Consolidated Guidelines For Hiv Care in Ghana

CONSOLIDATED
GUIDELINES FOR HIV

CARE IN GHANA
Test, Treat & Track
October 2022
Consolidated Guidelines for HIV care in Ghana 1

CONTENTS
ABBREVIATIONS /ACRONYMS 8
ACKNOWLEDGEMENT 11
FOREWORD 14
INTRODUCTION 16
SUMMARY OF UPDATES 20
CHAPTER ONE
HIV TESTING AND COUNSELLING SERVICES (HTS) 25
1.1 HIV TESTING AND COUNSELLING:
GUIDING PRINCIPLES 26
1.2 PRE-TEST INFORMATION AND EDUCATION 32
1.3 POST-TEST COUNSELLING AND EDUCATION 33
1.4 HIV TESTING AND COUNSELLING APPROACHES 34
1.5 PROVISION OF HTS SERVICES IN GHANA 36
1.6 COUPLE AND PARTNER HIV COUNSELLING
AND TESTING 38
1.7 SOCIAL NETWORK-BASED APPROACH 39
1.8 TESTING AMONG INFANTS AND CHILDREN 39
1.9 DISCLOSURE OF HIV STATUS TO A CHILD 41
1.10 HIV TESTING AND COUNSELLING AMONG
ADOLESCENTS 42
BLOOD DONORS 43
KEY AND AT RISK POPULATIONS 43
1.13 HIV SELF-TESTING (HIVST) 43
1.14 HIV TESTING ALGORITHM FOR NON-PREGNANT
POPULATIONS IN GHANA 46
2 Consolidated Guidelines for HIV care in Ghana

CHAPTER TWO
LINKAGE TO CARE AND OTHER SERVICES 49
2.1 REFERRALS AND LINKAGES TO OTHER SERVICES 51
CHAPTER THREE
INITIATION INTO HIV CARE 52
CHAPTER FOUR
ANTIRETROVIRAL THERAPY 57
4.1 GOAL 58
4.2 RECOMMENDED ANTIRETROVIRALS (ARVs) IN GHANA 58
4.3 CONSIDERATIONS FOR ART REGIMEN FOR
ADULTS (20 YEARS AND ABOVE) AND
ADOLESCENTS (10 TO 19 YEARS) 63
4.4 CONSIDERATIONS FOR ART REGIMEN FOR CHILDREN 68
4.5 RECOMMENDATIONS FOR SPECIAL CONDITIONS 77
4.6 DRUG TOXICITY 82
4.7 DRUG-DRUG INTERACTIONS 83
4.8 GRADING OF ADVERSE EVENTS 84
4.9 GUIDING PRINCIPLES IN THE MANAGEMENT OF ARVS
ADVERSE EVENTS 84
CHAPTER FIVE
ELIMINATION OF MOTHER-TO-CHILD TRANSMISSION (EMTCT) 86
5.1 EMTCT GUIDING PRINCIPLES
5.2 GUIDING PRINCIPLES FOR HIV TESTING FOR EMTCT 91
5.3 HIV TESTING STRATEGIES FOR EMTCT 91
5.4 OTHER OPPORTUNITIES FOR HIV TESTING AND
COUNSELLING 93
5.5 HIV TESTING ALGORITHMS FOR EMTCT 94
5.6 CARE FOR PREGNANT WOMEN 99
5.7 POST PARTUM CARE OF HIV INFECTED WOMEN,
WOMEN OF UNKNOWN STATUS AND THE NEWBORN 105
5.8 EMTCT LOGISTICS MANAGEMENT 115
5.9 MONITORING AND EVALUATION 115
CHAPTER SIX
MONITORING OF CLIENTS ON ART 117
6.1 CLINICAL MONITORING 117
6.2 LABORATORY MONITORING 120

CHAPTER SEVEN
CHANGING OR INTERRUPTING THERAPY 125
7.1 INTERRUPTION OF THERAPY 125
7.2 TREATMENT CHANGES 125
CHAPTER EIGHT
OPPORTUNISTIC INFECTION MANAGEMENT AND
PROPHYLAXIS FOR HIV-RELATED INFECTIONS AMONG ADULTS,
ADOLESCENTS AND CHILDREN 130
8.1 MANAGEMENT OF OPPORTUNISTIC INFECTIONS 130
8.2 PROPHYLAXIS FOR HIV-RELATED INFECTIONS
AMONG ADULTS, ADOLESCENTS AND CHILDREN 133
8.3 FLUCONAZOLE PROPHYLAXIS 138
CHAPTER NINE
MANAGING ADVANCED DISEASE 139
CHAPTER TEN
PRE AND POST EXPOSURE PROPHYLAXIS 145
10.1 PRE-EXPOSURE PROPHYLAXIS (PrEP) 145
10.2 POST EXPOSURE PROPHYLAXIS (PEP) 151
CHAPTER ELEVEN
SUPPLY CHAIN MANAGEMENT AND RATIONAL USE OF
HIV COMMODITIES 167
11.1 SUPPLY CHAIN MANAGEMENT 167
CHAPTER TWELVE
HIV DATA MANAGEMENT 176
12.1 HEALTH INFORMATION MANAGEMENT SYSTEM (HMIS) 177
CHAPTER THIRTEEN
HIV CARE DURING COVID-19 AND FUTURE OUTBREAKS 180
CHAPTER FOURTEEN
HIV AND NONCOMMUNICABLE DISEASES 183

14.1 CONSIDERATIONS FOR MANAGING NCDS IN PLHIV 184
14.2 MENTAL HEALTH AMONG PEOPLE LIVING WITH HIV 185
CHAPTER FIFTEEN
HIV AND CERVICAL CANCER 187
15.1 SCREENING AND TREATMENT RECOMMENDATIONS
TO PREVENT CERVICAL CANCER IN PERSONS LIVING
WITH HIV 188
APPENDIX 1
CLINICAL STAGING OF HIV/AIDS FOR ADULTS AND
ADOLESCENTS (≥15YRS) 198
APPENDIX 2
WHO CLINICAL STAGING OF HIV AND AIDS FOR INFANTS AND
CHILDREN 200
• A2.1 PERSONS AGED UNDER 15 YEARS WITH CONFIRMED
LABORATORY EVIDENCE OF HIV INFECTION 200
• A2.2 PRESUMPTIVE DIAGNOSIS OF CLINICAL STAGE 4 HIV IN
CHILDREN AGED UNDER 18 MONTHS 203
• A2.3 IMMUNOLOGICAL CATEGORIES FOR PAEDIATRIC HIV
INFECTION 204
APPENDIX 3
ALGORITHM FOR DIAGNOSIS OF TUBERCULOSIS 206
• A3.1 CHILDREN LIVING WITH HIV 206
• A3.2 ADULT & ADOLESCENT LIVING WITH HIV 207
• A3.3 CHILDREN IN CLOSE CONTACT WITH TB PATIENT 208
APPENDIX 4
ALGORITHMS FOR THE MANAGEMENT OF HEPATITIS B-VIRUS
CO-INFECTION WITH HIV 209
APPENDIX 5
DRUG INFORMATION 210
• A5.1 DRUG-DRUG INTERACTIONS 210
• A5.2 ADULT & ADOLESCENT DRUG DOSAGE, FORMULATIONS
AND ADVERSE EFFECTS 212
• A5.3 PAEDIATRIC DRUG DOSAGE, FORMULATIONS AND
ADVERSE EFFECTS 214

APPENDIX 6
PEP FOR RAPE SURVIVORS 219
• A6.1 FORENSIC EVIDENCE COLLECTION 219
• A6.2 DRUG RECOMMENDATION FOR HIV PEP IN ADULTS AND
ADOLESCENTS (>40KG) INCLUDING PREGNANT AND
LACTATING WOMEN 221
• A6.3 PEP AND MANAGEMENT RECORD FORM FOR RAPE
SURVIVORS 222
• A6.4 POST EXPOSURE PROPHYLAXIS OF HIV MONTHLY
RETURNS FORM 226
APPENDIX 7
TREATMENT MONITORING ALGORITHM 227
List of Tables
Table 3.1 Baseline Laboratory Investigations 56
Table 4.1 Recommended ARVs in Ghana 60
Table 4.2 Preferred and alternative first-line ART 62
regimens for adults, adolescents, children and neonates 62
Table 4.3 Preferred and alternative second-line ART regimens for adults,
adolescents, children and infants 63
Table 4.4 Considerations for First Line ART Regimen for Adults and
Adolescents (Including Pregnant Women) 64
Table 4.5 Considerations for Second Line ART Regimen for Adults and
Adolescents (Including Pregnant Women) 66
Table 4.6 Considerations for Third Line ART Regimen for Adults and
Adolescents (including Pregnant Women) 67
Table 4.7 Considerations for First Line ART Regimen for Neonates
(First 28 Days of Life) 68
Table 4.8 Considerations for First-Line ART Regimen for Children 69
Table 4.9 Considerations for Second-Line ART Regimen for Children 72
Table 4.10 Considerations for Third-Line ART Regimen for Children 76
Table 4.11 Guidance for adjusting ART when rifampicin-based
TB treatment starts 80

Table 4.12 Common ARV Toxicities 82
Table 4.13 Grading of Adverse Events 84
Table 7.1 WHO definitions of clinical, immunological and 127
virological failure for the decision to switch ART regimens 127
Table 7.2 Clinical Events Indicating Possible Treatment Failure 129
Table 8.1 Recommended criteria for initiating and discontinuing
Co-trimoxazole Prophylaxis 135
Table 8.2 Optimal Co-trimoxazole dosing for children 136
Table 9.1 Components of the package of care for people with advanced
HIV disease 142
Table 10.1 Care pathway for people exposed to HIV 152
Table 10.2 Recommended ARVS for PEP 155
Table 10.3 Recommended monitoring of drug toxicity and HIV 156
serology of exposed individuals 156
List of Figures
Figure 1.1 HIV testing algorithm for non-pregnant women and
general population 47
Figure 5.1 HIV Testing Algorithm for Antenatal clients 95
Figure 5.2 Algorithm for Early infant prophylaxis and diagnosis 97
Figure 5.5.2 HIV Testing Algorithm for Antenatal clients 94
Figure 5.5.3 Algorithm for Early infant prophylaxis and diagnosis 96
Figure 8.4 Algorithm for providing a package of care for
people with advanced HIV disease 143
Figure 9.1 Algorithm for providing a package of care for people with
advanced HIV disease 144
Figure 15.1 Primary Cytology Screening and Colposcopy Triage (Screen,
Triage and Treat Approach) 191
Figure 15.2 HPV DNA Screening and HPV16/18 Triage
(Screen, Triage and Treat Approach) 192
Figure 15.3 Primary HPV DNA Screening and VIA Triage
(Screen, Triage and Treat Approach) 193
Figure 15.4 Primary HPV DNA Screening and Colposcopy
Triage (Screen, Triage and Treat Approach) 194
Figure 15.5 Primary HPV SCREENING and Cytology Triage
Followed by Colposcopy (Screen, Triage and Treat Approach) 195
Figure 15.6 Follow-Up Tests At 12 Months Post-Treatment for
Women Living with HIV 196

ABBREVIATIONS /ACRONYMS
AIDS - Acquired Immune Deficiency Syndrome

AIS - Adenocarcinoma in situ
ANC - Antenatal Clinic
ART - Antiretroviral Therapy
CKC - Cold Knife Conization
CHW - Community Health Worker
CHN - Community Health Nurse
CBTC - Community Based Testing and Counselling
DHIMS - District Health Information Management
System
DMOC - Differentiated Models of Care
DTG - Dolutegravir
DSD - Differentiated Service Delivery
EID - Early Infant Diagnosis
EMTCT - Elimination of Mother-To-Child\
Transmission of HIV
FBTC - Facility Based Testing and Counselling
GAC - Ghana AIDS Commission
FDA - Food and Drugs Authority
FDC - Fixed Dose Combination
GDHS - Ghana Demographic and Health Survey
GFATM - Global Fund to Fight AIDS, TB and Malaria

GHS - Ghana Health Service
HeFRA - Health Facilities Regulatory Authority
HIV - Human Immunodeficiency Virus
HPV - Human Papilloma Virus
HTS - HIV Testing Service
HSS - HIV Sentinel Survey
IBBSS - Integrated Biological Behavioural Surveillance
Survey
IPD - In-patient Department
TPT - TB Preventive Therapy
INSTIs - Integrase Strand Transfer Inhibitors
LLETZ - Large-Loop Excision of the Transformation Zone
LMIS - Logistics Management and Information
System
LTFU - Loss-To-Follow Up
MOH - Ministry of Health
NACP - National AIDS/STI Control Programme
NGO - Non-Governmental Organization
PEP - Post-Exposure Prophylaxis
PITC - Provider-Initiated Testing and Counselling
PLHIV - Persons Living with HIV
PMTCT - Prevention of Mother - To –Child-
Transmission of HIV
PrEP - Pre-Exposure Prophylaxis
PSM - Procurement and Supply Management
SI - Strategic Information
SOP - Standard Operating Procedure
STI - Sexually Transmitted Infection
TAF - Tenofovir Alafenamide
TB - Tuberculosis

TLD - Tenofovir/Lamivudine/Dolutegravir drug
combination
TLE - Tenofovir/Lamivudine/Efavirenz drug
combination
UNAIDS - The Joint United Nations Programme on
HIV/AIDS
VIA - Visual inspection with Acetic Acid
VL - Viral Load
VLSUP - Viral Load Scale-up Plan
WHO - World Health Organization
WHO/AFRO - World Health Organization/ Regional Office
for Africa

ACKNOWLEDGEMENT
T
he Ghana Health Service wishes to acknowledge the
continued support of the World Health Organization
(WHO) towards the adaptation of WHO Consolidated
Guidance for the review of the Guidelines for HIV care
and Antiretroviral Therapy in Ghana.
The review was based on global evidence and country

experiences in the implementation of HIV prevention, treatment
services. We are grateful to Dr. Nana Ayegua Hagan Seneadza,
who led the updates to this guideline. We wish to acknowledge
the monumental role of all technical contributors to previous
editions especially the ART Working Group (TWG) members.
The Ghana Health Service is also grateful for all the contributions
made to this document by other stakeholders, particularly the
WHO, UNICEF, UNAIDS, USAID, IAS, ICAP-CQUIN, Ghana
AIDS Commission and the Global Fund to fight AIDS, TB and
Malaria.
I commend all CEOs of respective Ministry of Health agencies,

Ghana Health Service Divisional, Regional and District directors

for their continued oversight of all disease surveillance, control
and prevention activities under the technical guidance of the
Director, Public Health.
The development of this updated edition of the consolidated HIV

Care guidelines was made possible through the leadership of the
Programme Manager, staff of the NACP and the entire cadre
of service providers whose hard work has ensured the progress
chalked in the prevention and control of HIV in Ghana till date.
We extend our heartfelt thanks to our colleagues, partners and

stakeholders who took time from their busy schedules to validate
the updated guidelines:
Dr. Stephen Ayisi Addo - NACP
Dr. Kwadwo Koduah Owusu - NACP
Dr. Anthony Ashinyo - NACP
E. Sefah Boakye-Yiadom - Global Fund Logistics Support
Project
Dr. Kafui Senya - World Health Organization
Dr. Nyonuku Baddoo - NACP
Seth Twum - Akuse Government Hospital, E/R
Dr. Adu-Gyamfi Raphael - NACP
Jenevieve Klu - NACP
Courage Botchway K. - GHS-Volta RHD
Reynolds Asare - WAPCAS
Winifred N.O. Armah-Attoh - NACP
Rowland Adukpo - NACP
Dr. Anthony Enimil - KATH/KNUST
Patricia Porekuu - TA
Georgina Benya - CHAG
Dr. Ekua Houphouet - USAID

Damaris Forson - USAID GHSC-PSM
Emmanuel Obeng-Hinneh - Bono RHD
Dr. Parbie Abbeyquaye Emmanuel - 37 Millitary Hosp.
Dr. Mark Bayor Kyengbe - Bole Hospital
Priscilla Mawuli Awo Ekpale - KBTH
Dr. Sheila Bawa - Suntreso Gov’t Hospital
Comfort. A. Anane-Kyei - Agona Gov’t Hospital
Marian Honu - Consultant
Dr. Kate Coleman-Sarfo - 37 Military Hospital
Joseph K. Addae - CHAG/CSS
Irene Alimah Lansah - NACP
Dr. Michael Deladem Kwashie - USAID Strengthening
the care Continuum Project
Prof. Kwasi Torpey - University of Ghana
School of Public Health
Dr. Elizabeth Agyare - World Health Organization
Dr. Renicha McCree - UNAIDS
Caroline Adonadaga - NACP
Prof. Dorcas Obiri-Yeboah - School of Medical Sciences,
University of Cape Coast.
Rev. Kenneth Ayeh Danso -NACP
Dr. Patrick Kuma-Aboagye

Director General
Ghana Health Service

FOREWORD
T
he World Health Organization (WHO) has developed
and updated guidelines for scaling up antiretroviral
therapy in resource-limited settings. The treatment
guidelines for a public health approach act as guidance
for countries to facilitate the proper management and scale up
of Antiretroviral Therapy (ART). This public health approach
is geared towards universal access, standardization, and
simplification of Antiretroviral (ARV) drug regimens to support
the implementation of evidence-based treatment programmes
in resource-limited settings. The goal is to avoid the use of
substandard treatment protocols and to reduce the potential
for the emergence of drug-resistant virus strains. The detailed
national ART guidelines provide recommendations for managing
toxicity or treatment failure and recommends formulations for
weight and age that can help to standardize prescribing and
dispensing practices and facilitate forecasting for ARV drugs.
This updated national HIV Care guidelines include newly

recommended HIV testing and linkage strategies, ARV drug
regimens, formulations and diagnostics that are appropriate to
the local setting. This version provides an update to the previous
consolidated guidelines. The national guideline review process

included extensive consultations with various stakeholders
through workshops and technical working group meetings. The
purpose of reviewing the existing guideline is to ensure that the
country is up to date with current trends and recommendations
in HIV care.
This document remains the basis for planning and organisation

of HIV service delivery at all levels of implementation in both
government, non-governmental and private health institutions
in Ghana. To ensure a rational use of medicines, patients must
receive medications appropriate for their clinical needs, in doses
that meet their own individual requirements for an adequate
period and at the lowest cost to the patient and the community.
ART is a complex undertaking that involves a large variety and
quantity of highly active drugs. It is a lifelong treatment that
is regularly reviewed with the addition of new molecules. It is
therefore very important for all HIV commodities procured in
Ghana to be governed by these guidelines since inappropriate
use may have unwanted consequences at both the individual
and population levels. To promote an effective utilization of
this guideline only trained and authorized persons in certified
health care facilities are allowed to prescribe ARVs, and all HIV
commodities are not to be sold to the public unless authorized by
the Ministry of Health.
Honourable Kwaku Agyeman Manu (MP)

Minister for Health

INTRODUCTION
G
hana has a low HIV prevalence, with the epidemic
being generalized in the population. In 2020, the
HIV prevalence was 1.68% with an estimated 346,120
persons living with HIV (PLHIV) (GAC National
and subnational HIV and AIDS estimates and projections, 2020
report).
A total of 1,837,149 HIV tests were conducted in 2020 with a

yield of 3.2%. Of these 861,030 (47%) were pregnant women with
a yield of 1.5%. Thirty-one thousand and thirty-five (31,035)
persons were newly enrolled on ART in 2020 contributing to the
total 208,811 active clients on ART by end of December 2020. As
the number of persons living with HIV on ART increases, the
HIV population is projected to increase as AIDS-related deaths
decrease. Of all people living with HIV in Ghana as at the end of
December 2020, 63% knew their status; 95% were on ART and
73% were virally suppressed (2020 NACP Annual Report, 2021).
The median HIV prevalence in women attending antenatal care

in 2020 was 2.0% (HSS Report 2020, NACP/GHS). Mother- to-
child transmission of HIV is the second most common mode of

transmission, after sexual transmission, and accounts for HIV
infections in almost all children under 15 years.
Differentiated strategies across the cascade of HIV care therefore

are being implemented to meet the needs of different populations
to accelerate progress towards achieving the ambitious 95-95-95
targets of which Ghana is currently at 63-95-73 (GAC National
and subnational HIV and AIDS estimates and projections, 2020
report).
Differentiated Service Delivery is a client-centred approach to

address challenges by adapting services to the needs of clients
while reducing the burden on the health system. The principles
of differentiated service delivery may be applied from testing
through to ART initiation, long-term ART delivery and achieving
virological suppression. Differentiated service delivery is also not
just for clients successfully established on ART. Service delivery
should be adapted for clients with advanced HIV disease both
at ART initiation, where there is evidence of treatment failure
on ART and for specific populations. Refer to the Differentiated
Service Delivery Operational Manual.
Provider Initiated Testing and Counselling (PITC) which

entails the routine offer of HIV testing and counselling to
clients in the health facilities at entry points with high yield is
being implemented. These points with high yield include the
DOTS corners, Emergency Room, ANC, PNC, CWC, OPD and
Nutritional Rehabilitation Units. PLHIV should also be offered
family and partner testing, so their contacts are diagnosed as well
(family-based index client testing). Populations like men and
key populations who are not coming to the facilities to test need
differentiated testing services in the form of targeted outreaches.

Treat All is the strategy being used to offer ART to all HIV
positive clients linked to care, irrespective of WHO staging of
the disease or the CD4 cell count/ml.
If they are established on ART, PLHIV can be given clinic

appointments twice a year (quarterly for children below 5 years).
This enables health care workers to provide focused and priority
attention to the clients who aren’t virally suppressed or present to
the clinic in a very sick state.
Currently, viral load testing is used to monitor clients on

treatment. Any client who is not virally suppressed has to be
managed according to national guidelines (see Appendix 7).
These updated guidelines take into consideration

recommendations made by the WHO in the July 2021 guidelines
including Dolutegravir for treatment of children below 20kg.
It is expected that the implementation of these revised national

guidelines at all levels of healthcare delivery including community
level facilities, private hospitals and maternity homes will lead to
the attainment of the ambitious UNAIDS 95-95-95 goals by 2025
and epidemic control (UNAIDS, 2020).

PURPOSE
The purpose of this updated document is to provide current HIV
care guidelines for all age groups and populations in Ghana.
OBJECTIVES
The objectives of this document are:
· To provide updated guidelines for HIV Testing and Treatment
based on current evidence.
· To standardize the provision of comprehensive HIV Care in-
country.
· To provide direction on procurement, logistics management
and information on HIV and AIDS Commodities.
· To provide guidance on the documentation and reporting of
key ART indicators.

SUMMARY OF UPDATES
F
ollowing updates to the WHO guidelines in July 2021,
it became necessary to update these national guidelines
to incorporate key recommendations relevant to Ghana’s
context with the aim of providing current standardized
and comprehensive HIV care guidelines for the country. Below
are details of the main updates.
New definition of ‘established on ART’

The 2021 WHO consolidated guidelines recommends an
updated terminology for a ‘stable client on ART’ to ‘established
on ART’. This recommendation has been adopted, therefore the
new definition for ‘established on ART’ is:
• receiving ART for at least six months;
• no current illness, which does not include well-controlled
chronic health conditions;
• good understanding of lifelong adherence: adequate
adherence counselling provided; and
• evidence of treatment success: at least one suppressed viral
load result within the past six months (if viral load is not
available: CD4 count >200 cells/mm3 or CD4 count >350
cells/mm3 for children 3-5 years or weight gain, absence of
symptoms and concurrent infections).

Chapter One: HIV TESTING AND COUNSELLING
SERVICES (HTS)
Legal and Ethical Issues
Regulations pertaining to the disclosure of an individual’s HIV
status to a partner and informed consent in accordance with the
legal framework for providing HIV services in Ghana, L.I 2403
of the Ghana AIDS Commission Regulation, 2020 have been
included in this updated guideline.
HIV Testing Services

• Integrated testing for HIV, syphilis and hepatitis B is also
recommended to all pregnant women at least once.
• Re-testing of pregnant women during the 3rd trimester.
• Point-of-care nucleic acid testing to diagnose HIV among
infants and children younger than 18 months of age.
Recommendations for testing and retesting during ART initiation

have also been included as follows:
• For women who are already known to be living with HIV,

their syphilis status should be determined.
• Retesting among people with HIV who already know their
status, including those on treatment, is not recommended as
it can provide inconsistent results if the person with HIV is on
ART.
HIV Testing and Counselling Approaches

• A social network-based approach to testing has been
introduced in this update.
Chapter Four
Antiretroviral Therapy
This chapter has been updated to include the preferred and
alternative second-line ART regimens for adults, adolescents,

children and infants including recommendations for using DTG
10 based regimen for children above 3 kg and more than four
weeks old. Consistent with broader efforts to improve toxicity
profiles, Tenofovir alafenamide (TAF ) has also been included as
an option in special circumstances.
Chapter Five
Elimination of Mother-To-Child Transmission (EMTCT)
The first two prongs of the EMTCT strategy- Primary prevention
of HIV infection in women of childbearing age and prevention of
unintended pregnancies among women infected with HIV have
been included in this updated guideline.
The algorithm for early infant diagnosis has also been described.
The management of Syphilis in pregnant women has also been
updated.
Chapter Seven
Changing or Interrupting Therapy
The diagnosis of treatment failure based on WHO definitions has
been updated to include clinical, immunological and virological
failure.
Chapter Nine
Managing Advanced Disease
This guideline has been updated with a section on Managing
Advanced Disease documenting WHO guidelines’ recommended
package of interventions for clients presenting with advanced
HIV disease.
Chapter Ten
Pre and Post Exposure Prophylaxis
PrEP has been documented as being safe even among pregnant

women. Dapivirine vaginal ring has been recommended as an
acceptable option for PrEP in women who are unable or do not
want to take oral PrEP. Long acting cabotegravir (CAB-LA) has
also been added to the PrEP options for HIV-1.
Chapter Thirteen
HIV Care During Covid-19 And Future Outbreaks
To provide mitigation measures against interruptions in HIV
services during emergencies, as was observed with the COVID-19
pandemic, considerations have been outlined in this update for
integration of management of outbreaks/emergencies with HIV
care.
Included in this update are treatment considerations specific for

COVID-19 infections and vaccination in a PLHIV.
Chapter Fourteen
HIV and Noncommunicable Diseases
Considerations for the management of NCDs including
mental health conditions in PLHIV have been included.
Chapter Fifteen
The recommendations for management of cervical cancer among
PLHIV based on the Screen, Triage and Treat Approach have
been included.
Tables and Figures

Figures depicting algorithms for HIV testing for different
populations, early infant diagnosis, TB screening and various
scenarios for the cervical cancer Screen Triage and Treat
Approach.

Appendices
Monitoring of Treatment
An update in the definition of clients on ART who are
virologically suppressed has also been adopted. Whereas it used
to be defined as having a VL ≤ 1000 copies/ml, the new definition
is VL ≤ 50 copies/ml. An updated algorithm to provide guidance
on monitoring and the respective actions to be taken based on
the new definition is included in this guideline.

C HA P T E R ON E
HIV TESTING AND

COUNSELLING SERVICES
(HTS)
HIV testing is a process that determines whether a person is

infected with HIV or not by detecting antibodies or antigens
associated with HIV in blood and other body fluids. HIV
testing is the gateway to prevention, care, treatment and support
services for PLHIV. Through HTS people can learn about and
accept their sero-status in a confidential environment where
they are counseled on strategies to prevent infection to self
and others, receive emotional care and be referred for medical
and psychosocial services when appropriate. HTS also helps
to decrease stigma as it encourages community acceptance of
PLHIV and willingness to participate in national response to
HIV/AIDS. Those who are not HIV-infected will be linked to
appropriate services to prevent HIV infection and those who use
drugs, to harm reduction services. This process comprises the
provision of pre-test information, HIV testing, disclosure and
post-test counselling and education.

