Program Announcement 04064

HIV Prevention Projects for Community-Based

Organizations
Quick Facts
Program Announcement 04064
Consolidates six previous cooperative agreements (!"# HIV Prevention $mong %ay
&en of Color' !(# Community-Based HIV Prevention Projects for $frican $mericans'
!)# HIV Prevention Projects for $frican-$merican *ait+-Based Organizations' !!!(,#
HIV Prevention Projects for Community-Based Organizations' !!"!!# Community-Based
-trategies to Increase HIV .esting of Persons at Hig+ /is0 in Communities of Color' and
!"!,,# Community Coalition 1evelopment Projects for $frican-$merican Communities2
into one compre+ensive program announcement
Incorporates ( of C1C3s 4$dvancing HIV Prevention5 strategies6
o Implementation of ne7 models for diagnosing HIV infections outside medical
settings
o Prevention of ne7 infections 8y 7or0ing 7it+ persons diagnosed 7it+ HIV and
t+eir partners
Application Process
) communication tools used to provide information and9or tec+nical assistance to
applicants6
o 8last fax to more t+an (#!!! +ealt+ departments and community-8ased
organizations CBOs2
o national satellite 8roadcast (simultaneously transmitted via 1is+ :et7or0#
Internet# and
teleconference2
o 7e8 conferences and postings
o pre-application 7or0s+ops
o interactive informational 1V1s
o toll-free telep+one +elp line
; regional CBO consultations +eld (-pring (!!,2 in C+icago# :e7 <or0# -an *rancisco#
and &iami
=>) ?etters of Intent received and @>( applications
@, applicants met eligi8ility reAuirements ("@ 7ere late and "= 7ere ineligi8le2
Of "! previously funded CBOs6 ")@ applied# >, received pre-decisional site visits
( (P1-Vs2# and ); selected for funding' ;>B of CBOs selected for funding 7ere
previously funded
P$ !;!); funding decisions 7ere 8ased on a +ig+ly competitive national process (-ee
ta8le for step-8y- step process description2
Awards Made
">; P1-Vs 7ere made
&ay ("# (!!;6 $7ards announced to t+e pu8lic
@-year project period funded6 Culy "# (!!; t+roug+ Cune ,!# (!! (8udget periods are "(
mont+s2
D; million a7arded (approximately26
o D,! million under Category $ (serving +ig+-ris0 racial9et+nic minority
communities2
o D" million under Category B (serving +ig+-ris0 groups# regardless of
race9et+nicity2
D,;@#!!!# average a7ard per CBO
";" CBOs funded6 " under Category $# organizations serving +ig+-ris0 racial and et+nic
minority communities' @! under Category B# organizations serving +ig+-ris0 groups
regardless of race9et+nicity
;= CBOs target yout+
@; CBOs target men 7+o +ave sex 7it+ men (&-&2 primary
(, CBOs target Injecting drug users (I1Es2
;" CBOs target +eterosexuals
&ore t+an one ris0 group targeted 8y most CBOs6 ""! target &-&# ) target I1Es# and
"") target +eterosexuals
Application Review Process
Step 1 C1C revie7ed t+e applications to ensure t+at t+ey met all eligi8ility reAuirements# as
outlined in t+e program announcementF

Step 2 .+e applications 7ere revie7ed 8y -pecial Gmp+asis Panels (-GP2F
-GP mem8ers are external experts not affiliated 7it+ C1CF .+e federal
government employs t+is met+od of grant revie7 8ecause it offers an
independent# 8alanced and o8jective perspective in t+e revie7 of grant
applicationsF
.+e -GP is granted t+e aut+ority to revie7 and score eac+ applicationF
$ total of "@) external revie7ers 7ere recruited to serve on )! revie7 panelsF
Gac+ panel 7as composed of a 8e+avioral scientist# an epidemiologist or
evaluator# and a community mem8er 7it+ HIV prevention experienceF $ll
revie7ers +ad at least t+ree years of relevant experienceF
Gac+ application 7as revie7ed 8y a primary and secondary revie7er and t+e
panel t+en discussed t+e revie7 noting strengt+s and 7ea0nesses t+at 7ere
recorded for t+e summary statementF
.+e applications 7ere scored 8y t+e panel and applications 7ere ran0 ordered
8y C1C 8ased on numeric scores from t+ese panelsF





Step Once C1C completed t+e ran0ing# C1C systematically applied funding caps to
ensure t+at t+e num8er of grantees corresponded to regional $I1- incidence#
and to ot+er funding preferences as stated in t+e program announcementF Our
intent 7as to ensure reasona8le representation among at-ris0 populations# ris0
8e+aviors# and race9et+nicityF *or example# t+e +ig+est scoring organizations in
t+e 7estern region 7ere included for funding up to t+e point t+at t+e cap ("@B2
for t+e 7estern region 7as ac+ievedF
.+e rationale for t+ese adjustments is to ensure t+e 8est matc+ 8et7een
funding decisions and HIV9$I1- epidemiology on a regional 8asisF






Step 4 -ite visits 7ere performed 8y C1C staff to ensure t+at t+e applicant +as
