis treatment and provision of
protective foot wears) should be reported quarterly.
10.12 COMPLICATIONS OF LEPROSY AND
THEIR MANAGEMENT
Leprosy reaction
Leprosy reaction is an immunological response to the bacillus.
Most of the problems related to leprosy (deformity and disability
resulting in stigma and suffering of the patient) are primarily
caused by the damage that results from leprosy reactions. Early
detection and adequate management of reactions are therefore
important activities.
Leprosy reaction is the appearance of symptoms and signs of
acute inflammation in the lesions of a leprosy patient. Clinically,
there is redness, swelling and sometimes tenderness of skin
lesions. There may be swelling, pain and tenderness of nerves,
often accompanied by loss of function. New lesions may appear.
There are two types of reaction:
1. Reversal Reaction (or type 1 reaction)

119
2. Erythema Nodosum Leprosum (ENL) or type 2 reaction
Both types of leprosy reaction can occur before the start of
treatment, during treatment and after release from treatment. Both
can be divided into mild or severe reactions. Only when the
reaction is severe, treatment with corticosteroids is necessary.
If the reaction occurs after Release From Treatment, the
differentiation with a relapse can be very difficult. Relapses,
however, occur very rarely.
1. Type I (reversal) reaction
a. Mild reversal reaction: signs and treatment
Mild reversal reaction is characterized by the presence of oedema
and erythema of skin lesions only. There may be mild fever and
some general discomfort. If there are any signs of neuritis such as
nerve pain or tenderness or loss of nerve function, the reaction is
no longer mild, and should be managed as a severe reaction.
The treatment of mild reaction is symptomatic with analgesics
such as aspirin and rest with sedatives.
The patient should be examined after one week. If there are still
signs of reaction, the treatment should be continued for another
week, after which the patient should be examined again. Check
for new nerve damage at every clinic attendance. If this has
occurred, the patient is suffering from a severe reaction and
should be managed accordingly. If the mild reaction continues for
longer than 6 weeks the patient should also be treated as suffering
from a severe reaction.
b. Severe reversal reaction: signs and treatment
A reversal reaction is considered severe and should be treated
with a course of prednisolone when one or more of the following
signs are present:
! Pain, or tenderness on palpation in one or more nerves, with
or without loss of nerve function.
! Change in VMT (including eye closure) of less than six
months duration. The change can be from strong to weak,

120
 from weak to paralyzed, or from strong to paralysed.
! Change in ST of less than six months duration. A change is
considered to be significant when any hand or foot has
increased loss of sensation at two or more points.
! A raised, red swollen patch overlying or around an eye.
! Red, raised and ulcerating skin lesions.
! Oedema of hands or feet.
! A mild reaction lasting more than 6 weeks.
Patients who present with one or more of the signs given above
and who do not present with any condition which requires referral
to hospital should be given ambulatory treatment with
prednisolone. Patients with nerve involvement should also be
advised to rest the affected limb.
2. Type II Reaction (Erythema Nodosum Leprosum: ENL)
Severe ENL: signs and treatment
An ENL reaction is characterized by the appearance of tender,
reddish skin nodules (erythema nodosum). It occurs in MB
leprosy only. ENL is considered severe if one or more of the
following signs are found:
! Appearance of ENL nodules with ulceration (ulcerating
ENL).
! Tenderness on palpation or spontaneous pain in (a) nerve
trunk(s).
! Loss of muscle strength and/or loss of sensation in eyes,
hands or feet, for less than 6 months.
! Painful eyes, with redness around the limbus cornea,
increased lacrimation, fixed narrowing (constriction) of the
pupil and diminishing vision (irido-cyclitis).
! Painful testicular swelling (orchitis).
! Painful swollen fingers (dactylitis).
! General condition: fever and malaise.
Patients may experience several episodes of ENL, one after the
other (recurrent ENL). MB patients may develop a reversal
reaction and an ENL reaction simultaneously. All patients with
severe ENL should be referred immediately with their clinical
records to hospital for treatment.

121
Ambulatory or hospital treatment
Prednisolone treatment of reversal reaction can be done in the
field (ambulatory) safely, provided that certain conditions are
excluded. Patients with severe ENL reaction, however, should
always be admitted as this may be a life-threatening condition.
For all patients with severe reversal reaction thorough history
should be taken and examination should be carried out, in order to
rule out the conditions which all require admission.

Criteria for admission

! Severe ENL reaction.

! Deep ulcer(s).
! Red and/or painful eye.
! Pregnancy.
! TB or any other severe infectious disease.
! Younger than 12 years of age.
! Recent history of peptic ulcer in the stomach or
duodenum.
! History of diabetes.
! General illness with fever.
! Patient who did not improve during a previous
course.
! Patient who improved during previous courses, but
who develops a reaction for the 3rd time.

Prednisolone is a potent corticosteroid drug. As the drug may also

affect various other conditions, always take the precautions set
out in the box below before prescribing a prednisolone course.

The dosage and duration of treatment is different for PB and MB

patients (table 13). Prednisolone is supplied in blister packs. Each
blister contains 2 weeks treatment at different strengths, so that
only one tablet is taken daily, in the morning after a meal. Patients
should be carefully educated on the requirements for successful
treatment and the risks involved in steroid treatment.
Conditions to be treated before starting prednisolone
treatment
122Appropriate treatment should be given for the following
concurrent diseases:

! Diarrhoea, with blood and/or mucus. If present, the

patient may suffer from dysentery (amoebic and/or
bacillary).
! Conjunctivitis and trachoma.
! Scabies.
! Worm infestations.
Ambulatory treatment of severe reversal reaction with
Prednisolone
Duration of treatment
Daily dose
MB PB (do not exceed 1 mg per kg
body weight)

4 weeks 2 weeks 40 mg

4 weeks 2 weeks 30 mg

4 weeks 2 weeks 20 mg

4 weeks 2 weeks 15 mg

4 weeks 2 weeks 10 mg

4 weeks 2 weeks 5 mg
Total 12
Total 24 weeks
weeks
STOP

Patients should collect a two weeks dose of prednisolone blister

from the health facility. It is important that the blister pack with
the correct dosage is given, according to the table above. Health
staff should inquire about problems and side-effects. If problems
or side-effects occur, the patient should be immediately referred
to the next higher health facility. If there are no problems or side-

123
effects patients should be examined (VMT and ST assessment) at
every clinic attendance.
The standard course of prednisolone needs adjustment for the
following:
a) Any patient in whom nerve function deteriorates during
the standard course or who does not show improvement
after 4 weeks of prednisolone. These patients should be
referred to hospital where higher dosages of prednisolone
will be given.
b) When a patient misses one blister of two weeks treatment.
In these patients, the condition should be assessed. If the
nerve problem still exists the dose of prednisolone due last
time should be given. If the condition for which
prednisolone was given is not present any more,
continuation of prednisolone should be with the dose
which would now be due.
c) If a patient fails to attend for 4 weeks or more and then
comes again, the condition should be assessed:

! If the condition is still present, the course of prednisolone

should be repeated, after thorough education of the
patient.
! If the condition has deteriorated, the patient should be
referred to hospital, with a full explanation about the
reason for referral.
When a patient has responded positively to a previous full course
of prednisolone, but the reaction re-occurs or the nerve function
deteriorates, then a second course of prednisolone can be
prescribed, provided there are no contraindications. The
examination procedures given above should be repeated.
A patient who has not responded positively to a previous course
of prednisolone (did not regain nerve function, or deteriorated
during the course, or within two weeks thereafter) should be
referred to hospital.
Patients who responded to prednisolone, but develop a reaction
for the third time should also be referred to hospital.

124
Management of severe reaction in the hospital
For hospitalized patients the initial dose of prednisolone will be as
high as 80mg in a daily single morning dose. The dose can be
tapered by 10mg every 2-4 weeks depending on the severity and
response to treatment until a level of 40mg is reached. Then
normal tapering off should recommence as indicated in the table
14. If at any dosage, the clinical signs of reaction fail to improve
after 5-7
days, or if nerve damage increases the prednisolone dosage
should be doubled for about 2 weeks. Then reduce step wise at
intervals of 2-4 weeks or so till it returns to the previous level and
then normal tapering off should then recommence.

Possible complications of Prednisolone

! Exacerbation of TB, of which no symptoms were
present at the time of starting treatment with
prednisolone. If TB is suspected, the patient should
be referred to hospital immediately.
! Signs of diabetes: thirst, excessive urination. Check
the urine for glucose and, if positive, refer the patient
to hospital immediately.
! Abdominal discomfort: the patient should be treated
with an antacid.
! Stomach bleeding: never administer prednisolone in
conjunction with aspirin or ibuprofen derivatives.
These drugs strongly increase the risk of stomach
bleeding when combined with prednisolone.