1.1 HIV TESTING AND COUNSELLING:
GUIDING PRINCIPLES
The guiding principles for HIV Testing and Counselling (HTC)
are Confidentiality, Informed consent, Post-test Counselling and
support services, Correct test results and Connection to services:
1. Confidentiality:
Maintaining confidentiality is an important responsibility of
all healthcare providers. Clients should however be informed
that their HIV test results may be disclosed to other healthcare
providers to ensure they receive appropriate medical care.
2. Informed consent:
Written consent is not required but it is the responsibility of
providers to ensure that:
• Clients understand the purpose and benefits of testing.
• Client’s decision to refuse testing is respected.
3. Post- test Counselling and Support services:

The result of an HIV test should always be offered to a person
with appropriate post-test information, Counselling or referral.
4. Correct test results:

Providers of HTS must strive to provide high quality testing
services. Quality Assurance mechanisms should ensure that
people receive a correct diagnosis
5. Connection to services:
In the context of “test and treat” HTS providers should ensure
they provide immediate linkage to treatment, care and support

Limits to Confidentiality
Ethical and legal limits to confidentiality should be discussed
with clients. If disclosure is in the best interest of the client or
is required by law; clients must first be notified and invited to
disclose the information themselves. If the client is unwilling to
disclose such information, the counselor must advise the client
that he/she is legally obliged to do so. Only relevant information
may be shared in these circumstances. Counsellors should
understand that such decisions should only be made when prior
consultation with a supervisor or senior colleague indicate it is
absolutely necessary.
Confidentiality in Record Keeping

Clients’ records must be stored securely. In a clinical setting
only personnel with direct responsibility for a client’s medical
condition should have access to the records. All personnel with
access to medical records on which HIV test results are recorded
should be trained in procedures to maintain confidentiality of
HIV test results. Where records are taken home, clients should
be informed about the risks of breaches in confidentiality.
Shared confidentiality Referrals

When clients are referred for additional services such as
Prevention of Mother-To-Child Transmission (PMTCT),
Sexually Transmitted Infection (STI) clinic and treatment of
Opportunistic Infections including TB, psychological and social
services including home based care etc., it is usually preferable
to state the client’s name. The counsellor should ensure that the
client understands the reasons for giving his/her name on the
referral letter. Referrals to other services should be based on
the client’s specific needs, life situation and test results. HTS
counsellors should ensure that organizations to which they
refer and release the client’s name and test results are practicing

careful procedures for confidentiality of test results. As much as
possible, such referral letters should be addressed to a specific
facility providing the additional services required.
Informed Decision Making

When HTS services are provided within a health facility, it
is necessary to distinguish between Client-Initiated Testing
and Counselling (CITC) and Provider–Initiated Testing and
Counselling (PITC). For CITC, the client shall be offered pre-
test counselling. For PITC, it is recommended that adequate
information be given to the client before the test is performed.
Written results
HTS sites must provide written results which must be dated
and signed. Clients requesting testing for official reasons, such
as employment or to obtain a visa, where written results are
required, should be referred to an approved laboratory, hospital
or clinic for the type of testing.
Legal and Ethical issues

The legal and human rights of HTS clients should be protected
at all times in the context of other individual legal and human
rights as well as public health interest. Clients using HIV Testing
Services (HTS) especially those who test HIV positive should not
be stigmatized or exposed to discrimination.
For the disclosure of an individual’s HIV status to a partner, the
following regulations should apply:
1. A health care provider may inform the partner of a person
under care of the health care provider of the HIV status of
that person only if the following conditions are met:
a) the health care provider reasonably believes in good faith

that the partner is at significant risk of transmission of HIV
from the person;
b) the person living with HIV has been counselled to inform the
partner;
c) the health care provider is satisfied that the person living with
HIV does not intend to inform the partner;
d) the health care provider has informed the person living with
HIV of the intention to disclose the HIV positive status of
that person to the partner; and
e) the disclosure to the partner is made in person and with
appropriate counselling or referral for counselling.
2. Sub regulation (1) shall not apply where the health care
provider reasonably believes that the disclosure of the
information may result in
a) violence;
b) abandonment; or
c) an action that may have a severe negative effect on the
physical or mental health and safety of the
(i) person living with HIV;
(ii) children of a person living with HIV; or
(iii) someone who is close to the person living with HIV
Further guidance on the legal framework for providing other

HIV services in Ghana can be found in the L.I 2403, section 32,
Ghana AIDS Commission Regulation, 2020.
Right to privacy
Privacy is particularly emphasized in the context of HIVAIDS,

given the stigma and discrimination associated with HIV/AIDS.
Adequate safeguards must be in place at the HTS- sites to ensure
that confidentiality is protected and that information about HIV
status is not disclosed without the consent of the individual.
There is a need to define how privacy should be protected (i.e.
during testing, result disclosure, record keeping, etc.) There is a
need also to define exceptions to this rule (i.e. immediate impact
on the lives of others, rape etc.).
Right to non-discrimination, equal protection and equality

before the law
Participating in HTS must not constitute a source of
discrimination against the individual (HTS client); especially
those found to be positive should not be denied services or other
benefits on the ground of their HIV status.
Right to marry
An HIV positive client has the right to marry but should ensure
that disclosure of his/her HIV status is made to his/her partner
before marriage. Non-disclosure to a partner before marriage
constitutes a violation of the partner’s human rights. Willful
infection of a partner with a venereal disease constitutes a
criminal offence under the Criminal Code of Ghana.
Right to informed consent

It is generally recommended in the practice of medicine that for
any medical procedure, informed consent be obtained. Given
the risks associated with HIV/AIDS, obtaining informed consent
must be given special attention; and the risks and benefits of HTS
must be fully explained to the client to ensure informed consent.
Informed consent may be verbal or written. In case of written
consent, forms must be signed or thumb printed by the client

before testing. The age of consent as provided by the L.I 2403,
section 23 and 24, Ghana AIDS Commission Regulation, 2020
are as follows:
1. A person of the age of sixteen years or above may give consent to

be tested for HIV
2. A trained service provider shall assist a person of the age of

sixteen years or above who consents to be tested, to know the
HIV status of that person
3. A parent, a legal guardian or the next of kin of a person who

a) Is below the age of sixteen years; or
b) Has a mental incapacity may give consent for that person
to be tested for HIV
4. Despite subregulation (3), where the person is below the age of

sixteen years and it is in the best interest of the person, a trained
service provider shall assist that person to
a) Know the HIV status of that person;
b) Have access to follow-up services available
5. Where the person who is below the age of sixteen years is a

student at a residential educational institution, the head of the
institution, or a representative of the head of the institution may,
if the parents of that person or the next of kin of that person are
unavailable, give consent to the test.
Where a person, or a parent or guardian of a person accepts or

declines a test for HIV, a healthcare provider shall record that fact
in the medical file of that person.
Protecting human rights within an HTS site

In addition to information giving, counselling, confidentiality
and informed consent, protecting the human rights of HTS
clients should be promoted through the adoption of an ethical
code of conduct for all those involved in HTS services. Such a
code should include a commitment to competence, respect for
the rights of individuals, professional conduct and integrity in
the discharge of duties.
1.2 PRE-TEST INFORMATION AND EDUCATION

All HTS service providers (health worker or lay) shall be trained to
offer HTS per the following standards:
• Establish a good relationship between yourself and the client.

• Identify yourself and clarify your role.
• Establish what prompted the client to visit the centre.
• Assure confidentiality.
• Obtain client’s particulars: name or code name, age; sex;
residential address; telephone number, occupation; education;
tribe; religion; marital status; economic status.
• Assess the client’s knowledge of HIV and AIDS,
misconceptions/ misunderstandings.
• Correct misconceptions/ misunderstandings and give the
necessary information on basic facts on HIV and AIDS
including the window period.
• Explain what a positive, negative and indeterminate result
means.
• Explore who the client would like to talk to about test results.
• Explain how long it will take for results to be ready and talk
about limitations of test.
• If the client decides to undergo testing, obtain informed
consent before the test is done.
• Provide opportunity for the client to ask questions.

1.3 POST-TEST COUNSELLING AND
EDUCATION
• Congratulate client for waiting for test result.
• Give the test result as soon as possible in a neutral tone of
voice.
• For a positive test result, say: “Your test result is positive. That
means you are infected with HIV”.
• For a negative test result, say: “Your test result is negative.
That means HIV antibodies were not detected in your blood”.
• Pause for the client to assimilate results communicated.
• Assess understanding by asking the client to tell you what the
test result means.
• Ask the client how he or she feels about the result and allow
expression of emotional reactions.
• Continue with counselling on behavioural change either
to maintain negative status or live positively with positive test
results only when the client is ready to talk about what he or
she is planning to do next.
• Offer to test nuclear family members through the index client.
• Draw a risk reduction plan or other behaviour change
strategies, depending on the test result and the risk assessment/
client’s situation.
• For clients with positive test results, discuss the need for
linkage and initiation on ART within 7 days, the need for and
benefits of lifelong adherence to ARVs including
Undetectable=Untransmissible (U=U) messages, as well as
plans for partner notification, and testing.
• For clients with negative test results, discuss the need for
comprehensive HIV prevention services even throughout
pregnancy and breastfeeding to help them remain HIV-
negative. This includes counselling, condom use, harm
reduction, and pre- and post-exposure prophylaxis as needed.
• Perform a psychosocial support assessment.

• Encourage clients to accept and live positively even if they
face stigma and discrimination (S&D) as well as psychological
problems.
• Counsel the client on positive living (acceptance of status,
nutrition, early identification and treatment of infections,
avoidance of isolation, exercise, ART etc.).
• All HIV positive clients have to disclose their status to
their sexual partner(s). This may be done as passive or assisted
notification (see Differentiated Service Delivery (DSD)
manual section 3.2).
1.4 HIV TESTING AND COUNSELLING

APPROACHES
Client Initiated Testing and Counselling (CITC)

This is traditionally known as Voluntary Counselling and Testing
(VCT). In this type of HTS, the individual of his own accord
goes to an HTS site and requests for the HIV test. CITC does
not yield adequate coverage in both high-income and resource-
constrained settings. Uptake of CITC has been hampered by
many of the same factors that limit uptake of other HIV-related
services, including stigma and discrimination, limited access to
treatment, care and health services delivery in general, as well as
gender issues.
Provider Initiated Testing and Counselling (PITC)

The PITC is the offer of HIV tests to all clients who utilize health
services. It presents an opportunity to ensure that HIV is more
systematically diagnosed in order to facilitate patient access to
needed HIV prevention, treatment, care and support services.
PITC is recommended for the following categories of persons:
• adults, adolescents and children with signs and symptoms or
medical conditions that indicate possible HIV infection,

including Tuberculosis (TB)
• HIV-exposed children and symptomatic infants and children,
• malnourished children,
• people with Sexually Transmitted Infections (STIs),
• people with hepatitis,
• all pregnant women attending antenatal care settings,
• Key Populations (KPs), notably Men who have Sex with Men
(MSM), Transgender (TG), Female Sex Workers (FSWs),
people who use drugs with a history or current injecting
practices, migrant workers and their spouses with history
of possible unsafe exposures, people in prison, and all others
deemed at high risk of HIV.
In order to implement PITC services the following should be

taken into consideration. PITC should be provided by healthcare
providers trained to provide PITC services. PITC should be
provided within the following units:
• Inpatient Department (IPD)
• TB unit,
• STI clinic,
• RCH settings,
• PMTCT sites,
Clients presenting at OPDs, including referrals to other support

services are to be offered PITC services after appropriate triaging
has been done .
The first user of the test result is the health care provider who
uses the HIV test to make a diagnosis and provide appropriate
treatment and/or referral. There are three types of PITC. These
are: routine offer, diagnostic and mandatory testing.

Routine PITC
Routinely offered PITC is when HTS is offered to all clients using
the health facility irrespective of their reasons for doing so. Note
that routine offer does not mean routine testing.
Diagnostic PITC
Diagnostic PITC is where HTS services are offered to clients who
have signs and symptoms that are consistent with HIV related
disease or AIDS to aid clinical management.
Mandatory PITC
Mandatory testing is the situation in which HIV testing is ordered
for specific purposes and situations. Mandatory testing is not
permitted unless under the following situations as stipulated in
the Ghana HIV and AIDS policy:
1. By court order.
2. Screening of all donated blood before transfusion or donation
of body organs.
3. Sexual offenders.
4. Person is unconscious and unable to give consent.
5. A medical practitioner reasonably believes that such a test is
clinically necessary or desirable in the interest of that person.
1.5 PROVISION OF HTS SERVICES IN GHANA

To increase access to HIV diagnosis and detection of persons
living with HIV, HTS shall be provided in both public and
private health care facilities: In addition to improving access to
HIV testing, differentiated testing models should be prioritized
to identify those people living with HIV who do not yet know
their status in order to appropriately link them to HIV services.

Hence, identifying high-yield testing strategies for the general
population and supporting testing in specific populations with
high HIV prevalence (female sex workers, men who have sex
with men etc) should be prioritized.
For the general population, high-yield strategies that should be

prioritized include:
■ Facility-based provider-initiated testing and counselling
(PITC).
All clients presenting with sexually transmitted infection
(STIs), TB and clients presenting with symptoms and signs of
HIV should be tested with priority.
■ Index client testing both at facility and community.
■ HIV self-testing in the community.
■ Social Network-Based testing in the community.
Facility-Based Provision of HIV Testing and Counselling

Services
Facility-based HTS are available either at general health service
sites or at stand-alone sites for HIV testing. These health facilities
follow two approaches: Client-Initiated Testing and Counselling
(CITC) and Provider-Initiated Testing and Counselling (PITC).
Both approaches are voluntary, where the client gives verbal
consent for HIV testing. HIV testing will be routinely offered
by health workers to all patients at the OPD/IPD, STI, TB, ART
clinics, emergency settings and across all entry points where
feasible in all health facilities. Children will access HTS through
Early Infant Diagnosis (EID), index testing and PITC based on
risk after applying the screening tool at both outpatient and
inpatient departments.

Community-Based Provision of HIV Testing and Counselling
Services
Community-based HTS refers to a situation where an HTS
provider visits a community and offers HTS services to
individuals, couples, and families within the community
setting. This may include a number of approaches: door-to-
door/home-based testing and testing at the workplace, schools,
universities, special testing campaigns and events. Alternatively,
clients or patients currently enrolled on treatment may request
HTS providers to visit their communities or homes to conduct
HTS for them or their family members. The trained health care
professionals or HTS providers visit the home with their consent
and offer HTS services to their partner(s), spouse(s), or family
member(s). Thus, community HTS includes aspects of both
PITC and CITC.
1.6 COUPLE AND PARTNER HIV COUNSELLING

AND TESTING
Couple and partner HIV testing and counselling including
disclosure should be encouraged, supported and offered in all
settings where HIV testing and counselling is provided, including
antenatal, TB clinics, STI clinics, hospitals, Primary Health Care;
health posts, community led HTS. Couple/partner testing and
counselling can identify sero-concordant and sero-discordant
couples who can be linked to services for HIV prevention
and treatment. Such HTS need to be offered to married and
cohabiting couples, premarital couples and other sex partners.
When found positive, mutual disclosure needs to be encouraged.
Service providers must be aware of potential intimate partner-
based aggression and violence and need to support individuals
who do not want to test with their partners and/or do not
agree to mutual disclosure. Such clients can be encouraged and

HIV testing offered for sex partners, children and other family
members, which can be done individually, through couple
testing, index case testing, family testing or partner notification,
or intimate partner notification by provider, with permission,
if feasible. As with all HIV testing and counselling approaches,
couple HIV testing and counselling should be voluntary but
freely promoted and offered by the service providers. Partner
consent is not mandatory for HIV testing and counselling.
1.7 SOCIAL NETWORK-BASED APPROACH

Social network–based approaches can be offered as an HIV
testing approach for key populations as part of a comprehensive
package of care and prevention. Details of the implementation
can be found in the 2022 Differentiated Service Delivery (DSD)
Operational Manual.
1.8 TESTING AMONG INFANTS AND CHILDREN

In the paediatric setting, the entry points into HIV care are
mainly through PITC. Health-care workers should see every
patient encounter as an opportunity for providing PITC. Parents
and caregivers should be encouraged to know their status, as
well as that of their children and family members. Where PITC
is practiced, more children are tested for and diagnosed with
HIV, and can therefore access treatment services. Under some
circumstances and depending on national legal requirements, a
child considered to be sufficiently mature may give consent for
an HIV test (See Chapter 2 of 2022 DSD Operational Manual).
Point-of-care nucleic acid testing should be used to diagnose

HIV among infants and children younger than 18 months of age
where available.

Infants and children should be tested in the following
circumstances:
1. To identify the HIV status of all exposed infants for the
purpose of appropriate follow-up, which includes provision
of co-trimoxazole prophylaxis, antiretroviral prophylaxis
and/or treatment;
2. Within six weeks of birth or soon thereafter for infants known
to be exposed to HIV through mother-to-child transmission
to enable early diagnosis of HIV with virologic testing;
3. To diagnose all HIV-exposed infants who initially tested
negative in the first six weeks of life with virologic testing at
nine months;
4. At 18 months, confirm the HIV status of children born to
HIV positive mothers 3 months after complete cessation of
breastfeeding.
5. For the purpose of individual diagnosis in a child who is ill
(e.g. presenting with an HIV-associated illness, such as
tuberculosis or malnutrition, or other recurrent common
childhood illnesses such as pneumonia or diarrhoea);
6. For the purpose of individual diagnosis where another sibling
or parent has been diagnosed with HIV or where there is a
history that the parents have died as a result of AIDS or other
undiagnosed debilitating illness in the family;
7. In cases where a child has been exposed or potentially exposed
to HIV.
• Through sexual abuse or
• Through contaminated needle sticks or receipt of
potentially infectious blood or blood products (or
through other routes, e.g. wet nursing).
(Refer to algorithm for Early infant Diagnosis, Chapter 5,
Figure 5.5.3)

1.9 DISCLOSURE OF HIV STATUS TO A CHILD
Disclosure refers to the process of informing the child about
their HIV status. It also refers to person telling others of their
HIV status. In HTS with infants and children, disclosure is an
ongoing process continuing as the child matures. The parents/
care givers must be involved although the support of health care
worker is also required. It is important for the child to be able to
participate in their own health care. Many parents/care givers are
reluctant to disclose the HIV test result and status to their young
children and often seek to postpone the discussion well into the
teens. Health care providers should ensure that;
• Disclosure of the HIV status to the child is discussed with the
parents or guardians from the time of diagnosis.
• The process of disclosure is done over time, beginning as early
as possible. Usually, one can start mentioning to a 4 – 6 years
old HIV-infected child that they have a chronic disease that
requires regular clinic visits and medicines every day. This
needs to be done usually when the child starts asking questions
about the disease or the medication, he/she is taking or when
acting in a way that suggests that he/she is feeling isolated
from other children because of the disease. Close coordination
with the guardian/parent of the child in question is crucial.
• At about 8 – 10 years it is recommended that full disclosure of
HIV and AIDS be offered but in a caring and supportive
manner and environment. Before their early teen years HIV-
infected children should know that they are infected with
HIV, learn how it is spread and how to stay healthy.
It has been shown that children cope better with their HIV
status when properly counselled. It is particularly important
that adolescents be informed of their HIV status so that they

can become active participants in their own care. Following
challenges in disclosure, close coordination with the guardian/
parent of the child is crucial. Parents/guardians should be offered
disclosure counselling to prepare and enable them to support
disclosure in their children. Health care workers should be
equipped with knowledge and skill on disclosure counselling.

ADOLESCENTS
Adolescents above 16 years of age can give consent for HIV
testing without parental permission. For adolescents younger
than 16 years, parents or guardians can give consent to receive
HTS. Counselling of adolescents requires a non-judgmental
attitude and assurance of confidentiality. It is preferable if the
client is accompanied by a trusted adult able to provide support
and assimilate information. Information should be appropriate
for the adolescent client’s level of understanding and education.
Adolescents may have concerns about sex, current and future
relationships, fear of rejection and having a family in the future.
All these fears can be addressed during post-test counselling
and at subsequent visits. Often, people need some time alone
to assimilate a positive HIV test result and formulate questions
and concerns. The role of post-test counselling is to contain any
anxieties, provide support and reassurance, and to initiate plans
with respect to disclosure, and follow-up visits for treatment and
counselling.
Adolescents who test HIV negative must be counselled and

advised on how to protect themselves to stay negative, as well
as the importance of re-testing and testing with any current
or future sexual partners. HTS for adolescents offers many
important benefits. Adolescents who learn that they have
been diagnosed with HIV are more likely to obtain emotional
support and practise preventive behaviours to reduce the risk of

transmitting HIV to others and are more likely to receive HIV
treatment and care.

BLOOD DONORS
Blood donors and donated blood units shall be screened for HIV
according to national algorithms. Under specific emergency
life-or-death conditions, mainly where fresh blood transfusion
is required, blood donors shall be screened for HIV using a
rapid HIV test. All blood donors are required to complete a
donor screening questionnaire prior to donating blood. When
the donated blood unit is found reactive for HIV, it should be
discarded, and the donor referred for confirmatory testing and
further management for HIV.

KEY AND AT RISK POPULATIONS
Key Populations will also access HTS through lay providers
(peer-led) models at HTS sites and mobile outreach to hotspots
and KP friendly locations and through the use of social network-
based approaches, moonlight testing during evening hours in
high-risk settings and focused outreach to specific workplaces
for military personnel, truckers, miners and prison guards peers
in an effort to reach high risk men.
1.13 HIV SELF-TESTING (HIVST)

HIV self-testing (HIVST) is a process in which a person collects
his/her own specimen (oral fluid or blood) and then performs
an HIV test and interprets the result, often in a private setting,
either alone or with someone he/she trusts. HIV self-testing is an
empowering and innovative way to reach more people with HIV
and help achieve aspirational targets. Expanded use of HIVST

can contribute to these global targets by reaching the first-
time testers, people with undiagnosed HIV or those at ongoing
risk who need frequent retesting. HIVST reduces the number
of visits to facilities for frequent testers and eliminates travel
distances or long waiting periods to access HIV testing due to
the convenience it offers. HIVST is recommended as a triaging
and complementary test in Ghana in accordance with HIV LI
under the Ghana AIDS Commission Act 683. The following
guidance shall be followed by all persons eligible for promoting
or undertaking HIVST;
1. The result of a single RDT is not sufficient for HIV positive
diagnosis. HIVST requires self-testers with a reactive result to
receive further testing from a trained provider using a
validated national testing algorithm.
2. To facilitate the point above all service providers offering
HIVST kits shall provide pretest HIV information, explain
the procedure for use of HIVST kits including interpretation
of test results and post-test counselling and linkage
information to client.
3. Assisted HIVST is recommended for adolescents: the
adolescent is issued with the Self-Test kits and guided by
a trained tester through the process of taking the test and
interpreting the results and then assisted with linkage to
prevention and or treatment services.
4. All self-testers with a non-reactive test result should re-test
for exposure to HIV in the succeeding six weeks or if they are
at high HIV risk again prior to sixth week.
5. HIVST is not recommended for people taking antiretroviral
drugs as this may cause a false non-reactive result and false
assumption of cure.

6. HIV RDT for self-testing, either oral or blood-based, shall be
periodically evaluated and recommended for use in-country
by the Ministry of Health (National AIDS/STI Control
Programme of the Ghana Health Service).
7. All HIVST RDTs recommended for use in Ghana shall
have the relevant international (WHO) product quality pre-
certification and valid Ghana FDA registration.
8. The procurement and distribution of approved HIVST kits
will be by both public and private health sector in line with
national procurement laws. Key private pharmacy outlets will
be engaged and oriented to facilitate access in accordance
with national guidelines.
9. HIVST kits may be procured and offered to the public by only
MOH/GHS-NACP recognized health institutions and
pharmacies accredited by Health Facility Regulatory
Authority (HeFRA) to all persons who meet age criteria for
voluntary HIV testing in Ghana.
10. All approved HIVST RDT must retain clear instructions and
procedure for use disposal and reporting of the kits.
11. All facilities accredited to procure and distribute HIVST
RDTs shall be required to routinely report through the
national health data repository (DHIS 2 of Ghana Health
Service) for timely collation and reporting.
12. The country will also test other innovative approaches to
increase HIV testing, which includes the use of mobile
technologies, using standard computer applications, etc.

1.14 HIV TESTING ALGORITHM FOR NON-
PREGNANT POPULATIONS IN GHANA
The national testing algorithm for establishing the sero-status of
a person shall be a three-step process for all eligible populations
irrespective of prior use of a preliminary test such as an HIVST.
A positive status shall thus be established by the use of three
rapid diagnostic tests as indicated in Figure 1 below. Currently
the kits recommended for testing in Ghana are First Response
HIV 1&2 (first test), First Response HIV/Syphilis Duo(first test
for pregnant women), Oraquick HIV 1&2 (Second test) and SD
Bioline HIV 1&2 (Third test).
For women who are already known to be living with HIV, their
syphilis status should be determined.
Retesting among people with HIV who already know their status,
including those on treatment, is not recommended as it can
provide inconsistent results if the person with HIV is on ART.

Figure 1.1 HIV testing algorithm for non-pregnant
women and general population

Diagnosing HIV infection in children under 18 months
Diagnosis of HIV infection in babies born to women living with
HIV cannot be confirmed by conventional antibody tests due
to the presence of residual maternal antibodies. These maternal
antibodies may persist in the infant for as long as 18 months.
Hence, virological assays such as HIV DNA–PCR or total nucleic
acid-based assays represent the gold standard for diagnosing of
HIV infection in children younger than 18 months.

C HA P T E R T WO
LINKAGE TO CARE AND

OTHER SERVICES
Linkage is defined as a set of actions and activities that support

people testing for HIV and people diagnosed with HIV in
engaging with appropriate prevention, care and treatment
services for their HIV status. With reference to people with
HIV, it refers to the period beginning with HIV diagnosis and
ending with enrolment in care or treatment. Special efforts
should be made to link people who have a reactive test result
in a community setting to facility-based services for additional
testing and HIV diagnosis. For those diagnosed HIV positive in
a facility, immediate linkage to clinical care is critical to ensure
ART initiation and follow-up.
HTS must be accompanied by assured linkages to prevention,

treatment, care and support services, including services for ART,
TB, STI, RCH e.g. family planning, Psycho-social and judicial
services. This will enable early enrolment in treatment, as well
as access to services to prevent further transmission of HIV,
prevent other OIs and comorbidities. This is especially important
to prevent clients from being lost to follow-up. Making these

linkages is the responsibility of HTS providers. This may include
assisting with transportation of the client; involving community
in-reach workers; identifying and finding people lost to follow-
up; ensuring support from peers or expert clients patients; and
using new technologies such a social, medical, and mobile phone
reminder text messaging.
LINKAGE STEPS (see Chapter 3)

• All HIV-positive clients testing positive at a facility should be
escorted (with their consent) to the point for ART registration
and clinical assessment. This should ideally be done by the
HCW who has performed the test or by a lay worker.
• All clients who have tested HIV positive in the community
should be linked, with their consent, with a community health
nurse or other community-based lay worker for further
clinical assessment and care. The person who has performed
community testing should link the client to their ART site of
choice and, within a month, follow up to ensure that linkage
has occurred.
• All linkages must be documented in a simple linkage register
or booklet to facilitate client monitoring and reporting.
• If not linked, tracing should be performed by the community-
based HCW.
Detailed guidelines on linkage and initiation into HIV care can

be found in the Operational Manual for Differentiated Service
delivery for HIV in Ghana (Chapter 2, Page 13).

2.1 REFERRALS AND LINKAGES TO OTHER
SERVICES
ART is only a part of the continuum of care in the comprehensive
care package for PLHIV. Strong linkages within and outside
the health system with other providers of care and support will
further strengthen the effective management of clients. ART sites
should have linkages with other comprehensive care services
such as:
• HTS,
• EMTCT, DOTS Centres
• Management of Opportunistic Infections
• Nutritional Support
• Home-Based Care and Care for Orphans Vulnerable Children
• Psychosocial Support and STI services
• NCD services including mental health
Referrals should follow the normal health system channels and

in addition there should be networking with other stakeholders
such as those in the community e.g. PLHIV associations, lay
workers, home-based care providers, Social workers and Legal
Workers.
ART sites should form linkages with one another to facilitate

referral and exchange of information and resources.

C HA P T E R T H R E E
INITIATION INTO
HIV CARE
HIV infection is a chronic condition that requires lifelong

therapy. It is therefore important that the team should ascertain
that the client is willing, ready and able to sustain therapy as
interruption of treatment will be detrimental to the health of the
client. Interruption could lead to development of drug resistance
and increase the likelihood of transmission of a resistant virus
which would have further public health implications.
ART initiation can be differentiated according to the following

categories of clients:
■ Persons presenting to care when clinically well (Stage 1 and 2
and CD4 >200 cells/mm3)
■ Persons presenting to care with advanced HIV disease (Stage
3 or 4 and/or CD4 <200 cells/mm3).
An individual clinically stable on ART, now described as ‘established

on ART’ is a PLHIV:
• receiving ART for at least six months;
• no current illness, which does not include well-controlled
chronic health conditions;

• good understanding of lifelong adherence: adequate
adherence counselling provided; and
• evidence of treatment success: at least one suppressed viral
load result within the past six months (if viral load is not
available: CD4 count >200 cells/mm3 or CD4 count >350
for children 3-5 years or weight gain, absence of symptoms
and concurrent infections).
Refer to Differentiated Service Delivery For HIV in Ghana
Operational Manual Chapter 4.
Clinical Evaluation
A comprehensive clinical evaluation is required before ART can
be initiated. This is aimed at:
• Confirming HIV infection.
• Identifying past HIV related illnesses.
• Identifying current HIV related illnesses requiring treatment.
• Identifying co-existing medical conditions and pregnancy as
these may influence the choice of therapy.
• Assessing nutritional status.
• Assessing capacity to adhere to treatment.
• Assessing clinical stage and CD4 count for decisions on
provision of the advanced HIV disease package.
These can be achieved by:

1. Taking a detailed medical and social history.
2. Carrying out a complete physical examination.
3. Conducting appropriate laboratory investigations.
The Medical History should include:

• Date of initial HIV diagnosis and type of HIV infection.
• Current symptoms and concerns including a symptom screen
for tuberculosis (See Appendix 3 for TB screening algorithm)
and Hepatitis B and C.

• Past Medical History including diagnosis of tuberculosis.
• Drug history including treatment for TB and Hepatitis.
• Previous ARV exposure.
• Sexual history and past symptoms of STI.
• Obstetrics and Gynaecological history including family
planning.
• Social history including family support systems and income.
• History of substance abuse.
The physical examination should have the following components:

• Client’s weight and height.
• Skin- looking out for the following: Herpes Zoster (old scars
and new lesions), Herpes simplex, Molluscum contangiosum,
Kaposi’s sarcoma, Pruritic Papular Dermatitis or Eruptions or
Prurigo and Plane warts.
• Mouth- Oropharyngeal mucosa, Candidiasis, Oral Hairy
Leukoplakia, Gingivitis, Mouth ulcers and Kaposi sarcoma.
• Lymphadenitis/lymphadenopathy
• Respiratory (Sinusitis, Otitis, Pneumonia, TB) and
Cardiovascular system (Cardiomyopathy)
• Genito-urinary system
• Gastrointestinal system (Oesophagitis, Diarrhoea etc.).
• Anorectal area for discharge, ulcers, enlarged glands and
growths.
• Nervous and musculo-skeletal systems including mental
status, motor and sensory deficits.
• Fundoscopy whenever possible for retinitis or papilloedema
and Cytomegalovirus (CMV) retinitis.
• Detailed examination of Genital Tract for discharge, ulcers,
enlarged glands and growths.