accuratelyc+aracterized its administrative and tec+nical a8ility to perform t+e
proposed activitiesF
.+is process resulted in a small num8er of organizations 8eing eliminated from
furt+er consideration
CDC's HIV/AIDS
Prevention Activities
As a part of its overall public health mission, CDC provides national leadership in
helping control the HIV epidemic by working with community, state, national, and
international partners in surveillance, research, prevention and evaluation activities.
hese activities are critically important, as CDC estimates that between !"",""" and
#"",""" Americans currently are living with HIV. Also, the number of people living with
AID$ is increasing, as effective new drug therapies are keeping HIV%infected persons
healthy longer and dramatically reducing the death rate.
What is CDC's HIV/AIDS prevention strategy?
CDC employs a comprehensive approach to preventing further spread of HIV and AID$.
$trategies include monitoring the epidemic to target prevention and care activities,
researching the effectiveness of prevention methods, funding local prevention efforts for
high%risk communities, and fostering linkages with care and treatment programs. CDC is
working in collaboration with many other governmental and nongovernmental partners at
all levels to implement, evaluate, and further develop and strengthen effective HIV
prevention efforts nationwide. CDC also is providing financial and technical support for
disease surveillance& HIV antibody counseling, testing, and referral services& partner
counseling and referral services& street and community outreach& risk%reduction
counseling& prevention case management& prevention and treatment of other se'ually
transmitted diseases that can increase risks for HIV transmission& public information and
education& school%based education on AID$& international research studies& technology
transfer systems& organi(ational capacity building& and program%relevant epidemiologic,
sociobehavioral, and evaluation research.
How are CDC funds distributed?
In fiscal year )""*, nearly !" percent of CDC+ s HIV prevention funds were distributed
e'ternally through cooperative agreements, grants, and contracts, primarily to state and
local agencies. he largest portion of CDC+ s HIV prevention resources is awarded to
state, local, and territorial health departments. $ome of these funds support more than )""
local and regional HIV ,revention Community ,lanning groups.
How are prevention activities organied?
The National Center for HIV, STD and TB Prevention
Division of HIV/AIDS Prevention
he Division of HIV-AID$ ,revention is the primary division charged with CDC.s HIV
mission of preventing HIV infection and reducing the incidence of HIV%related illness
and death, in collaboration with community, state, and national partners. Its nine branches
oversee a variety of activities in support of this mission.
The Behavioral Intervention Research Branch applies current theory, practice,
and empirical findings in designing and conducting research on state%of%the%art
interventions to prevent HIV infection. Characteristics of the research include the
use of formative studies to develop interventions, such as the e'amination of
psychosocial and cultural determinants of risk behaviors, the collection and
analysis of process and outcome data that includes both /ualitative and
/uantitative measures, and the use of rigorous study designs to e'amine
intervention effectiveness. 0urther, branch staff members assist in translating and
replicating research findings for use in HIV prevention programs.
The Prevention Progras Branch works with $tate and local public health
departments, nongovernmental national-regional and local partners, and others to
develop and implement programs, policies, and activities that mobili(e affiliates
and communities to become involved with and support local and statewide HIV
prevention programs and activities. It plans, implements, and manages strategies
and resources for HIV prevention in $tate and local health departments,
community%based organi(ations, and other nongovernmental organi(ations to
build comprehensive public health%private sector partnerships to prevent
HIV-AID$& provides technical consultation and program oversight to $tate and
local health departments, community planning groups, and nongovernmental
partners in operational aspects of HIV prevention& establishes guidelines and
policies for implementation and continuation of $tate and local HIV prevention
programs& and develops new operational programs and program announcements
for HIV prevention.