Prevention of (further) disability

All leprosy patients are at risk of developing disability at any time
(before, during and after treatment). Disability and deformity
primarily result directly or indirectly from function loss of
peripheral nerves supplying eyes, hands and/or feet.
It is, therefore, the task of all health staff working with leprosy
patients to preserve nerve function and to prevent further

125
deformity and disability in those cases with some irreversible
disability present at the time of diagnosis.
The best ways to prevent disabilities are:
! Early diagnosis and prompt treatment.
! Recognise nerve function impairment at the time of
diagnosis and start treatment with steroids if it occurred
recently.
! Train patients in self-care.
! Educate patients to recognise early signs of nerve function
impairment and to report this immediately.
! Recognise signs and symptoms of leprosy reactions with
nerve involvement and start treatment with steroids.
Training in self-care for patients with disability of eye, hand or
foot
Prevention of disability (POD) depends, to a very large extent, on
the patients themselves. Priority should be given to POD by
simple methods with emphasis on self-care, i.e. what the patients
can do themselves to prevent development and/or worsening of
disabilities. Therefore, the patient has to learn how to avoid the
complications of the disease. Patients should be trained
continuously by general health staff on how to prevent further
disability and deformity by self-care (section 4.2.1).
Aims of self-care:
1. To promote interdependence and independence among
leprosy patients living close together.
2. To promote the use of locally available self-care materials for
skin care and care of small wounds.
3. To encourage ex-patients to support each other to maintain
interest in life long care.
Protective footwear
Patients with sensory loss should wear protective footwear. For
the patient who does not have deformed feet but has anaesthetic
feet, almost any shoe that fits reasonably well is better than going
barefoot out of doors. Patients should collect canvas shoes,
embedded with micro cellular rubber (MCR), and other

126
orthopaedic appliances from MDT providing health facilities and
nearby orthopaedic workshops respectively. When a health
facility runs short of this canvas shoes supplied by the control
programme, patient should be encouraged to buy their own
protective foot wear from the local market. The protective
footwear should be not tight and with a soft inner layer.

Closed plastic shoes are not suitable as they enhance sweating,

blister, infection of the skin and underlying tissues.

Septic and re-constructive surgery

There are surgical procedures and techniques to correct or limit
the deterioration of deformities and disabilities. Sophisticated
surgical procedures and techniques like tendon transfer
operations, plastic surgery and others will be carried out at
ALERT, the specialized referral hospital, by highly qualified
surgeons.
Socio-Economic Rehabilitation (SER)
Rehabilitation may be defined as the diagnosis, treatment and
prevention of de-habilitation. De-habilitation due to leprosy can
cause a patient to lose his family and place in society, his work
and means of livelihood, or his self-respect.
The main goals of SER:
• Restoration of dignity.
• Increased economic independence.
• Reduction of stigma and the achievement of integration of
patients in the society.
Rehabilitation and reintegration of patients in society can only be
achieved by the sustained efforts of patients, the health worker
and the community as a whole. It is wise to focus on patients’
abilities rather than their disabilities. This can be achieved
more effectively through a community-based approach than
through the traditional institution-based approach.
The following points should be emphasised in rehabilitation:
• Rehabilitation should take place in the environment in which
the patient lives, which might require some adaptation of the
home.

127
• Health education should form an important component of
rehabilitation.
• Rehabilitation of leprosy patients should be an integral part of
general rehabilitation services.
10.13 PREVENTION OF LEPROSY
Chemo-prophylaxis
Unlike TB, there is no indication for chemoprophylaxis for
leprosy.
BCG
BCG vaccination has a documented and substantial effect in
preventing leprosy and is therefore considered as an important
tool for leprosy control.

10.14 RELAPSE
A patient should be diagnosed as a "relapse" if he/she has
previously completed a full course of MDT and returns 2 years
later with signs of active leprosy (of the same classification as the
original classification) requiring chemotherapy. Relapses after a
complete course of MDT are very rare. A patient who has MB
disease after being treated as a PB case is a mis-classification and
has to start MB treatment (section 3.2.5).
One or more of the following signs are indications of a relapse:
• Active skin lesions: appearance of new skin lesions.
increased erythema (redness) in previously existing lesions.
• New nerve lesions: enlargement and/or tenderness of one or
more nerves which were previously normal
Table 14: Differentiation between relapse and Reactions

Criteria Relapse Reaction

Development of signs Slow Sudden

Site New patches Over old patches

128
 Nerves usually, skin
Tenderness/ pain No
sometimes

Damage Slow Sudden and rapid

General condition Not affected Often fever, joint pain etc.

Duration after
> 2 years < 2 years
treatment completion

Relapses after the complete course of MDT are very rare

Diagnostic procedures and management of patients suspected

of having a relapse.
A patient who, after release from MDT, presents with one or more
of the above mentioned signs should be fully examined.
Suspected relapse cases must be referred to a health facility,
which has the expertise to diagnose and treat this condition. All
relevant documents must be sent along with the patient.

129
11 COMMUNITY PARTICIPATION IN TBL
CONTROL
11.1 Objectives
The accessibility of DOTS service is a key point for TB control.
The geographical DOTS coverage is 90% (it means that 90% of
Woreda are covered by DOTS service); the health facilities
coverage is 72.3%, hence, given the limited infrastructure in the
country, only 60% of the population has access to DOTS services.
The objectives of community participation are to develop
partnership between the health services and civil society aimed at
contributing to Tuberculosis, Leprosy and TB-HIV care.
Responsibility for TB control remains with the NTP, but general
health services become available as close as possible to the
community and the awareness and demand for service increases.
Community participation can also enhance:
- Support to patients throughout treatment until cure
- Patient, family and community education and prevention
- Case detection (referral of patients with chronic cough)
- Advocacy for political commitment to TB control
- Accountability of local Health Professionals to
communities
11.2 Program implementers of community-based care
The major implementers of community involvement in TBL and
TB/HIV control are:
# Health Extension Workers (HEWs)
# Community members and Community organizations
- The Government of Ethiopia, based on the experience gained
from Health Sector Development Programme I (HSDP I .1997 –
2000), has decided to introduce Health Service Extension Package
as a sub-component of Health Sector Development Programme II
(HSDP II 2002 –2005). This Health Service Extension
Programme (HSEP) aims at improving equitable access to
preventive essential health interventions through community
based health services, with strong focus on sustained preventive
health actions and increased health awareness. The health
extension service is being provided as a package focusing on
130
preventive health measures targeting households, particularly
women/mothers, at the kebele level. At present, more than 24000
HEWs have been trained and deployed, and are actually working
at community level. Most have been specifically oriented and are
carrying out activities concerning TB and TB/HIV prevention and
control.
- “Community” refers to “a group of people who have something
in common and will act together in their common interest”.
Various community members can play a role in community-based
care:
• Volunteer Health Promoters,
• Religious leaders,
• Traditional leaders and village leaders,
• Eddirs, Mohiber, Sembetei,
• women’s organizations,
• peer groups,
• family members ,
• influential members of the community,
• NGOs, Faith Based Organization FBOs.
The ways in which communities can potentially contribute to TB
control as part of TLCP activities are therefore activities, which
help to improve the community awareness on TB, the case
detection rate and, ultimately, the treatment outcomes.
Once initiated, effective community contribution to TBL and
TB/HIV care, especially Community based DOTS, requires a
strong monitoring and reporting system, access to laboratory
facilities, and uninterrupted drug supply, all components of
DOTS.

131
 11.3 IMPLEMENTATION OF COMMUNITY
BASED CARE
Steps to be taken when planning to increase community
contribution to TBL and TB/HIV care include:
- obtaining political commitment from local leaders and
health authorities;
- conducting a situational analysis that includes all TBL and
TB/HIV services and community contributions to TBL and
TB/HIV care;
- identifying all relevant partners that might play a role in
enabling community contribution to TBL and TB/HIV care,
especially the one already providing health or social support
within the community;
- specifying the roles and functions of each player in the
delivery system;
- establishing partner relationships between stakeholders in
the context of the existing health delivery system and
CBOs;
- select appropriate providers for well defined services;
- developing and conduct a training plan for all partners and
implementing it accordingly;
- designing and producing relevant tools tailored to the roles
of various partners;
- setting mechanisms for monitoring and evaluation of the
service;
- ensuring availability of a reliable recording and reporting
system;
- check access to laboratory facilities, and regular drug
supply;
- ensuring that community service is complementing but not
replacing TBL and TB/HIV programmes.
The implementation of Community TBL and TB/HIV services
calls for the involvement of trained and supervised community
members (Health Extension Workers and/or Community
Volunteers) to support TBL and TB/HIV control activities, in
particular:

132
! disseminate information and increase community awareness
on risks, transmission and prevention features of TB,
Leprosy and TB/HIV through meetings and conversation
within the community;
! contribute to early case detection by identifying TB and
Leprosy suspects (intensified case finding) and referring
them for examination;
! strengthen the operational linkage between the community
and the health institutions;
! trace absentees, motivate and refer them back to the
treatment health facility;
! provide counselling, support and may contribute to reducing
the stigma of the diseases (TBL and TB/HIV);
! refer patients who have adverse drug reactions.
Key activities should be documented and reported to the nearest
health facility, and supervised by the nearest health facilities. In
particular, the Health Extension Worker (HEWs) shoulders the
following responsibilities:
! developing activity plan and implementing it when it is
approved.
! keeping record of all TBL patients in the kebele.
! submitting regular monthly, quarterly and annual reports to
the Health Facility.
! supervising community volunteers who serve as community
service providers.
Given the increasing burden of TB/HIV co-epidemics,
community volunteers should be actively involved in TB/HIV
collaborative activities (prevention, care and support). The
community volunteers who give support to family members of the
sick are instrumental in the home-based care of TB/HIV patients.
The efficient implementation of community TBL and TB/HIV
care is supported by actual decentralization of the health care
system, adequate community resources, community
empowerment, and a functioning Health Service Extension
Programme.