Laboratory Evaluation
The reasons for investigations are:
• Confirmation of HIV infection and type (HIV1, HIV2, HIV1
and 2).
• To detect advanced HIV disease at presentation
• Whether female clients are pregnant.
• The presence of opportunistic infections.
• The presence of co-morbid diseases.
Further information on the client’s baseline laboratory tests can

be seen in Table 3.1 below. Within the context of Good Clinical
Practice, these baseline tests should not be a barrier to ART
initiation. ART can be initiated while the laboratory tests are
done after ART. Where a laboratory test is essential to guide
decision for ART initiation, it must be secured by all means prior
to ART initiation in line with Good Clinical Practice principles.
Where a client is found to have any opportunistic infection, it
should be treated, and ART initiated when the client is stabilised.
A package of interventions including screening, treatment and/

or prophylaxis for major opportunistic infections, rapid ART
initiation and intensified adherence support interventions is
strongly recommended for everyone presenting with advanced
HIV disease.
PLHIV presenting for the first time or those returning to care

should undergo history and clinical examination to evaluate
for opportunistic infections (such as signs and symptoms of TB
meningitis and signs and symptoms suggesting cryptococcal
meningitis) before rapid ART initiation is offered. Immediate
ART initiation is contraindicated among people living with
HIV who have cryptococcal meningitis because of the increased

mortality presumed to be caused by immune reconstitution
inflammatory syndrome in the central nervous system.
Table 3.1 Baseline Laboratory Investigations
Haematological test Full blood count

Blood Urea
Biochemical test Electrolytes and Creatinine
Liver Function tests
Fasting Blood Sugar
Cholesterol and lipid profile
Routine examinations Urinalysis (Urine R/E)

Pregnancy Test (Females)
Respiratory examinations TB screening

GeneXpert
Chest X-ray
Serological Test Hepatitis B Surface antigen

Immunological test CD4
These tests are performed Histology on skin and lymph node

depending on signs, biopsy
symptoms or age Kidney biopsy
Screening for STIs
Pap smear, HPV DNA
Abdominal Ultrasound

C HA P T E R F OU R
ANTIRETROVIRAL
THERAPY
The current National HIV Strategic Plan and Health Sector

Strategic framework 2021-2025 has a goal of enrolling at least
95% of persons living with HIV on ART and achieve viral load
suppression in 95% by 2025 in accordance with new UNAIDS
95-95-95 targets. Antiretroviral therapy is a lifelong activity and
distinctive strategies are necessary to ensure its effectiveness and
prevent development of drug resistance.
The proven effectiveness of Antiretroviral medications (ARVs),

the simplicity or complexity of the regimen, the need for careful
monitoring and adherence to therapy were considered in the
formulation of ART regimen outlined in this guideline. It is
essential that specific services and facilities be in place before
considering the introduction of ART into any health care setting.
Sites shall undergo assessment, and be assisted to meet a set of
national criteria before accreditation to provide ART is given.
However, accreditation may be suspended or withdrawn if a
facility consistently fails to adhere to national standards. The
management of PLHIV is best achieved using a multidisciplinary

team approach. The team should ideally comprise the following
categories of individuals;
• Clinician/Prescriber
• Nurse
• Pharmacy staff
• Counsellor
• Nutritionist/dietician
• Social worker
• Laboratory staff
• Psychosocial support provider
4.1 GOAL
The provision of comprehensive HIV care and the administering
of ART aim at attaining the following goals.
1. The suppression of HIV replication, as reflected in plasma
HIV concentration, to as low as possible and for as long as
possible.
2. The enhancement or preservation of the immune function
(CD4 restoration), thereby preventing or delaying the clinical
progression of HIV disease.
3. Improvement in quality of life.
4. Reduction in HIV related morbidity and mortality.
5. Promotion of growth and neurological development in
children.
4.2 RECOMMENDED ANTIRETROVIRALS

(ARVs) IN GHANA
The approach to antiretroviral treatment and the design of
therapeutic regimens have been influenced by the following key
findings from studies on the pathogenesis of HIV infection.
• Demonstration that a continuous high-level of replication of
HIV is present from the early stages of infection.

• Demonstration that the measured concentration of plasma
viral load is predictive of the subsequent risk of disease
progression and death.
• Proof that combination antiretroviral treatment is able
to consistently suppress HIV replication and also able to
significantly delay disease progression to AIDS.
• Since on-going replication of HIV drives the disease process,
the ideal target of antiretroviral treatment is to obtain timely
and sustained suppression of viral replication.
• It should be made known to the patient that ART is not a
cure. It only suppresses viral replication and makes the patient
clinically better.
• Transmission of HIV can occur while on ART and so
preventive measures should still be applied including safe sex
such as male and female condom use.
• Once the patient starts ART, treatment should continue for
the lifetime of the patient. Stopping treatment leads to a
sudden increase in the viral load and increases the emergence
of resistant strains of the virus.
• The patient who interrupts treatment needs to be reassessed
before the reintroduction of ART.

Table 4.1 Recommended ARVs in Ghana
Nucleoside Nucleotide Non- Protease Integrase

Reverse Reverse Nucleoside Inhibitors Strand
Transcriptase Transcriptase Reverse (PI) Transfer
Inhibitors Inhibitor Transcriptase Inhibitors
(NRTI) (NtRTI) Inhibitors (INSTI)
(NNRTI)
Abacavir Tenofovir Efavirenz Ritonavir Dolutegravir

(ABC) Alafenamide (EFV) boosted (DTG)
(TAF) Lopinavir
(LPV/r)
Zidovudine Tenofovir Nevirapine Ritonavir Raltegravir

(AZT/ZDV) Disoproxil (NVP) boosted (RAL)
Fumarate Atazanavir
(TDF) (ATV/r)
Lamivudine Dapivirine Ritonavir Cabotegravir

(3TC) (DPV) boosted (CAB-LA)
Darunavir
(DRV/r)
Emtricitabine
(FTC)
Fixed dose combinations of these drugs are preferred to single

dose preparations because they improve adherence to treatment.
In Ghana the preferred formulations shall be the triple fixed
dose forms, where available. Using simplified less toxic and more
convenient regimens as Fixed Dose Combinations (FDC) is
recommended for first line ART in Ghana. Mono therapy or dual

therapy (treatment with one or two drugs only) is contraindicated
for treatment of PLHIV.
Tables 4.2 – 4.10 below, show the recommended drug

combinations for use in Ghana. The first line regimen is the first
option for treatment of all patients who fit the treatment criteria.
The second line regimen is used when there is evidence of
treatment failure with the first line regimen. This should be
confirmed preferably by viral load monitoring. In this case the
whole regimen should be changed.
Dosages of the regimen will be found in drug information

attached in Appendix 5. A third line or salvage therapy is
recommended for those who have failed second line treatment.
Baseline investigation for such patients should include viral load
and drug resistance testing. This must be done in consultation
with a specialist.

Table 4.2 Preferred and alternative first-line ART
regimens for adults, adolescents, children and
neonates
Populations Preferred first- Alternative first- Special circumstances
line regimen line regimen
Adults and TDF + 3TC (or TDF + 3TC + TDF + 3TC (or FTC) +
Adolescents FTC) + DTG EFV 400mg EFV600mg
(including AZT + 3TC + EFV 600
pregnant mg
women) TDF + 3TC (or FTC)
+ PI/r
TDF + 3TC (or FTC)
+ RAL
Children ABC + 3TC + ABC + 3TC + ABC + 3TC + DTG

DTG LPV/r TDF + 3TC (or FTC)
TDF+ 3TC (or + PI/r
FTC) + DTG ABC + 3TC + EFV
ABC + 3TC + RAL
AZT + 3TC + EFV
AZT + 3TC + LPV/r
(or RAL)
Neonates AZT (or ABC) AZT + 3TC + AZT + 3TC + LPV/r

+ 3TC + RAL NVP

Table 4. 3 Preferred and alternative second-line ART regimens
for adults, adolescents, children and infants
Populations Failing first- Preferred Alternative second-

line regimen second-line line
regimen regimens
TDF + 3TC (or AZT+ 3TC AZT + 3TC + DRV/r

Adults and FTC) + DTG + ATV/r (or
Adolescents LPV/r)
(including TDF + 3TC (or AZT +3TC + AZT + 3TC + ATV/r
pregnant FTC) + EFV DTG (or LPV/r
women) (or NVP) or DRV/r)
AZT + 3TC TDF+ 3TC (or TDF + 3TC (or FTC) +

+EFV (or FTC) + DTG ATV/r
NVP) (or LPV/r or DRV/r )
ABC + 3TC + AZT+ 3TC + AZT +3TC + DRV/r

DTG LPV/r (or ATV/
r)
Children
and ABC (or AZT) AZT (or ABC) + AZT (or ABC) +3TC
Infants +3TC + LPV/r 3TC + DTG + RAL
ABC (or AZT) AZT (or ABC) + AZT (or ABC) +3TC +
+ 3TC + EFV 3TC + DTG LPV/r
(or ATV/r)
AZT + 3TC + ABC + 3TC + ABC + 3TC + LPV/r
NVP DTG (or ATV/r)
4.3 CONSIDERATIONS FOR ART REGIMEN

FOR ADULTS (20 YEARS AND ABOVE) AND
ADOLESCENTS (10 TO 19 YEARS)
Adults including pregnant women (>20years); Adolescents
including pregnant adolescents (10-19 years); Dual HIV-1 and
HIV-2 infection; HIV-1 infection; HIV-2 infection.

Table 4.4 Considerations for First Line ART Regimen for
Adults and Adolescents (Including Pregnant
Women)
Drugs Caution Comments
Preferred Regimen
Tenofovir (TDF) Caution with Monitor renal function including
+ TDF in renal urinalysis.
Lamivudine (3TC) dysfunction.
(or Emtricitabine DTG cannot be ABC can replace TDF in renal
(FTC)) used with some impairment.
+ anticonvulsants Women of childbearing potential
Dolutegravir (such as who intend to become pregnant
(DTG) carbamazepine or who are not otherwise using
and contraception should be informed
phenobarbitone) of the potential increase in the
and should risk of neural tube defects (at
not be conception and up to the end of
simultaneously first trimester) before being offered
administered DTG.
with antacids, DTG can be taken with or without
laxatives and food.
multivitamin
supplements
because of the
risk of chelation

Drugs Caution Comments
Alternative Regimen
Tenofovir (TDF) Caution with Monitor renal function including
+ TDF in renal urinalysis
Lamivudine (3TC) dysfunction ABC can replace TDF in renal
(or Emtricitabine impairment.
(FTC)) Caution with Monitor liver function tests
+ EFV in liver before and during treatment in
Efavirenz (EFV) disease patients with underlying hepatic
disease, including hepatitis
Discontinue B or C co-infection, marked
EFV if severe transaminase elevations, or who
agitation or are taking medications associated
psychosis with liver toxicity. If AST/ALT
occurs more than 5 times upper limit
of normal (ULN) or if elevation
of serum transaminases is
accompanied by clinical signs or
symptoms of hepatitis or hepatic
decompensation, discontinue
therapy.
Nervous system symptoms are
frequent and usually begin 1-2 days
after initiating therapy and resolve
in 2-4 weeks; dosing at bedtime
may improve tolerability.
Abacavir (ABC) ABC is TDF can be used in place of ABC.

+ contraindicated
Lamivudine(3TC) in ABC Use ABC if client not eligible for
(or Emtricitabine hypersensitivity TDF or ZDV.
(FTC))
+
Efavirenz (EFV)

Table 4.5 Considerations for Second Line ART Regimen for
Adults and Adolescents (Including Pregnant
Women)
Drugs Comments
First Zidovudine (AZT/ Use ABC if client not eligible for

Alternative ZDV) ZDV due to Hb <8g/dL or client
+ had a TDF-based first line
Lamivudine (3TC)
(or Emtricitabine If Hb is <8g/dL or drops >25%
(FTC)) from the baseline value for a client
+ started on ZDV as second line, use
Lopinavir/r (LPV/r) ABC
(or Atazanavir/r,
ATV/r) Use ZDV for clients who had ABC
as first line
Use PI for clients who were on

DTG as first line
Second Tenofovir Use DTG for clients who were on

Alternative (TDF) EFV as first line
+
Lamivudine (3TC) ZDV can be used in place of TDF
(or Emtricitabine for clients who had ABC as first
(FTC)) line or have renal impairment so
+ cannot use TDF.
Dolutegravir (DTG) Consider ABC if client has used
Tenofovir TDF in first line and
(TDF) ZDV is contraindicated due to
+ Hb is <8g/dL or Hb drops >25%
Lamivudine (3TC) from the baseline value for a client
(or Emtricitabine started on ZDV as second line
(FTC))
+
Lopinavir/r (LPV/r)
(or Atazanavir/r (A)

Table 4.6 Considerations for Third Line ART Regimen for
Adults and Adolescents (including Pregnant
Women)
Drugs Comments
First Darunavir/r (DRV/r) If possible, consider optimization

Alternative + Raltegravir (RAL) using genotyping before selecting
+ 1 or 2 NRTI 3rd line regimen.
DRV/r must be taken with food.
RAL can be taken with or without
food
For PI-experienced people, the
recommended DRV/r dose should
be 600 mg/100 mg twice daily.
DTG can be used as 3rd line in
place of RAL but should be taken
twice daily
Second DRV/r +2NRTIs DRV/r must be taken with food in

Alternative ±NNRTI PI-experienced patients. DRV/r
should be given 600mg/100mg
twice daily
DTG can be used as 3rd line in

place of RAL but should be taken
twice daily

4.4 CONSIDERATIONS FOR ART REGIMEN FOR
CHILDREN
Table 4.7 Considerations for First Line ART Regimen for
Neonates (First 28 Days of Life)
Drugs Contra-indications/ Comments

Caution
Preferred Regimen
Zidovudine (ZDV) ZDV is Replace ZDV with
+ contraindicated in ABC in severe
Lamivudine (3TC) (or severe anaemia (Hb < anaemia (Hb < 8g/dL)
Emtricitabine (FTC)) 8g/dL)
+ Raltegravir to be
Raltegravir (RAL) replaced with LPV/r
after two weeks of life.
DTG can be used after
4 weeks of life and
weight 3kg
Alternative Regimen
Zidovudine (ZDV) ZDV is Replace ZDV with

+ contraindicated in ABC in severe
Lamivudine (3TC) severe anaemia (Hb < anaemia (Hb < 8g/dL)
(or Emtricitabine 8g/dL)
(FTC)) Replace NVP with
+ NVP is LPV/r after two weeks
Nevirapine (NVP) contraindicated in of life.
Liver dysfunction and
hypersensitivity

Table 4.8 Considerations for First-Line ART Regimen for
Children
Contra-
Weight Drugs indications/ Comments
band Caution
Preferred Regimen
≥ 30Kg Tenofovir (TDF) TDF is Give TDF
+ contraindicated in every 48 hours
Lamivudine (3TC) renal impairment. if Creatinine
(or Emtricitabine Clearance is less
(FTC) than 50ml/min
+
Dolutegravir
(DTG)
20 to 29.9Kg Abacavir (ABC) ABC is Replace ABC

+ contraindicated with ZDV
Lamivudine (3TC) in ABC
(or Emtricitabine hypersensitivity
(FTC))
+
Dolutegravir
(DTG)
3- 19.9Kg Abacavir (ABC) Abacavir is Replace ABC

+ contraindicated with ZDV
Lamivudine (3TC) in Abacavir
(or Emtricitabine hypersensitivity
(FTC)
+
Dolutegravir As long as the
(DTG) child is above 3
kg and more than
four weeks old

Contra-
Weight band Drugs indications/ Comments
Caution
Alternate Regimen
Abacavir (ABC) ABC is ABC can be used
≥30Kg + contraindicated where client is
Lamivudine (3TC) in ABC not eligible for
(or Emtricitabine hypersensitivity TDF or ZDV
(FTC)) EFV is an option If ABC is
+ but DTG is contraindicated,
Dolutegravir preferred ZDV or can be
(DTG) used
Zidovudine Zidovudine is ABC can replace

(ZDV) contraindicated ZDV
+ in severe anaemia
Lamivudine (3TC) (<8g/dL)
(or Emtricitabine
20 to 29.9Kg (FTC))
+
Lopinavir/r
(LPV/r)
Zidovudine Zidovudine is ABC can replace

(ZDV) contraindicated ZDV
+ in severe anaemia
Lamivudine (3TC) (<8g/dL)
(or Emtricitabine)
+
DTG

Contra-
Weight band Drugs indications/ Comments
Caution
Zidovudine Zidovudine is ZDV can replace

(ZDV) (or contraindicated ABC
Abacavir (ABC)) in severe anaemia
+ (<8g/dL)
Lamivudine (3TC) ABC is
+ contraindicated
Lopinavir LPV/r in ABC
3 to 19.9Kg hypersensitivity
Abacavir (ABC) ABC is ABC can replace

(or Zidovudine contraindicated ZDV
(ZDV) in ABC
+ hypersensitivity Replace EFV with
Lamivudine (3TC) EFV should not be LPV/r
(or Emtricitabine given to children
(FTC) less than 3 years old
+ or less than 10Kg.
Efavirenz (EFV) EFV is
contraindicated
in EFV-related
persistent CNS
toxicity

Table 4.9 Considerations for Second-Line ART Regimen for Children
Preferred Contraindica-
Weight Initial First- second line tions/ caution Comments
band line regimen regimen
Tenofovir Zidovudine ZDV is LPV/r can
(TDF) (ZDV) contraindicated be taken
+ + in severe with or
Lamivudine Lamivudine anaemia (Hb < without
(3TC) (3TC) 8g/dL) food.
(or (or Pancreatitis, Monitor
Emtricitabine Emtricitabine hepatotoxicity GIT com-
(FTC)) (FTC)) and metabolic plaints if on
+ + disorders are LPV/r
Dolutegravir Lopinavir/r some adverse
≥30Kg (DTG) (LPV/r) (or effects of LPV/r
Atazanavir/r
(ATV/r)
Zidovudine Abacavir ABC is Monitor

(ZDV) (ABC) contraindicated GIT com-
+ + in ABC plaints if on
Lamivudine Lamivudine hypersensitivity LPV/r
(3TC) (or (3TC) Pancreatitis,
Emtricitabine + hepatotoxicity
(FTC) Lopinavir/r and metabolic
+ (LPV/r) (or disorders are
Dolutegravir Atazanavir/r some adverse
(DTG) (ATV/r) effects of LPV/r

Abacavir Zidovudine ZDV is Maintain
≥30Kg (ABC) (ZDV) contraindicated ABC if
+ + in severe ZDV is
Lamivudine Lamivudine anaemia contraindi-
(3TC) (or (3TC) (or (Hb<8g/dL) cated
Emtricitabine Emtricitabine
(FTC)) (FTC))
+ +
Dolutegravir Lopinavir/r
(DTG) (LPV/r) (or
Atazanavir/r
(ATV/r)
Abacavir Zidovudine ZDV is Monitor

(ABC) (ZDV) contraindicated GIT com-
+ + in severe plaints if on
Lamivudine Lamivudine anaemia (Hb < LPV/r
(3TC) (or (3TC) (or 8g/dL)
20 to Emtricitabine Emtricitabine
29.9Kg (FTC)) (FTC))
+ +
Dolutegravir Lopinavir/r
(DTG) (LPV/r) (or
Atazanavir/r
Zidovudine (ATV/r))
(ZDV)
+
Lamivudine
(3TC) (or
Emtricitabine
(FTC))
+
Lopinavir/r
(LPV/r)

Zidovudine Abacavir ABC is
20 to (ZDV) (ABC) contraindicated
29.9Kg + + in ABC
Lamivudine Lamivudine hypersensitivity
(3TC) (or (3TC) (or DTG is
emtricitabine) Emtricitabine contraindicated
+ (FTC)) in children who
Nevirapine + weigh less than
(NVP) Dolutegravir 20kg
Abacavir Zidovudine ZDV is

(ABC) (ZDV) contraindicated
+ + in severe
Lamivudine Lamivudine anaemia (Hb <
(3TC) (or (3TC) (or 8g/dL)
(FTC) (FTC)
+ + Lopinavir/r
3 to DTG (LPV/r)
19.9Kg
Abacavir Zidovudine ABC is
(ABC) (ZDV) contraindicated
+ + in ABC
Lamivudine Lamivudine hypersensitivity
(3TC) (or (3TC) (or
Emtricitabine Emtricitabine ZDV is
(FTC) (FTC) contraindicated
+ + in severe
Lopinavir/r DTG anaemia (Hb <
(LPV/r) 8g/dL)

Zidovudine Abacavir ABC is
(ZDV) (or (ABC) (or contraindicated
Abacavir Zidovudine in ABC
(ABC)) (ZDV)) hypersensitivity
+ +
Lamivudine Lamivudine
3 to (3TC) (3TC) (or
19.9Kg + Emtricitabine
Lopinavir (FTC))
(LPV/r) +
DTG
Abacavir Zidovudine ZDV is EFV is

(ABC) (or (ZDV) (or contraindicated contrain-
Zidovudine Abacavir in severe dicated if
(ZDV) (ABC)) anaemia (Hb < less than 3
+ + 8g/dL) years old or
Lamivudine Lamivudine weighs less
(3TC) (or (3TC) (or than 10Kg.
(FTC)) (FTC)
+ +
Efavirenz DTG/
(EFV Lopinavir/r
(LPV/r)

Table 4.10 Considerations for Third-Line ART Regimen for
Children
Recommended Contraindications/ Comments

Third-line regimen caution
Darunavir/r (DRV/r) Severe hypersensitivity DRV/r should be given

+ reactions with DRV/r with food.
Dolutegravir (DTG) can occur, In PI-experienced
± DRV/r can worsen patients DRV/r should
1-2 NRTIs hepatic dysfunction be given BID.
if there is underlying If DTG or RAL
liver disease (INSTI) has been used
before, when added as
a 3rd line, DTG must
be administered twice
daily. Where possible
consider optimization
using genotyping.
Tenofovir alafenamide (TAF) is a prodrug of Tenofovir . Studies

have suggested improved renal and bone safety markers com-
pared with TDF. Therefore, TAF may be considered an option
for special circumstances when bone and renal toxicity are a
particular concern (such as the presence of osteoporosis or
mild chronic renal disease and concomitant use of nephrotoxic
drugs).
Transitioning to optimal DTG-based drug regimens for

children
DTG-based regimens provide a more efficacious and tolerated

option that overcomes potential resistance to NNRTIs and
provides the opportunity to fully harmonize regimens across
children and adults.

Based on the anticipated individual (palatability, potency, ease
of administration, once-daily administration, and drug–drug
interaction profile) and programmatic (cost, simplification and
consolidation of demand and procurement) benefits, the WHO
recommends a rapid programmatic transition to DTG-based
regimens for infants and children who are currently established
on ART regardless of their current regimen.
4.5 RECOMMENDATIONS FOR SPECIAL

CONDITIONS
4.5.1 Hepatitis B/HIV Co-Infection

For children born after 2002, it is anticipated that PENTAVALENT
vaccine in Ghana will cover all immunized children.
For children above 3 years of age with hepatitis B, the preferred

regimen is Abacavir (ABC) or paediatric formulations of
Tenofovir, if available + (Emtricitabine (FTC) or Lamivudine
(3TC) + DTG. Adult and adolescent clients who are co-infected
with Hepatitis B will take TDF + 3TC as first line backbone which
may be combined with DTG or EFV as the guidelines state above
in Table 4.3. When they fail first line, the recommended second
line is AZT + TDF + 3TC + PI.
4.5.2 TB/HIV Co-Infection

Persons living with HIV should be systematically screened for
TB disease at each visit to a health facility using the algorithm for
diagnosis of TB (Appendix 3).
In using differentiated delivery the aim of TB/HIV integration is

to ensure that:

■ All clients diagnosed with TB are tested for HIV as an entry
point to HIV care.
■ Intensified case finding (ICF) is implemented so that all HIV
positive clients are screened for TB at every clinical visit. TB
screening does not need to be performed at every refill visit
unless the client has a respiratory complaint. Refer to
Differentiated Service Delivery in HIV in Ghana, Operational
Manual, Chapter 7
Newly diagnosed PLHIV who are screened negative for TB should

be provided TB Preventive Therapy (TPT) in accordance with
the National Guidelines for Latent TB Infection Management in
Ghana
All HIV positive clients with TB shall be treated in accordance

with the National Tuberculosis Programme Guidelines. (See
Guidelines for Clinical Management of TB and HIV co-
infection in Ghana). The regimen consists of initiation phase
of Rifampicin, Isoniazid, Pyrazinamide and Ethambutol for 2
months and a continuation phase of Rifampicin and Isoniazid
for 4 months. In the treatment of tuberculosis some important
interactions should be considered. Rifampicin, PIs and NNRTIs
are metabolised by the same liver enzyme system (cytochrome
P450). Thus, Rifampicin, which stimulates the enzyme, can
lead to a reduction in the blood levels of the PIs and NNRTIs.
PIs and NNRTIs may also inhibit or enhance this enzyme
system to different extents and can lead to altered blood levels
of Rifampicin. The metabolism of Integrase Strand Transfer
Inhibitors (INSTIs) such as DTG have been found to be affected
by the enzyme inducing effect of Rifampicin. The dose of DTG

needs to be adjusted because of drug–drug interactions with
rifampicin to ensure effective during co-treatment for TB in
terms of suppressing viral loads, time to suppress viral loads and
improvement in CD4 cell counts.
These drug-drug interactions may result in ineffective

antiretroviral or anti-tuberculous therapy or drug toxicity. To
reduce the effect of drug-drug interactions, the following options
must be followed in the treatment of HIV positive clients with
TB co-infection.
Adults
Clients co-infected with HIV and Tuberculosis should be treated
in accordance with the National Tuberculosis Programme
Guidelines. Preferred first line in this case is TDF + 3TC (or
FTC) + DTG but where DTG is not tolerated or contraindicated,
replace with EFV. Revert to standard first line upon completion
of TB treatment. For clients who are on DTG-based regimen,
they have to receive an additional 50 mg of DTG 12 hours after
taking their main DTG-based ARV drug regimen (DTG is taken
twice daily in TB management on Rifampicin-containing TB
therapy).
Children
Any child with active TB disease should begin TB treatment
immediately, with rapid initiation of ART once TB meningitis and
other nervous system infections have been ruled out. For infants
and children on LPV/r-based regimen (2NRTIs + Lopinavir/
ritonavir) who have to take a rifampicin-containing regimen for
TB, LPV/r has to be super-boosted with additional Ritonavir or
change to triple NRTIs for the duration of TB treatment. The

usual ratio of Lopinavir to Ritonavir is 4:1 but in super-boosting
the ratio becomes 1:1.
For children on DTG-based regimen, DTG should be taken twice

daily in TB management on Rifampicin-containing TB therapy.
The DTG dose will need to remain twice daily for two weeks after
the last dose of rifampicin has been given.
Table 4.11 Guidance for adjusting ART when rifampicin-based

TB treatment starts
ART regimen What to do when TB treatment is

started
Neonates RAL-baseda Dose adjustment needed: see the

annexes for ARV dosing
NVP-based Change of regimen needed: NVP to
be replaced as soon as possible with
DTG or LPV/r (with appropriate dose
adjustment)
Children DTG-based Dose adjustment needed
LPV/r-based Transition to DTG-based regimen
(with appropriate dose adjustment) is
preferable, and if not possible, LPV/r
dose adjustment is needed: see the
RAL-based regimen Transition to DTG-based regimen
(with appropriate dose adjustment)
is preferable, and if not possible, RAL
dose adjustment is needed: see the

ART regimen What to do when TB treatment is
started
ATV/r-based Change of regimen needed: replace

regimen ATV/r with DTG if DTG naive, with
LPV/r if DTG experienced
DRV/r-based Change of regimen needed: replace

regimen DRVr with DTG if DTG naive, with
LPV/r if DTG experienced
a Preferred for ART initiation while receiving TB treatment.
Clients Not On ART

Start ART in all HIV/TB co-infected individuals. The ART must
be started as soon as practicable within two weeks but not later
than 8 weeks of starting TB treatment. In clients with MDR TB
and HIV co-infection, ART regimen is the same as above.
Clients Already On ART

Transition to the preferred DTG-based regimen with appropriate
dose adjustment and start TB treatment as soon as possible.
Drug resistant TB
Start ART for all persons with HIV and drug-resistant TB,
requiring second-line anti-TB drugs irrespective of CD4 cell
count, as early as possible (within the first eight weeks) following
initiation of anti-TB treatment

4.6 DRUG TOXICITY
This refers to the inability of the patient to tolerate the side effects
of the medication and/or significant organ dysfunction. See table
below for some common ARV Toxicities.
Table 4.12 Common ARV Toxicities
HAEMATOLOGICAL Drug-induced bone marrow suppression,

TOXICITY most commonly seen with AZT (anaemia,
neutropenia).
MITOCHONDRIAL Primarily seen with the NRTI drugs, including
DYSFUNCTION lactic acidosis, hepatic toxicity, pancreatitis,
peripheral neuropathy, lipoatrophy, myopathy.
RENAL TOXICITY Renal tubular dysfunction is associated with

Tenofovir (TDF). ATV/r can also cause
nephrolithiasis.
OTHER METABOLIC More common with PIs and INSTIs. Include

ABNORMALITIES hyperlipidaemia, fat accumulation, insulin
resistance, diabetes and osteopenia.
Lipodystrophy is also associated with
Zidovudine. The risk of cardiovascular events
with Abacavir (ABC) is still debatable.
ALLERGIC Skin rashes and hypersensitivity reactions,

REACTIONS more common with the NNRTI drugs but also
seen with certain NRTI drugs, such as ABC and
some PIs.
HEPATIC TOXICITY Liver enzyme elevation with DTG especially

in patients with HBV or HCV co-infection.
DRV/r also causes liver enzyme elevation
MUSCULAR TOXICITY Muscle weakness and sometimes

rhabdomyolysis seen with RAL

4.7 DRUG-DRUG INTERACTIONS
Drug interactions may occur between any medications taken by
an individual. For a PLHIV, drugs may be taken for prophylaxis
and treatment of opportunistic infections, and diseases. Drug
interactions may occur between:
• Different antiretroviral drugs.
• Medicines used for the management of Opportunistic
Infections and Antiretroviral drugs
• Prescription and non-prescription medication or
alternative medicine
• Between medicines and food
• Certain recreational drugs and prescribed medications
Some important drug interactions:

• Trimethoprim-sulfamethoxazole, ganciclovir, acyclovir and
hydroxyurea can have potentially additive haematologic
toxicity when given together with Zidovudine. Careful
haematologic monitoring is necessary.
• Dapsone may lead to additive neurotoxicity with Zidovudine.
• Ketoconazole and Fluconazole may inhibit the metabolism of
Protease Inhibitors and may result in PI toxicity.

4.8 GRADING OF ADVERSE EVENTS
Table 4.13 Grading of Adverse Events
GRADE SEVERITY ACTION
1 Mild Transient or mild discomfort:

no limitation in activity; no medical
intervention/therapy required
2 Moderate Limitation in activity- some assistance

may be needed; minimal or no medical
intervention required
3 Severe Marked limitation in activity- some

assistance usually required; medical
intervention/therapy required-
Hospitalization possible
4 Severe Extreme limitation in activity -

Life-Threatening significant assistance required; significant
medical intervention/ therapy required;
hospitalization and home-based care
4.9 GUIDING PRINCIPLES IN THE

MANAGEMENT OF ARVS ADVERSE EVENTS
1. Evaluate concurrent medications and establish whether
the toxicity is attributable to an ARV or to a non-ARV
medication taken at the same time.
2. Consider other disease processes (e.g. viral hepatitis in an
individual on ARVs who develops jaundice) because
not all problems that arise during treatment are caused by
ARVs.

3. Manage the adverse event according to severity:
• Grade 4 (severe life-threatening reactions): Immediately
discontinue all ARVs, manage the medical event (i.e.
symptomatic and supportive therapy) and reintroduce ARVs
using a modified regimen (i.e. with an ARV substitution
for the offending drug) when the client is stabilized.
• Grade 3 (severe reactions): Substitute the offending drug
without stopping ART.
• Grade 2 (moderate reactions): Consider continuation of ART
as long as feasible. If the client does not improve on
symptomatic therapy, consider single-drug substitutions.
• Grade1 (mild reactions) are bothersome but do not require
changes in therapy.
4. Stress the maintenance of adherence despite toxicity for mild
and moderate reactions.
5. If there is a need to discontinue ART because of life-
threatening toxicity, all ARVs should be stopped until
the client is stabilized.