The Progra !val"ation Research Branch evaluates the processes, outcomes,
and impacts of CDC HIV prevention programs, activities, and policies for their
improvement and accountability& develops and enhances evaluation methods and
systems& and serves as a resource for building evaluation capacity.
The Technical Inforation and Co"nications Branch uses both electronic
media and printed materials to communicate scientific, statistical, programmatic,
and technical information on HIV-AID$ to health care professionals, public
health officials, prevention partners, federal government officials, and the general
public.
The Ca#acit$ B"ilding Branch assists providers in enhancing the capacity of
individuals, organi(ations, and communities to conduct more effective and
efficient HIV and AID$ prevention services.
The !#ideiolog$ Branch's mission is to conduct biomedical and behavioral
epidemiologic research to reduce HIV infection and disease progression.
Accordingly, scientists in the 1pidemiology 2ranch design and conduct studies in
the 3nited $tates and internationally to determine risk factors for HIV infection
and disease, and to evaluate innovative biomedical and behavioral interventions in
adults and children for preventing HIV infection and HIV%related disease. hese
studies are conducted by four research $ections including the HIV Vaccine
$ection, the 4other%Child ransmission 5 ,ediatric and Adolescent $tudies
$ection, the Clinical 1pidemiology $ection, and the $e'ual ransmission and
In6ection Drug 3se $tudies $ection. Domestically, the 1pidemiology 2ranch is
currently collaborating with partners in )7 states, and internationally is working
with partners in hailand, Cote d+Ivoire, 8enya, 2otswana, 3ganda, and 9ussia.
The Prevention Services Research Branch conducts research to develop and
improve HIV prevention strategies. his includes conducting studies :*; to
identify and evaluate specific at%risk populations, :); of the determinants of risk
for HIV infection in specific populations, :<; of HIV counseling and testing
activities, and :=; of HIV genotypic variations and antiretroviral drug resistance.
his branch also is responsible for collecting data on the e'tent of HIV prevalence
and incidence in the 3nited $tates, for assisting other Centers within CDC to
evaluate new HIV%related tests, and for maintaining a repository of stored sera and
cells for studies of HIV infection.
The Statistics and Data %anageent Branch provides statistical support,
software systems design, and data management support for HIV-AID$
surveillance, HIV serosurveys, epidemiologic studies, and other studies conducted
within the division& develops methods and coordinates efforts by statisticians to
estimate the incidence of HIV infection& participates in the design, data analysis,
and manuscript preparation for epidemiologic and behavioral studies and clinical
trials& and conducts data analyses re/uired by law for the allocation of HIV-AID$
prevention and treatment funds. he branch also provides national leadership in
the development of statistical and data management planning, policy,
implementation, and evaluation.
The S"rveillance Branch conducts a national program of surveillance and
research to monitor and characteri(e the HIV-AID$ epidemic, and its
determinants and impact, to guide public health action at federal, state, and local
levels. his includes surveillance of HIV infection and AID$ in collaboration with
$tate and local health departments to provide population%based data for research,
evaluation, and prevention at the >ational, $tate, and local levels. he branch
maintains, analy(es, and disseminates information from the national confidential
registry of HIV-AID$ cases& monitors HIV%related morbidity and mortality and
the use of ,H$ recommendations for prevention and treatment of HIV infection
and AID$& and conducts population%based surveillance of HIV%related risk
behaviors in collaboration with state and local health departments.
The National Center for HIV, STD and TB Prevention
&lo'al AIDS Progra
he ?lobal AID$ ,rogram :?A,; e'ists to help prevent HIV infection, improve care and
support and build capacity to address the global HIV-AID$ pandemic. ?A, provides
financial and technical assistance through partnerships with communities, governments,
and national and international entities working in resource%constrained countries.
What other CDC offices conduct HIV prevention activities?
Additional HIV prevention, education, and research programs are conducted in other
CDC centers, institutes, and offices.