Constraints in implementation of community TBL and TB/HIV

133
care are (i) poverty and basic needs requirements, which hinder
participation of community members in the care of their own sick
(ii) difficulties to maintain motivation and awareness, (iii)
financial constraints faced by community organizations.
Community health service is cheaper and more cost-effective than
facility-based care, especially hospital-based. However initial
resources are required for start up activities such as training of
care providers, setting up systems, patient follow up, supervision,
monitoring and evaluation. Managerial expertise is essential in
creating and maintaining links between the control programmes,
general health services and community care providers. Training
of community care providers is essential and should focus on a
limited number of activities. The community care providers
should always benefit from regular, frequent and supportive
supervision.
Community health care should be implemented in a phased
manner and the following points are to be considered:
- introduce the service in small scope, evaluate the results
and then, if successful, scale up.
- allow a sufficiently long period for any changes to be
adopted and to prove themselves.
- transfer management responsibility and authority.

Successful community based TBL and TB/HIV service calls for

mechanisms:
• to identify and mobilize the appropriate organizations;
• to take examples and evidences from community Dots
programs doing well;
• to develop links between TBL/TB/HIV control programmes,
general health services and the community organization(s);
• to train and supervise community members;
• to develop and introduce a recording and reporting system in
the community;
• to provide support to patients throughout their treatment until
cure

134
Community Based DOTS in Oromia Region

In East and West Harargae (Oromia Region), Community Based DOTS was
introduced in 2006. For increasing access to DOTS services and improve the
case detection, the community volunteers, health extension workers and other
community health workers hereinafter named Community DOTS Supporters
(CDS) were actively involved. CDS were trained to recognize TB symptoms
and refer the suspect TB patients to nearby health institution for sputum
examination, and to identify the adverse effects of anti-TB drugs. Through this
approach the case detection rate in East and West Harargae improved from
20.8% to 32.6 % after the introduction of Community Based DOTS.

Community DOTS supporters have the role to sensitize the community about
tuberculosis through delivering health education about the disease in public
gatherings and through house to house visit. Community DOTS Supporters
also trace individuals with symptoms of TB and motivate and convince them to
go to health facilities where sputum examination service is given. After the
patients are diagnosed to have TB, Community DOTS Supporters will directly
observe the patients treatment.

The Community DOTS supporters are constituted by Health Extension

Workers, malaria workers, family planning workers and community volunteers
depending on their availability in the individual Woreda. However, the vast
majority of CDS in this project are community volunteers. One CDS was
trained from each Kebele; one Kebele in average had 1,000 households. The
community volunteers were selected by the health workers in collaboration
with Kebele authorities. The CDSs were supervised by the health worker in the
health stations.

The CDSs received training in: suspect identification, diagnosis, treatment

schedule, follow-up, adverse effects of the drugs, delivery of health education.
The CDSs make regular house to house visits, in order to identify suspects and
give health education at public gatherings. They never handle anti-TB drugs
directly: the drugs are delivered to the patients and CDS make sure that the
patient takes the treatment correctly.

The CDS were provided with referral cards from health facilities (on which
stamp of the health station/centre is issued). As soon as the CDS identifies a
suspect s/he provides the filled and signed referral card to the suspect and urge
him/her to go to the nearby health facility for sputum microscopy. After the
sputum test, the patient reports back to the CDS and return the referral card that
states the outcome of the microscopy. The health facilities and the health
workers will treat suspects bearing the referral card differently to get the
sputum microscopy service immediately.

Essentially CDSs were selected voluntarily and no incentive was given for
them.
12 PUBLIC-PRIVATE MIX (PPM) IN TB CARE

135
Improving the DOTS coverage and increasing TB case detection
rate call for engaging all care providers in the country. Cognizant
of the current situation in Ethiopia, one of the strategies of the
national TB and Leprosy control program is to involve the private
sector in TB and TB/HIV control program.
The term ‘PPM DOTS’ has evolved to represent a comprehensive
approach to link all relevant health care providers for DOTS
implementation. It incorporates all forms of public-private (e.g.
government health office with not-for-profit private health
facility), public-public (e.g. hospitals, public health centers with
army, prison, etc) or private-private (e.g. traditional healers with
private-for-profit health facility) collaborations for the common
purpose of controlling TB in a community. This demonstrates that
virtually all types of potential health care providers fit within the
umbrella of PPM DOTS. However, global knowledge as well as
in-country experiences is still limited to a few types of providers.
At present, Ethiopia’s PPM model focused on for-profit private
providers, and service provision has started in Nov 2006 with 20
private health facilities as pilot project in Addis Ababa and
Oromiya region.
12.1 RATIONALE FOR PPM IN ETHIOPIA
• Quantitatively, the private sector plays a significant
growing role in the delivery of health care of Ethiopia
• The private sector contains a large pool of personnel that
could play an important role in increasing awareness and
detecting TB and other public health problems
• The private health care provision is increasingly
becoming dependable partner in Ethiopia and it is
advisable to extend its contribution in the era where
DOTS expansion is the strategy to successful TB
control.
• Standard of care (quality) among private health care
providers need to be addressed through formal
engagement of these providers and assessed.

136
 12.2 EXPERIENCE OF PPM ETHIOPIA

PPM program in Ethiopia has been implemented after holding

policy dialogue with different partners and stakeholders including
the private sector, preparation of PPM guidelines and rapid
assessment tool in consultation with nationally established
technical working group, training of private service providers, and
supply of anti-TB drugs, reagents and reporting formats.
The private health facilities involved in this pilot project are
reporting to their respective health office (since the 2000). Three
hospitals and eight higher clinics in Addis Ababa, and one
hospital and eight higher clinics in Oromia are engaged in PPM
program.
They already contribute to the national efforts to increase TB
Case Finding: these 20 private health facilities already reported
1,266 TB cases, out of which 262 (20.7%) are smear positives,
589 (46%) smear negatives, and 397 (31%) extra-pulmonary
cases.
Generally, the willingness and commitment of private health care
providers to care for TB patients is encouraging and this means
new opportunity to expand the service. However, inclusion of
more private health facilities in the scale up phase will put more
pressure on the public health structures for program monitoring.
Adequate capacity of Regional and Woreda health offices is
essential in monitoring PPM program in order to bring about the
desired impact of PPM at country level.

12.3 A STEP BY STEP APPROACH FOR SCALING

UP PPM DOTS

Practical guidelines have been developed and tested for the

implementation of PPM DOTS in Ethiopia: the approach outlined
is not a one-size-fit-all approach, but it is adaptable and can be
easily tailored to meet the specific needs and to address the
unique challenges of particular regions and sub regions.

The guidelines emphasize clearly defined roles, and recommend

137
close and collaborative relationship between the regional health
bureaus and private sector facilities.

Key responsibilities of the regional / woreda health offices:

! Supply anti-TB drugs free of charge with adequate
shelf life
! Establish a reliable system for re-supply
! Monitor, evaluate and serve as steward for the
program

Key commitments of private providers:

! Follow the national norms and standards include in
national manual for TB & TB/HIV
! Not sell or use TB drugs and supplies for other
purpose
! Report on program activities following FMOH
reporting format and system
! Communicate promptly to Woreda offices regarding
defaulters

138
 TEN KEY STEPS FOR SCALING UP TB & TB/HIV CARE IN
PRIVATE HEALTH FACILITIES IN ETHIOPIA

10. Monitoring
and Evaluation
9. Referral network

8. Supportive Supervision

7. Community Mobilization

6. Logistics management

5. Capacity Building (training)

4. Memorandum of Understanding
3. Rapid Needs Assessment

2. Site Selection

1. Consensus and Sensitization

139
13 ADVOCACY COMMUNICATION AND SOCIAL
MOBLIZATION (ACSM)
The purpose of ACSM is to help addressing four key challenges
in controlling TBL & TB/HIV:
• combating stigma and discrimination,
• empowering people affected by the diseases, and
disseminating adequate information
• mobilizing political commitment and resources.
• increase awareness and demand for services, thus
improving case detection and treatment adherence,
These challenges will not be met without greater prioritisations
and improvement in TBL & TB/HIV related communication
activities. Health education is neither a one-way, nor a one-time
undertaking, but a continuous process which should lead to a
better understanding, to a change in attitude and to action aimed
at coping with problems. Although DOTS/MDT solves part of
the problem of non-compliance, its success depends largely on
how effective health workers are in seeking and obtaining the full
co-operation of the patients and the community.
Target group for ACSM

Communication for TBL control program is dealing with

informing and creating awareness among the general public
about the diseases, and empowering people to take action.
Therefore, the main target for ACSM in TBL and TB/HIV
prevention and control are patients, their families, and the
community.