C HA P T E R F I V E
ELIMINATION OF MOTHER-
TO-CHILD TRANSMISSION
(EMTCT)
Mother-to-child transmission of HIV (MTCT), also known as

‘vertical transmission’, refers to the transmission of HIV from
a mother (living with HIV) to her child during pregnancy,
labour, delivery or breastfeeding. Interventions to eliminate this
transmission should aim at preventing HIV infection in women;
preventing unintended pregnancies among women living with
HIV; preventing mother-to-child transmission of HIV; and
providing care and support to women living with HIV and their
infants.
5.1 EMTCT GUIDING PRINCIPLES

The EMTCT guidelines are developed in line with guiding
principles recommended by the WHO as a public health approach
for increasing access to EMTCT services. This approach involves
the EMTCT programme being built around standardized
regimens and protocols according to national guidelines and
delivering a comprehensive package of services based on the UN
strategic approach to the prevention of HIV infection in infants
and young children.

The EMTCT programme in Ghana is also based on the WHO
promoted comprehensive strategic approach to the prevention
of HIV infection in infants and young children as well as keeping
their mothers alive. The programme includes:
1. Integrated delivery of interventions for EMTCT within
reproductive, maternal, newborn child and adolescent health
services including links between the services is key.
Programmes to prevent MTCT shall be implemented and
scaled up both as important prevention interventions and
as access points for care, treatment and support for women
and girls living with HIV, their children and families. For this
to happen, interventions to prevent MTCT need to be
integrated into reproductive, maternal, neonatal child and
adolescent health services, services for sexually transmitted
infections and programmes for HIV treatment and care.
2. Women’s health is the overarching priority in decisions

about ARV treatment before and during pregnancy to
improve maternal and child survival. For pregnant women
living with HIV, treatment reduces maternal mortality and
morbidity. It is the most effective method of preventing
MTCT of HIV by securing maternal health and improving
the chances of survival of her child.
3. Necessity for highly effective ARV regimens and simple

formulations for eliminating transmission to infants and
young children.
4. Task sharing to remove all barriers to identifying the infected

and initiation of therapy within EMTCT and ANC, Labour &
Delivery (L&D) units, PNC and other childcare settings.

5. Urgent need to scale up services to achieve equitable national
coverage and universal access aiming for impact and equity.
6. Emphasizing partnerships with and participation of people

living with HIV and communities including male involvement.
GOAL OF EMTCT IN GHANA

The goal of EMTCT is to provide a comprehensive family centered
continuum of promotive, preventive, clinical and supportive
services in conjunction with other public health interventions to
maintain the health of the mother and prevent the transmission
of HIV from a mother to her infant(s).
THE STRATEGY FOR EMTCT IN GHANA

The components of the strategy are:
1. Primary prevention of HIV infection in women of childbearing
age.
2. Prevention of unintended pregnancies among women
infected with HIV.
3. Prevention of HIV transmission from women infected with
HIV to their infants.
4. Provision of treatment, care and support to women infected
with HIV, their infants and their families.
Primary prevention of HIV infection in women of childbear-

ing age
This includes prevention of HIV among women of reproductive
age within services related to reproductive health such as antenatal
care, postpartum and postnatal care and other health and HIV
service delivery points, including working with community
structures. Education about HIV and contraception is also

crucial. Comprehensive education with focus on gender rights
and gender power dynamics have been found to be effective in
reducing HIV and other sexually transmitted infections (STIs).
Prevention of unintended pregnancies among women infect-

ed with HIV
This involves providing appropriate counselling and support, and
contraceptives, to women living with HIV to meet their unmet
needs for family planning and spacing of births, and to optimize
health outcomes for these women and their children.
When women living with HIV are supported through family

planning services to plan when they do and do not have children,
the number of children being born with HIV reduces. The
integration of family planning services into HIV services is an
important approach to making both more accessible to women
and couples living with HIV.
The first 2 components are addressed in detail in other documents

such as the Reproductive Health Policy and Standards and
Adolescent Reproductive Health Policy. The rest of this EMTCT
policy document focuses on component 3 and 4 of the strategy.
APPROACH FOR THE PROVISION OF EMTCT

SERVICES IN GHANA
EMTCT services shall be provided in both public and private
health care settings in Ghana where antenatal, delivery and
postnatal services are conducted. The national strategies for
providing services for the prevention of mother-to-child
transmission of HIV have two main approaches:

Facility-based care
It comprises clinical and public health interventions in health care
settings, both public and private, which reduce the transmission
of HIV from a pregnant woman to the new-born. These consist
of the provision of:
• IEC and BCC on the transmission of HIV and STI, and sexual
and reproductive health (SRH) in general.
• Both client and provider-initiated testing and counselling
strategies.
• Antiretroviral therapy and management of opportunistic
infections.
• Continued supportive counselling for all mothers living with
HIV.
• Counselling on and support for infant feeding and Early
Childhood Development (ECD).
• PrEP for pregnant and breastfeeding women at substantial
risk of acquiring HIV
Outreach/community-based services
• Psychosocial care and community support for both HIV
prevention and care.
• Outreach maternity services.
• Child Welfare Clinic.
• Nutritional counselling and support for safer infant feeding
practices.
• Home visits by Community Health Officers and others.
• Linkages of families and household members to care.
• Mother, child and adolescent support groups.
COST OF CARE
Subject to any policy directive or law to the contrary that shall
subsequently be made or enacted, every mother accessing

EMTCT service interventions shall be provided services free of
charge; and this shall include ante-natal care, labour and delivery,
as well as postnatal care up to 18 months.
5.2 GUIDING PRINCIPLES FOR HIV TESTING

FOR EMTCT
The guiding principles for HIV testing in EMTCT setting are the
same as for general HTS. They include Confidentiality, Informed
consent and Post-test Counselling and support services as
detailed in chapter one under HTS. In brief;
Confidentiality: Maintaining confidentiality is an important
responsibility of all healthcare providers. Clients should however
be informed that their HIV test results may be disclosed to other
healthcare providers to ensure they receive appropriate medical
care.
Informed consent: In the context of EMTCT, written consent is

not required but it is the responsibility of providers to ensure
that: Clients understand the purpose and benefits of testing and
Client’s decision to refuse testing is respected.
Post- test Counselling and Support services: The result of an HIV

test should always be offered to a person with appropriate post-
test information, counselling or referral.
5.3 HIV TESTING STRATEGIES FOR EMTCT

HIV testing is a process that determines whether a person is
infected with HIV or not. HIV testing detects antibodies or
antigens associated with HIV in blood and other body fluids.
5.3.1 Framework for Testing

In the context of MTCT prevention, HIV testing shall be
integrated into Reproductive and Child Health (RCH) services.
All pregnant women accessing RCH services shall receive
information on HIV testing. All HIV testing and counselling
shall be performed by trained counselors and nurses.
5.3.2 Advantages of Testing and Counselling for EMTCT

After testing, HIV negative pregnant women are to be counselled
to enable them remain uninfected. HIV negative pregnant women
at substantial risk of acquiring HIV, in addition to benefiting
from PrEP may be eligible for interventions (except for ART) for
pregnant women living with HIV below. For pregnant women
who test positive, counselling shall be undertaken to help them:
1. Make informed decisions about their pregnancy
2. Receive appropriate and timely interventions to reduce
MTCT including:
a. Follow up and on-going health care for themselves, their
HIV exposed infants and family.
b. Antiretroviral treatment.
c. Infant feeding counselling and support.
d. Information and counselling on family planning.
5.3.3 Routine Offer of HIV (and Syphilis) Testing

Irrespective of the types of testing strategies indicated in chapter
one (HTS), the main mode of testing for EMTCT in Ghana shall
be the provider-initiated testing strategy. Consequently, HIV
Testing and Counselling shall be routinely offered to all pregnant
women as part of initial and subsequent ANC services as early
as possible in the pregnancy. All women after an initial negative
HIV test result shall be encouraged to have the test repeated in
the third trimester. The minimum amount of information that
should be provided to clients includes the following:
1. Clinical and prevention benefits of testing.
2. Right to refuse.
3. Follow-up services offered.

In the event of a positive test result, anticipating the need to
inform partners and other family members who may be at risk of
exposure to HIV infection is necessary.
5.3.4 When a Client Declines to Test

Some women may initially decline an HIV test as a result of some
concerns. They might accept at a later date, especially if their
reasons for declining are discussed and addressed. It is therefore
important to continue routine offer of testing during subsequent
visits. Certain women will continue to decline testing and their
decisions shall be respected and documented in the medical
record. Their refusal shall not compromise the quality of care
they receive.
5.4 OTHER OPPORTUNITIES FOR HIV TESTING

AND COUNSELLING
5.4.1 HIV Testing during Labour

Any woman with undocumented HIV status at the time of labor
shall be offered HIV testing and counselling. Testing shall not
however be done during the active stage of labour or in the
second stage of labour. Immediate initiation of appropriate
antiretroviral treatment shall be recommended to women in
labour in the event of a positive test.
5.4.2 Post-partum and Newborn Testing

A woman whose HIV status is unknown postpartum shall be
offered HIV testing and counselling. In the situation where
the mother’s HIV status is unknown postpartum and she is
unavailable to be counseled and tested, rapid testing of the
newborn as soon as possible after birth (within 48 hours
postpartum) is recommended.
In all of the above, a positive HIV test indicates the baby is HIV

exposed and shall be offered the recommended antiretroviral
prophylaxis and care as early as possible until their status is
confirmed with HIV PCR testing within the first six weeks of life.
In case of an indeterminate result, the infant should be put on

antiretroviral prophylaxis and then followed up with further
testing to confirm the status of the child.
5.4.3 Couple and Partner HIV counselling and Testing

Couple and partner HIV testing and counselling including
disclosure should be encouraged, supported and offered. Partner
consent is not mandatory for HIV testing and counselling.
5.5 HIV TESTING ALGORITHMS FOR EMTCT

All pregnant women should be tested for HIV, syphilis and
Hepatitis B virus (HBV) at least once and as early as possible in
the pregnancy. For Pregnant women the First Response combo
(first test) should be an integrated testing for HIV, Syphilis and
Hepatitis B and if reactive for HIV, followed by Oraquick HIV
1&2 (Second test) and SD Bioline HIV 1&2 (Third test). Testing
for HBV should be done at the same time as the duo HIV/syphilis
test.
A pack of First response kit which includes the HIV/syphilis duo

and Hepatitis B test kit should be used if available. Re-testing for
HIV in pregnant women (who initially tested negative) should
be done at 34weeks.
Provider-assisted referral for ART services should be offered to

people with HIV as part of a comprehensive package of testing
and care.

Figure 5.1 HIV Testing Algorithm for Antenatal
clients

5.5.1 Algorithm for Early Infant Diagnosis (EID)
a. Zero to six weeks test in HIV-Exposed Infants: Samples
from HIV-Exposed Infants (HEIs) should be collected for
HIV PCR testing within the first 6 weeks of life.
b. Test for infants who test negative within the first six weeks
of life: Samples from HIV-Exposed Infants (HEIs) who tested
negative within the first six weeks of life should be collected at
9 months for HIV PCR testing.
c. Test for infants who test negative at 9months of life: Samples

from HIV-Exposed Infants (HEIs) who tested negative at 9
months should be tested at 18 months using the national
antibody testing algorithm.
d. Infants with positive HIV PCR test results should have

a repeat test at ART initiation. The ART initiation should not
be delayed whilst waiting for the repeat test results.
e. A negative HIV test for an HEI who is still breastfeeding, is

inconclusive.
For HIV PCR, the negative test result is conclusive six weeks after
complete cessation of breast feeding.
For antibody testing in children 18 months and above, a negative

test result is conclusive 12 weeks after complete cessation of
breast feeding. Figure 5.5.3 below shows the algorithm for early
infant prophylaxis and diagnosis.

Figure 5.2 Algorithm for Early infant prophylaxis
and diagnosis

5.5.2 Recommended Antiretroviral Protocols for EMTCT
Antiretroviral therapy shall be given to all pregnant and
breastfeeding women living with HIV for treatment and
prevention of mother to child transmission of HIV regardless
of their stage or immune status. This reflects a reinforcement
in policy to offer lifelong treatment of all mothers living with
HIV for EMTCT.
The regimens for pregnant women are the same as for the general
population.
5.5.2.1 Preferred ART Regimen for EMTCT

All pregnant women should be put on the preferred ART
regimen. The preferred treatment regimen is a triple fixed-dose
formulation of:
TDF+ 3TC (or FTC) + DTG
The alternate regimen for EMTCT are:
a. ABC + 3TC (or FTC) + DTG
b. TDF + 3TC (or FTC) + EFV
c. ABC + 3TC (or FTC) + EFV
5.5.2.2 ARV Prophylaxis for the HIV-Exposed

Infant
All HIV-exposed infants irrespective of feeding option, are to be
provided within 48 hours of birth with: AZT 12 hourly + NVP
daily for 12 weeks.
Where AZT is contraindicated (e.g. anaemia or bleeding

disorder), NVP daily for twelve weeks should be given. Breast
feeding is recommended for up to 12 months; with first 6 months
being exclusive breastfeeding.

5.6 CARE FOR PREGNANT WOMEN
Clients identified as having HIV infection during pregnancy
require active follow-up counselling and support services to
facilitate the acceptance of their sero-status and linkage to
treatment and care services. Women with unknown HIV status
shall be routinely offered HIV testing and counselling any time
they access maternity services and be given the necessary care
and interventions to reduce the possible risk of MTCT. The
comprehensive care of persons living with HIV require both
acute (immediate) and chronic (long term) care at the health
facility and at home. Care providers caring for HIV positive
pregnant women will be required to provide management for
acute care problems and illnesses associated with HIV infection
such as opportunistic infections which include bacterial, skin,
neurologic, and mental health problems, whilst also addressing
the long-term needs associated with chronic diseases. This calls
for planned management and good client-provider partnership.
Pregnancy provides a unique opportunity for such a long-term
relationship between the care provider and the HIV positive
client. Principles of chronic care must guide this relationship.
These principles focus on clients’ concerns and priorities, as well
as supporting client’s self-management. Care providers must be
guided by the 5 ‘As” of ASSESS, ADVISE, AGREE, ASSIST, and
ARRANGE, in their dealings with their clients. Follow-up of the
HIV pregnant woman must be proactive but also according to
their emotional, physical, and psychosocial needs.
A team approach to care is important and must include linkages

to the Paediatrician, Obstetrician, Physician, Psychologist,
medical social worker, ART centers, family planning services,
and community-based support services.

Good documentation and communication are important to
support such continuum of care.
Care providers must understand that the socio-cultural milieu,
gender issues, economic situations can affect the HIV-positive
mother’s behaviour and adherence to advice and treatment. This
understanding is necessary for the provision of optimum care.
The midwife shall remain the primary care provider until after
the post-partum period. Thereafter, the mother-baby pair shall
be seen at the RCH/Child Welfare Clinic.
5.6.1 Management of Syphilis in Pregnant Women

Clients with or without HIV who are found to have syphilis
should be managed and the treatment should be given as early
as possible when detected during pregnancy. The recommended
management for syphilis is the same as for those who do not have
HIV and is based on the current National Standard Treatment
guidelines as follows:
a. Recommended regimen
Benzathine Penicillin G, IM, 1.2 MU in each buttock (total
dose 2.4 MU) stat.
Alternative regimen
• Procaine benzylpenicillin, 1.2 million IU daily, by
intramuscular injection, for 10 consecutive days
Alternative regimen for penicillin-allergic pregnant women

For those with penicillin-allergy, the recommendation is to use,
with caution, erythromycin 500 mg orally four times daily for 14
days or ceftriaxone 1 g intramuscularly once daily for 10–14 days
or azithromycin 2 g once orally

Although erythromycin and azithromycin treat the pregnant
women, they do not cross the placental barrier completely and as
a result the foetus is not treated. It is therefore necessary to treat
the newborn infant soon after delivery.
Alternative regimen for penicillin-allergic non-pregnant

patients
• Doxycycline 100mg orally twice daily for 14 days
OR
• Tetracycline, 500mg orally 4 times daily for 14 days
5.6.2 Before Pregnancy

Adopting practices that ensure that women are able to plan when
they do and do not have children, whilst maintaining safer sexual
practices is key to having better outcomes when the women
decide to get pregnant.
• Health Information and Education
• Maternal nutrition.
• Safer sex practices.
• Counselling and support for Family planning.
• HIV Testing and Counselling
■ Routine Offer (Provider-Initiated TC),
■ Partner(s) HIV Testing and Counselling
5.6.3 During Pregnancy

The essential antenatal care package shall include, but not be
limited to the following:
• Health Information and Education
• Birth preparedness and complication readiness.
• Maternal nutrition.
• Health problems in pregnancy associated with HIV infection.
• Safer sex practices.

• Family planning.
• HIV Testing and Counselling
■ Routine Offer (Provider-Initiated TC),
■ Partner(s) HIV Testing and Counselling.
■ Repeat HIV TC at 34 weeks for a woman who tested
negative in the early stages of pregnancy.
■ Women of unknown HIV status shall routinely be
offered HIV TC at all ANC visits
■ Offer PrEP to HIV negative women at substantial risk of
acquiring HIV infection.
• Follow up counselling on subsequent visits.
• Intermittent preventive therapy (IPT) for malaria.
• Screening for and treatment of anemia.
• Tetanus Toxoid Immunization
• De-worming
• Prevention, Screening and management of STIs (including
syphilis and HBV).
• Provision of information on early recognition and treatment
of STIs
• Follow up care and treatment of HIV positive women
• Viral Load Assessment
• Clinical assessment (WHO staging; see Appendix)
• Prevention, Screening, TPT, and Treatment of TB
• Initiation of ART for PMTCT
• Co-trimoxazole prophylaxis (*Do not give SP/IPT to clients
on Co-trimoxazole prophylaxis).
• Nutritional support and counselling
■ Initiation of micronutrient supplementation for the
mother (vitamin, folic acid and iron)
■ Counselling and support on infant feeding choices
■ A woman who is HIV-positive shall be supported

to make an informed decision between breastfeeding
and replacement feeding (Refer to: National
Breastfeeding Policy.
Viral load testing for pregnant women

Whenever possible, use same-day point-of-care testing for viral
load testing of pregnant and breastfeeding women to expedite
the return of results and clinical decision-making. If this is
not available, viral load specimens and results for pregnant
and breastfeeding women should be given priority across the
laboratory referral process (including specimen collection,
testing and return of results).
Adherence counselling should be provided at all antenatal care

and postnatal visits to ensure that viral suppression is maintained
throughout pregnancy and breastfeeding.
For all pregnant women, regardless of ART initiation timing:
conduct viral load testing at 34–36 weeks of gestation (or at
the latest at delivery) to identify women who may be at risk of
treatment failure and/or may deliver infants at higher risk of
perinatal transmission.
Action: if viral load >50 copies/ml, follow the treatment

monitoring algorithm
Where available, consider infant nucleic acid testing at birth.
In addition:
a) For pregnant women receiving ART before conception:

conduct a viral load test at the first antenatal care visit (or when
first presenting) to identify women at increased risk of in utero
transmission.

Action: If viral load >50 copies/ml, follow treatment monitoring
algorithm and consider infant nucleic acid testing at birth where
available.
b) For pregnant women starting ART during pregnancy: conduct

a viral load by three months after ART initiation to ensure that
there has been rapid viral suppression.
Action: If viral load >50 copies/ml, follow the treatment

monitoring algorithm.
Regardless of the maternal viral load, the infants of mothers

starting ART at any time during pregnancy could be considered
for birth testing where available.
c) For all breastfeeding women, regardless of when ART was

initiated: conduct a viral load test three months after delivery
and every six months thereafter to detect viraemic episodes
during the postnatal period.
Action: if viral load >50 copies/ml, follow the treatment

monitoring algorithm, conduct infant HIV testing immediately
and consider reinitiating enhanced postnatal prophylaxis for the
infant.
5.6.4 During Labour and Delivery
Safe delivery services

Vaginal delivery is still the safest mode of delivery. Caesarean
section shall be considered on obstetric grounds rather than
solely for PMTCT. Where Caesarean section is indicated this
must be performed promptly.

Minimise the risk of postpartum haemorrhage by active
management of third stage of labour and use safe blood
transfusion practices.
Interventions that can reduce MTCT include the following:

1. Administration of ARV treatment during labour in accordance
with national protocols.
2. Routinely offering testing and counselling during latent phase
of labour where feasible for women of unknown HIV status.
3. Use of good infection prevention practices for all client care.
4. Performing vaginal examinations as per partograph protocols
and /or when absolutely necessary and with appropriate clean
technique.
5. Avoiding prolonged labour (use a partogram to measure the
progress of labour).
6. Avoiding routine artificial rupture of membranes.
7. Avoiding unnecessary invasive procedures during and after
delivery e.g. routine episiotomy, vacuum delivery, milking of
umbilical cord and routine suctioning of baby.
5.7 POST PARTUM CARE OF HIV INFECTED

WOMEN, WOMEN OF UNKNOWN STATUS
AND THE NEWBORN
5.7.1 Care for Mother

Though not limited to the following, post-partum care for the
mother shall include:
• Women of unknown HIV status shall be routinely offered
HTS and retesting offered to women found to be negative but
at a substantial risk of HIV infection.
• Information Education and Counselling (IEC) on for

example danger signs, self-care, nutrition and postpartum
clinic attendance.
• Screening for health problems associated with HIV infection
in postpartum period e.g. puerperal sepsis and anaemia.
• Screening and treatment for STIs.
• Counselling on breast and cervical cancer screening.
• On-going Counselling and support.
• Provision of medical and psychosocial supportive care.
• Prophylaxis with Co-trimoxazole and treatment for OIs and
other infections for HIV positive symptomatic mothers.
• All HIV positive mothers and exposed infants shall be linked
to care and follow up.
5.7.2 Newborn Care

• Provide standard newborn care.
• Initiate and support infant feeding choice.
• Initiate ARV prophylaxis in infants of HIV positive mothers.
• Provide immunization (BCG and OPV).
5.7.3 Discharge After Delivery

The mother and baby shall be followed up after delivery to
ensure continuity of care started in the antenatal period. As
much as possible appointments for mother and baby shall be
synchronised.
Checklist for Discharge after Delivery

✓ Give counselling and support on method of infant feeding
chosen by mother (see below) and on maternal nutrition
including micronutrient supplementation.
✓ General physical examination of infant to exclude birth
injuries and congenital abnormalities.
✓ Physical examination of mother for anaemia and sepsis or

signs of other opportunistic infections.
✓ Supply drugs and explain dosage, timing, adherence and
duration of ARV treatment for mother and ARV prophylaxis
for baby.
✓ OI prophylaxis for mother.
✓ Educate on recognition of ill health in mother and new-born
and appropriate actions to be taken.
✓ Advice and support on preventive measures such as hygienic
practices, malaria prevention.
✓ Ensure BCG/OPV immunisation for infant has been given.
✓ Record infant weight, length and head circumference in Child
Health Record booklet.
✓ Psychosocial /Community support.
✓ Give appointment for first Post-natal clinic visit (3-7 days).
✓ Counselling on safe sex and FP?
5.7.4 Post-Natal Follow-Up

Clinic visit
Follow up visits for healthy mothers at the Post-natal clinic shall
be within 3-7 days and at 6weeks postpartum. Women who
delivered at home shall be encouraged to report to the postnatal
clinic within 48 hours after delivery. The HIV positive mother
and HEI shall be linked to both the RCH/Child Welfare Clinics.
Mothers with HIV-related complications should be seen more
frequently as needed.
3 -7 days postnatal clinic visit

Mother
→ History and physical exam to exclude complications such
as pallor, complications related to genital tract and breasts
(engorgement, cracked nipples, infection) etc.
→ Discuss chosen infant feeding option and challenges.

→ Discuss Safe Sex and Family Planning.
→ Provide OI prophylaxis.
→ Emphasize ART adherence.
→ Provide adequate supply of ART until six weeks visit. Give
6week appointment for Post-natal clinic.
→ Assess Nutritional/ Psychosocial /Community support.
→ Women of unknown HIV status shall be routinely offered
HIV TC.
New-born
→ History and physical exam including assessment for pallor,
jaundice, weight, length, head circumference, birth injuries
and congenital abnormalities, developmental assessments.
Assess to also determine whether the child is receiving
nurturing care. Refer for clinical care if indicated.
→ Assess adherence to feeding choice, provide counselling and
support (see below).
→ BCG/OPV if not already given.
→ Assess adherence to infant ARV prophylaxis and ensure
adequate supply until next scheduled visit at 6 weeks.
→ Educate on recognition of ill health (especially for anaemia)
in new-born and appropriate actions to be taken.
→ Schedule appointment to see the child at Maternal New-born,
Child and Adolescent Health (MNCH)/Child Welfare clinic
at age six weeks.
→ Where mother is not available to be offered testing and
counselling, a serological test shall be offered to establish
whether the baby is HIV exposed or not.
→ Take Dried Blood Spot (DBS) or blood sample for early infant
diagnosis (EID).
6week postnatal clinic visit

Mother
→ Ensure that all routine assessments have been carried out for
the mother at 3-7 days postnatal visit;
→ Provide Comprehensive HIV care and treatment.
→ Supply ART drugs until next scheduled follow-up visit.
Infant
→ History and physical exam including assessment for pallor,
jaundice, weight, length, head circumference and
development. Assess to also determine whether the child is
receiving nurturing care. Refer for clinical care if indicated.
→ Assess adherence to feeding choice, provide counselling and
support (see below).
→ Pentavalent/OPV immunisation.
→ Assess adherence to ARV prophylaxis and continue till twelve
weeks.
→ If first EID test is positive, provide Comprehensive HIV care
and treatment.
→ Start Co-trimoxazole prophylaxis once daily for all HIV
exposed babies from six weeks onwards.
→ If EID has not been done already, take Dried Blood Spot
(DBS) for EID.
Maternal, Neonatal and Child Health (MNCH)/Child Welfare

Clinic
Beyond the six weeks post-natal period, HIV positive

mothers and their new babies will require continuing care.
Such comprehensive care is best provided through linkage or
integration of maternal and child health care services to the ART
Clinics. As much as possible appointments for mother and baby
shall be synchronised.

Schedule monthly follow-up visits for healthy mothers and
babies until 12 months of age then every 3 months. For mothers/
babies with problems, schedule more frequent visits as needed.
Mother
→ Assess for general wellbeing (including childcare and
support).
→ Assess for opportunistic infections and manage accordingly.
→ Inquire about adherence to ART.
→ Inquire about adherence to agreed infant feeding plan.
→ Provide counselling and support as needed.
→ Monitor viral load according to adult ART protocol.
Infant
Whenever the mother brings the child to the clinic, the
baby should be monitored for adherence to co-trimoxazole
prophylaxis, weight gain, development and evidence of OI.
Additional sessions may be required during special high-risk
periods, such as when the:
• Child is sick or not gaining weight appropriately.
• Mother returns to work.
• Mother decides to change feeding methods.
Duration of follow-up depends on when HIV infection status is

determined and on feeding method. At each visit the following
activities should take place:
✓ HIV PCR test if not yet done.
✓ Initiate ART in all HIV infected infants regardless of CD4
count or WHO staging.
✓ History and physical exam including assessment for pallor,
weight, length, head circumference, development and features

of HIV associated illnesses.
✓ Counselling and support on feeding.
✓ Immunisations according to national immunization schedule.
Symptomatic infants (Stage 4) should not be given yellow
fever immunisation.
✓ Continue Co-trimoxazole prophylaxis once daily in all infants
who are at risk or are HIV positive.
✓ Early and aggressive treatment of opportunistic infections
(OIs).
✓ Nutrition intervention.
✓ Vitamin A supplementation.
5.7.5 Infant Feeding

For breastfed infants, refer Algorithm for EID (Figure 5.5.3)
Mothers known to be HIV-infected will be provided with
lifelong ART interventions to reduce HIV transmission through
breastfeeding. In view of this, mothers who are HIV-positive
shall be counseled on infant feeding over the course of several
sessions during the antenatal period. At least three counselling
sessions shall take place sometime during ANC after post-test
counselling.
Mothers shall be counselled to exclusively breastfeed their

infants for the first 6 months of life introducing appropriate
complementary foods thereafter and continuing breastfeeding for
the first 12 months of life. Breastfeeding should be stopped only
when a nutritionally adequate diet can be provided. Avoidance of
mixed feeding during the first 6 months should be emphasized.
Mothers and their infants shall be seen regularly to monitor
wellbeing and infant feeding progress.
The following recommendations are made:

1. Mothers known to be HIV-infected who decide to stop
breastfeeding at any time before 12 months should be
supported to stop gradually within one month.
2. Mothers must continue their ART throughout the
breastfeeding period and for life.
3. When mothers known to be HIV-infected decide to stop
breastfeeding at any time, infants should be provided with
safe and adequate replacement feeds to enable normal growth
and development.
4. Mothers known to be HIV-infected should only give
commercial infant formula milk as a replacement feed to
their HIV-exposed infants or infants who are of unknown
HIV status, when the following specific conditions are met:
a. safe water and sanitation are assured at the household
level and in the community; and
b. the mother, or other caregiver can reliably provide
sufficient infant formula milk to support normal growth
and development of the infant; and
c. the mother or caregiver can prepare it cleanly and
frequently enough so that it is safe and carries a low risk
of diarrhoea and malnutrition; and the mother or
caregiver can, in the first six months, exclusively give
infant formula milk; and
d. the family is supportive of this practice; and the mother
or caregiver can access health care that offers
comprehensive child health services.
5. If infants and young children are known to be HIV-infected,
mothers are strongly encouraged to exclusively breastfeed for
the first six months of life and continue breastfeeding as per
the recommendations for the general population, that is, up
to two years or beyond.
Counselling should emphasise the following:

→ Information about the risk of HIV transmission through
breastfeeding.
→ Reduction of risk of transmission of HIV through breast milk
by ARVs.
→ Advantages and disadvantages of breastfeeding.
→ Consideration for local customs, practices, and beliefs when
helping a mother to make infant-feeding choices.
→ Disadvantages of practising mixed feeding during the first 6
months.
→ Skilled counselling and support for appropriate infant feeding
practices and ARV interventions shall be provided to all
pregnant women and mothers.
Note: Mixed feeding should be avoided in the first 6 months.
In settings in which health services provide and support lifelong

ART, including adherence counselling, and promote and support
breastfeeding among women living with HIV, the duration of
breastfeeding may not be restricted. Mothers living with HIV (and
whose infants are HIV uninfected or of unknown HIV status)
should exclusively breastfeed their infants for the first six months
of life, introducing appropriate complementary foods thereafter
and continue breastfeeding until 12 months. Breastfeeding
should then only stop once a nutritionally adequate and safe diet
without breast milk can be provided.
However, mothers living with HIV and health-care workers

can be reassured that ART reduces the risk of postnatal HIV
transmission in the context of breastfeeding. Although exclusive
breastfeeding is recommended, practising mixed feeding is not a
reason to stop breastfeeding in the presence of ARV drugs.
Evaluation of Child at 18 Months and above
At 18 months the definitive HIV infection status of all HIV-

exposed children should be determined using antibody test. If
the child is still breastfeeding, the test should be repeated at least
12 weeks after cessation of breastfeeding.
✓ A child whose serologic test is positive should receive
comprehensive HIV care and ART for life.
✓ Co-trimoxazole prophylaxis should be stopped in non-
infected child.
✓ The serologically negative child should be discharged from
follow up at ART clinic back to MNCH clinic.
5.7.6 Psychosocial and Community Support

Women shall be supported and encouraged to undergo pre-
marital and couple counselling and testing for HIV. Women who
test positive shall be provided with follow-up counselling and
support and encouraged to disclose test results to their partners
and families.
By disclosing her HIV status to her partner and family, the
woman would be in a better position to:
• Access EMTCT interventions.
• Receive support from her partner (s) and family when
accessing EMTCT and HIV treatment, care, and support
services.
• Encourage the partner(s) to go for HIV testing and
counselling.
• Prevent the spread of HIV to her partner(s).
• Have other children tested. The family shall be encouraged to
support the woman in making and adhering to the infant feeding
choice that works best for her. Mothers and their newborn babies
should be linked to social support systems. After delivery and
before discharge from the health facility, the mother, partner and/
or family shall be given specific information on care and support;

this will include the names of social support organizations, their
addresses, and the kind of service they provide and their work
schedule.
Providing psychosocial support
Midwives and other care givers providing care for HIV positive
mothers can provide support to these clients by:
→ Providing continuing counselling support throughout
pregnancy, childbirth, postpartum and postnatal periods.
→ Helping mothers identify confidants and other support
persons.
→ Counselling identified confidants/support persons on their
expected roles and responsibilities.
→ Linking them to other support groups and institutions such
as social welfare, PLHIV etc.
5.8 EMTCT LOGISTICS MANAGEMENT

All ARVs and rapid diagnostic kits shall be procured solely by
Ministry of Health (MOH) in Ghana. All facilities accredited for
EMTCT services shall be supplied ARV in line with the supply
chain management of MOH.
The pharmacy staff at the facility level shall ensure that all:
1. The medications required for EMTCT are available and
adequately stored at the facility.
2. Logistics Management Information System (LMIS) reporting
forms are sent to the next level in a timely manner.
5.9 MONITORING AND EVALUATION

This shall be done using standard indicators from data capture
registers, reports and monitoring visits. EMTCT indicators
shall be integrated with reproductive and child health records to

facilitate easy collation and reporting. Day to day (Transactional)
ART/EMTCT data should be captured using the ART e-tracker.
Monthly data on EMTCT shall be validated and reported
through the District Health Information Management System.
Periodic assessment of the EMTCT service quality and data
shall be carried out to evaluate its effectiveness and efficiency.
Facilities providing EMTCT services shall also be enrolled
into an HIV proficiency testing programme to assure valid test
results for quality service. This will be complemented by periodic
laboratory quality assurance support for all HCWs providing
rapid serological HIV testing within EMTCT and other service
settings in accordance with national algorithms and protocols.