The National Center for Infectio"s Diseases (NCID)
>CID+s Division of AID$, $D, and 2 @aboratory 9esearch provides laboratory
research on HIV and laboratory support for the surveillance, epidemiologic, and
clinical activities of >CH$,. It also conducts laboratory and epidemiologic
studies of HIV%infected and uninfected persons with hemophilia and assists in the
design, implementation, and evaluation of prevention and counseling programs
for them and their families.
he Division of Healthcare Auality ,romotion, also located in >CID, assists the
3.$. ,ublic Health $ervice, state and local health departments, hospitals, and
professional organi(ations worldwide in the prevention and control of
nosocomially ac/uired HIV infection.
The National Center for Chronic Disease Prevention and Health Prootion
(NCCDPHP)
he Division of Adolescent and $chool Health, >CCD,H,, provides support to
national, state, and local education agencies and other organi(ations with the
capacity to address adolescent health to assist them in identifying and preventing
HIV risk behaviors among youth.
>CCD,H,+ s Division of 9eproductive Health conducts epidemiologic, applied
behavioral, and operations research on the prevention of HIV in women at risk for
both HIV and unintended pregnancy.
The National Center for !nvironental Health* s Clinical Biocheistr$ Branch
operates a multicomponent /uality assurance program for laboratories testing dried blood
spots for HIV antibodies, provides method development and analytical services for the
measurement of (idovudine and other antiretroviral drugs in epidemiological studies, and
provides consultative services for emerging concerns in laboratory /uality assurance.
The National Center for Health Statistics collects HIV-AID$%related data in many of
its data systems, including HIV%related deaths from the >ational Vital $tatistics $ystem,
use of health services from the >ational Health Care $urveys, and data on HIV%related
knowledge and HIV testing behaviors from the >ational Health Interview $urvey and the
periodic >ational $urvey of 0amily ?rowth.
The National Instit"te for +cc"#ational Safet$ and Health* s HIV Activit$ focuses on
developing, implementing, and evaluating strategies for the prevention of occupational
transmission of HIV, with special emphasis on personal protective e/uipment,
engineering controls, and evaluation of organi(ational and behavioral factors that
influence prevention strategies.
The P"'lic Health Practice Progra +ffice strengthens the community practice of
HIV-AID$ prevention by developing and delivering training, improving the /uality of
clinical laboratory testing, developing computing and telecommunications tools, and
conducting research into effective public health practice.
!or "ore infor"ation###
CDC,IN-+.
*%!""%CDC%I>0B :)<)%=C<C;
DE *%!!!%)<)%C<=!
In 1nglish, en 1spaFol
)= Hours-Day
CDC's HIV/AIDS
Prevention Activities
As a part of its overall public health mission, CDC provides national leadership in
helping control the HIV epidemic by working with community, state, national, and
international partners in surveillance, research, prevention and evaluation activities.
hese activities are critically important, as CDC estimates that between !"",""" and
#"",""" Americans currently are living with HIV. Also, the number of people living with
AID$ is increasing, as effective new drug therapies are keeping HIV%infected persons
healthy longer and dramatically reducing the death rate.
What is CDC's HIV/AIDS prevention strategy?
CDC employs a comprehensive approach to preventing further spread of HIV and AID$.
$trategies include monitoring the epidemic to target prevention and care activities,
researching the effectiveness of prevention methods, funding local prevention efforts for
high%risk communities, and fostering linkages with care and treatment programs. CDC is
working in collaboration with many other governmental and nongovernmental partners at
all levels to implement, evaluate, and further develop and strengthen effective HIV
prevention efforts nationwide. CDC also is providing financial and technical support for
disease surveillance& HIV antibody counseling, testing, and referral services& partner
counseling and referral services& street and community outreach& risk%reduction
counseling& prevention case management& prevention and treatment of other se'ually
transmitted diseases that can increase risks for HIV transmission& public information and
education& school%based education on AID$& international research studies& technology
transfer systems& organi(ational capacity building& and program%relevant epidemiologic,
sociobehavioral, and evaluation research.
How are CDC funds distributed?
In fiscal year )""*, nearly !" percent of CDC+ s HIV prevention funds were distributed
e'ternally through cooperative agreements, grants, and contracts, primarily to state and
local agencies. he largest portion of CDC+ s HIV prevention resources is awarded to
state, local, and territorial health departments. $ome of these funds support more than )""
local and regional HIV ,revention Community ,lanning groups.