ACSM is a shared responsibility of the general health staff, the

patients and the communities.
Every health worker should be involved in ACSM activities

13.1 ACSM FOR PATIENTS AND SERVICE

PROVIDERS

Communication with patients about their disease and its

140
complications - e.g. leprosy self-care for prevention of
disabilities- is a continuous process. This process goes on as long
as the patient requires chemotherapy or, as in leprosy ‘released
from treatment’ (RFT), is at risk to develop further disability. The
health staff must be trained and motivated to ensure effective
communication with their patients.
Communication with patients should be performed in groups as
well as with individual patients. The education should never be a
one way approach (i.e., a lecture whereby one person gives a talk
to an audience).
A two-way communication flow should always be maintained.
Patients should be stimulated to give their comments,
communicate their feelings, ask questions and give suggestions.
Demonstrations should accompany the explanations and the
patients should be requested to practice any procedures with their
actions observed and encouraged accordingly.
Group education is important before starting chemotherapy in
order to explain the new treatment and the importance of regular
attendance. It is he key of adherence. Education in self-care to
leprosy patients with similar disability problems can also be done
in groups. Direct communication with the patients is the best way
to obtain feedback, to understand the problems patients face and
also to find possible solutions together.

141
 13.1.1 What a patient should know at the diagnosis
of TB, TB/HIV and leprosy
Tuberculosis, TB/HIV and Leprosy
! TB/Leprosy are infectious diseases caused by bacilli, not
by a curse or witchcraft
! With appropriate treatment TB and Leprosy are curable,
whereas HIV is manageable
! Tablets need to be taken daily, as prescribed, and at the
same time each day
! Usually TB patients will become non-infectious after two
weeks of the treatment
! Both HIV-positive and HIV-negative TB patients can be
equally cured from TB
! Drugs should never be given to anyone else
! The patient should encourage his/her household contacts to
have themselves checked
! Patients should be educated to use ABC (Abstinence,
Behavioural change, Condoms) methods to prevent
themselves from getting infected by HIV

TB specific messages
! For New patients in the intensive phase anti-TB drugs will
be taken every day for two months under direct
observation by an authorized person; drugs must be
collected every month for the next six months during the
continuation phase.
! For patients on Re-treatment, drugs will be taken every
day for three months and every other day for five months
under direct observation by an authorized person.
Leprosy specific messages
! MDT drugs must be collected from the clinic every 4
weeks on the clinic day
! Much of the damage that occurs to nerves and tissues
before the patient commences MDT cannot be reversed.
! In many patients, patches will remain even after the MDT
course is finished. The patches will disappear slowly in a
period of 1-3 years.

142
 What a patient should know about his/her drugs
! The colour and number of drugs that must be taken.
! The drugs must be taken in a single dose and must be kept
at home out of reach of children
! The unsupervised drugs can also be taken in the evening
just before going to bed in case of nausea after ingesting
them.
! Awareness of the common side effects of the drugs in
order to prevent interrupting the treatment, in particular
normal change in the colour of the skin or the urine. What
to do in case of more severe side effects must be clearly
explained.
! When the patient plans to travel he/ she should inform the
staff so that relevant arrangements can be made to avoid
treatment interruption.
! To inform the health staff when there is intention to move
to another area. The staff will then write a transfer letter
and give advice on where the patient should continue
treatment.
! To report to the staff if and when the condition worsens.
Leprosy specific messages
A patient on MDT should report to the staff as soon as one of the
following happens:
! Patches become red and swollen again.
! Sudden weakness of muscles is noticed.
! One or both of the eyes get red and painful.
! Pain in one of the limbs is noticed.
! Appearance of red, swollen, tender nodules in the skin.
When a patient is treated with prednisolone, he/she should know:
1. The side-effects of prednisolone, the need to report these
immediately
2. The danger of abrupt discontinuation of prednisolone
treatment.
3. If a patient develops rashes with severe itching he should
stop the treatment and report to the clinic immediately.

143
 13.2 THE TB/HIV CO-EPIDEMIC
Communication and social mobilization should address TB/HIV
co-infection, ‘the two diseases in one patient’. ACSM is a shared
responsibility of the general health staff, the patients, family
members, all stakeholders and the communities at large, aiming
at:
• Increased awareness and knowledge on the mode of
transmission, prevention and control of Tuberculosis
• Providing awareness and knowledge of the individuals,
families and communities on main symptoms and signs of TB
and promote early health care seeking behaviour.
• Enhancing awareness and knowledge on mode of HIV/AIDS
transmission and its prevention, treatment and care and
support for victims of HIV/AIDS and other STIs control
(ABC) and related methods and to facilitate behaviour change
• educating, motivating and helping HIV-positive clients,
without active TB, to accept IPT and HIV positive TB
patients to accept CPT and adhere to these
• educating, motivating and helping TB/HIV patients to adhere
to anti-TB and ART treatment
• Promoting awareness and knowledge on importance of
follow-up and the consequences of defaulting treatment
• Both HIV and TB are infectious diseases caused by virus and
bacilli, not by a curse or witchcraft.
• Other people may have also been infected by the bacillus and
may develop the TB disease. The patient should encourage
his/her household contacts to have them checked (for TB if
they develop cough for " 2 weeks).
• Educate and counsel HIV positive client to practise safe sex
and encourage to have his/her partner to have counselled and
HIV tested
• Advise and counsel the HIV positive client on the indication,
dosage and adherence, efficacy of IPT in preventing TB
disease, side effects and importance of follow-up.
• Advise and counsel the HIV positive TB patient on the
indication, dosage and adherence, efficacy of CPT in reducing
mortality due to opportunistic infections, side effects and
importance of follow-up.
13.3 LEPROSY PATIENT WHEN RELEASED FROM
144
 TREATMENT (RFT)

Leprosy reactions can develop after MDT and these reactions can
be effectively treated. Early reporting is absolutely essential to
prevent irreversible damage.
Patient should be adviced:

• To report to health facility when they notice new patches or if

old patches become thick and red.
• To report to health facility when they notice pain in their
hands and feet or red painful eyes, or new development of
loss of sensation and/or muscle strength.
The above symptoms may indicate that the disease has started
again, or that a reaction is taking place.

13.3.1 Education in self-care for patients with

disability of eye, hand or foot
The prevention of disability depends to a very large extent on the
patients themselves. Therefore, patients must learn how to avoid
the complications of the disease. Self care is intending:
1. To promote interdependence and independence among
leprosy patients living close together
2. To promote the use of locally available self-care
materials.
3. To encourage ex-patients to support each other to
maintain interest in life long care.
13.3.2 Care of the hands
Important rules for the prevention of insensitive hands:
Think: Is this material hot? Use an area of normal sensation
to test before touching with an insensitive hand.
Look: While working near hot materials, the eye is the
mother who watches the hand.
Take care: Use a cloth or padded handle during managing hot
materials.

145
 13.3.3 Care of the skin and feet
When the hands or feet have lost sensation it is important to
prevent them from becoming dry and cracked. For that:
1) Wash the feet and hands every evening after work
2) Soak the hands or feet in water for 20 minutes.
3) After soaking, scrape away any dead skin; do not use sharp
materials for scraping.
4) Oil the skin with Vaseline.
The following are important to prevent ulcers.
1) Protect feet that have lost feeling by wearing the right kind
of shoes, walk short distance and avoid walking on rough
ground.
2) Inspect your feet every night after washing them. Press on
pressure points of the foot. If you find any part which is red
or painful on pressure or swollen: these are danger signs
3) If ulcer starts developing, prevent it by not walking (rest).
13.3.4 Care of the eyes
1) In the early stage of eyelid weakness, daily exercise can
help. Exercise three times daily.
2) If the eyeball has no sensation, inspect your eyes every day.
Use a mirror to see if there are pieces of dust in the eye and
remove them with clean pieces of cotton.
3) At night, cover the eyes with an eye shield, a clean cloth or
the beds sheet.
4) If sunlight hurts the eye, wear an eyeshade or a hat with a
wide brim.
5) Wash eyes carefully every day to keep flies away.
13.4 THE PATIENT AND THE COMMUNITY
13.4.1 The patient and family members
Communication with family members should enable:
• Patient to get care and support from family members
• Counteract stigma related to TB, TB/HIV and Leprosy
• Identify other patients with early TB/Leprosy
Contacts of new PTB and leprosy patients are persons that have
146
been living in close contact with the patient (index case) and
thereby have an increased risk of having been infected with TB or
leprosy.
For operational reasons contacts are defined as: all persons that
are living together with the patient in the same household.
In the case of TB, all contacts aged under five years and among
those who are older only those having signs and symptoms
suggestive of TB should be examined.
In the case of leprosy encourage all newly diagnosed patients to
bring their household contacts for examination at the clinic. All
contacts should be examined as soon as possible after diagnosis of
the patient. In some circumstances it may be more effective to
undertake a visit to the household (e.g. if there are many who and
they live far away).
Before visiting the household:
! the general health staff must make an appointment with the
patient at a convenient time for his/ her contacts to be
present.
During the visit:
! briefly describe the disease (its cause, signs, symptoms,
treatment). Inform the contacts that there is a possibility that
they may have the disease or may develop it in the future.
! encourage those present to give sputum for smear
microscopy if they have symptoms suggestive of TB or skin
lesions (for leprosy).
! contacts without TB symptoms or skin lesions should be
advised to be on the lookout for TB symptoms or leprosy
skin lesions and report to the clinic if these occur.
! throughout the visit to the household encourage people to ask
any questions they may have.