C HA P T E R SI X
MONITORING OF CLIENTS
ON ART
6.1 CLINICAL MONITORING

Clients on ART should be closely followed-up to assess
adherence to therapy as well as tolerance and efficacy of the
treatment. Regular laboratory monitoring after start of ART is
necessary to identify side effects, toxicity, viral suppression and
drug resistance. Intensive follow up should be done in the first
few weeks of management. Management of the PLHIV should
be a team approach between the clinician, nurse, counsellor,
pharmacist, laboratory personnel, any other service provider and
confidante who will support the client with his/her management.
The client should be seen a few days (not more than 14 days)
after initiation of therapy. After the first few weeks, follow up can
be at monthly intervals for the first 3 months, then at intervals of
2 – 3 months as necessary and later adjusted to fit a differentiated
care approach.
With the accelerated introduction of new ARV drugs, often

occurring in the context of limited clinical experience outside
trial settings, pharmacovigilance systems should be developed

or strengthened as efforts to optimize ARV drugs for children
are ongoing. The transition to optimal formulations can happen
concurrently with pharmacovigilance strengthening activities.
Existing pharmacovigilance systems can be modified to include
newly available and optimal ARV drugs for children rather than
developing parallel systems, which can be both time and cost
intensive. Updating pharmacovigilance reporting forms and
systems is important to capture adverse drug reactions during
DTG introduction and possible drug intolerance to DTG.
6.1.1 Monitoring of Adherence

Adherence to ART is essential and more than 95% adherence is
required for effectiveness of therapy. To improve adherence, the
initial counselling sessions should be comprehensive and should
result in well informed decisions and commitment by the client.
Disclosure to and the use of adherence monitors has been found
to be effective in improving adherence. In addition, there should
be available information and a committed supporting medical
team. Adherence to treatment should be discussed in-depth at
each follow-up visit.
Measurement of Adherence
Adherence should be monitored using one of the following
methods:
• Self-reports
• Pill counts
• Pharmacy records

Monitoring of Adverse Effect
Causes of any new symptoms and signs should be identified after
initiation of ART. New symptoms may be due to;
→ Intercurrent illnesses,
→ Adverse reactions to antiretroviral drugs and other drugs and
→ Opportunistic infections becoming clinically apparent as a
result of immune reconstitution.
Where opportunistic infections become clinically apparent as

a result of immune reconstitution syndrome (IRS), these need
to be diagnosed and treated. Clients should be observed at
each clinic visit for opportunistic infections and screened for
TB at every visit. Adverse effects of drugs should be explained
to clients and appropriate measures taken. Antiretroviral
agents are responsible for a broad range of adverse effects
from low grade self-limiting to life-threatening side-effects.
Differentiating between complications of HIV disease and
ART toxicity is sometimes difficult. Alternative explanations
for a client’s presenting symptoms should be considered before
it is concluded that toxicity is ART-related. Regardless of their
severity, adverse events may affect adherence to therapy. Drug
toxicity refers to the inability of the client to tolerate the side
effects of the medication and/or significant organ dysfunction as
in Table 4.9 above. A proactive approach to managing toxicity
is recommended. Ancillary laboratory tests should be done to
confirm adverse effects such as anaemia, neutropenia among
others (see laboratory monitoring).

Monitoring of Efficacy
Indicators for improvement in the client’s condition are:
• Gain in body weight.
• Decrease in frequency or severity of opportunistic infections.
• Increase in CD4 count.
• Improvement in full blood counts.
• Sustained suppression of viral load.
Important clinical signs of response to ARV therapy in children

include:
• Improvement in growth of children previously failing to grow.
• Improvement in neurological symptoms.
• Development in children with delayed developmental
milestones or encephalopathy.
• Decreased frequency of infections (oral thrush, bacterial and
other opportunistic infections).
In addition to the clinical assessment recommended in adults,

clinical monitoring of treatment in children should include:
• Nutritional status: mid-upper arm circumference (children
6months -5years).
• Height, weight and head circumference.
• Weight for height Z-score.
• Developmental milestones.
• Neurological symptoms and signs.
6.2 LABORATORY MONITORING

Regular laboratory monitoring after start of ART is necessary
to identify side effects, toxicity, viral suppression and drug
resistance of the client. TB screening should be done at each
visit to the clinic using the TB screening algorithm (appendix 3).
Clients with a positive screening test must be evaluated for active
TB disease.

6.2.1 HIV VIRAL LOAD AND RESISTANCE TESTING
GUIDE
WHAT IS VIRAL LOAD (VL)?

HIV Viral Load is the quantity of HIV (specific HIV RNA) present
in the blood (plasma) at a given time. This does not include HIV
outside the bloodstream such as those in the brain and other
tissues. The levels of Viral Load can be a predictor of disease
progression to AIDS and for those on Antiretrovirals (ARVS) an
indicator of response to Antiretroviral Therapy (ART).
MEASUREMENT OF VIRAL LOAD

Viral Load measurement is done using the Polymerase Chain
Reaction (PCR) method which allows for measuring viral RNA.
The results are reported as copies of HIV RNA per milliliter of
plasma (copies/ml), as for example 270,000 copies/ml or ≤50
copies/ml (which is usually reported as viral suppression).
INTERPRETATION OF HIV VIRAL LOAD TESTING

RESULTS
Viral loads measurements must always be interpreted bearing
in mind that results are affected by laboratory variation and
assay fluctuations that may lead to 10-30 percent variation in
a test result if the same sample is repeated on the same assay
in the same laboratory. For example, 100,000copies/ml is not
significantly different from 130,000copies/ml, and 1,100copies/
ml is not significantly different from 990copies/ml. The results are
also affected by patient variables such as acute illness, and recent
vaccinations which may require deferral of viral load testing for
at least 4 weeks, or a repeat after 4 weeks for proper appreciation
of results. Inpatients who have been on ART for more than 6
months, there is said to be treatment failure, where viral loads

of more than 1,000 copies/ml are obtained for 2 viral loads at
least 3 months apart indicating a need to change in antiretroviral
regimen. (REFER Appendix 7 Treatment monitoring algorithm)
INDICATIONS FOR VIRAL LOAD TESTING (WHEN TO

REQUEST FOR VIRAL LOAD)
For the purpose of Monitoring of HIV treatment (ART),
a. Routine viral load monitoring for early detection of treatment
failure, obtain and review result by 6 months after ART
initiation, 12 months after ART initiation and yearly
thereafter.
b. Diagnosis of Treatment Failure.
c. Prior to HIV Drug Resistance Testing.
USE OF VIRAL LOAD TESTING RESULTS

a. To determine the efficacy of Treatment Regimen.
b. To determine adherence to treatment.
c. To diagnose Treatment Failure.
Note: Switching to second line must be done after consultation.
HIV DRUG-RESISTANCE TESTING

HIV Drug-resistance testing is used to determine changes in
the virus (mutations) that will make the virus not responsive to
particular anti-retrovirals. In Ghana, our standard resistance test
is the genotypic test which enables detections of mutations in
the different drug classes, e.g. NRTI, NNRTI and PI. Phenotypic
tests can also be applied but these are not routine in Ghana.
INDICATIONS FOR HIV DRUG RESISTANCE TESTING

a. Virological failure in patients on treatment.
b. Monitoring of emergence of HIV Drug-resistance (usually as
a survey or follow-up in a cohort of patients on treatment).
c. Establishment of threshold of resistance in PLHIV population
at initiation of ART (usually done as a study).
d. Assessment of efficacy of new ARVS about to be introduced
or those which have been in use for some time.
INTERPRETATION OF HIV DRUG RESISTANCE TESTING

RESULTS
Interpretation is dependent on the purpose for which the test
was conducted. As a sequel to virologic failure, the resistance
test will give an indication as to which class of ARVS and which
particular ARVS the virus had become resistant to in that
particular patient. In the case of emergence and threshold study
type resistance testing, the result would give an indication of the
levels of emergence of resistance in the population on treatment
over time and the levels of resistance amongst population of
PLHIV at the initiation of treatment respectively. Resistance
testing for assessing the efficacy of ARVS provides that baseline
information required for decision making.
REQUESTING DRUG-RESISTANCE TESTING IN GHANA

HIV Drug-resistance testing is conducted in Ghana by the
Noguchi Memorial Institute for Medical Research at the
University of Ghana, Legon.
6.2.2 ANCILLIARY TESTS

The following ancillary tests should be done at 6 month intervals
at least:
• Full blood count (clients on Zidovudine may require frequent
Hb monitoring).
• Urine R/E.
• Fasting Blood Sugar and Lipid profile
(if the client is on PIs or INSTI’s).
• BUE and Creatinine.
• Liver function tests (ALT, AST).

C HA P T E R SEV E N
CHANGING OR
INTERRUPTING THERAPY
7.1 INTERRUPTION OF THERAPY

Interruption of therapy refers to the temporary or permanent
discontinuation of all drugs at the same time. The administration
of one or two drugs only should not be done for any reason as this
may result in the development of resistant viruses. Interruption
of therapy should be done by the clinician in consultation with
the client under the following circumstances:
• Intolerable side effects
• Severe drug interactions
• Persistent poor adherence
7.2 TREATMENT CHANGES

Therapy changes are similar for adults and children changes
to antiretroviral therapy may be done under the following
circumstances:
• Drug toxicity
• Treatment Failure.
In children, important clinical signs of treatment failure include:

• A lack of growth among children who show an initial
growth response to therapy;
• A loss of neurodevelopment milestones
• Development of encephalopathy
• Recurrence of infections, such as oral candidiasis
refractory to treatment.
Before an ARV regimen is thought to be failing, based on clinical

criteria, the child should have had a reasonable time on the ART
(i.e. must have received the ART for at least 6months). A switch
to a second line regimen is recommended when virological
failure is recognized.
7.2.1 CRITERIA FOR CHANGING THERAPY

The trained healthcare worker in consultation with the other
team members and the client may change antiretroviral therapy
under the following circumstances:
• Drug toxicity (This has been dealt with earlier in chapter 4).
• Treatment Failure.
7.2.1.1 TREATMENT FAILURE

This can be defined clinically by disease progression,
immunologically by a decrease in CD4 count or virologically by
an increase in viral load. Treatment failure may occur soon after
initiation as may be in a case of transmitted resistance viruses or
may occur sometime after treatment.

DIAGNOS IS OF TREATMENT FAILURE
Table 7.1 WHO definitions of clinical, immunological and
virological failure for the decision to switch ART
regimens
Failure Definition Comments
Clinical failure Adults and adolescents The condition must

New or recurrent be differentiated from
clinical event immune reconstitution
indicating severe inflammatory syndrome
immunodeficiency occurring after initiating
(WHO clinical stage ART.
4 condition) after six For adults, certain WHO
months of effective clinical stage 3 conditions
treatment. (pulmonary TB and severe
Children bacterial infections) may
New or recurrent also indicate treatment
clinical event indicating failure.
advanced or severe
immunodeficiency
(WHO
clinical stage 3 and
4 clinical conditions
except for TB) after
six months of effective
treatment.
Immunological Adults and adolescents Without concomitant or

failure CD4 count at 250 cells/ recent
mm3 following clinical infection to cause a
failure or Persistent transient decline in the
CD4 cell count below CD4 cell count. Current
100 cells/mm3 WHO clinical and
immunological criteria
Children have low sensitivity and
Younger than five years positive predictive value
Persistent CD4 cell for identifying individuals
count below 200 cells/ with virological failure.
mm3. There is currently no
proposed alternative
Older than five years definition of treatment
Persistent CD4 cell failure and no validated
count below 100 cells/ alternative definition of
mm3. immunological failure.

Failure Definition Comments
Virological Viral load above 1000 An individual must be

failure copies/mL based on taking ART for six months
two consecutive viral before it can be determined
load measurements that a regimen has failed.
three months apart, Individuals with viral load
with adherence support > 50 to ≤ 1000 copies,
following the first viral maintain ARV regimen,
load test. Switch ART enhance adherence
after first viral load counselling and repeat
>1,000 copies/mL for viral load testing after three
those receiving NNRTI- months. Consider switch
based regimens. after second viral load >
50 to ≤ 1000 copies/mL
if people are on NNRTI-
based ART.
Note: under no circumstances should a client be switched to

second line based solely on clinical failure. If clinical failure is
evident, do viral load for confirmation.
The main reasons for treatment failure are;
1. Poor prescribing practices.
2. Poor adherence.
3. Pre-existing viral drug resistance.
4. Insufficient drug levels (serum and cellular).
5. Insufficient ARVS potency.
6. Unreliable drug supply.
Viral suppression: Viral suppression is a viral load that is
undetectable (equal to or less than 50 copies/ml).
Low-level viraemia: Low-level viraemia is one or more viral load
results that are detectable (more than 50 copies/ml) but equal to
or less than 1000 copies/ml.

Table 7.2 Clinical Events Indicating Possible Treatment
Failure
New or recurrent clinical Management options

event develops after at
least 6 months on ART
No new events or Stage 1 • Do not switch to new regimen
events • Maintain regular follow-up
• Reinforce adherence to therapy
Stage 2 events • Treat and manage event

• Do not switch to a new regimen
• Assess adherence and offer support
• Assess nutritional status and offer
support
• Schedule earlier visit for clinical review
and viral load measurement.
Stage 3 events • Treat and manage event and monitor

response
• Check if on treatment 6 months or more
• Assess nutritional status and offer support
•Check viral load
• Institute early follow-up
Stage 4 events • Treat and manage event

• Check if on treatment 6 months or more
• Assess nutritional status and offer support
• Check viral load
• Consider switching regimen if adherence
is optimal and viral load is persistently
higher than 1,000 copies/ml after three VL
tests.

C HA P T E R E IG H T
OPPORTUNISTIC INFECTION
MANAGEMENT AND
PROPHYLAXIS FOR HIV-
RELATED INFECTIONS
AMONG ADULTS,
ADOLESCENTS AND
CHILDREN
8.1 MANAGEMENT OF OPPORTUNISTIC

INFECTIONS
This should follow established protocols for the management of
opportunistic infections. Opportunistic infections need to be
treated as much as possible before the initiation of ART.
8.1.1 Cryptococcal disease

Cryptococcal meningitis accounts for an estimated 15% of all
people dying from AIDS-related causes globally, three
quarters of which are in sub-Saharan Africa. Less common
presentations of cryptococcal disease include pulmonary disease,
skin, lymph node and bone disease

Management
Immediate ART initiation is not recommended for adults,
adolescents and children living with HIV who have cryptococcal
meningitis because of the risk of increased mortality and ART
initiation should be deferred 4–6 weeks from the initiation of
antifungal treatment
Induction
The following is recommended as the preferred induction
regimen.
• For adults, adolescents and children, a short-course (one-
week) induction regimen with amphotericin B deoxycholate
(1.0 mg/kg per day) and flucytosine (100 mg/kg per day,
divided into four doses per day) or
• Two weeks of fluconazole (1200 mg daily, 12 mg/kg per day
for children and adolescents) + flucytosine
(100 mg/kg per day, divided into four doses per day) (39) or
• Two weeks of amphotericin B deoxycholate (1.0 mg/kg per
day) + fluconazole (1200 mg daily, 12 mg/kg per day for
children and adolescents up to a maximum of 800 mg daily)
Consolidation
Fluconazole (400–800 mg daily for adults or 6–12 mg/kg per day
for children and adolescents up to a
maximum of 800 mg daily) (for eight weeks following the
induction phase)
Maintenance (or secondary prophylaxis)

Fluconazole (200 mg daily for adults or 6 mg/kg per day for
adolescents and children) is recommended for the maintenance
phase

Routine use of adjunctive corticosteroid therapy during the
induction phase is not recommended in treating adults,
adolescents and children who have HIV-associated cryptococcal
meningitis
Pneumocystis jirovecii pneumonia

Pneumocystis jirovecii pneumonia is a leading cause of mortality
among hospitalized adults (13%) and children (29%) living with
HIV.
Management
Septrin 4 tablets (1920mg) bd
Toxoplasmosis
Cerebral toxoplasmosis is the most frequent cause of expansive
brain lesions among adults living with HIV not receiving co-
trimoxazole.
Management
Sulphadiazine 1gm 6hrly x 6 weeks + Pyrimethamine 100mg st,
50mg dly x 6 weeks+ Folinic acid 10-25mg dly
Or
Septrin 4 tablets (1920mg) bd
Or
Clindamycin 450-600mg +Pyrimethamine 200mg stat then 50-
75mg daily + leucovorin/folinic acid 10-20mg daily X 6 weeks

8.2 PROPHYLAXIS FOR HIV-RELATED
INFECTIONS AMONG ADULTS,
ADOLESCENTS AND CHILDREN
8.2.1 CO-TRIMOXAZOLE PROPHYLAXIS

Co-trimoxazole is a fixed-dose combination of two anti-microbial
drugs (sulfamethoxazole and trimethoprim) that covers a variety
of bacterial, fungal and protozoan infections. It has advantages
of being an off-patent drug that is widely available everywhere.
Since 2006 WHO has recommended the use of Co-trimoxazole
as a preventive therapy for people living with HIV to reduce HIV-
related morbidity and mortality particularly those associated
with Pneumocystis jirovecii pneumonia, toxoplasmosis, malaria,
pneumonia and diarrhoea.
Its use has proven to be an effective, well tolerated and inexpensive

intervention particularly in low resource settings where HIV
related morbidity and mortality from infections are high. The use
of Cotrimoxazole prophylaxis should therefore be considered an
integral component of HIV and AIDS patient care.
8.2.1.1 Eligible patients

Co-trimoxazole prophylaxis is recommended for:
→ Adults (including pregnant women) with severe or
advanced HIV clinical disease (WHO stage 3 or 4) and/
or with a CD4+ count of ≤350 cells/mm3.
→ Co-trimoxazole prophylaxis is also recommended for
PLHIV in countries where malaria and severe bacterial
infections are endemic.
→ HIV-infected people with active TB disease regardless of
CD4+ cell counts.
→ Infants, children and adolescents with HIV, irrespective

of clinical and immune conditions. Priority should be
given to all children younger than 5 years old regardless
of CD4 cell count or clinical stage and children with
severe or advanced HIV clinical disease (WHO clinical
stage 3 or 4) and/or those with a CD4 count of ≤350 cells/mm3.
HIV-exposed infants 4–6 weeks of age and should be continued
until HIV infection has been excluded by an age-appropriate
HIV test to establish final diagnosis after complete cessation of
breastfeeding.
8.2.1.2 Non eligible patients

→ Patients with partial or complete G6PD defects.
→ Patients with blood Dyscrasias such as Porphyria.
→ With known allergies to Sulphur
→ It should also be used with caution in patients with
severe liver and renal disease.
8.2.1.3 Initiating Treatment of Co-trimoxazole

→ Screen patient for any contraindications to Co-
Trimoxazole use e.g. known allergies to Sulphur or
history of Haemolytic blood diseases e.g. G6PD.
→ Initiate treatment if client meets criteria for prophylaxis
as described below in Table 8.1.

Table 8.1: Recommended criteria for initiating and
discontinuing Co-trimoxazole Prophylaxis
HIV Recommendation
Population
group Criteria for initiation Criteria for discontinuing
Adults Severe or advanced Adults (including

(including HIV clinical disease (WHO pregnant women) with
pregnant stage 3 or 4) and/or with a HIV infection who are
mothers) CD4 count of ≤350 cells/ established on ART *,
mm3. with evidence of immune
recovery and viral
suppression.
Children and Infants, children and

Adolescents adolescents with HIV,
irrespective of clinical
and immune conditions.
Priority should be given to
all children younger than 5
years old regardless of CD4
cell count or clinical stage
and children with severe
or advanced HIV clinical
disease
(WHO clinical stage 3 or
4) and/or those with a CD4
count of ≤350 cells/mm3.
HIV exposed HIV-exposed infants 4–6 When risk of transmission

but uninfected weeks of age. ends (e.g. complete
infants cessation of breastfeeding)
or HIV infection is
excluded by an age-
appropriate HIV test to
establish final diagnosis.
TB infected HIV-infected people with

active TB disease.

8.2.1.4 Co-trimoxazole Dosage
Adults and Adolescents:
The recommended dose of Co-trimoxazole for adults living with
HIV is:
- 960 mg daily (800 mg sulfamethoxazole + 160 mg trimethoprim,
either as a 960-mg double-strength tablet or two 480-mg single-
strength tablets).
NOTE: Intermittent preventive treatment of malaria (SP/
IPT) should not be provided in addition to Co-trimoxazole
prophylaxis for pregnant women with HIV.
Infants and Children

- The dosing of Co-trimoxazole prophylaxis for children is
optimized based on body weight. See table below
Table 8.2 Optimal Co-trimoxazole dosing for children
Strength of
Co-trimoxazole Number of tablets or ml/wt. (Kg)
Tablet (mg) or Suspension
10.0 0- 14.0- 20.0 - 25.0 -
mg/5ml
3.0-5.9 6.0-9.9 13.9 19.9 24.9 34.9
Suspension 200/40 mg/ml 2.5ml 5.0ml 5.0ml 10.0ml 10.0ml -
Dispersible tablets 100/20 mg 1 2 2 4 4 -
Tablets (scored) 400/80 mg - 0.5 0.5 1 1 2
Tablets (scored) 800/160 mg - - - 0.5 0.5 1

8.2.1.5 Client Follow up and Monitoring
All clients on Co-trimoxazole treatment must be counselled
about the medication and followed up closely. All patients must
be advised:
• To take adequate amounts of fluid daily.
• To discontinue medication and report back immediately if
the develop any adverse effects such as skin rashes, jaundice,
mental confusion, vomiting etc.
• To include folate rich foods (e.g. green leafy vegetables like
cocoyam leaves ‘nkontonmire’, cassava leaves, jute leaves
‘adεmε’) in their diets as Trimethoprim is a folate antagonist.
If pregnant, she must also be encouraged to take her daily
folic acid 5mg supplement.
• Micronutrient supplementation which includes Selenium
has been found to suppress disease progression and provide
direct improvement of CD4+ count. (The country will explore
complementary immune boosters).
Monitor all clients on Co-trimoxazole via Laboratory tests such

as;
• Full blood counts 6 monthly if feasible.
• Liver function tests 3 - 6 monthly especially for patients with
concurrent Hepatitis B or C infection.
Discontinue Co-trimoxazole if:

• Patients develop severe adverse side effects such as Stevens
Johnson’s Syndrome.
• When risk of HIV-related infectious morbidities no longer
exist as spelled out in the criteria above (Table 8.1).

8.3 FLUCONAZOLE PROPHYLAXIS
Fluconazole is an azole antifungal that stops growth of certain
types of fungus and yeast infections like oral and oesophageal
candidiasis, vaginal candidiasis, Cryptococcal meningitis
and Coccidioidomycosis. After appropriate treatment for
Cryptococcal and Coccidioidomycosis infections, secondary
prophylaxis with fluconazole is given to prevent relapse.
Precaution: Use with caution in: Liver disease, Kidney disease

and Heart Disease.
Contraindications: Pregnancy, Concurrent use with QT-

prolonging drugs and Infants less than 6 months old.
Dosage:
Adults: The recommended dose of Fluconazole for secondary
prophylaxis in adults and adolescents living with HIV is: 150 to
200mg daily.
Children and Adolescents: The dose is optimized based on body

weight: 6 to 12mg/kg body weight daily.
Discontinue if rash develops or when viral suppression is

achieved.

C HA P T E R N I N E
MANAGING ADVANCED
DISEASE
A package of interventions including screening, treatment and/

or prophylaxis for major opportunistic infections, rapid ART
initiation and intensified adherence support interventions should
be offered to everyone presenting with advanced HIV disease.
Advanced HIV disease for adults and adolescents including

children five years and older is defined as having a CD4 cell count
of less than 200 cells/mm3 or WHO clinical stage 3 or 4 disease.
Children older than two years who have been receiving ART for
more than one year and are clinically established should not be
considered to have advanced disease and should be eligible for
multi-month ART dispensing.
Advanced HIV disease includes people presenting to care for

the first time following an HIV diagnosis and people who have
treatment failure and consequent decline in CD4 cell count.
Individuals who had previously initiated ART and are re-

engaging with care after a period of ART interruption should
be assessed for advanced HIV disease and should be offered the
advanced HIV disease package as appropriate.
People presenting with advanced HIV disease are at high risk

of death, even after starting ART, with the risk increasing with
decreasing CD4 cell count, especially with CD4 cell count
<100 cells/mm3. Advanced HIV disease is also associated with
increased health-care costs increased risk of opportunistic
infections, immune reconstitution inflammatory syndrome,
incomplete immune reconstitution, higher viral reservoirs,
higher inflammation, increased risk of AIDS-related and non-
AIDS-related comorbidities, use of more health-care services
and more frequent monitoring needs.
Leading causes of mortality among adults with advanced

HIV disease globally include TB, severe bacterial infections,
cryptococcal disease, histoplasmosis, toxoplasmosis and
Pneumocystis jirovecii pneumonia. Other invasive fungal
infections have been recently estimated as contributing
significantly to the number of people dying from AIDS-related
causes
Children and adolescents who had previously initiated ART and

are re-engaging with care after a period of ART interruption
should be assessed for advanced HIV disease and should be
offered the advanced HIV disease package as appropriate.
The major causes of morbidity and mortality among children

living with HIV in low- and middle-income countries are
pneumonia (including P. jirovecii pneumonia), TB, bloodstream
infections, diarrhoeal disease and severe acute malnutrition.

Assessing Advanced HIV disease
CD4 count should be used to identify people with advanced
HIV disease. If not available, WHO staging should be used. All
children younger than five years who are not already receiving
ART are considered to have advanced HIV disease.
Lack of same-day availability of CD4 count results should not be

a barrier to initiating ART on the same day.
Table 13.1 summarizes the specific components of the package

of interventions that should be offered to people presenting with
advanced HIV disease. The algorithm for providing a package of
care for people with advanced HIV disease is shown in Figure
13.1.