How are prevention activities organied?
The National Center for HIV, STD and TB Prevention
Division of HIV/AIDS Prevention
he Division of HIV-AID$ ,revention is the primary division charged with CDC.s HIV
mission of preventing HIV infection and reducing the incidence of HIV%related illness
and death, in collaboration with community, state, and national partners. Its nine branches
oversee a variety of activities in support of this mission.
The Behavioral Intervention Research Branch applies current theory, practice,
and empirical findings in designing and conducting research on state%of%the%art
interventions to prevent HIV infection. Characteristics of the research include the
use of formative studies to develop interventions, such as the e'amination of
psychosocial and cultural determinants of risk behaviors, the collection and
analysis of process and outcome data that includes both /ualitative and
/uantitative measures, and the use of rigorous study designs to e'amine
intervention effectiveness. 0urther, branch staff members assist in translating and
replicating research findings for use in HIV prevention programs.
The Prevention Progras Branch works with $tate and local public health
departments, nongovernmental national-regional and local partners, and others to
develop and implement programs, policies, and activities that mobili(e affiliates
and communities to become involved with and support local and statewide HIV
prevention programs and activities. It plans, implements, and manages strategies
and resources for HIV prevention in $tate and local health departments,
community%based organi(ations, and other nongovernmental organi(ations to
build comprehensive public health%private sector partnerships to prevent
HIV-AID$& provides technical consultation and program oversight to $tate and
local health departments, community planning groups, and nongovernmental
partners in operational aspects of HIV prevention& establishes guidelines and
policies for implementation and continuation of $tate and local HIV prevention
programs& and develops new operational programs and program announcements
for HIV prevention.
The Progra !val"ation Research Branch evaluates the processes, outcomes,
and impacts of CDC HIV prevention programs, activities, and policies for their
improvement and accountability& develops and enhances evaluation methods and
systems& and serves as a resource for building evaluation capacity.
The Technical Inforation and Co"nications Branch uses both electronic
media and printed materials to communicate scientific, statistical, programmatic,
and technical information on HIV-AID$ to health care professionals, public
health officials, prevention partners, federal government officials, and the general
public.
The Ca#acit$ B"ilding Branch assists providers in enhancing the capacity of
individuals, organi(ations, and communities to conduct more effective and
efficient HIV and AID$ prevention services.
The !#ideiolog$ Branch's mission is to conduct biomedical and behavioral
epidemiologic research to reduce HIV infection and disease progression.
Accordingly, scientists in the 1pidemiology 2ranch design and conduct studies in
the 3nited $tates and internationally to determine risk factors for HIV infection
and disease, and to evaluate innovative biomedical and behavioral interventions in
adults and children for preventing HIV infection and HIV%related disease. hese
studies are conducted by four research $ections including the HIV Vaccine
$ection, the 4other%Child ransmission 5 ,ediatric and Adolescent $tudies
$ection, the Clinical 1pidemiology $ection, and the $e'ual ransmission and
In6ection Drug 3se $tudies $ection. Domestically, the 1pidemiology 2ranch is
currently collaborating with partners in )7 states, and internationally is working
with partners in hailand, Cote d+Ivoire, 8enya, 2otswana, 3ganda, and 9ussia.
The Prevention Services Research Branch conducts research to develop and
improve HIV prevention strategies. his includes conducting studies :*; to
identify and evaluate specific at%risk populations, :); of the determinants of risk
for HIV infection in specific populations, :<; of HIV counseling and testing
activities, and :=; of HIV genotypic variations and antiretroviral drug resistance.
his branch also is responsible for collecting data on the e'tent of HIV prevalence
and incidence in the 3nited $tates, for assisting other Centers within CDC to
evaluate new HIV%related tests, and for maintaining a repository of stored sera and
cells for studies of HIV infection.
The Statistics and Data %anageent Branch provides statistical support,
software systems design, and data management support for HIV-AID$
surveillance, HIV serosurveys, epidemiologic studies, and other studies conducted
within the division& develops methods and coordinates efforts by statisticians to
estimate the incidence of HIV infection& participates in the design, data analysis,
and manuscript preparation for epidemiologic and behavioral studies and clinical
trials& and conducts data analyses re/uired by law for the allocation of HIV-AID$
prevention and treatment funds. he branch also provides national leadership in
the development of statistical and data management planning, policy,
implementation, and evaluation.