147
 13.4.2 The community

ACSM activities should facilitate:

• Case finding: identifying symptomatic individuals and
sending them to health units;
• Treatment compliance: encouraging patients to take their
drugs regularly;
• Tracing defaulters: helping in tracing and convincing
defaulters to resume treatment;
• BCG vaccination: advising parents of infants to have the
infants vaccinated.

The content of communication to the patient, family members and

the community should basically be the same.

148
14 RECORDING AND REPORTING IN TB, LEPROSY
AND TB/HIV
14.1 INTRODUCTION
The quarterly reporting of statistics on patients diagnosed with
TB, leprosy and TB/HIV and the results of treatment is essential
for the assessment of the programme. Regular assessment is done
at the woreda, zonal, regional and national levels where
epidemiological and operational indicators for monitoring of the
TLCP are calculated and compiled. Quarterly reports are
completed according to the Ethiopian fiscal year. The reporting of
TB, Leprosy and TB/HIV collaborative activities will eventually
be integrated into the Health Management Information System
(HMIS). However, until the HMIS is fully functional, the
reporting of TBL and TB-HIV activities continues to be reported
through the program.
14.2 REGISTERS, RECORDS AND REPORTS
The recording and reporting forms and the instructions on how
these should be filled in are given in annex XII. The following
general principles apply to the TLCP in all areas of the country:
! The Health Centre (HC) and hospital usually the
diagnostic centres for a defined health service area (HSA),
are the focus of activities.
! All forms and registers are identical throughout the
country.
! Forms and registers are designed and used for TB,
Leprosy and TB/HIV collaborative activities so that a
minimum number of forms must be kept as much as
possible.
14.2.1 Tuberculosis and TB/HIV
Unit TB and TB/HIV Register
This is kept at each health unit providing TB or TB/HIV services.
There is space for recording patient identifications, the intensive
phase treatment, as well as the continuation phase. It also
provides space for recording information on TB/HIV
149
collaborative activities. Full address of the patient and his/her
contact person is required for tracing purposes.
14.2.2 Leprosy
Leprosy Patient Record Card
The front page of the leprosy patient record card is used for
recording patient identification, history of the disease process,
diagnosis and classification of leprosy as well as the nerve
function assessment and disability grade at the time of diagnosis.
The inner parts of the card provide space for follow up VMT and
ST examinations to be performed on regular basis for all patients
on treatment. The back-side (top half) of the card provides space
for recording the results of assessments of the disability and
overall condition of the patient at the time of completion of
treatment. The bottom half of the back-side of the leprosy patient
record card provides checklist for assessing the eligibility of the
patient for ambulatory steroid treatment and for the initiation and
recording of steroids. If a second course of steroids is required, a
second card can be used and attached to the first one.
This card allows the detection and treatment of neuritis (new
nerve damage). At each examination, one section of the card is
used to record the VMT/ST findings. These findings are then
compared with the last record, to detect any change, which is the
most important indicator of ongoing nerve damage. If new nerve
damage is detected, procedures for starting steroids should be
initiated. Each leprosy patient has to be examined for VMT and
ST at every visit. If a patient returns after completion of
treatment for any reason, VMT/ST should be done and the results
recorded in the next free section on the card.
Unit Leprosy Register
This is kept and maintained, like its TB counterpart, at every
health unit treating leprosy patients and it contains the patient
identifications and treatment details of every patient.

150
 14.2.3 Forms and registers used for both TB and
Leprosy
Request for sputum/skin smear examination
All suspect cases of pulmonary TB (cough # 2 weeks) and
doubtful cases of leprosy should be sent to the laboratory with this
form. When follow-up smears are done (routinely only for TB),
the unit TB number and the month of follow-up should be
recorded. When the form is returned, the Lab. Serial Number
should be recorded in the appropriate Unit register, alongside
other details of the patient.
Laboratory Register
It is used for recording TB and leprosy smear results. When
follow-up smears are done (routinely only for TB) the Unit TB
Number should be recorded in the Lab Register under the
appropriate column.
Referral and Transfer Form
This is printed with one side for TB and TB/HIV and the other
side for leprosy. It has three functions:
! Referral of patients diagnosed in one unit to initiate treatment at
another unit.
! Transfer of patients on treatment to continue their treatment at
another unit1.
! Referral of patients for further investigation and management2.

Quarterly Case-Finding Report Form

This quarterly report is used for both TB and Leprosy (front and
back pages). The report is compiled based on the information
available in the Unit TB and Leprosy Registers. This TB and

1 When a patient is transferred for continuation of treatment, the

receiving unit is expected to complete the lower portion of the transfer
form and send to the original health unit where the patient came from
after the result of treatment is known.
2 The health institution that received a case for further investigation and
management should use a new referral/transfer form to give complete
details of the management of the patient, when the patient is referred
back to the original health unit.
151
Leprosy case-finding quarterly report form will be functional until
the HMIS is in full swing at which time it will be replaced by a
different quarterly reporting form developed by the HMIS (the
HMIS quarterly reporting form is also presented in the annexes.
Quarterly Results of Treatment Report Form
This quarterly report is used for both TB and Leprosy (front and
back pages). The report is compiled based on the information
available in the Unit TB and Leprosy Registers. This TB and
Leprosy results of treatment quarterly report form will be
functional until the HMIS is in full swing at which time it will be
replaced by a different quarterly reporting form developed by the
HMIS (the HMIS quarterly reporting form is also presented in the
Annex 8, 12 HMIS TB, Leprosy & TB_HIV quarterly report
form).

Quarterly report on TB/HIV collaborative activities

This quarterly report is used for the reporting of TB/HIV
collaborative activities. The report is compiled based on the
information available in the Unit TB Registers, VCT registers as
well as Pre ART and ART registers. This TB/HIV collaborative
activity quarterly report form will be functional until the HMIS is
in full swing at which time it will be replaced by a different
quarterly reporting form developed by the HMIS (the HMIS
quarterly reporting form is also presented in the annexes.
Compilation and submission of quarterly reports on TB and
Leprosy case-finding and results of treatment as well as TB/HIV
collaborative activities
The information in the quarterly TB and Leprosy case-finding and
results of treatment as well as TB/HIV collaborative activities
report forms or in the HMIS quarterly report forms have to be
filled in completely and correctly. The responsibilities at the
different levels of the health system are explained below.
• The Health Facilities should compile reports, assess, analyse
and act on them before forwarding to the Woreda health
office or sub city health offices. The reports have to reach the
Woreda or sub city health offices within 3 days of the end of
the respective quarter.

152
 • The Woreda Health Offices should make sure that all health
facilities in their respective Woreda have submitted quarterly
TB, Leprosy and TB/HIV reports. The woreda health offices
should verify the reports for completeness, correctness and
consistency of information. They have to analyse the reports
and act on them accordingly before forwarding them to the
zonal health department/offices/desks. The Woreda health
offices should also send feedback to the health facilities every
quarter on regular basis. Furthermore, they have to make sure
that the reports have reached the zonal level within the
following 6 days.
• The Zonal Health Departments/offices/desks or sub cities
health offices should make sure that all Woredas or HFs (in
the case of AA) in their respective zones/subcities (in the case
of AA) have submitted the quarterly TB, Leprosy and
TB/HIV reports. The zonal health departments/offices/desks
or sub city health offices should verify the reports for
completeness, correctness and consistency of information.
They have to analyze the reports and act on them accordingly
before forwarding the zonal/sub city/special woreda
aggregated reports and copies of the woreda/HF (in AA) to
the regional health bureau. The zonal health
departments/offices/desks or sub city health offices should
also send feedback to the woredas or HFs (in AA) every
quarter on regular basis. Furthermore, they have to make sure
that the reports have reached the regional health bureau
within the following 7 days.
• The Regional Health Bureaus should make sure that all
zones/sub cities/special woredas in their respective region
have submitted the quarterly TB, Leprosy and TB/HIV
reports. The regional health bureau should verify the reports
for completeness, correctness and consistency of information.
They have to analyze the reports and act on them accordingly
before forwarding the regional aggregated reports and copies
of zonal/sub city/special woreda reports to the TLCT/FMOH
and HMIS-PPD of the FMOH. The regional health bureaus
should also send feedback to the zones/sub cities/special
woredas every quarter on regular basis. Furthermore, they
have to make sure that the reports have reached the Federal
153
 Ministry of Health within the following 5 days.
• The TLCT/FMOH should make sure that all regional
states and the two city administrative councils have submitted
the quarterly TB, Leprosy and TB/HIV reports. The
TLCT/FMOH should verify the reports for completeness,
correctness and consistency of information. TLCT/FMOH
has to analyze the reports and act on them accordingly before
disseminating information to all concerned bodies. The
TLCT/FMOH should also send feedback to the regions every
quarter on regular basis. Furthermore, TLCT/FMOH has to
make sure that the reports have reached at the Federal
Ministry of Health within three weeks of the end of the
respective quarter.