Table 9.1 Components of the package of care for people with
advanced HIV disease
Intervention CD4 cell count Adults Adoles- Children

cents <10 years
Screening Screening tools for TB disease Any Yes Yes Yes

and for adults and adolescents: (symp-
diagnosis WHO-recommended four tom
symptom screen, chest X-ray, screen
C-reactive protein, WHO only)
recommended molecular
rapid diagnostic test for TB,
alone or
in combination. Screening
tools for TB disease among
children: symptom screening
for children living with HIV.
WHO-recommended Any Yes Yes Yes

molecular rapid diagnostics
as the first test for pulmonary
TB diagnosis among those
who screen positive for
TB and investigations for
extrapulmonary TB as
applicable; chest X-ray may
also be used to support
investigations.
LF-LAM to assist TB ≤200 cells/mm3 Yes Yes Yes

diagnosis among people with (inpatient)
symptoms ≤100 cells/mm3
and signs of TB (outpatient)
Or any CD4
count with
symptoms or if
seriously ill
Cryptococcal antigen Recommended Yes Yes No

screening for <100 cells/
mm3 and
considered for
200
cells/mm3

Intervention CD4 cell count Adults Adoles- Children
cents <10 years
Prophylaxis Co-trimoxazole prophylaxis <350 cells/mm3 Yes Yes Yes

and or clinical stage
pre- 3 or 4. Any
emptive CD4 count in
treatment settings with
high prevalence
of malaria or
severe bacterial
infections
TB preventive treatmenta Any Yes Yes Yes
Fluconazole pre-emptive <100 cells/mm3 Yes Yes Not

applica-
therapy for cryptococcal ble
antigen–positive people (screen-
without evidence of ing not
ad-
meningitis vised)
ART Rapid ART initiationb Any Yes Yes Yes

initiation
Defer initiation if clinical Any Yes Yes Yes
symptoms suggest meningitis
(TB or cryptococcal)
Adapted Tailored counselling to <200 cells/mm3 Yes Yes Yes

adherence ensure optimal adherence to
support the advanced HIV disease
package, including home
visits if feasible
a TB preventive treatment should be provided in accordance with current WHO guidance .

b People receiving a positive WHO four-symptom screen should initiate ART while being evaluated for TB if clinical signs
and symptoms of meningitis are absent.
A seriously ill adult is defined as having any of the following

danger signs: respiratory rate ≥30 breaths per minute; heart
rate ≥120 beats per minute; or unable to walk unaided. Other
clinical conditions, such as body temperature ≥39°C, can also be
considered based on local epidemiology and clinical judgement

Figure. 9.1 Algorithm for providing a package of care for people
with advanced HIV disease
TB symptoms present Investigations positive for TB

STEP 1 Perform XpertR MTB/RIF(WMRD) Start TB treatment
Take history and as the first test; LF-LAM may be
examination used if CD4 ≤100 cells/mm3 or the
person is seriously ill (at any CD4
cell count) Investigations negative for TB
STEP 2 Consider other diagnoses: if TB
Screen for symptoms of TB is considered unlikely, start TB
TB symptoms absent preventive treatment according to
Start TB preventive treatment the recommendations; consider
according to the recommendations presumptive TB treatment for
people who are seriously ill even if
the TB test is negative or the result
Meningitis symptoms present is unavailable
STEP 3
Assess for symptoms of Perform serum, plasma or whole
meningitis blood cryptococcal antigen test,
(headache and confusion) lumbar puncturea, CSF cryptococcal Treat according to the result
antigen test, XpertR MTB/RIF and If screening tests are not available
microscopyb and the person is seriously unwell,
consider presumptive treatment
STEP 4 for TB meningitis, cryptococcal
Treat other opportunistic Meningitis symptoms absent meningitis and bacterial meningitis
infections and possible
bacterial infections. If not receiving ART and CD4
Empirical treatment of <100 cells/mm3 perform blood
pneumocystis or bacterial cryptococcal antigen test
pneumonia should be
considered for people with Blood cryptococcal antigen
severe respiratory distress positive
ART naive If feasible and there are no
Offer rapid ART initiation or contraindications, perform lumbar
delay initiation according to puncture
STEP 5 the recommendations for TB or
Start co-trimoxazole cryptococcal disease
prophylaxis according to
WHO recommendations CSF cryptococcal antigen positive
Previously receiving ART Start treatment for cryptococcal
(interrupted treatment) meningitis
Offer rapid ART initiation or delay
STEP 6 according to the recommendations
Is the person receiving ART? for TB or cryptococcal disease;
consider restarting on an alternative
CSF cryptococcal antigen negative
ART regimen
or lumbar puncture not feasible
STEP 7 Start pre-emptive treatment for
Offer intensified adherence cryptococcosis
support for medication for Currently receiving ART
opportunistic infections, Check viral load and assess for
ART and monitoring of treatment failure; if the person is
condition; home visits experiencing clinical treatment
should be considered and failure and/or seriously unwell and
rapid tracing of people who viral load >1000 copies/ml or not
missed appointments available, consider expedited switch
to a new regimen depending on
the clinical history; if possible, use
point of care viral load testing
ART: antiretroviral therapy; CSF: cerebrospinal fluid; TB, tuberculosis; LF-LAM: lateral flow urine lipoarabinomannan assay.
a Everyone who is cryptococcal antigen positive and has headache or confusion should have a lumbar puncture.
b In settings where test results are available quickly, testing for cryptococcal infection before TB infection would be more cost-effective.


C HA P T E R T E N
PRE AND POST EXPOSURE

PROPHYLAXIS
10.1 PRE-EXPOSURE PROPHYLAXIS (PrEP)
Introduction
Pre-Exposure Prophylaxis (PrEP) with oral Tenofovir (TDF)
or TDF co-formulated with Emtricitabine (TDF/FTC)
demonstrated substantial HIV prevention benefits in clinical
trials. With strong evidence for the efficacy and effectiveness of
daily oral PrEP across multiple studies; WHO issued guidance
on PrEP use in high HIV incidence settings to people having
substantial risk of HIV acquisition (WHO, 2015). PrEP is defined
by WHO as the use of antiretroviral drugs before HIV exposure
by people who are not infected with HIV in order to block or
prevent the acquisition of HIV. PrEP should be offered as part
of the ‘Combination Prevention’ package that includes HIV
Testing Services (HTS), male and female condoms, lubricants,
ART for HIV-positive partners in sero-discordant couples and
STI prevention and management.

PrEP is safe to use during pregnancy to block or prevent the
acquisition of HIV by the pregnant woman in a sero-discordant
relationship. The benefits of preventing HIV acquisition in the
mother, and the accompanying reduced risk of mother-to-child
HIV transmission outweigh any potential risks of PrEP, including
any risks of fetal and infant exposure to TDF and FTC in PrEP
regimens.
PrEP can be delivered through the use of a vaginal ring containing

dapivirine, a novel non-nucleoside reverse transcriptase inhibitor
(NNRTI). This could provide an acceptable option for women
who are unable or do not want to take oral PrEP. The dapivirine
vaginal ring, which is worn in the vagina, is made of silicone and
contains dapivirine, which is released into the vagina slowly over
one month. The ring should be worn continuously in the vagina
for one month and then should be replaced by a new ring. The
risk of HIV-1 infection is reduced 24 hours after ring insertion.
In addition, long-acting cabotegravir (CAB-LA), an integrase

strand transfer inhibitor (INSTI), has been recommended
by WHO as pre-exposure prophylaxis (PrEP) for HIV-1. It is
also safe and highly effective in preventing acquisition of HIV
infection among those who are at substantial risk.
Eligibility Criteria for PrEP
Any sexually active HIV-negative person at substantial risk of

acquiring HIV. Those at high risk include but not limited to the
following:
1. HIV negative people in sero-discordant relationships with
a partner who is not confirmed as virologically suppressed
(VL <50 copies/ml).

2. All HIV negative people in sero-discordant relationships,
regardless of VL of the partner, who want to conceive.
3. Partner(s) of unknown HIV status.
4. Recent/ recurrent STIs.
5. Multiple and/ or concurrent sexual partners.
6. History of inconsistent or no condom use.
7. Recurrent PEP users.
8. History of sex whilst under the influence of alcohol or
recreational drugs.
Note: PrEP should always be taken as an additional prevention

strategy in combination with a comprehensive prevention
package such as condom use.
Contraindications
The following are contraindications of PrEP:
1. HIV positive status: Evidence or suspicion of HIV primary
infection (characterized by flu-like symptoms) and suspicion
that person might be in window period following potential
exposure.
2. Adolescents <35kg or <15 years who are not Tanner stage 3 or
greater (should not get TDF)
3. Abnormal Creatinine Clearance rate <60ml/min.
4. TDF for PrEP should not be co-administered with other
nephrotoxic drugs, for example, aminoglycosides.
5. Unwilling or unable to return for 3-monthly HIV testing,
counselling and safety monitoring visits.
6. Known allergies to any of the PrEP drugs.
7. Unwilling to get tested for HIV.

Note: it is critically important to take a thorough history
(particularly sexual) to determine PrEP eligibility. When there
is suspicion of HIV primary infection and/or when there is a
history of possible recent HIV exposure; PrEP can be deferred
for 4 weeks and the client re-tested to ascertain HIV status.
PrEP ARV Regimen
Daily oral Tenofovir/Emtricitabine (TDF/FTC 300mg/200mg)

or TDF/3TC 300mg/300mg with the following considerations:
• Oral PrEP may be used intermittently during periods of
perceived HIV acquisition risk, rather than continually and
lifelong, as is the case with antiretroviral treatment.
• It is important to bear in mind that it takes 7 days of daily
dosing PrEP to reach adequate anal/rectal tissue levels and
up to 20 days of daily dosing to achieve protective vaginal
tissue. During this period, other protective precautions must
be used, such as abstinence or condoms.
• PrEP medications should be continued for 7 days after the
last potential HIV exposure in those wanting to stop taking
PrEP. These should also be borne in mind in users who stop
and start PrEP according to their periods of risk.
Refer to the National PrEP Implementation Guide for additional
details on CAB-LA and Dapivirine ring.
Summary of Pre-exposure prophylaxis visits and procedures:

→ Assess risk and eligibility --thorough history (sexual) and
physical examination.
→ Educate about the risks and benefits of PrEP and Contraceptive
counselling.
→ Conduct relevant laboratory tests—HIV test, Creatinine
Clearance and HBsAg and Confirm eligibility (including

investigation results and creatinine clearance (CrCl-
calculation).
→ Provide STI treatment if indicated.
→ Educate client about PrEP side-effects and management.
→ Educate client about signs and symptoms of acute HIV
infection.
→ Discuss with client on the adoption of healthy life-styles such
as avoiding alcohol, tobacco and recreational drugs.
→ Provide condoms and lubricants.
→ Provide one-month TDF/FTC (FDC) prescription and
follow-up date.
→ Arrange follow up visit: Same as at PrEP initiation visit PLUS:
→ Assess tolerability, side effects and effective use (adherence).
Actively manage side effects, Contraceptive services review
test results—HIV test, CrCl etc.
• Provide 3 months prescription and follow up date Four-
month follow-up and 3-monthly maintenance visits.
• Repeat procedures done at one-month follow-up i.e.
Tests:
• 4th Month—HIV test, STI symptom screening, CrCl,
• 3 monthly afterwards—HIV test, Pregnancy test, HBsAg
(at 6 months only).
• 6 monthly afterwards—CrCl, STI symptom screening,
rapid syphilis test and HIV test.
Note: Condoms and condom-compatible lubrication should be

provided, and arrangements made for follow-up.
Side effects of PrEP medicines:

PrEP is usually safe, with no side-effects for 90% of users. Minor
side effects: About 10% of people who start PrEP will have some

short-term mild side-effects. These may include gastrointestinal
symptoms (diarrhoea, nausea, decreased appetite, abdominal
cramping, or flatulence). Dizziness or headaches have also been
experienced. Such side-effects are usually mild and resolve
without stopping PrEP. Typically, these symptoms start in the
first few days or weeks of PrEP use and last a few days and almost
always less than 1 month.
Stopping PrEP
PrEP should be stopped when:
1. Whenever an HIV test is positive. If a client tests HIV positive,
discontinue PrEP and refer for enrolment into HIV care.
2. At client’s request.
3. For safety concerns/ side effects (CrCl<60ml/Min).
4. If risks of PrEP outweigh benefits.
Additional Notes for Implementing PrEP

Medical officers and nurses trained to provide ART can provide
PrEP. The PrEP initiation visit should preferably take place on
the same day of screening.
Also all clients offered PrEP must be registered and clinical

records well documented.
PrEP data must be summarized and reported monthly per the
following indicators:
1. Number of HIV negative clients given PrEP disaggregated by
age and gender.
2. Number of clients taking PrEP who tested HIV positive at
follow-up visit month 1,3,6 and 12.
3. Number of clients who discontinued PrEP disaggregated by
gender, age and reason.
4. Number of clients who developed STI during PrEP.

5. Number of PrEP clients who received treatment for STI.
6. Number of clients given condoms at initiation of PrEP.
10.2 POST EXPOSURE PROPHYLAXIS (PEP)

The use of Antiretroviral drugs for post-exposure prevention
of HIV infection following occupational exposure to HIV for
health workers has been ongoing since the early 1990s. The
provision of HIV post-exposure prophylaxis has in recent years
been extended to other non-occupational exposures, including
unprotected sexual exposure, injecting drug use and exposure
following sexual assault. The clinical management guidance
outlined in this section provides current evidence-based
recommendations for providing post-exposure prophylaxis for
all individuals (adults, adolescents and children) exposed to a
potential HIV source.
STANDARD OF CARE FOR INDIVIDUALS EXPOSED TO

HIV
Every individual exposed to potential HIV source should be
assessed by a trained health-care worker. Essential components
of post exposure care should include assessing the mechanism
of exposure and eligibility for post-exposure prophylaxis,
examination of any wound and initial first-aid treatment.
Baseline and post prophylaxis treatment testing for HIV should
be offered however denial of consent or lack of access to test
should not delay initiating post-exposure prophylaxis where
warranted. Any prescription of post-exposure prophylaxis
should follow consent based on an understanding of the risks
and benefits, including discussion of possible side effects and the
importance of full adherence to post-exposure prophylaxis. In
cases that do not require post exposure prophylaxis, the exposed
person should still be counselled about limiting future exposure
risk. HIV testing may be provided to such individuals if desired.

Table 10.1 Care pathway for people exposed to HIV
1. Assessment
2. Counselling
and support
3. Prescription of
ARVS
4. Follow Up
10.2.1 Eligibility for Post-Exposure Prophylaxis: Risk

Assessment
Post-exposure prophylaxis should be offered, and initiated as
early as possible, to all individuals with exposure that has the
potential for HIV transmission, and ideally within 72 hours.
Assessment for eligibility should be based on the HIV status of
the source whenever possible and may include consideration of
local population and risk group prevalence. Exposures that may
warrant post-exposure prophylaxis include:
✓ Parenteral or mucous membrane exposure (sexual
exposure and splashes to the eye, nose or oral cavity).

✓ Contact with the following bodily fluids: blood, blood-
stained saliva, breast-milk, genital secretions and
cerebrospinal, amniotic, rectal, peritoneal, synovial,
pericardial or pleural fluids.
The risk of infection appears higher after:

✓ Exposure to a large quantity of blood or to other infectious
fluids
✓ Exposure to the blood of a patient in an advanced HIV disease
stage
✓ A deep percutaneous injury
✓ An injury with a hollow bore, blood filled needle.
Exposure to HIV may be classified in three categories as described

below:
Very Low risk exposure
Exposure of potentially infectious material to intact skin.
Low risk exposure

1. Exposure to a small volume of blood or body fluids
contaminated with blood from asymptomatic HIV-positive
patients.
2. An injury with a solid needle.
3. Any superficial injury or mucocutaneous exposure.
High-risk exposure
1. Exposure to a large volume of blood or potentially infectious
fluids.
2. Exposure to blood or body fluids contaminated with blood
from a patient with a high viral load. i.e. patients in the AIDS
phase or early sero-conversion phase of HIV infection.

3. Injury with a hollow bore needle
4. Deep and extensive injury from a contaminated sharp
instrument.
5. Exposure to blood from an HIV Drug resistant patient.
Exposures that do not require post-exposure prophylaxis

include:
1. Exposure of potentially infectious material to intact skin,
2. when the exposed individual is already HIV positive,
3. when the source is established to be HIV negative and
4. exposure to bodily fluids that does not pose a significant risk
i.e. tears, non-blood-stained saliva, urine and sweat.
10.2.2 Counselling, Testing and Support

The exposed individual accessing PEP must be offered
counselling and testing immediately from a trained counsellor.
The risks and benefits of testing should be sufficiently explained
to the individual so that an informed decision can be made.
Testing must also be repeated after the PEP treatment period.
Where an exposed individual declines testing for HIV infection
after counselling, this must be documented. He or she must not
be denied access to PEP on account of refusal to test or lack of
access to testing services.
All known source-patients shall also be counselled and tested

for HIV infection if this is not known. Where the source tests
negative, they should be encouraged to repeat the test after 3
months. Counselling and support should continue throughout
the PEP period and thereafter if necessary. Counsellor must
emphasize safe sex including condom use.

10.2.3 Prescribing and dispensing post-exposure prophylaxis
medicine
If therapy is necessary, it should be initiated promptly, preferably
within 1-2 hours post–exposure and not more than 72 hours
after exposure. A 28-day course of ARVS drugs should be offered
and prescribed. (See Table 9.1)
All Individuals receiving PEP should be educated about risks
and benefits of post-exposure prophylaxis, and consent should
be obtained. They should be informed of potential drug–drug
interactions and possible side effects and toxicity. The importance
of adherence to treatment must be stressed upon as critical for
optimum outcome.
10.2.4 Baseline laboratory tests including

Full blood count, Liver and renal function tests, Hepatitis
B Surface Antigen, HIV serology or PCR should be done if
available.
Table 10.2 Recommended ARVS for PEP
Age Group RECOMMENDED PROPHYLAXIS
Children (<10 years old) AZT + 3TC (or FTC) + DTG or LPV/r
OR
ABC + 3TC(or FTC) + LPV/r or
TDF + 3TC (or FTC) + LPV/r can be
considered as alternative regimen if the
child weighs above 30kg.
Adults and Adolescents TDF + 3TC+ DTG or LPV/r

(including pregnant and
lactating mothers)

10.2.5 FOLLOW UP
A follow-up appointment for people prescribed post-exposure
prophylaxis should be scheduled for a repeat HIV test 3 months
following HIV exposure. Review of an individual during the 28-
day period is not essential, but individuals should be encouraged
to seek assistance if they experience side effects that interfere
with taking ARVS drugs or adherence problems.
Any further contact with a person prescribed post-exposure

prophylaxis should emphasize the importance of completing the
full 28-day course and reducing future risk of HIV infection.
If the source is established to be HIV negative during the course
of post-exposure prophylaxis, ARVS drugs may be discontinued.
During the period of prophylaxis, a number of baseline and
follow-up investigations may need to be done to determine HIV
sero-status, and to monitor the level of drug toxicity.
Table 10.3 Recommended monitoring of drug toxicity and HIV

serology of exposed individuals
Baseline tests: Full blood count

Liver and renal function tests,
Hepatitis B Surface Antigen
HIV serology or PCR if available
Two weeks: Full blood count

Liver and renal function tests
Six weeks: HIV serology

Three months: HIV serology
Six months: HIV serology

10.2.6 PEP for Health Care Workers
The risk of exposure to blood and blood borne pathogens is
slightly greater for health care personnel than people who do
not work in health care settings. Workplace accidents or injuries
that expose the health worker to body fluids of a patient may
occur. Post Exposure Prophylaxis (PEP) reduces the likelihood
of HIV infection after exposure. PEP may either prevent the
establishment of infection or prevent new infection while
allowing clearance of already infected cells. PEP is particularly
effective within 1–2 hours and not more than 72 hours after
exposure. Exposures that create risk for health workers may be
defined as an exposure from infected blood, tissue or other body
fluids through:
• A percutaneous injury (e.g. a needle stick or cut with a sharp
object), or
• A mucocutaneous membrane or non-intact skin (e.g. skin
that is chapped, abraded, or affected by dermatitis) contact.
The risk of infection for HIV after a percutaneous injury is

approximately 0.3%. Transmission rates after exposures of
mucous membrane or non-intact skin are lower (0.1%) than
from percutaneous injuries.
10.3.1 Reducing Risks of Exposure

→ Infection prevention programmes should be in place in all
health care settings and health workers should follow
Standard Infection Prevention and Control Precautions at all
times to prevent exposure.
→ Hands should be washed properly and frequently before and
after handling all patients.
→ Gloves must be worn before any kind of invasive procedure or
when venous or arterial access is being performed.

→ Personal Protective Equipment (Gloves, gowns, boots eye
wear and masks) should be used appropriately for patient
care.
→ Sharps should be used with caution with all patients. Sharps
should be disposed of in a puncture proof receptacle
immediately after use. These should be available nearby.
In the event of possible exposure to HIV the incident should be

documented and the following actions taken:
1: Treatment of exposure site

The wound site should be cleaned with soap and water. In the
case of mucous membranes, exposed area should be flushed with
plenty of water. Eyes should be flushed with water or saline.
2: Assess the level of risk

The risk of exposure should be assessed in terms of possible
transmission of HIV infection as described above.
3: Counsel and Test

The health care workers accessing PEP must receive counselling
and testing immediately from a trained counsellor. This should
continue throughout the PEP period and thereafter if necessary.
Where an exposed individual declines to test for HIV infection
after counselling, this must be documented.
4. Prescribe PEP (See guidelines for ARVS in Table 9.1)

Note however that in the health care settings, in addition to risks
for HIV transmission the risks for HBV and HCV transmission
are even higher. Measures to address these risks should also be
considered. They include routine vaccination against HBV and
HBV immunoglobulin where appropriate following exposure.

The health worker should be counselled and supported to
complete his/her PEP per the above stated guidelines. Health
workers who sero-convert should have access to comprehensive
care and ART services as spelt out in the “Workplace HIV and
AIDS Policy and Technical Guidelines for the Health Sector”
10.3.2 Reporting and Documenting Occupational Exposure to

HIV
All occupational exposures should be reported immediately
to the supervisor; circumstances of the exposure and PEP
management should be recorded. Details should include:
→ Date and time of exposure.
→ Where and how the exposure occurred, exposure site on the
body and type of sharp device.
→ Type and estimated amount of exposure fluid, severity (depth/
extent) of the exposure.
→ Source of exposure and whether the source material contained
HIV or blood.
→ Clinical status of source patient.
→ Relevant information about exposed health care worker
(medical conditions, vaccination including Hepatitis B, and
medications, pregnancy or breast-feeding).
→ Document counselling, post exposure management and
follow up.
Note that the health worker’s privacy should be respected and

confidentiality maintained. Reporting and recordkeeping should be
in accordance with the national occupational health policies.
10.3.3 PEP For Survivors of Sexual Violence

Ghana has in recent times seen an upsurge of violent crime
including sexual violence of various forms such as rape

and defilement. Rape and defilement are violent traumatic
experiences for the survivors who are affected physically,
emotionally and socially. Survivors may react in different ways to
such traumatic experiences and they may have to be handled and
managed cautiously in order not to aggravate their psychological
trauma. Survivors could be women or men, boys or girls; but
most often, women and girls are the victims and the perpetrators
are usually men. It is important to recognize that rape and
defilement are criminal offences in Ghana. Survivors and the
general public should be encouraged to report such occurrences
to law enforcement agencies. The healthcare provider must
therefore be abreast with the legal requirements regarding the
management of the survivor. This includes documentation and
reporting as well as the provision of emergency contraception,
abortion, counselling, testing and prevention of STIs such as
HIV infection. Healthcare workers must understand that their
duty is to provide basic medical and psychological intervention
to survivors and referral to relevant agencies for other needed
services.
These guidelines are to be used in the context of the clinical
management of survivors of sexual assault within the regular
health care setting. This includes:
✓ Screening for pregnancy and prevention/management of
pregnancy.
✓ Screening for and treatment of Sexually Transmitted
Infections (STIs).
✓ Provision of PEP for HIV.
✓ Collection of evidence for possible future prosecution*.
✓ Rendering of psychological support.
✓ These guidelines focus on female victims of sexual assault but
the principles are the same in the management of male victims

as well as for minors.
✓ Experience with prophylaxis relating to occupational
exposure and prevention of mother-to-child transmission
(PMTCT) however suggest that starting PEP as soon as
possible and indeed within 72 hours after the rape is most
beneficial.
Medico-legal Considerations*
Healthcare providers must appreciate that the establishment of
the case of rape is a legal matter to be determined by a court
of competent jurisdiction and not a decision for the healthcare
worker to make. The healthcare worker is providing a service
with the presumption that there has been an alleged case of rape
or defilement which may or may not be proven.
For the purpose of these guidelines, the term “rape” means “rape,
defilement or non-consensual carnal knowledge”.
This document should not be used as an absolute guide for

a forensic examination and the collection of specimens for
prosecution. Such a requirement will need a referral to a
gynaecologist, a clinician trained in forensic medicine, or other
specialist.
Although only a small percentage of alleged rape cases actually

go on trial, it is important that the healthcare worker keeps
detailed and accurate documentation in the event of the need to
testify in court.
10.3.3.1 Survivor Care and Referral

Care of survivors of sexual violence must be undertaken by
a team of care providers including clinicians, obstetrician

gynaecologist, PEP focal person psychologist and forensic
pathologist. Survivors reporting for care may include individuals
who report directly following the alleged incident, client referred
later with resulting complications such as pregnancy or STI.
Occasionally clients may be referred by the courts after criminal
procedures have been initiated.
Where a client is referred from another service provider for PEP

or the courts, the attending PEP care provider must be satisfied
the client has already received or receives all other relevant care
components for such survivors of sexual assault as described
above.
All Clients reporting directly to a facility following an alleged

incident of rape should be assessed comprehensively by a
clinician and counselled appropriately for the administration of
needed interventions. The client should be referred for further
care and action as needed with the relevant experts.
Survivors/families should be counselled to also report the matter

to the police if not already done. In cases of minors the care
provider is required by law to notify law enforcement agencies
and social welfare offices of the incident.
10.3.3.2 Clinical assessment of Survivor

I. Take accurate and detailed history, considering the fact
that this could be very sensitive and emotionally
traumatic for the client.
II. Ensure right to privacy, confidentiality, information and
non-discrimination.
III. Clarify the kind of sexual assault and orifices involved in
the assault.

IV. Determine whether the perpetrator constitutes a high
risk or otherwise.
V. Find out the sexual history of the client both before and
after the assault. Assess the overall risk of client.
VI. Perform all relevant physical and genital examinations,
and collect forensic evidence as may be required by law
if you are the clinician primarily responsible for the case.
(See Appendix).
VII. Offer counselling and testing for HIV and screen for
other STIs including Syphilis, Hepatitis B where
screening tests are available.
VIII.Where client is found to be HIV positive, she/he must
be counselled and referred to an ART centre for
comprehensive HIV care and support services.
IX. Treat any STIs found or suspected on screening.
X. In the case of a child survivor:
a. History should be taken from both the minor
and the parent or legal guardian. It is preferable
to have the parent or guardian wait outside
during the interview and have an independent
trusted person/chaperone present. Avoid asking
leading questions.
b. For the examination either a parent and/or
chaperone must be present.
XI. Document all findings of the assessment and
interventions including the outcome of the HIV test, STI
and Hepatitis B screening.
XII. Where the client declines to undertake the HIV test,
document this refusal and make client fill and sign the
National PEP and Management Record Form for Rape
Survivors indicating the refusal.

10.3.3.3 Assessment of Exposure Risk
The following factors must be considered in the assessment of
risk:
✓ Perpetrator is unknown or HIV status of perpetrator is
unknown.
✓ Perpetrator’s HIV status is known to be positive.
✓ Perpetrator is an injection drug user or armed robber.
✓ Whether the alleged sexual violation involved anal
penetration.
✓ Whether the survivor was allegedly raped by more than one
person.
✓ Vaginal penetration with associated genital injuries.
✓ Whether survivor is a minor.
10.3.3.4 Protocol For PEP and Preventive Treatment of

STI
I. If survivor presents within 72 Hours of the Incident
a) Prevent HIV Transmission through the provision of PEP
using three ARVS according to national protocol and as
spelt out under Appendix.
b) Treat STIs according to national guidelines.
c) If HBsAg result is negative prevent Hepatitis B infection
by initiating the appropriate vaccination protocol.
d) Pregnancy can be prevented by providing emergency
contraception in accordance with the National
Reproductive Health Service Policy. Pregnancy test must
be done to first exclude an existing pregnancy.
e) Clean and treat any tears, cuts, abrasions and other
injuries. If there are major contaminated wounds
consider giving antibiotic cover.
f) Tetanus prophylaxis (tetanus toxoid – TT) may also be
indicated where there are wounds or break in mucosa.

II. If survivor presents more than 72 Hours after the Incident
a) PEP may not be beneficial when started after 72 hours
but decision to start should be made on case by case
basis. Client should be offered CT and appropriate follow
up instituted.
b) Assess and examine for STIs and provide treatment
according to national STI treatment guidelines.
c) If HBsAg test result is negative recommend vaccination
against Hepatitis B infection, using the appropriate
protocol.
d) If the survivor presents after 72 hours but within 120
hours (5 days) provide emergency contraception in
accordance with the National Reproductive Health
Service Policy and Standards.
e) Pregnancy test must be done to exclude an existing
pregnancy.
f) Treat or refer all wounds, abscesses and other injuries
and complications. Vaccinate against tetanus if client has
not been fully vaccinated.
10.3.3.5 Follow-Up Care

I. For Survivors who received PEP.
a. One-week follow-up visit:
i. Evaluate PEP, STI and other treatment.
ii. Evaluate for STI and provide treatment as appropriate.
iii. Discuss CT for future HIV testing.
b. Six-week and three-month follow-up visits:
i. Offer CT for HIV.
ii. Evaluate for STIs and treat as appropriate.
iii. Evaluate for pregnancy and provide counselling
II. For Survivors who do not receive PEP.

a. Two-week follow-up visit:
i. Check if STI and/or other treatment have been adhered
to.
ii. Evaluate for pregnancy and provide counselling.
iii. Discuss TC for future HIV testing.
b. Three-month follow-up visit:
i. Offer TC for HIV.
ii. Evaluate for STIs and treat as appropriate.
iii. Assess pregnancy status.
In all cases evaluate mental and emotional status at every visit,

and refer or manage as needed. For minors assess the safety
of their environment (Place of residence and school etc.) for
possible re-location.
10.3.4 Documentations and other Potential Forensic Evidence

1. All information gathered from history, referral notes,
assessments, and from physical and genital examination must
be clearly documented, dated, signed and appropriately filed
under strict confidentiality.
2. All laboratory test results must be acknowledged and stored
with patient records.
3. Document all referrals to and from or within your facility.
4. Fill all forms required under these guidelines and according
to national policies and guidelines.
5. Note that proper documentation will facilitate testimony in a
court of law.