The S"rveillance Branch conducts a national program of surveillance and
research to monitor and characteri(e the HIV-AID$ epidemic, and its
determinants and impact, to guide public health action at federal, state, and local
levels. his includes surveillance of HIV infection and AID$ in collaboration with
$tate and local health departments to provide population%based data for research,
evaluation, and prevention at the >ational, $tate, and local levels. he branch
maintains, analy(es, and disseminates information from the national confidential
registry of HIV-AID$ cases& monitors HIV%related morbidity and mortality and
the use of ,H$ recommendations for prevention and treatment of HIV infection
and AID$& and conducts population%based surveillance of HIV%related risk
behaviors in collaboration with state and local health departments.
The National Center for HIV, STD and TB Prevention
&lo'al AIDS Progra
he ?lobal AID$ ,rogram :?A,; e'ists to help prevent HIV infection, improve care and
support and build capacity to address the global HIV-AID$ pandemic. ?A, provides
financial and technical assistance through partnerships with communities, governments,
and national and international entities working in resource%constrained countries.
What other CDC offices conduct HIV prevention activities?
Additional HIV prevention, education, and research programs are conducted in other
CDC centers, institutes, and offices.
The National Center for Infectio"s Diseases (NCID)
>CID+s Division of AID$, $D, and 2 @aboratory 9esearch provides laboratory
research on HIV and laboratory support for the surveillance, epidemiologic, and
clinical activities of >CH$,. It also conducts laboratory and epidemiologic
studies of HIV%infected and uninfected persons with hemophilia and assists in the
design, implementation, and evaluation of prevention and counseling programs
for them and their families.
he Division of Healthcare Auality ,romotion, also located in >CID, assists the
3.$. ,ublic Health $ervice, state and local health departments, hospitals, and
professional organi(ations worldwide in the prevention and control of
nosocomially ac/uired HIV infection.
The National Center for Chronic Disease Prevention and Health Prootion
(NCCDPHP)
he Division of Adolescent and $chool Health, >CCD,H,, provides support to
national, state, and local education agencies and other organi(ations with the
capacity to address adolescent health to assist them in identifying and preventing
HIV risk behaviors among youth.
>CCD,H,+ s Division of 9eproductive Health conducts epidemiologic, applied
behavioral, and operations research on the prevention of HIV in women at risk for
both HIV and unintended pregnancy.
The National Center for !nvironental Health* s Clinical Biocheistr$ Branch
operates a multicomponent /uality assurance program for laboratories testing dried blood
spots for HIV antibodies, provides method development and analytical services for the
measurement of (idovudine and other antiretroviral drugs in epidemiological studies, and
provides consultative services for emerging concerns in laboratory /uality assurance.
The National Center for Health Statistics collects HIV-AID$%related data in many of
its data systems, including HIV%related deaths from the >ational Vital $tatistics $ystem,
use of health services from the >ational Health Care $urveys, and data on HIV%related
knowledge and HIV testing behaviors from the >ational Health Interview $urvey and the
periodic >ational $urvey of 0amily ?rowth.
The National Instit"te for +cc"#ational Safet$ and Health* s HIV Activit$ focuses on
developing, implementing, and evaluating strategies for the prevention of occupational
transmission of HIV, with special emphasis on personal protective e/uipment,
engineering controls, and evaluation of organi(ational and behavioral factors that
influence prevention strategies.
The P"'lic Health Practice Progra +ffice strengthens the community practice of
HIV-AID$ prevention by developing and delivering training, improving the /uality of
clinical laboratory testing, developing computing and telecommunications tools, and
conducting research into effective public health practice.
!or "ore infor"ation###
CDC,IN-+.
*%!""%CDC%I>0B :)<)%=C<C;
DE *%!!!%)<)%C<=!
In 1nglish, en 1spaFol
)= Hours-Day
The Deadl$ Intersection
Bet/een TB and HIV
uberculosis :2; is a disease that is spread from person%to%person through the air, and it
is particularly dangerous for people infected with HIV. Gorldwide, 2 is the leading
cause of death among people infected with HIV.