Patient Identity Card

This card, which contains personal information and the Unit TB
or Leprosy Number, is carried by the patient in order to inform
other medical personnel of his/her condition, in case of
emergencies and to record the next date for the clinic visit. It can
be written in the local language.
Quarterly TB and Leprosy Activity Report Form
Both pages of this form are to be completed at the end of every
quarter and sent to the next higher level along with the case-
finding and treatment outcome reports. The activities to be
reported using this form are training in TBL and TB/HIV control,
supervisory activities, DOTS-MDT service expansion, TBL
review meeting and POD activities (See annexes)
Care after RFT register
This register is used for the registration of leprosy patients who
were declared cured and presented back to the health facility with
different complaints. The register provides space for recording the
type of care given to the patient. The register is presented in the
annexes.

154
15 SUPPORTIVE SUPERVISION AND REVIEW
MEETINGS
Supervision aims at ensuring and improving quality,
effectiveness, efficiency of services provided; it should also
enhance competence and satisfaction of the staff engaged in TBL
prevention and control as well as TB/HIV collaborative activities
at all levels. Supervision consists of observation, discussion,
support and guidance. Therefore, it is an essential tool in the
management of staff and facilities and should be done on a
regular basis.
The overall aim of supervision is the promotion of continuous
improvement in the performance of the staff.
The immediate objectives of supervision are the following:
! To assure that TLCP and TB/HIV implementation
guidelines are properly implemented.
! To ascertain that TBL and TB/HIV care is provided and
recorded according to the instructions norms and
standards.
! To identify factors that may inhibit or enhance proper
implementation of the programme.
! To develop micro-plan with the health to improve staff
performance in TBL and TB/HIV service delivery.
! To motivate, train and support all health staff and sustain
high level working morale.
15.1 LEVELS OF SUPERVISION

15.1.1 Health facility level

Supportive supervision has to start from within the health facility.

The head of the health facility or any other designated person
should make sure that activities are carried out according to the
instructions outlined in the TBL and TB/HIV manuals. The heads
of the facilities or any other designated person should carry out
very frequent (preferably weekly) and regular visits to the TBL
clinics (units), VCT clinics and HIV chronic care units.
During his/her visit to all these units, the supervisor is expected to
155
observe how activities are carried out, check registers and records
as well as the quarterly reporting of activities and give guidance
and feedback. The supervisor is also expected to motivate,
encourage and support the staff actively involved in the provision
of DOTS/MDT as well as TB/HIV services. Hence, the health
facilities should not wait until supervisors from Woreda, zone,
regional health bureau or the central level to come and tell them
how they are doing.
15.1.2 Woreda (District) level

The Woreda health office is responsible to carry out TBL and

TB/HIV specific supportive supervisions visits in health facilities
and health posts (health extension workers) monthly on a regular
basis. Supportive supervision should always be carried out using
standardized checklist. During the visit of facility, he/she should
observe how activities are undertaken; check registers and records
as well as TBL and TB/HIV quarterly reports for completeness,
correctness and consistency of information. The supervisors
should encourage, motivate and support the General Health
Workers engaged in the TBL and TB/HIV service delivery.
During the supportive supervision, drugs and supplies should be
checked thoroughly. During the visits to the health posts, the
supervisors are expected to check the identification and referral of
TB and leprosy suspects to the health facilities. The supervisors
should encourage, motivate and support the HEWs to exert the
maximum effort to mobilize the community in the fight against
TB and leprosy as well as to intensify the identification and
referral of TBL suspects.
The planned/scheduled visits should preferably coincide with
fixed leprosy clinic days and the staff of the health facilities
should usually be informed about the visits beforehand.
The supervisory findings (strengths, weaknesses and problems)
and recommendations have to be discussed with the heads of the
health facilities visited and those health workers engaged in the
provision of TBL and TB/HIV services to try overcoming
obstacles and improving performances. The supervisors must
prepare comprehensive reports on their observations and findings
including recommendations and disseminate the reports to all
156
supervised institutions and all other concerned bodies.
15.1.3 Zonal level

The Zonal health departments/offices/ or sub-cities in Addis

Ababa are responsible to carry out TBL and TB/HIV specific
supportive supervision to Woreda health offices, health facilities
(GHWs) and health posts (health extension workers) monthly on
regular basis. Before supervision, the supervisor must get
previous information and reports concerning the health facility to
be supervised.
During the supervisory visit, he/she should observe how activities
are undertaken, check registers and records as well as TBL and
TB/HIV quarterly reports for completeness, correctness and
consistency of information. The supervisors should encourage,
motivate and support the staff engaged in the TBL and TB/HIV
program implementation. During the supportive supervision,
drugs and supplies should be checked thoroughly. During the
visits to the health posts, the supervisors are expected to check the
identification and referral of TB and leprosy suspects for
examination at the health facilities. The supervisors should
encourage, motivate and support the HEWs to exert the maximum
effort to mobilize the community in the fight against TB and
leprosy as well as to intensify the identification and referral of
TBL suspects.
The supervision has to be planned and communicated to the
institutions to be supervised well ahead of time.
The supervisory findings (strengths, weaknesses and problems)
and recommendations have to be discussed with the heads of the
institutions visited with the aim of overcoming obstacles and
improving performance. The supervisors must prepare
comprehensive report on their observations and findings including
recommendations and disseminate the reports to all supervised
institutions and all other concerned bodies. Supportive
supervision should always be carried out using standardized
checklist (See annexes).
15.1.4 Regional level

The regional health bureau is responsible to carry out TBL and

157
TB/HIV specific supportive supervision to zones, sub cities,
woreda health offices, health facilities (GHWs) and health posts
(health extension workers) monthly on regular basis. During the
supervisory visit, the supervisor should observe how activities are
undertaken, check registers, supervision reports and records as
well as TBL and TB/HIV quarterly reports for completeness,
correctness and consistency of information. The supervisors
should also encourage, motivate and support the all engaged in
the TBL and TB/HIV program implementation. During the
supportive supervision, drugs and supplies should be checked
thoroughly. During the visits to the health posts, the supervisors
are expected to check the identification and referral of TB and
leprosy suspects for examination at the health facilities. The
supervisors should encourage, motivate and support the HEWs to
exert the maximum effort to mobilize the community in the fight
against TB and leprosy as well as to intensify the identification
and referral of TBL suspects.
The supervision has to be planned and communicated to the
institutions to be supervised well ahead of time.
The supervisory findings (strengths, weaknesses and problems)
and recommendations have to be discussed with the heads of the
institutions visited with the aim of overcoming obstacles and
improving performance. The supervisors must prepare
comprehensive report on their observations and findings including
recommendations and disseminate the reports to all supervised
institutions and all other concerned bodies.
Regional health bureaus as much as possible should adhere to
monthly and regular TB, Leprosy and TB/HIV supportive
supervision to zones, sub cities, woredas, health facilities and
health posts under their jurisdiction for the sake of ensuring
quality and standard of TBL and TB/HIV service provision.
Supportive supervision should always be carried out using
standardized checklist.
15.1.5 Central level