C HA P T E R E L EV E N
SUPPLY CHAIN
MANAGEMENT AND
RATIONAL USE OF HIV
COMMODITIES
11.1 SUPPLY CHAIN MANAGEMENT

The ultimate purpose of public health supply chain systems is
to serve the clients with appropriate commodities in the right
quantity, at the right time, place and cost. In the context of HIV
and AIDS programmes, this means ensuring an uninterrupted
supply of HIV and AIDS commodities to all people living with
HIV and AIDS (PLHIV). This is because more than 95 percent
adherence to ART is required for treatment regimens to be
effective over the long term.
A comprehensive HIV/AIDS programme requires a wide range of

commodities to support a range of interventions that encompass
prevention, care and treatment.
A key objective of the National HIV/AIDS response is to ensure

all people living with HIV/AIDS will be initiated on ART. This
requires a strong procurement and supply management (PSM)
system. Supply chain managers and ART programme managers

should collaborate to ensure that the national supply system
functions properly.
The key components of procurement and supply management

cycle includes:
• Product selection.
• Forecasting and supply planning.
• Procurement.
• Storage and distribution.
• Logistics Management Information System (LMIS).
• Use or dispensing to clients.
• Quality monitoring.
• Policy.
11.1.1 Selection of Pharmaceuticals and Diagnostics

The World Health Organization (WHO) has developed and
updated guidelines for scaling up antiretroviral therapy in
resource-limited settings. The treatment guidelines for a public
health approach act as guidance for countries to facilitate the
proper management and scale up of antiretroviral therapy (ART).
The public health approach is geared towards universal access,
standardization, and simplification of antiretroviral (ARV) drug
regimens to support the implementation of evidence-based
treatment programmes in resource-limited settings. The goal
is to avoid the use of substandard treatment protocols and to
reduce the potential for the emergence of drug-resistant virus
strains. This updated national HIV Care guideline include
newly recommended ARV drug regimens and formulations and
diagnostics that are appropriate to the local setting.
The detailed guidelines in chapter 4 provide recommendations

for managing toxicity or treatment failure and recommends

formulations for weight and age that can help to standardize
prescribing and dispensing practices and facilitate forecasting
for ARV drugs. It also provides clear criteria for first, second
and third-line regimens; for the management of patients
experiencing toxicity or treatment failure; and for the treatment
of specific subgroups, such as patients with tuberculosis, pregnant
women, children and health workers who require post-exposure
prophylaxis.
11.1.2 Rational Use of Medicines (RUM)

Rational use of medicines requires that patients receive
medications appropriate for their clinical needs, in doses that
meet their own individual requirements for an adequate period
and at the lowest cost to the patient and the community. ART is
a complex undertaking that involves a large variety and quantity
of highly active drugs. It is a lifelong treatment that is regularly
reviewed with the addition of new molecules. It is therefore very
important to use ART medicines rationally since inappropriate
use may have unwanted consequences at both the individual and
the population levels. Irrational use of HIV medicines may lead
to:
• Treatment failure.
• Rapid development of drug resistance.
• Increase in the risk of toxicity.
• Increased cost of treatment.
• Spread of new HIV infections.
To promote rational use of medicines:

1. Only trained and authorized persons in certified health care
facilities are allowed to prescribe ARVs.
2. Prescriptions for ARVs should clearly indicate the name/

Patient ID number, age, sex, body weight, medicines, dosage,
and should include the name and signature.
3. ARVs should only be dispensed to treatment-ready patients
with clear instructions and advice.
4. The dispenser should ensure that ARV prescriptions are
appropriately written and signed by an authorized prescriber
before dispensing.
5. ARVs should only be given to the named patient or appointed
adherence assistant.
6. Adequate time should be scheduled for antiretroviral
dispensing and counselling.
7. The dispenser should make sure that the patient understands
the dosage and drug intake schedule as well as instructions
regarding the storage and food requirements.
8. The dispenser should also caution patients about possible
side effects and drug-drug interactions and respond to specific
questions and problems related to ARV treatment encountered
by patients.
9. The dispenser should advise patients on measures to be taken
to reduce the side effects, including immediate return to the
clinic when they experience serious adverse effects.
11.1.3 Forecasting and Supply planning

(Quantification)
The NACP will work with the national quantification team
and key stakeholders to conduct annual quantification of HIV/
AIDS commodities. Medium-term forecasts which normally
span a two-year period will be prepared using multiple data
sources such as morbidity, consumption and service data. The
forecasts and procurement plans will be revised in accordance
with National quantification guidelines every six months to
allow for adjustment in the supply plan in line with prevailing
consumption trends.

Quantification will provide the basis for commodity funding gap
analysis and coordination of Government and partner funding
to ensure uninterrupted supply of HIV/AIDS commodities.
11.1.4 Procurement
A uniform and harmonized procurement system is required
to efficiently procure quality- assured and affordable HIV and
AIDS commodities. Procurement should be based on supply
plans derived from national quantification and routine pipeline
updates.
Transparent procedures should be adopted to achieve best-

value for money procurement and a quality assurance system
implemented to procure, store and distribute high-quality HIV
and AIDS commodities.
ARVs shall be classified as Programme medicines and shall be by

prescription only and not for sale in the open market.
Procurement systems should:
✓ Secure the most effective, heat-stable, fixed-dose quality-
assured ARV drug formulations in the right quantities at the
lowest possible cost in a timely manner.
✓ Request the partners supporting the national HIV
programme to consolidate and harmonize ARV drugs and
diagnostics procurement and supply management systems
and pool demands for ARV drugs and diagnostics, exploring
options for pooling under a common tender system.
✓ Follow the principles described in the United Nations
interagency guidelines for donated drugs.

11.1.5 Inventory Management, Storage and
Distribution
At the end of each month, physical inventory count shall be
conducted, and the available stock shall be checked against the
stock records.
HIV and AIDS commodities and related supplies should be

ordered in line with regional LMD schedule. Requisitions
should be submitted to the Regional Medical Stores using the
appropriate requisition tool (Manual or electronic).
The RMS will review orders, process and deliver the requested
commodities directly to the health facility or agreed delivery
point.
Facilities should receive commodities in line with standard

operating procedures for receiving commodities at health
facilities.
Stocks that have a short shelf life that cannot be used before their
expiry dates shall be redistributed accordingly to facilities in
need using a redistribution form.
Damaged and expired commodities should be immediately
separated from usable stock and disposed of following
appropriate procedures.
Facilities should have adequate storage space with conducive

storage conditions manned by trained personnel with appropriate
logistics tools to manage supplies effectively.
Commodities must be stored and issued according to the first-

to-expire first-out (FEFO) procedure of stock management.

11.1.6 Record Keeping
All information regarding ARVs and OI medicine dispensed
should be recorded in a dedicated register book (dispensing
registers/ or in the pharmacy database) and patient appointment
card.
All information regarding usage of all Laboratory related HIV

commodities such as Rapid Diagnostic Test (RDT) kits and
reagents should be recorded in the Laboratory register.
At the store, all HIV commodity transactions should be recorded

in the paper-based inventory control cards/bin cards, store
ledgers and/or electronic LMIS.
Reports on HIV and AIDS commodities consumption and stocks

should be kept and tracked by health facilities. Health facilities
should use this information to forecast and quantify their needs.
11.1.7 Ghana Integrated Logistics Management

Information System (GhiLMIS)
The current LMIS system uses manual process and tools. Ghana
is currently implementing an end-to-end electronic LMIS
system. The implementation of the Ghana Integrated Logistics
Management Information System (GhiLMIS) will automate
and optimize all current processes including replenishment
planning; warehousing; inventory management, forecasting and
quantification, transportation and reporting.

11.1.8 Supply Chain Monitoring
Monitoring and evaluation of supply chain functions will be
conducted to ensure that targets are met, and corrective actions
are implemented. This will ensure:
✓ Commodity availability at the service delivery points to
impact on quality of care.
✓ Planned logistics activities are carried out according to
schedule.
✓ Proper record keeping, improved data collection, analysis,
reporting and timely decision-making and planning.
✓ Supply chain monitoring, supportive supervisions and on
-the-Job training will be conducted regularly to address
system inefficiencies.
✓ Procurement, storage, distribution, dispensing procedures
and records, and stock on hand will be subject to internal and
external audit.
11.1.9 Staffing for Effective PSM

ARV managers /dispensers shall work closely with clinical
staff to ensure appropriate prescribing especially on dosage
and appropriate ARV combinations (ARV regimens). Good
collaboration will ensure correct estimates of the number of new
patients to be initiated on treatment for proper ordering of their
medicines.
Commodity managers within health facilities need to keep

clinical staff informed of the current stock levels of ARVs,
diagnostics and Laboratory consumables particularly of items
nearing stock-out and those in excess and at risk of expiry.
In the event of nationwide supply shortage, commodity managers

should communicate this information to clinical staff so that
they can pursue the best course of action.

Pharmacists/dispensers are expected to keep abreast with new
information and changes in ARVs and act as a resource to
clinicians and other health care workers in advising on possible
drug related side effects, changes in formulations or regimens
and informing clinicians on available formulations and drug
combinations (ARV regimens).
11.1.10 Pharmacovigilance
WHO defines Pharmacovigilance (PV) as the science and
activities relating to the detection, assessment, understanding and
prevention of adverse effects or any other drug related problems.
Monitoring and reporting of adverse drug events should be done
according to the Ghana Food and Drugs Authority’s (FDA)
guidelines. Adverse drug reactions reporting forms (blue forms)
will be distributed to facilities that have been certified to deliver
ART. It is important that health facilities record the adverse drug
reactions and report the information to FDA. Furthermore,
facilities are encouraged to use the information to monitor
patients and switch regimens where necessary.
11.1.11 Post-Market Surveillance

Post-market surveillance is a set of activities conducted by
regulatory authorities and manufacturers, to collect and evaluate
experience gained from health products that have been placed
on the market and to identify the need to take any action. Post-
market surveillance is a crucial tool for the country to ensure that
health products continue to be safe and well performing, and to
ensure actions are undertaken if the risk of continued use of the
health product outweighs the benefit. The evaluation of post-
market surveillance experiences can also highlight opportunities
to improve the health product.

C H A P T E R T W E LV E
HIV DATA
MANAGEMENT
Data management forms an important component of the entire

clinical care programme. Good data management practices ensure
availability of information for patient care, policy development,
planning, research, monitoring, evaluation, quantification and
forecasting of commodities (ARVS and other consumables),
advocacy and resource mobilization. The generation of strategic
data require the use of adaptable registers, tools and indicators
such as:
• Monthly facility record of number of people tested for HIV.
• Monthly log book for HIV Rapid test kit usage.
• Monthly LMIS report form.
• Monthly Assessment of stock status and order calculation
work sheet (Adult and Paediatric).
• Monthly summary report form of ART patients.
• Monthly PMTCT and HTS summary report form.
• Monthly report form of EID tests performed.
• ART client booklet (Includes patient register, initial and
follow-up assessment forms for adults and children and HIV
exposed baby follow-up form).

• ART, PEP, ANC and HTS registers.
• Monthly report form of VL tests performed.
• Monthly report of number and percentage of virally
suppressed clients.
To enhance the integration of services towards improvement of

service coverage, HIV tools will be integrated in existing data
collection tools to eliminate duplicate recording and reporting
by service providers. For instance, PMTCT indicators are part
of ANC indicators and captured in a single register. Quality data
is ensured through well harmonized and standardized country
indicators and reporting tools.
12.1 HEALTH INFORMATION MANAGEMENT

SYSTEM (HMIS)
This information is collected using client booklet for adults
and paediatric; and captured electronically. Where applicable,
information collated on monthly summary forms must be
transmitted on a timely basis from each facility to the District/
Regional Health Directorate for onward transmission to the
national level for NACP attention. The following information
should be obtained from each patient:
• Demographic data.
• Medical History (including a diagnosis of, Hepatitis and TB).
• Obstetrics and Gynaecological history including family
planning.
• Sexual infection history including STI.
• HIV status of partner and children.
• Social History.
• Physical Examination.
• Psychosocial Evaluation.
• Laboratory Evaluation.

• Drug Treatment.
• Adherence to ARVS.
• Side Effects of ARVS.
The information received at the national level shall be processed

for programming purposes and in support of the decision making
process. Feedback will be provided by NACP to the facilities,
health administrators and all relevant stakeholders.
12.2 DATA SYSTEMS

The Ministry of Health’s Information Exchange (MoH/HIE)
reflects the current concrete reality of “ground-up approach” of
health service data flow; and systems delivering valid data for use.
The two main existing functional components are the DHIMS
II and the E-tracker. This reduces the burden of duplicating
data gathering efforts and enhances the value of information
otherwise not possible when viewed in isolation.
12.2.1 DHIMS II
DHIMS II is a comprehensive web-based Health Management
Information System (HMIS) supporting data reporting
and analytical needs of health facilities and district health
administrations. It is used by health facilities and district health
directorates to collect, collate, transmit and analyze routine
health service data (i.e. aggregated or transactional).
12.2.2 HIV/AIDS E-Tracker Module

The E-Tracker is an extension of the DHIMS II platform and
supports data management and analysis of transactional or
disaggregated data at the facility level. It enhances the management
of case-based records of clients and track clients over time using
a flexible set of identifiers to assure data confidentiality and

integrity. The primary objective of e-tracker is to facilitate the
generation of clients currently on ART at all times and to ensure
an improvement in the tracking of clients lost-to-follow-up The
system has the added functionality of capturing information
about anonymous events and cases.
The HIV/AIDS E-tracker module includes a logistic management

component (referred as the Logistics Management Information
System [LMIS]) which ensures that all logistics related data are
appropriately collected and managed from the facility level.
The deployment of e-tracker requires the use of both soft and
hardware at facility, regional and national levels supported by
a reliable internet connection. The hard ware includes but not
limited to tablets, computers, laptops and dedicated servers for
hosting the anticipated huge client data.
To minimize the impact of an unstable internet system for

relaying client data, both online and offline versions shall be
deployed as part of e-tracker implementation.
Staffing for data management will include data officers, health

information officers and service providers trained to facilitate
the timely reporting of key HIV related indicators.
To ensure a full benefit of the e-tracker system for HIV data

management, the system will be expanded to cover the full
continuum of HIV care i.e. HIV testing, treatment and follow-up
care in all Ghana health service facilities nationwide.

C HA P T E R T H I RT E E N
HIV CARE DURING

COVID-19 AND FUTURE
OUTBREAKS
The COVID-19 pandemic slowed HIV community mobilization

efforts whiles exposing weak health systems and deteriorating
socio-economic conditions. The pandemic resulted in
interruptions to health services and supplies, affecting ART and
other essential services for many PLHIV.
There is the need to develop mitigation measures such that

COVID-19 and other future pandemics do not cause massive
interruptions to HIV services as was witnessed. The following
operational considerations are proposed to maintain essential
HIV services in the context of COVID-19 but can be adapted for
future pandemics.
13.1 GENERAL CONSIDERATIONS

• HIV facility visits should be limited to those that are
considered medically essential to reduce the risk and burden
to recipients of care and healthcare providers.
• Facilities should consider shifting HIV services to within

the community, fully engaging community cadres or setting
up temporary clinics within the community where applicable.
• For clients that require a facility visit, ensure all COVID-19
protocols are observed. Streamline clinic patient flow, stagger
clinic appointments and conduct HIV care and treatments
services in dedicated spaces that are physically separate from
COVID-19 treatment areas. PLHIV with COVID-19 should
however be treated at the COVID-19 dedicated areas.
• Where applicable, health care providers and patients should
use telehealth options such as phone calls or other virtual
options for routine or non-urgent consultations (including
HIV adherence counselling), with careful consideration for
patient privacy and confidentiality. This can also be applied
to peer support groups and home visits.
Prevention
• Condom distribution, PrEP, and PEP may be particularly
important during periods of ongoing confinement, in
addition to preventive and psychosocial services for gender-
based violence and child protection. Innovative ways such as
using digital platforms where applicable, can be employed.
• HIV testing may be affected by reductions in facility
utilization and community testing activities, however, it
should be prioritized for patients with clinical suspicion of
or known exposure to HIV, and in healthcare settings
providing antenatal care, TB, sexually transmitted infection
or malnutrition services. HIVST can be utilized where
applicable to screen persons for further testing. Patient
tracking, tracing and linkage to care should be conducted
over the telephone or a virtual platform. Only when
impossible should in-person tracking be conducted in which
case PPEs should be provided.

ART
• Six month multi-month scripting should be offered to eligible
clients.
Viral Load:
• Where prioritization is required, VL and early infant
diagnosis services should first be provided to children,
pregnant and breastfeeding women, and adults with recent
documented non-suppression.
• Dried Blood Spot specimen collected during home visits can
be used for EID in this context.
• Consideration should also be given to those with signs of
treatment failure, and patients requiring initial VL assessment
after ART initiation.
Treatment considerations
Dexamethasone is used at doses ranging from 6 mg up to 20

mg daily for short duration for people with COVID-19. At such
doses, dexamethasone has a weak to moderate inducing effect that
does not warrant any dose adjustment of EFV, NVP, PIs, DTG or
RAL. Conversely, EFV and NVP may decrease dexamethasone
concentrations, and doubling of the dexamethasone dose is
therefore recommended. Currently no known drug–drug
interactions between ARV drugs and the COVID-19 vaccines
have been documented.

C HA P T E R F OU RT E E N
HIV AND
NONCOMMUNICABLE
DISEASES
Assessment and management of cardiovascular risk should

be provided for all individuals living with HIV according to
standard protocols recommended for general population.
Strategies for the prevention and risk reduction of cardiovascular

diseases by addressing modifiable factors such as blood pressure,
smoking, obesity status, unhealthy diet and lack of physical
activity should be applied to all people living with HIV.
Compared with the general population, people living with

HIV have increased risk of developing a range of chronic
noncommunicable diseases, including cardiovascular disease,
hypertension, diabetes, chronic obstructive pulmonary disease,
kidney disease and cancer.
A package of essential noncommunicable disease interventions

for assessing and managing the major noncommunicable
diseases from the primary care level to the district hospital level

are mainly focused on cardiovascular disease risk, including
high blood pressure, type 2 diabetes, chronic respiratory diseases
(asthma and chronic obstructive pulmonary disease) and early
identification of breast and cervical cancer.
14.1 CONSIDERATIONS FOR MANAGING NCDS

IN PLHIV
Screening for cardiac, hypertension, renal, diabetes,
neurocognitive disease should be done for all PLHIV including
CALHIV. Children from age 3 should be screened for
hypertension at every visit and checking blood sugar at least once
a year. Monitoring growth, musculoskeletal and neurocognitive
development in CALHIV is important. Human papillomavirus
vaccination for adolescents is recommended. Screening for
cervical cancer after sexual debut should be encouraged. School-
based programmes to provide educational support to empower
children to take control of their own health should be explored.
Leveraging existing early child development platforms for
supporting CWHIV.
Health education messages to prevent non-communicable

diseases (NCDs) should be integrated into the routine health
education messages at the OPD and in ART counselling. These
should include advice on stopping smoking, a healthy diet that
includes the reduction of salt, and having regular and adequate
exercise.
Where NCDs are identified but can’t be managed in the same

ART clinic, arrangements should be made for co-management
with other providers preferably on the same day.

14.2 Mental health among people living with HIV
People living with HIV are at high risk of mental, nervous system
and substance use disorders with depression being one of the
most prevalent mental health comorbidities in PLHIV. PLHIV
who have depression are less likely to achieve optimal treatment
adherence. Although chronic HIV care settings provide an
opportunity to detect and manage depression among people
living with HIV, it is often overlooked and unrecognized by
healthcare providers. Treatment or lack of treatment for mental
health disorders can affect general health, adherence to ARV
drugs and retention in care and may lead to potential side-effects
and drug–drug interactions being overlooked.
Assessment and management of depression should be included

in the package of HIV care services for all individuals living with
HIV. Linkage to community-based psychosocial support services
should be encouraged.
Health care workers should suspect depression in a PLHIV

presenting with symptoms such as:
• sadness,
• tearfulness
• emptiness or hopelessness
• frequent outbursts, irritability or frustration, even over small
matters
• Loss of interest or pleasure in most or all normal activities,
such as sex, hobbies, or sports
• Inability to sleep or excessive tiredness and lack of energy, so
even small tasks take extra effort
• Changes in appetite — reduced or even increased appetite
• Slowed thinking, speaking or body movements

• Feelings of worthlessness or guilt, fixating on past failures or
blaming yourself for things that aren’t your responsibility
• Trouble thinking, concentrating, making decisions, and
remembering things
• Frequent or recurrent mention of death, suicidal thoughts,
suicide attempts or suicide
• Unexplained physical problems, such as back pain or
headaches
When depression is suspected, the health care worker should

• provide counselling to help the PLHIV understand the need
for seeking help from a mental health expert.
• Liaise with and link the PLHIV with the mental health expert/
institution
• Follow up with the PLHIV to ensure that the necessary care
has been provided
• Ensure that the PLHIV is continues to receive are for HIV and
other comorbidities.

C HA P T E R F I F T E E N
HIV AND CERVICAL

CANCER
Cervical cancer is one of the leading causes of mortality among

women. Nearly all cases are caused by two strains of the hu-
man papillomavirus (HPV): HPV-16 and HPV-18 transmitted
sexually. To prevent cervical cancer, the WHO recommends
vaccinating girls aged 9 to 14 years, when most have not started
sexual activity.
Compared to HIV-negative women, women living with HIV

positive have been found to have a higher incidence of Human
Papilloma virus infection. Early detection and treatment remain
crucial in the prevention of advanced disease and associated
morbidity and mortality.

15.1 SCREENING AND TREATMENT
RECOMMENDATIONS TO PREVENT
CERVICAL CANCER IN PERSONS LIVING
WITH HIV
The WHO recommends the Screen, Triage and Treat approach
for PLHIV. Cervical cancer screening and treatment should
be provided to women, transgender men, and non-binary and
intersex individuals who have a cervix.
Screening
This involves the use of Human Papilloma virus (HPV) DNA
detection as the primary screening test for women living with
HIV. However, if the existing programme has cytology or Visual
inspection with acetic acid (VIA) as the primary screening test,
rescreening with the same test should be continued until HPV
DNA testing is operational among both the general population
of women and women living with HIV.
Regular cervical cancer screening is recommended from the age

of 25 years among women living with HIV at a regular screen-
ing interval of every 3 to 5 years when using HPV DNA detec-
tion as the primary screening test among women living with
HIV.
Priority should be given to screening women living with HIV

aged 25–49 years. When tools are available to manage women
living with HIV aged 50–65 years, those in that age bracket who
have never been screened should also be prioritized.
After the age of 50 years, WHO suggests screening is stopped

after two consecutive negative screening results consistent with

the recommended regular screening intervals among both the
general population of women and women living with HIV
Where HPV DNA testing is not yet operational, WHO suggests

a regular screening interval of every 3 years when using VIA or
cytology as the primary screening test, among both the general
population of women and women living with HIV.
Triaging
• Triaging, using partial genotyping, colposcopy, VIA or
cytology is recommended after a positive HPV DNA test.
• Women living with HIV who have screened positive on an
HPV DNA primary screening test and then negative on a
triage test, are retested with HPV DNA testing at 12 months
and, if negative, move to the recommended regular screening
interval (every 3 to 5 years).
• For women who had cytology as their primary screening test
and tested positive, then had normal results on colposcopy,
it is recommended that they are retested with HPV DNA
testing at 12 months and, if negative, move to the recommended
regular screening interval (every 3 to 5 years).
• Women living with HIV who have been treated for
histologically confirmed CIN2/3 or adenocarcinoma in situ
(AIS), or treated as a result of a positive screening test are to
be
▶ To be retested at 12 months with HPV DNA testing
when available, rather than with cytology or VIA or co-
testing
▶ and, if negative, are to be retested again at 12 months
▶ and, if negative again, move to the recommended regular
screening interval

Treatment
Treatment should be initiated as soon as possible, among non-
pregnant women, within six months to reduce the risk of loss to
follow-up.
For pregnant women, treatment should be deferred until after

pregnancy. In situations where treatment is not provided within
the six-month period, the woman should be re-evaluated before
treatment.
The recommended treatment is a large-loop excision of the

transformation zone (LLETZ) or cold knife conization (CKC)
for women who have histologically confirmed adenocarcinoma
in situ (AIS).
Algorithms for the different scenarios of the Screen, Triage and

Treat approach are provided below.

Figure 15.1. Primary Cytology Screening and Colposcopy Triage
(Screen, Triage and Treat Approach)
For both the general population of women and women living with
HIV
Cytology
(conventional or liquid-based)
Negative > ASCUSa

a
ASCUS
Rescreen in
3 years with Immediate triage with HPV Colposcopy
cytology test
HPV negative HPV positive Further

managment based
on colposcopy
diagnosis or
histopathology
Rescreen in 3 years diagnosis
with cytology
Negative > ASCUSa

Rescreen in
3 years with Colposcopy
cytology
aSome programmes prefer to use LSIL threshold.

ASCUS; atypical squamous cells of undetermined significance; HPV; human papillomavirus; LSIL; low-grade squamous intraepithelial
lesion.

Figure 15.2 HPV DNA Screening and HPV16/18 Triage
HIV
HPV DNA testing
(self-sampled or collected by clinician)
Negative Positive
Rescreen with Other high-risk HPV

HPV 16/18 positive
HPV test in 5 positivee
to 10 years for
the general
population of VIA triage
women and in 3 to Determine eligibility for
5 years for women ablative treatment (after
living with HIV application of 3-5% acetic
acid with or without Follow steps after VIA
magnification) triage in Algorithm 5
Eligible for ablation Not eligible for Suspected

(discuss LLETZ vs ablation cancer
thermal ablation in
women with lesions
and HIV)
LLETZbc Evaluation, biopsy
and further
management
Ablative treatmenta Histologyd
≤CIN3/AIS Cancer
Post-treatment follow-up after 1 year
aAblative treatment includes cryotherapy and thermal ablation.

bCold knife conization (CKC) if LLETZ not available.
cLLETZ and LEEP (loop electrosurgical excision procedure) indicate the same procedure.
dHistology may not be available m certain settings; women should be advised to attend follow-up after 1 year or to report earlier, if they have
any of the symptoms of cervical cancer.
eMay or may not be positive for HPV 45. AIS: adenocarcinoma m situ; CIN: cervical intraepitheial neoplasia; LLETZ: large-loop excision of
the transformation zone: VIA: visual inspection with acetic acid.

Figure 15.3 Primary HPV DNA Screening and VIA Triage
HIV
HPV DNA testing
Rescreen with VIA triage

HPV test in 5
to 10 years for
the general
population of
women and in 3 to
5 years for women Suspected
living with HIV Positive cancer
Evaluation,
Eligible for Not eligible for biopsy and
Negative ablation ablation further
management
Ablative for LLETZbc

Repeat HPV test treatmenta
after 2 years for the
general population Histologyd
of woman or after
1 year for women
living with HIV
Ablative for Cancer
treatment
Post-treatment follow-up after 1 year
aAblative treatment includes cryotherapy and thermal ablation.

bCold knife conization (CKC) if LlETZ not available.
cLLETZ and LEEP (loop electrosurgical excision procedure) indcate the same procedure.
dHistology may not be available m certain settings; women should be advised to attend follow-up after 1 year or to report earlier, if they have
any of the symptoms of cervical cancer.
Al$: adcnocarcmoma in situ: ON: cervical intraepithelial neoplasia; HPV: human papillomavirus; LLETZ: large-loop exosion of the
transformation zone; VIA: visual inspection with acetic add.

Figure 15.4. Primary HPV DNA Screening and Colposcopy
Triage (Screen, Triage and Treat Approach)
HPV DNA testing

Negative Positive
Rescreen with HPV test

in 5 to 10 years for the Colposcopy
general population of
women and in 3 to 5
years for women living
with HIV
Further management
based on colposcopy
diagnosis or
histopathology diagnosis

Figure 15.5. Primary HPV Screening and Cytology Triage
Followed by Colposcopy (Screen, Triage and Treat
Approach)
HIV
HPV DNA testing
Negative Positive
Rescreen with HPV test Cytology triage

in 5 to 10 years for the
general population of
women and in 3 to 5 years
for women living with
HIV
Negative ASCUS or worse
Repeat HPV
test after 2 years Colposcopy
for the general
population of
women living with
HIV
Further
management
based on
colposcopy
Negative Positive diagnosis or
histopathology
diagnosis

Figure 15.6. Follow-Up Tests At 12 Months Post-Treatment for
Women Living with HIV
If treated with Ablation or LLETZ without

histopathology results available or, if treated
based on histopathology of CIN2/3 or AIS
Follow -up test at 12 months
Negative Positive Suspected cancer
Follow-up test
within 12 months
Re-treat with Evaluation, biopsy
LLETZa and further
management
Negative
Back to routine
screen interval
dependent on
primary screening Post-treatment follow-up test within 12
test months
a In circumstances where LLETZ not available. use cryotherapy or thermal ablation for retreatment if eligible.
AIS: adenocarcinoma in situ; CIN: cervical intraepitheial neoplasia; LLETZ: large-loop excision of the transformation zone.

APPENDICES

APPENDIX 1:
CLINICAL STAGING OF HIV/
AIDS FOR ADULTS AND
ADOLESCENTS (≥15YRS)
Stages
Clinical Stage I Asymptomatic

Persistent generalized lymphadenopathy
Clinical Stage 2 Moderate unexplained weight loss (<10% of presumed

or measured body weight)
Recurrent respiratory tract infections (RTIs, Sinusitis,
bronchitis, otitis media, pharyngitis)
Herpes zoster
Angular cheilitis
Recurrent oral ulcerations
Papular pruritic eruptions
Seborrhoeic dermatitis
Fungal nail infections of fingers.
Clinical Stage 3 Unexplained severe weight loss (>10% of presumed or

measured body weight)
Unexplained chronic diarrhoea for longer than one
month
Unexplained persistent fever (intermittent or constant
for longer than one month)
Persistent oral candidiasis
Oral hairy leukoplakia
Pulmonary tuberculosis
Severe bacterial infections (e.g. pneumonia, empyema,
meningitis, pyomyositis, bone or joint infection,
bacteraemia, severe pelvic inflammatory disease)
Acute necrotizing ulcerative stomatitis, gingivitis or
periodontitis
Unexplained anaemia (<8g/dl), neutropenia (<0.5x
109/l) and/or chronic thrombocytopenia (<50 x 109/l).