An estimated *"%*7 million Americans are infected with 2 bacteria, with the potential to
develop active 2 disease in the future. About *" percent of these infected individuals
will develop 2 at some point in their lives. However, the risk of developing 2 disease
is much greater for those infected with HIV and living with AID$. 2ecause HIV infection
so severely weakens the immune system, people dually infected with HIV and 2 have a
*"" times greater risk of developing active 2 disease and becoming infectious
compared to people not infected with HIV. CDC estimates that *" to *7 percent of all 2
cases and nearly <" percent of cases among people ages )7 to == are occurring in HIV%
infected individuals.
his high level of risk underscores the critical need for targeted 2 screening and
preventive treatment programs for HIV%infected people and those at greatest risk for HIV
infection. All #eo#le infected /ith HIV sho"ld 'e tested for TB, and, if infected,
co#lete #reventive thera#$ as soon as #ossi'le to #revent TB disease0
Intersection of $wo %&oba& 'pide"ics
Appro'imately ) billion people :one%third of the world.s population; are infected
with Mycobacterium tuberculosis, the cause of 2.
2 is the cause of death for one out of every three people with AID$ worldwide.
he spread of the HIV epidemic has significantly impacted the 2 epidemic %
one%third of the increase in 2 cases over the last five years can be attributed to
the HIV epidemic :$ourceE 3>AID$;.
$he Continued $hreat of (u&tidrug)*esistant $+
1very nation must face the challenge of combating multidrug%resistant :4D9; 2.
,eople infected with HIV and living with AID$ are at greater risk for developing 4D9
2. 4D9 2 is e'tremely difficult to treat and can be fatal. Ghile the number of cases
has remained stable in the 3nited $tates over the past few years, people with 4D9 2
have now been reported from =< states and the District of Columbia.
o prevent the continued emergence of drug%resistant strains of 2, treatment for 2
must be improved in the 3nited $tates and across the globe. Inconsistent or partial
treatment is the main cause of 2 that is resistant to available drugs :4D9%2.; he
most effective strategy for ensuring completion of treatment is Directly Bbserved
herapy, and its use must be e'panded.
Another challenge that individuals co%infected with HIV and 2 face is the possible
complications that can occur when taking HIV treatment regimens along with drugs
commonly used to treat 2. ,hysicians prescribing these drugs must carefully consider
all potential interactions.
Addressing the Dangers of the Interconnected TB/HIV !#ideics Re1"ires
!2#anded !fforts
2 control is an e'ercise in vigilance& the goal of controlling and eventually eliminating
2 re/uires a targeted and continuous effort to address the prevention and treatment
needs for those most at risk, including HIV%infected individuals. 1fforts to eliminate 2
are therefore essential to reducing the global toll of HIV.
!or "ore infor"ation###
CDC,IN-+.
*%!""%CDC%I>0B :)<)%=C<C;
DE *%!!!%)<)%C<=!
In 1nglish, en 1spaFol
)= Hours-Day
CDC National Prevention Inforation Net/or3.
,.B. 2o' C""<
9ockville, 4aryland )"!=#%C""<
*%!""%=7!%7)<*
Internet Reso"rces.