TB and Leprosy Control Team (TLCT) of the FMOH should

supervise every region at least two times per year. The aim of the

158
supervisory visit is to identify strengths, weaknesses, problems
and seek solutions jointly with the respective health bureaus. The
supportive supervisory is also important to provide guidance and
support to the regional TB and Leprosy prevention and control
program. The supportive supervision from the federal ministry
should be able to reach zones, woredas and HFs as well as health
posts that implement TB, Leprosy as well as TB/HIV activities.
Using the standardized supervision checklist, adequate
information are to be collected; registers, reports and other
relevant records have to be reviewed; and drugs and supply
situation is thoroughly checked. At the end of the visit, the
supervisory team discusses its findings (strengths, weaknesses
and problems) and workable recommendations with the heads of
the bureaus, zonal and woreda health offices, in order to
implement an effective control program. Following the visit, the
supervisory team should send supervision report to all supervised
levels.
15.2 SUPERVISION CHECKLIST AND REPORTS
In order to carry out meaningful supervision in a systematic
manner, supervisors at all levels should use comprehensive and
standardized supervision checklist for supervision of TLCP
management levels and the health facilities.
Before each visit the supervisor should review the assessment
made during the last visit, corrective action taken and features that
should demands special attention during the current visit.
After each supervisory visit the supervisor (supervisory team) has
to discuss strengths, weaknesses and problems identified, and
recommendations with the heads of health bureaus, and TBL
experts to make the control program successful. At the end of
each supervision visit, supervised institutions should be provided
with a supervision report and the supervisor him/herself must help
resolve blockage originated at various levels of the health system.
15.3 REVIEW MEETINGS
Review meetings organized at various levels create a very good
opportunity to review the status of programme implementation,
159
achievements and challenges and came up with workable
solutions for the problems and challenges encountered. They are
key element for program management.
Furthermore, review meetings are forums for exchange of ideas
and experiences among the health professionals and programme
coordinators involved in the implementation and coordination of
TB, Leprosy and TB/HIV activities. In these meetings,
programme coordinators from the next lower levels will present
activity reports of their respective area, including major
achievements and challenges/constraints encountered during the
period under review.
Review meeting is also a very good forum to convey new
developments to the frontline health workers and coordinators
that are actually executing programme activities on the ground.
Besides, such meetings create additional opportunity to verify TB,
Leprosy and TB/HIV data.
Given the size of the country, it is crucial to conduct TB review
meetings at Zonal, regional and central level on regular basis:
Zonal/sub city level review meetings with heads of the Woreda
health offices, Woreda CDC coordinators and relevant health staff
from TB diagnostic centers in attendance should be held twice a
year. Activities taking place at Woreda (district) level will then be
brought forward to the regional review meetings through zonal
health departments/offices/desks/sub city health offices.
Regional review meetings should also be held twice a year. The
regional coordinators in turn bring forward the achievements and
challenges with recommendations in their respective area at a
central level review meeting which is attended by officials of
RHBs, TB and Leprosy control teams and other relevant staff of
the RHBs, partners and all other stake holders of the program.

160
16 SUPPLIES AND LOGISTICS
It is very important to ensure that every health unit involved in the
prevention, diagnosis and treatment of Tuberculosis, Leprosy &
TB/HIV has an adequate and uninterrupted supply of drugs,
laboratory reagents and equipment in order to achieve sustainable
program implementation.
To ensure availability of sufficient amount of drugs there must
be:
• Accurate inventory records with clear responsibilities.
• Timely requisition of drugs and laboratory supplies.
• Adherence to the current method of calculating drug
requirements.
• Decentralized drug storage in adequate conditions.
• Well-defined responsibilities for the various activities
and steps.
• Regular communication between the pharmacy and
TBL and TB/HIV sections.

16.1 Procurement, storage, distribution and use of drugs

& consumption reporting
The flow of drugs and laboratory supplies follows the existing
national system for handling such supplies at all levels.
16.1.1 Procurement
TB and leprosy drugs procurement will be done in a timely
effective manner if and only if the regional TBL team members
have send on time the quarterly reports, stating caseload, drug and
laboratory supplies consumption and available stocks.
The stock available at every region should be determined before
new procurement procedure starts
Quantity of drugs and laboratory supplies to be procured for a
given period is based on:
• The total caseload reported;
• The number of TB case increment due to HIV prevalence;
• The current stock available;
• The need for buffer stock maintenance at different levels;
161
• Scale up or planned expansion;
• The consideration of contingency for depletion of buffer
stocks;
• Budget allocated for drugs and laboratory supplies.
16.1.2 Storage and Distribution
TLCP will prepare national distribution plan as soon as the
quarterly case reports are submitted from regions or federal health
institutions on the basis of the stock available at central store and
at regional level.
The amount of drugs and supplies to be distributed to the regions
and peripheral levels is determined by the number of patients
registered during the previous quarter, the replenishment of
peripheral stocks (see Table below) and must be adapted to
findings of field supervisions. Then distribution order is prepared
with protocol letter to PSLD/PHSDA who manages the central
stock with a copy to all regions considered in the distribution. The
method to calculate the drug requirements is presented in annex 7.
Table 15. Recommended stocks of drugs and supplies at
different levels of the health system
Order- and supply
Level Buffer Stock
frequency

Central yearly 1 year

Regional 6-monthly 3 months

Zonal quarterly 1 months

Woreda quarterly 1 months

Health Facility quarterly 1 months

At each level of the health system the issuance should be

governed by first-in first-out (FIFO) and first-expire-first-out
(FEFO) principles.
16.1.2.1 Operational rules for shelf life of TB drugs

The shelf life of TB drugs is limited. In order to avoid wastage

162
due to expiry, the following steps should be taken:
Central level:
! Drugs and medical supplies procured should be assured to
have at least 5/6 of their shelf-life when they arrive at the
central store.
! Periodic revision of the issuance and consumption of
drugs by the Regions.

Regional, Zonal, Woreda and Health Facility Levels:

! Ordering of drugs and supplies should be based on proper
quantification/consumption.
! If there is overstocked item with a shelf life of less than 6
months, it has to be immediately reported to the next
higher level.
! The drug utilisation pattern of health institutions needs to
be regularly monitored.

16.1.2.2 Ordering of drugs and medical supplies

Ordering of drugs and medical supplies for regional, zonal and
Woreda/health unit stores is based on the quarterly case
notification report and stock balance compiled by the RTLT or
ZTLE in collaboration with the pharmacy unit (see annex).
16.1.3 Rational use of drugs
Patients must receive medications appropriate to their clinical
needs, in doses that meet their own individual requirements, for
an adequate period of time free of charge.
Rational use of drugs implies promotion of rational prescribing,
ensuring good dispensing practice and encouraging appropriate
drug use by the patient and the community at large. This should
be part and parcel of programmatic activities at each and every
level.
16.1.4 Drug Consumption Reporting
This is the most important tool for TB and Leprosy drug supply. It
generates information on drug consumption pattern (monthly,

163
quarterly, yearly), current inventory and expiry status and exact
time when to order or procure. It also helps to monitor the rational
use of TB and Leprosy drugs.
For complete reporting of TB and Leprosy drugs consumption,
health facility, woreda, zonal and regional level TLCP formats are
available from TLCT and the respective RHBs. This report
should be submitted attached with the drug request forms.Flow
of drug consumption and available stock reporting:

Health Facility

Monthly

Woreda Health Office

Quarterly

Zonal Health Department

Quarterly

Regional Health Bureau

Quarterly

TLCT
16.1.5 Records and forms
The following records and forms are used for drugs and
laboratory supplies:
1. All government Vouchers (models) used for ordering,
receiving and issuing.
2. Stock card records and Bin cards.
3. Health facility level drug consumption reporting format.
4. Woreda level drug consumption reporting format.

164
5. Zonal level drug consumption reporting format.
6. Regional drug consumption reporting format.
7. Quarterly drugs and laboratory supplies order forms.

Items No 3-7 are supplied by PSLD/FMOH.

16.1.6 IEC/BCC materials
IEC/BCC materials are produced and distributed from TLCT to
regions. RTLTs should therefore distribute these materials on
time to zones, zones to woredas and woredas to health facilities.
Funds at times are also allocated for regions so that they can
produce IEC/BCC materials in local language and distribute it
accordingly. The distribution of IEC/BCC materials should be
made on time and the amount distributed to the next level should
be well documented. It is the responsibility of all parties involved
at all levels to properly use the IEC/BCC materials for the
intended purpose.
16.1.7 Supply of formats and registers
The Federal Ministry of Health TLCT will revise if there is a need
and prepare the printing and distribution order of all formats and
registers used by the control program. The share of each region is
determined by TLCT/FMOH and all regions collect their share at
PSLD and distribute down to zones, woredas and health facilities.
The distribution of formats and registers should be governed by
the rules and regulations of property administration.

16.2 Responsibilities
It is the responsibility of the TBL Team members and pharmacy
unities at all levels to:
! Keep sufficient stock of supplies;
! Order new supplies in time and safe-guard timely
distribution;
! Check the shelf-life of the drugs and take necessary
action;
! Keep up-to-date record and report on supplies received
and distributed;

165
 ! Promote and ensure rational prescribing, dispensing and
use of drugs.
According to the national Logistics master plan drug and
laboratory supplies distribution will be handled by PHARMID up
to Zonal level. The National TBL & TB/HIV control program will
adapt the opportunity when the program become fully on board,
till then Drug procurement will remain the sole responsibility of
the PSLD/FMoH after getting quantification and official
procurement request from the national TBL control
program/FMoH.
16.3 Quality check and quality control
! It is the responsibility of the procuring department or
Agency to procure quality drugs with all recommended
steps in WHO prequalified companies but DACA will
ensure drug registrations, onsite inspection at port arrival
and sample analysis and report the result to the National
TBL program/FMoH.
! Regions, Wordas and Health Facilities are encouraged to
report immediately if they face quality complains from
patients, health care staffs and store workers.
! Central referral and Regional/sub regional laboratories are
responsible to prepare the reagents with standard
procedure for periphery laboratories and regularly
implement EQA.
! Drug and reagent quality assessment conducted by
different parties in the country will be considered as an
input for the program.