Stages
Clinical Stage 4 HIV wasting syndrome

Pneumocystis (jiroveci) pneumonia
Recurrent severe bacterial pneumonia
Chronic herpes simplex infection (orolabial, genital or
anorectal of more than 1 month’s duration or visceral at
any site)
Oesophageal candidiasis (or candidiasis of trachea,
bronchi or lungs)
Extrapulmonary tuberculosis
Kaposi sarcoma
Cytomegalovirus infection (retinitis or infection of
other organs)
Central nervous system toxoplasmosis
HIV encephalopathy
Extrapulmonary Cryptococcosis, including meningitis
Disseminated non-tuberculous mycobacterial
infection
Progressive multifocal leukoencephalopathy
Chronic cryptosporidiosis
Chronic Isosporiasis
Disseminated mycosis (Extrapulmonary histoplasmosis,
coccidioidomycosis)
Lymphoma (cerebral or B-cell non-Hodgkin)
Symptomatic HIV-associated nephropathy or
cardiomyopathy
Recurrent septicaemia (including non-typhoidal
Salmonella)
Invasive cervical carcinoma
Atypical disseminated leishmaniasis

APPENDIX 2:
WHO CLINICAL STAGING OF
HIV AND AIDS FOR INFANTS
AND CHILDREN
A2.1
PERSONS AGED UNDER 15
YEARS WITH CONFIRMED
LABORATORY EVIDENCE OF
HIV INFECTION
Stages
Clinical Stage 1 Asymptomatic

Persistent Generalized Lymphadenopathy
Clinical Stage 2 Unexplained persistent hepato-splenomegaly

Recurrent or chronic upper respiratory tract infections
(otitis media, otorrhoea, sinusitis, tonsillitis)
Herpes zoster
Lineal gingival erythema
Recurrent oral ulceration
Papular pruritic eruption
Fungal nail infections
Extensive wart virus infection
Extensive Molluscum contangiosum
Unexplained persistent parotid enlargement.

Stages
Clinical Unexplained moderate malnutrition a not adequately

Stage 3 responding to standard therapy
Unexplained persistent diarrhoea (14 days or more)
Unexplained persistent fever (above 37.5°C, intermittent or
constant, for longer than one 1 month)
Persistent oral candidiasis (after first 6 weeks of life)
Oral hairy leukoplakia
Lymph node tuberculosis
Pulmonary tuberculosis
Severe recurrent bacterial pneumonia
Acute necrotizing ulcerative gingivitis or
periodontitis
Unexplained anaemia (<8g/dl), neutropenia (<0.5x 109/l)
and/or chronic thrombocytopenia (<50 x 109/l).
Symptomatic lymphoid interstitial pneumonitis
Chronic HIV-associated lung disease, including
bronchiectasis

Stages
Clinical Unexplained severe wasting, stunting or severe malnutrition b

Stage 4 not responding to standard therapy
Pneumocystis (jiroveci) pneumonia
Recurrent severe bacterial infections (such as empyema,
pyomyositis, bone or joint infection, meningitis, but excluding
pneumonia)
Chronic herpes simplex infection (orolabial or cutaneous of
more than 1 month’s duration or
visceral at any site)
Oesophageal candidiasis (or candidiasis of trachea, bronchi or
lungs)
Extrapulmonary tuberculosis
Kaposi sarcoma
Cytomegalovirus infection (retinitis or infection of other
organs with onset at age more than 1 month)
Central nervous system toxoplasmosis (after the neonatal
period)
HIV encephalopathy
Extrapulmonary Cryptococcosis, including meningitis
Disseminated non-tuberculous mycobacterial infection
Progressive multifocal leukoencephalopathy
Chronic cryptosporidiosis (with diarrhoea)
Chronic Isosporiasis
Disseminated endemic mycosis (Extrapulmonary
histoplasmosis, coccidioidomycosis, penicilliosis)
Cerebral or B-cell non-Hodgkin lymphoma
HIV-associated nephropathy or cardiomyopathy
a. For children younger than 5 years, moderate malnutrition is defined as weight-for-height <–2 z-score or mid-upper arm circumference
≥115 mm to <125 mm.
b. For children younger than 5 years of age, severe wasting is defined as weight-for-height <–3 z-score; stunting is defined as length-for-age/
height-for-age <–2 z-score; and severe acute malnutrition is either weight for height <–3 z-score or mid-upper arm circumference <115 mm
or the presence of oedema.
NB: Some additional specific conditions can be included in regional classifications, such as penicilliosis in Asia, HIV-associated rectovaginal
fistula in southern Africa and reactivation of trypanosomiasis in Latin America.

A2.2
PRESUMPTIVE DIAGNOSIS
OF CLINICAL STAGE 4 HIV IN
CHILDREN AGED UNDER 18
MONTHS
The presumptive diagnosis is designed for use where access to
confirmatory diagnostic testing for HIV infection by means of
virological testing for infants and children aged less than 18
months is not readily available. It is not recommended for use by
clinical care providers who are not trained in ART or experienced
in HIV care. It should be accompanied by immediate efforts to
confirm the HIV diagnosis with HIV PCR. Presumptive diagnosis
of clinical stage 4 disease suggests severe immunosuppression,
and ART is indicated. A presumptive diagnosis of stage 4 clinical
disease should be made if:
1. An infant is HIV-antibody positive (ELISA or rapid test),
aged under 18 months and symptomatic with two or
more of the following:
2. oral thrush
3. severe pneumonia
4. severe wasting/malnutrition
5. severe sepsis
6. Other factors that support the diagnosis of clinical stage
4 HIV infection in an HIV-Seropositive infant are:
7. recent HIV related maternal death
8. advanced HIV disease in the mother
9. CD4% < 20%
10. Confirmation of the diagnosis of HIV infection should
be sought as soon as possible.

A2.3
IMMUNOLOGICAL CATEGORIES
FOR PAEDIATRIC HIV
INFECTION
Immunological staging for children is also possible. The
absolute CD4 count and the percentage values in healthy infants
who are not infected with HIV are considerably higher than
those observed in uninfected adults, and slowly decline to adult
values by the age of 5 years. In considering absolute counts
or percentages, therefore, age must be taken into account as
a variable. The absolute CD4 count associated with a specific
level of immunosuppression tend to change with age, whereas
the CD4 percentage related to immunological damage does not
vary as much. Currently, therefore, the measurement of the CD4
percentage is recommended in children less than 5 years of age.
Just as in adults, immunological staging assists clinical decision
making in ART initiation for children more than 5 years of age.
CD4 LEVEL IN RELATION TO THE SEVERITY OF

IMMUNOSUPPRESSION
Classification of Age-related CD4 values

HIV associated
immune deficiency <11 months 12-35 36-59 ≥5yrs (cells/
(%) months (%) months (%) mm3)
Not Significant >35 >30 >25 >500
Mild 30-35 25-30 22-25 350-499
Advanced 25-30 20-25 15-20 200 - 349
Severe <25 <20 <15 <200 or <15%

CD4% Formula:
CD4% = ABSOLUTE CD4 COUNT X 100
TOTAL LYMPHOCYTE COUNT

APPENDIX 3
ALGORITHM FOR DIAGNOSIS
OF TUBERCULOSIS
A3.1
CHILDREN LIVING WITH HIV

A3.2
ADULT & ADOLESCENT LIVING
WITH HIV

A3.3
CHILDREN IN CLOSE CONTACT
WITH TB PATIENT

APPENDIX 4
ALGORITHMS FOR THE
MANAGEMENT OF HEPATITIS
B-VIRUS CO-INFECTION WITH
HIV
New HIV/HBV
Repeat HBsAg test after

6months
HBsAg still positive
Manage for HIV/HBV

1st line:
TDF + 3TC ( or FTC)+ DTG Manage for only HIV as per
Alternate 1st line: guidelines
TDF+ 3TC (or FTC) + EFV
2nd line:
3TC+ TDF+ LPV/r

APPENDIX 5
DRUG INFORMATION
A5.1
DRUG-DRUG INTERACTIONS
DRUG DRUG-DRUG INTERACTIONS
Abacavir Methadone, Phenobarbital, Phenytoin, Rifampicin
Atazanavir As part of the ARV regimen:

Efavirenz
Nevirapine (may increase risk of NVP toxicity)
Tipranavir
Other Drugs
Alfuzosin, alprazolam, astemizole, bepridil,
cisapride, ergot derivatives, garlic supplements,
irinotecan, lovastatin, midazolam, pimozide,
pitavastatin, proton pump inhibitors, ranolazine,
rifampin, rifapentine, high-dose sildenafil,
simvastatin, St. John’s wort, terfenadine, triazolam
Dolutegravir Antacids, laxatives, multivitamin supplements and
anticonvulsant such as carbamazepine
Efavirenz Nevirapine, Antiarrhythmics (Lidocaine,

amiodarone), Antiepileptics (Phenytoin,
Carbamazepine, Primidone), Antihistamines
(Astemizole, Terfenadine, Loratidine),
Benzodiazepine, Ergometrine, Grapefruit juice,
Indinavir, Lopinavir, Methadone, Nevirapine,
Phenobarbital, Rifampicin, Ritonavir, Oral
Contraceptives (oestrogen-based), Phenobarbital,
Benzodiazepine, Saquinavir, St. John’s Worts
(Herbal)
Emtricitabine Lamivudine

DRUG DRUG-DRUG INTERACTIONS
Lamivudine Emtricitabine,
Lopinavir/Ritonavir Artemether+Lumefantrine, Alprazolam,

Amiodarone, Astemizole, Carbamazipine,
Chlorpheniramine, Clarithromycin,
Dexamethasone, Diazepam, Efavirenz,
Erythromycin, Itraconazole, Ketaconazole,
Lidocaine, Loratidine, Metronidazole, Nelfinavir,
Oral contraceptives, Phenobarbitalone, Phenytoin,
Rifabutin, Rifampicin, Quinidine, Saquinavir,
Simvastatin, St. John’s worts, Tenofovir, Terfenadine,
Tricyclic antidepressants,
Nevirapine Carbamazepine, Cocaine, Efavirenz, Fluconazole,

Indinavir, Levonorgestrol, Medroxyprogesterone,
Methadone, Norethisterone, Oral contraceptives
(oestrogens and progestogens), Phenytoin, Protease
Inhibitors, Rifabutin, Rifampicin, Indinavir,
Efavirenz, Saquinavir, St. John’s worts, Warfarin,
Carbamazepine, Phenytoin, Cocaine.
Tenofovir Acyclovir, Aminoglycosides, Amphotericin B,

Didanosine, Lopinavir, Pentamidine, Probenecid,
Salicylates, Vancomycin
Zidovudine Cytotoxics (Doxorubicin etc) Fluconazole,

Ganciclovir, Ibuprofen, Interferon, Methadone,
Phenytoin, Pyrimethamine, Ribavirin,Rifampicin,
Stavudine, Valproic Acid

A5.2
ADULT & ADOLESCENT DRUG
DOSAGE, FORMULATIONS AND
ADVERSE EFFECTS
Drug Adult Formu- Adverse Adverse ef- Special
dosage lations effects fects serious, instruc-
Minor, fre- dose limiting tions
quent
Abacavir 300 mg Tablet Nausea, Poor Hyper- Caution in liver
bid Appetite, sensitivity or renal disease
Vomiting reaction Discontinue use
Fatigue Lactic aci- in symptoms of
Sleep dosis hypersensitivity
disturbance
Dolute- 50mg Tablet Insomnia, Neural tube Caution in

gravir daily weight gain/ defects, pregnancy first
clinical depression trimester
obesity and suicide
ideation
Efavirenz 600 mg Cap- Elevated Suicidal ide- Caution in liver
& 400mg sule/ Liver enzyme ations, Mania disease
daily Tablet Skin rash Teratoge-
CNS nicity
disturbances
Emtricit- 200mg Capsule Few side Lactic aci- Caution in liver

abine daily effects, rash, dosis or renal disease
(FTC) peripheral Hepato- Exacerbation
neuropathy megaly with of hepatitis
reported steatosis in patients
with chronic
hepatitis B may
occur on dis-
continuation of
Emtricitabine

Drug Adult Formu- Adverse Adverse ef- Special in-
dosage lations effects fects serious, structions
Minor, fre- dose limiting
quent
Lami- 150 mg Tablet Few side Lactic acido-
vudine bid effects, rash, sis (Rare)
(3TC) peripheral
neuropathy
reported
Lopina- 400 mg Tablet Diarrhoea, Hypersensi-

vir/ri- /100 mg nausea, dys- tivity
tonavir bid lipidemia, li- Pancreatitis
podystrophy,
headache Diabetes
Mellitus
Nevirap- 200 mg Tablet Skin rash Hypersensi- Caution in liver

ine daily for tivity disease
14 to Hepatotox-
28 days icity
then 200
mg bid
TAF 25 mg Tablet Weight gain, For children,

once Dyslipidae- adolescents,
daily mia adults weighing
25 kg
or more when
used with
unboosted
regimens such
as DTG
TDF 300 mg Tablet Nephrotoxici- To be taken

daily ty (Rare) with a meal
Zidovu- 300 mg Tablet Nausea Anaemia, Caution in:

dine bid Headache Neutropenia, pre-existing
( AZT) Fatigue gastrointesti- anaemia
Muscle pai nal intoler- Liver and renal
ance, insufficiency
Lactic aci-
dosis

A5.3
PAEDIATRIC DRUG DOSAGE,
FORMULATIONS AND ADVERSE
EFFECTS
Drug For- Dosage for Adverse Adverse ef- Special in-
mula- children effects fects serious, structions
tions Minor, fre- dose limiting
quent
Abacavir Oral 3 months to 16 Nausea Poor Hypersensi- Caution in liver
solution: years: 8 mg/ kg / Appetite tivity reaction or renal disease
20mg/ml dose bid (maxi- Vomiting
mum, 600mg daily) Fatigue Lactic aci- Discontinue use
Tablet: Sleep distur- dosis if symptoms of
300mg bance hypersensitivity
Dolute- Dis- 3–<6 kg, 5mg once

gravir persible daily Insomnia, Neural tube
Tablet: 6–<10 kg, 15mg weight gain/ defects,
10mg once daily clinical depression
10–<14 kg, 20mg obesity and suicide
once daily ideation
14–<20 kg, 25mg
once daily
Efa- Capsules: Capsule/Tablet Elevated Liv- Only for

virenz 50mg, 40 kg and over, 600 er enzyme children over 3
100mg, mg once daily; Skin rash years
200mg, over 3 years/10–14 Capsules may
600mg kg, 200 mg once CNS distur- be opened and
daily; bances added to food
15–19 kg, 250 mg but has a very
once daily; peppery taste
20–24 kg, 300 mg Avoid high fatty
once daily; foods
25–32 kg, 350 mg
once daily; Best given at
33–39 kg, 400 mg bed time to re-
once daily duce CNS side
effects

Drug Adult Formulations Adverse Adverse ef- Special in-
dosage effects fects serious, structions
quent
Oral As oral solution
solution: 40 kg and over, 720
30mg/ mg oncedaily;
ml note over 3 years/10–15
syrup kg, 270 mg once
requires daily;
higher 15–20 kg,300 mg
dosing once daily;
than cap- 20–24 kg, 360 mg
sules) once daily;
25–32 kg,450 mg
once daily;
33–39 kg, 510 mg
once daily
Emtricit- Oral Over 33 kg, 1 cap- Few side Lactic aci- Caution in liver
abine solution: sule (200 mg) or 24 effects, rash, dosis or renal disease
10mg/ml ml (240 mg) oral peripheral Exacerbation
(FTC) solution once daily neuropathy of hepatitis in
4 months–18 years, reported patients with
under 33 kg, 6 mg/ Hepatomegaly chronic hepati-
kg oralsolution with steatosis tis B may
once daily occur on dis-
continuation of
Emtricitabine
Lami- Tab- Infants under 1 Few side Lactic aci- Store at room
vudine let:150 month: 2mg/kg effects, neu- dosis temperature
(3TC) mg 12hourly tropenia, can be adminis-
Child over 1 tered with food.
Oral month: 4mg/kg 12 peripheral Decreased dos-
Solution: hourly neuropathy age with renal
10 mg / reported impairment
ml

quent
Lopina- Lopinavir/ Surface area Diarrhoea, Hypersensi- Preferably oral
vir/ 6months–13 years: nausea, dys- tivity solution and
Ritonavir Lopinavir, 225 lipidemia, li- capsules should
ritona- tablet: mg/m2 + ritona- podystrophy, Pancreatitis be refrigerated;
vir( 200mg/ vir,56.25 mg/m2 headache must be recon-
50mg twice daily Diabetes stituted imme-
LPV/r) Mellitus diately prior to
Oral Weight based administration
solution: 7–15 kg, Lopinavir, in water, milk,
Lopinavir/ 12 mg/kg +ritona- formula, pud-
Ritona- vir, 3 mg/kg twice ding, etc- do
vir:80/ daily; not use acidic
20mg per 15–40 kg, Lopina- food or juices
ml vir, 10 mg/kg+ increases bitter
ritonavir, 2.5 mg/ taste); solution
Lopinavir/ kg twice daily). stable for 6
ritonavir > 40 kg: Lopinavir hours
tablets 400 mg/Ritonavir
100 mg twice daily Because of diffi-
100mg/ culties with use
50mg of powder, tab-
lets preferred.
Powder and
tablets can be
stored at room
temperatures
Take with food
Drug interac-
tions (less than
ritonavir con-
taining protease
inhibitors

quent
If Rifampicin
co-administra-
tion, avoid use
Store suspen-
sion at room
temperature;
must shake well
Can give with
food can be
crushed and
combined with
small amount
of water or food
and immediate-
ly administered
warn parents
about
Rash.
Zidovu- Syrup: Neonatal dose: Nausea Anaemia, Caution in:

dine 10mg/ml Neutropenia, pre-existing
(AZT) Oral: 4mg/kg body Headache gastrointesti- anaemia
Capsules: weight 12hrly. nal intoler- Liver and renal
100mg Fatigue ance, insufficiency.
Paediatric dose:
Tablets: Muscle pains Lactic aci- Can be admin-
300mg 240mg/m2 every dosis istered with
12 hrs food
Store at room
Max-300mg every temperature
12hrs
* Adolescent dose is same as adult dosage see adult section.

Fixed dose combinations available in Ghana
Zidovudine + Lamivudine 300mg+150mg fixed dose,12hourly
Tenofovir + Lamivudine 300mg+300mg fixed dose, 24 hourly Side
effects of
Tenofovir + Emtricitabine 300mg+200mg fixed dose, 24 hourly fixed dose
Tenofovir + Lamivudine + 300mg+300mg+400mg fixed dose, prepara-
Efavirenz 24 hourly tions are
Tenofovir + Emtricitabine 300mg+200mg+600mg fixed dose, as for the
individual
+ Efavirenz 24 hourly compo-
Tenofovir + Lamivudine + 300mg+300mg+50mg nents
Dolutegravir

APPENDIX 6
PEP FOR RAPE SURVIVORS
A6.1
FORENSIC EVIDENCE
COLLECTION
It is ideal to document injuries and collect samples, such as blood,
hair, saliva and sperm within 72 hours of the incident. Whenever
possible, this should be done during the medical examination
following the order below:
Inspection of the Body

→ Examine the survivor’s clothing under good light before she
undresses.
→ Collect any foreign debris on clothes, body or in hair.
→ Let survivor undress while standing on a sheet of paper to
collect any debris that fall.
→ Examine the upper part of body first followed by the lower
half.
→ Collect torn and stained items of clothing if possible.
→ Document all injuries in as much detail as possible.
→ Take samples on body or from the mouth for semen analysis
in the event of ejaculation into survivor’s mouth.
→ Collect samples for DNA analysis from where there could be
the assailants saliva or semen on the skin, using cotton tipped-
swab moistened with sterile water.
→ Take blood and urine for toxicology testing if survivor was
drugged.

Inspection of the Perineum and Vulva
Inspect and collect samples for DNA analysis from around the
anus, perineum and vulva using separate cotton-tipped swabs
moistened with sterile water.
Examination of the Vagina and/or Rectum (depending on the

site of penetration or attempted penetration
→ Lubricate speculum with normal saline or clean water.
→ Using a cotton-tipped swab, collect fluid from the posterior
fornix for examination of sperm.
→ Use a wet mount to examine and take note of any motile
sperm. In addition to the first slide a second slide could be
made and both air-dried for future examinations.
→ Take specimen from the posterior fornix and the endocervical
canal for DNA analysis. Let them dry at room temperature.
→ Collect separate samples from the cervix and the vagina for
acid phosphatase analysis.
→ Obtain samples from the rectum for similar examinations, if
indicated.
Maintaining the Chain of Evidence

All evidence collected must be well processed, labelled, stored
and transported properly; and documentation must include a
signature of everyone who has possession of the evidence at any
time, from the person who collects it to the one who takes it to
the courtroom.
Evidence should be kept in a safe, secured place, and should be

released to the relevant authority at the request of the survivor,
the police with the consent of the survivor or at the request of a
court of competent jurisdiction.

A6.2
DRUG RECOMMENDATION
FOR HIV PEP IN ADULTS
AND ADOLESCENTS (>40KG)
INCLUDING PREGNANT AND
LACTATING WOMEN
DRUG RECOMMENDATION
TDF 300mg daily for 28 days +
FTC 200my daily for 28 days +
DTG 50mg daily x 28days
OR
TDF 300mg daily for 28 days +
FTC 200my daily for 28 days +
LPV/r 400mg/100mg 12hourly x 28days
OR
AZT 300mg 12hourly x 28 days +
3TC 150mg 12 hourly x 28 days +
LPV/r 400mg/100mg 12hourly x 28days
DRUG RECOMMENDATION FOR HIV PEP IN CHILDREN

Recommended drugs in children are the same as in the case of
the adult but dosing must be according to age and body weight
as outlined below:
WEIGHT OR AGE REGIMEN

Children 10 years and younger AZT (or ABC) + 3TC + LPV/r OR DTG
AZT and 3TC is the preferred backbone

regimen for HIV PEP

A6.3
PEP AND MANAGEMENT
RECORD FORM FOR RAPE
SURVIVORS
Facility:_____________________________________________
Date:_______________________________________________
Name of Survivor: ____________________________________
Age: __________________ Sex: __________________
Date of Incident: ___/___/___ Time of Incident: ____________

dd mm yy
Location of Incident: _________________________________

___________________________________________________
Brief Background and circumstances of the rape incident: ____
___________________________________________________
___________________________________________________
___________________________________________________
___________________________________________________
___________________________________________________
___________________________________________________
Survivor referred from another facility for the purpose of PEP
only:
Details of Sexual Violence:
Raped by more than one person Yes ☐ No☐

Sustained physical bodily injury Yes ☐ No☐
Injuries in the genital area Yes ☐ No☐
Assailant is not known to the Survivor Yes ☐ No☐
Assailant is a regular sexual partner of Survivor Yes ☐ No☐
Other (specify): ___________________________________
2. Action taken:
Attended to by a doctor Yes☐ No ☐
Other healthcare worker (specify): ____________________

Client Reported incident to police Yes☐ No ☐
3. Assailant Information:
Assailant identified? YES ☐ NO ☐
Serological status: HIV +ve ☐ HIV –ve ☐
Unknown ☐
4. Survivor’s Health Screen Information:

Pre-PEP HIV test done Yes ☐ No ☐
Pregnancy Test done Yes ☐ No ☐
Screening for STI done Yes ☐ No ☐

5. Outcome of Survivor’s Health Screen:
HIV Positive – Referred to ART Clinic Yes ☐ No ☐
Survivor Pregnant – Referred Yes ☐ No ☐
STIs treatment given Yes ☐ No ☐

Hepatitis vaccination given Yes ☐ No ☐
For client who was not pregnant was emergency
Contraception given? Yes ☐ No ☐
If Yes, specify type____________________________________
___________________________________________________
________________________________________________
6. PEP for HIV (even when Survivor refuses to undertake HIV
test)
PEP Started Yes ☐ No ☐
If Yes Start date _____/____/_____ Start time___________
dd mm yy
Stop date _____/____/_____

dd mm yy
Reasons for stopping: End of course ☐ Adverse reaction ☐

Other_______________________________________
7. Medications administered
Combivir (AZT/3TC) ☐ Lopinavir/r ☐ Atazanavir/r ☐
Others: Specify:___________________________________
8. Follow-up of a Survivor on PEP

HIV test at 6 weeks done Yes ☐ No ☐
HIV test at 3 months done Yes ☐ No ☐
HIV test at 6 months done Yes ☐ No ☐
Outcome of follow-up ________________________________

9. If PEP started but HIV test refused by Survivor she/he must
sign below
By signing I acknowledge that I have refused HIV testing prior
to taking PEP, contrary to medical advice.
Name:_____________________________________________
Signature: _________________
Date: ______________
Name of
Provider:___________________________________________
Signature: __________________
Date: _______________

A6.4
POST EXPOSURE PROPHYLAXIS
OF HIV MONTHLY RETURNS
FORM
Name of Facility:
Month:
Name of Person Filing Report:
INDICATOR Very low Risk Low Risk High Risk

Total Number of Healthcare Workers
(HCW) Reporting after Occupational
Exposure
Number Counselled for HIV

Number tested for HIV before PEP
Number HIV positive
Number starting PEP
Number completing PEP
Number of Rape Survivors Reporting
Number Counselled and Tested for

HIV before PEP
Number HIV positive
Number starting PEP
Number completing PEP
Follow-up Testing for HIV at 6 weeks, 3

months and 6 months
Exposed HCW Rape Survivors
positive negative positive negative

Number testing at 6 weeks
Number testing at 3 months
Number testing at 6 months

APPENDIX 7
TREATMENT MONITORING
ALGORITHM
Adherence counselling should be provided at all visits to ensure

that viral suppression is maintained or given priority throughout
care
a Switch after a single elevated viral load should be considered. b A second viral load may be considered before regimen switch if DTG-based
regimens are unavailable, and the results of a viral load test can be returned and acted on rapidly. c Conduct same-day testing using point-of-
care viral load testing for a repeat viral load test, where available, to expedite the return of results. If not available, viral load specimens and
results for a repeat viral load test should be given priority across the laboratory referral process (including specimen collection, testing and
return of results). d Consider switching ART for those receiving NNRTI-based regimens based on clinical considerations and address any
adherence concerns.

REFERENCES
1. WHO Consolidated Guidelines on HIV Prevention,

Testing, Treatment, Service Delivery And Monitoring:
Recommendations For A Public Health Approach, July
2021
2. Guidelines for managing advanced HIV disease and rapid
initiation of antiretroviral Therapy
3. 2020 HIV Sentinel Survey Report, National AID/SSTI
Control Programme, June 2021
4. UNAIDS, GLOBAL AIDS UPDATE, Seizing the moment—
Tackling entrenched inequalities to end epidemics, July,
2020
5. UNAIDS Regional Country Report 2020
6. WHO: Transitioning To The 2021 Optimal Formulary
For Antiretroviral Drugs For Children: Implementation
Considerations, July, 2021
7. WHO: Guidelines On HIV Testing Services HIV Self-
Testing And Partner Notification Supplement To
Consolidated Guidelines On HIV Testing Services,
December, 2016
8. Ghana Health Service, Ministry of Health. ABC of pre-
exposure prophylaxis (PrEP): Ghana implementation
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9. Gonzalez JS, Batchelder AW, Psaros C, Safren SA.
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https://apps.who.int/iris/handle/10665/325859
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on Task-sharing. June 2017.
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antiretroviral drugs for treating and preventing HIV
infection: recommendations for a public health approach
June 2013.
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Adults and Adolescents: Recommendations for a public
health approach, 2010 revision.

23. WHO: Antiretroviral Therapy for HIV Infection in
Infants and Children: Towards Universal Access.
Recommendations for a public health approach, 2010.
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Guidelines and Protocol. November 2009.
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Algorithm for the Management of Chronic Hepatitis
B Virus Infection in the United States: An Update.
Clinical Gastroenterology and Hepatology 2006; 4, No.
8: 1-27.
26. Brook MG, Gilson R & Wilkins EL. BHIVA Guidelines:
co-infection with HIV and chronic hepatitis B virus.
HIV Medicine, 2003,4,42-51.
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Opportunistic Infections Among HIV-Infected Adults
and Adolescents MMWR. December 17, 2004
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mmwrhtml/rr5315a1.htm accessed 29/06/08.
28. European AIDS Clinical Society (EACS) Guidelines
for the clinical management and treatment of chronic
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CONSOLIDATED

GUIDELINES FOR HIV

Consolidated Guidelines for HIV care in Ghana 1

2 Consolidated Guidelines for HIV care in Ghana

Consolidated Guidelines for HIV care in Ghana 3

4 Consolidated Guidelines for HIV care in Ghana

Consolidated Guidelines for HIV care in Ghana 5

6 Consolidated Guidelines for HIV care in Ghana

Consolidated Guidelines for HIV care in Ghana 7

AIDS - Acquired Immune Deficiency Syndrome

8 Consolidated Guidelines for HIV care in Ghana

Consolidated Guidelines for HIV care in Ghana 9

10 Consolidated Guidelines for HIV care in Ghana

The review was based on global evidence and country

I commend all CEOs of respective Ministry of Health agencies,

Consolidated Guidelines for HIV care in Ghana 11

The development of this updated edition of the consolidated HIV

We extend our heartfelt thanks to our colleagues, partners and

12 Consolidated Guidelines for HIV care in Ghana

Dr. Patrick Kuma-Aboagye

Consolidated Guidelines for HIV care in Ghana 13

This updated national HIV Care guidelines include newly

14 Consolidated Guidelines for HIV care in Ghana

This document remains the basis for planning and organisation

Honourable Kwaku Agyeman Manu (MP)

Consolidated Guidelines for HIV care in Ghana 15

A total of 1,837,149 HIV tests were conducted in 2020 with a

The median HIV prevalence in women attending antenatal care

16 Consolidated Guidelines for HIV care in Ghana

Differentiated strategies across the cascade of HIV care therefore

Differentiated Service Delivery is a client-centred approach to

Provider Initiated Testing and Counselling (PITC) which

Consolidated Guidelines for HIV care in Ghana 17

If they are established on ART, PLHIV can be given clinic

Currently, viral load testing is used to monitor clients on

These updated guidelines take into consideration

It is expected that the implementation of these revised national

18 Consolidated Guidelines for HIV care in Ghana

Consolidated Guidelines for HIV care in Ghana 19

New definition of ‘established on ART’

20 Consolidated Guidelines for HIV care in Ghana

HIV Testing Services

Recommendations for testing and retesting during ART initiation

• For women who are already known to be living with HIV,

HIV Testing and Counselling Approaches

Consolidated Guidelines for HIV care in Ghana 21

22 Consolidated Guidelines for HIV care in Ghana

Included in this update are treatment considerations specific for

Tables and Figures

Consolidated Guidelines for HIV care in Ghana 23

24 Consolidated Guidelines for HIV care in Ghana

HIV TESTING AND

HIV testing is a process that determines whether a person is

Consolidated Guidelines for HIV care in Ghana 25

3. Post- test Counselling and Support services:

4. Correct test results:

26 Consolidated Guidelines for HIV care in Ghana

Confidentiality in Record Keeping

Shared confidentiality Referrals