166
ANNEX 1: DUTIES AND RESPONSIBILITIES OF THE
DIFFERENT LEVELS IN THE HEALTH SYSTEM
National level

The TLCT at the FMOH is responsible for developing guidelines,

soliciting and co-ordinating external resources, providing
technical assistance to the Regional Health Bureaus (RHBs), and
monitoring the programme performance in accordance with the
national guidelines.
Regional level
Regional TBL Team/Unit (RTLT/U) is responsible for the
planning, guidance and supervision of TB, TB/HIV and leprosy
control activities in the Region.
Zonal level
The Zonal TBL Expert (ZTLE) is responsible for the planning,
guidance and supervision of TB, TB/HIV and Leprosy prevention
and control activities in the Zone.
District (Woreda) level

The Woreda TBL expert keeps the TB, TB/HIV and Leprosy
registers and provides guidance and supervision to the general
health staff that are responsible for implementation of the TB,
TB/HIV and leprosy control activities.
Health facility level
Health Posts
Health posts provide health education, refer TB suspects for
investigation and collect sputum smears (if appropriate), refer
leprosy suspects, give BCG vaccinations, retrieve
absentees/defaulters.
Health Centers
Health Centres and selected health stations (diagnostic centres)
carry out all activities as health posts, provide microscopy
services for sputum and skin smear examination, provide SCC for
TB and MDT for leprosy, diagnose and treat reactions and other
167
complications, carry out TB/HIV collaborative activities, refer to
higher level Smear negative and EPTB patients, provide support
to health post and health station staff, keep patient record cards
and manage drugs stock.
Hospitals
Hospitals carry out activities as health centres, provide referral
services for diagnosis and treatment and provide in-patient
services.
Functions of laboratories at various levels

Peripheral laboratory (primary role - service provision)

All basic services of a laboratory with special emphasis to those listed
down
Technical:
• Preparation and staining of smears
• Ziehl-Neelsen microscopy and recording of results
• Internal quality control
Administrative:
• Receipt of specimens and dispatch of results
• Cleaning and maintenance of equipment (microscopy)
• Maintenance of laboratory register
• Management or reagents and laboratory supplies

Regional Referral laboratory (primary role - quality control)

All basic services of a laboratory with special emphasis to those listed
down
Technical:
• fluorescence microscopy (optional)
• digestion and decontamination of specimens
• culture and identification of M. tuberculosis
• preparation and distribution of reagents for microscopy in peripheral
laboratories
Managerial:
• training of microscopists (laboratory technicians)
• support and supervision of peripheral staff with respect to microscopy
• quality improvement and proficiency testing of microscopy at
peripheral laboratories

168
National Referral laboratory (primary role - capacity building)

All basic services of a laboratory with special emphasis to those listed

down
Technical:
• drug susceptibility testing of M .tuberculosis isolates
• identification of mycobacteria other than M .tuberculosis
Administrative:
• technical control of and repair services for laboratory equipment
• development and dissemination of guidelines on tuberculosis
diagnosis , supervision and quality assurance
• collaboration with the central level of the National Tuberculosis
program in defining technical specification for equipment, reagents
and other materials and estimate equipment and laboratory materials
for the program budget
Managerial:
• training of regional referral laboratory staff in bacteriological
technique and their support activities; training, supervision, quality
assurance, safety measures and equipment maintenance
• Supervision of regional referral laboratories regarding bacteriological
methods and their support (training & supervision) to the periphery
laboratories
• Quality assurance in microscopy and culture performed at regional
referral laboratories
Research and surveillance:
• Organization of surveillance of primary and acquired mycobacterial
drug resistance
• Operational and applied research with the requirements and needs of
National Tuberculosis Control Program

169
ANNEX 2: ORGANOGRAM OF TLCP

Ministry of
Health

Regional Disease Prevention

and Control
Health Bureau
Department

Zonal Health TB and Leprosy

Desk Control Team

Woreda
RTLCT
Health Office

WTLE
ZTLE

Health
Facility

= Technical Supervision and Support

= Administrative Authority

170
ANNEX 3: DIAGNOSTIC ALGORITHMS FOR
PULMONARY TB AND EXTRA PULMONARY TB

Patient with symptoms suggestive of TB

Sputum microscopy for AFB

2 or 3 positive 3 negative smears
(three samples)

Only 1 positive

1 or 2 positive Examine 2 additional Both negative

sputum samples

Treat with non-specific broad-spectrum

antibiotics (excluding anti-TB drugs and
fluroquinolones) for 7-10 days

No improvement Review after 2-4

weeks

1-3 positive* * Repeat sputum All negative

microscopy (three
samples)
Improved

Chest X-ray
and physician’s judgment

No
Smear- Smear- Tuberculosis: No
positive negative Treatment Tubercul
Pulmonary Pulmonary based on osis
TB** TB clinical
evaluation

171
 * If initially all three smears are negative but after antibiotics
only one repeated smear appears positive, it is advised to carry
out two additional smears. If one or both are positive, proceed
with TB treatment. If both are negative, proceed with a chest
X-ray and evaluation for conditions other than TB.
** If the patient has never been treated before, register and treat as
a new PTB smear positive patient. If the patient has been
treated before, register for re-treatment regimen.

172
 a. The danger signs include anyone of: respiratory rate >30/min, fever>39ºC,
pulse rate >120/mm and unable to walk unaided
b. For countries with the adult HIV prevalence rate >1% or prevalence rate of
HIV among TB patients >5%
c. In the absence of HIV testing, classify HIV status unknown into HIV positive
depends on clinical assessment or national and/or local policy
d. AFB positive is defined as at least one positive and AFB Negative as two or
more negative smears.
e. CPT=Co-trimoxazole preventive therapy.
f. HIV assessment includes HIV clinical staging, determination of CD4 count if
available and referral for HIV care
g. The investigations with in the box should be done at the same time wherever
possible in order to decrease the number of visits and speed up the diagnoses.
h. Antibiotics (except fluoroquinolones) to cover both typical and atypical
bacteria should be considered
i. PCP: Pneumocystis carinii pneumonia
j. Advise to return for reassessment if symptoms occur

173
a. The danger signs include anyone of: respiratory rate >30/min, fever>39ºC,
pulse rate >120/mm and unable to walk unaided
b. The investigations with in the box should be done at the same time wherever
possible in order to decrease the number of visits and speed up the diagnoses.
c. For countries with the adult HIV prevalence rate >1% or prevalence rate of
HIV among TB patients >5%
d. Antibiotics (except fluoroquinolones) to cover both typical and atypical
bacteria should be considered
e. PCP: Pneumocystis carinii pneumonia
f. In the absence of HIV testing, classify HIV status unknown into HIV positive
depends on clinical assessment or national and/or local policy
g. AFB positive is defined as at least one positive and AFB Negative as two or
more negative smears.
h. Reassessment for TB includes AFB examination and clinical assessment

174
175
ANNEX 4: MANAGEMENT OF ENLARGED
LYMPHNODES

ENLARGED LYMPH NODES

LYMPH NODES ARE LYMPH NODES ARE MOBILE,

FIRM / HARD and
SOFT AND FLUCTUANT
APPEAR FIXED

REFER PATIENT EXTRA- INGUINAL

FOR BIOPSY INGUINAL SITE
SITES

SIGNS AND/OR REFER TO

SYMPTOMS OF ACTIVE OPD OR STI
TB CLINIC

BROAD-SPECTRUM
ANTI-BIOTICS FOR SPUTUM AFB x3
NO YES
3 WEEKS + CLINICAL
INVESTIGATIO
N
REVIEW AFTER 4-8 WEEKS

IMPROVED CONDITION SAME OR WORSE

INVESTIGATE FOR OTHER SITES OF

DISCHARGE
ACTIVE TB

PRESENT ABSENT

INITIATE ANTI-TB TREATMENT REFER PATIENT FOR

BIOPSY

176
ANNEX 5: MANAGEMENT OF LEPROSY RELATED
COMPLICATIONS
1. EYES

Lagophthalmos
• Treat with a course of steroids, if the episode is acute or
recent (less than 6 months).
• Teach blinking exercise.
• Prevention of drying, especially during sleep by using eye
ointment.
• If corneal sensation is impaired, the patient should be referred
to a physician.
Iridocyclitis
• Give aspirin, apply 1% atropine drops and steroid ointment,
cover the eye and refer.
Corneal ulcer
• Apply antibiotic ointment, cover eye and refer.
Sudden change in visual acuity
• Refer
2. HANDS
Insensitive hand
• Daily inspection.
• Use protective gloves/clothing and cooking pots with wooden
handles.
Injury
• Clean wound and apply dressing.
• Advise rest or immobilize affected part with splint.
• Teach how to protect hand.
Cracks and fissures
• Teach patient to soak the hands and apply oil regularly.
Stiff joint
• Teach exercises and advise massaging with oil.
Burns

177
• Apply clean dressing.
3. FEET
Insensitive feet
• Daily inspection.
• Avoid long distance walking.
• Use protective footwear.

Cracks and fissures

• Teach patients to soak feet and apply oil regularly.
Blister on sole or between toes
• Dress blister with clean cloth.
• Apply cotton wool and bandage.
• Rest, if necessary use crutches for walking.
• Elevate limb.
Ulcer
• Clean and apply antiseptic dressing.
• Rest.
• If no improvement, refer.
Sudden foot drop
• Bed rest and immobilize the affected limb.
• Give full course of steroids

178