>CH$,E httpE--www.cdc.gov-nchstp-od-nchstp.html
DHA,E httpE--www.cdc.gov-hiv
>,I>E httpE--www.cdcnpin.org
Division of 2 1liminationE httpE--www.cdc.gov-nchstp-tb
!rials o" #ail$ %ral !eno"ovir "or Preventing &'(
'n"ection
P)ase '' and ''' *linical !rials in +otswana, !)ailand and t)e -nited
States
:e7 approac+es to HIV prevention are urgently needed to stem t+e estimated five million ne7
HIV infections t+at occur 7orld7ide eac+ yearF H+ile 8e+avior c+ange programs +ave contri8uted
to dramatic reductions in t+e num8er of annual infections in t+e EF-F and many ot+er nations# far
too many individuals remain at +ig+ ris0F Hit+ an effective vaccine years a7ay# t+ere is mounting
evidence t+at antiretroviral drugs may 8e a8le to play animportant role in reducing HIV infectionF
$s part of its commitment to developing ne7 HIV prevention strategies# t+e Centers for 1isease
Control and Prevention (C1C2 is sponsoring t+ree clinical trials of t+e antiretroviral drug tenofovir
disoproxil fumarate (or 4tenofovir#5 8rand name 4VireadI52F
.+e trials are designed to ans7er important Auestions a8out t+e safety and efficacy of tenofovir
as a daily oral HIV preventative among t+ree populations at +ig+ ris0 for infection6 +eterosexuals
in Bots7ana# intravenous drug users in .+ailand and men 7+o +ave sex 7it+ men in t+e Enited
-tatesF .+e trials in Bots7ana and .+ailand are P+ase II9III safety and efficacy trials# 7+ile t+e
EF-F trial is a smaller# P+ase II extended safety trialF $ll t+ree sites 7ill also assess t+e effects of
ta0ing a daily pill on HIV ris0 8e+aviors# ad+erence to and accepta8ility of t+e regimen# and in
cases 7+ere participants 8ecome HIV infected# t+e resistance c+aracteristics of t+e acAuired
virusF .+is information 7ill 8e critical to guide future studies and HIV prevention programsF
-imilar HIV prevention trials of tenofovir are also 8eing planned or are under7ay among +ig+-ris0
populations in %+ana# &ala7i# and PeruF .+e studies in %+ana and &ala7i are 8eing conducted
8y researc+ers at *amily Healt+ International# 7it+ funding from t+e Bill and &elinda %ates
*oundationF .+e tenofovir trial in Peru 7ill 8e conducted 8y t+e :ational Institutes of Healt+F
Rationale "or !eno"ovir &'( Prevention !rials
/esearc+ers 8elieve t+at tenofovir# ta0en as a daily oral preventative# is one of t+e most important
ne7 prevention approac+es 8eing investigated todayF $n effective daily preventative could +elp
address t+e urgent need for female-controlled prevention met+ods and# 7+en com8ined 7it+
existing prevention measures# could +elp reduce ne7 HIV infections among men and 7omen at
+ig+ ris0F
.+e concept of providing a preventative treatment 8efore exposure to an infectious agent is not
ne7F *or example# 7+en individuals travel to an area 7+ere malaria is common# t+ey are advised
to ta0e medication to fig+t malaria 8efore and during travel to t+at regionF .+e medicine to prevent
illness is t+en already in t+eir 8loodstream if t+ey are exposed to t+e infectious agent t+at causes
malariaF
-everal sources of data suggest t+at t+e use of antiretroviral drugs in t+is manner may 8e
effective in reducing t+e ris0 of HIV infectionF .+eoretically# if HIV replication can 8e in+i8ited from
t+e very first moment t+e virus enters t+e 8ody# it may not 8e a8le to esta8lis+ a permanent
infectionF Providing antiretrovirals ($/Vs2 to HIV-infected 7omen during la8or and delivery and to
t+eir ne78orns immediately follo7ing 8irt+ +as 8een s+o7n to reduce t+e ris0 of mot+er-to-c+ild
transmission 8y a8out @!BF $dditionally# in o8servational studies# $/V regimens +ave 8een
associated 7it+ an =!B reduction in t+e ris0 of HIV infection among +ealt+ care 7or0ers follo7ing
needle stic0s and ot+er accidental exposures# 7+en treatment is initiated promptly and continued
for several 7ee0sF *inally# animal studies +ave s+o7n t+at tenofovir can prevent t+e transmission
of a virus similar to HIV in mon0eys 7+en given 8efore and immediately after a single retroviral
exposureF .+ese data# com8ined 7it+ its favora8le resistance and safety profile as an HIV
treatment# ma0e tenofovir an ideal candidate for HIV prevention trialsF
!eno"ovir *)aracteristics
Gsta8lis+ed safety as HIV
treatment
Potent antiretroviral
?ong duration of action

Once-daily dosing
?o7 level of resistance
.enofovir 7as approved 8y t+e EF-F *ood and 1rug $dministration in (!!" as a treatment for HIV
infection and +as 8een used 8y more t+an "@!#!!! people 7it+ HIV around t+e 7orldF $s a
treatment for HIV-infected individuals# tenofovir +as 8een s+o7n to 8e 8ot+ safe and effectiveF It
+as a relatively lo7 level of side effects and a slo7 development of associated drug resistance#
compared 7it+ ot+er availa8le HIV treatmentsF .+e most common side effects include nausea#
vomiting and loss of appetiteF Because it is ta0en orally only once a day# 7it+ or 7it+out food# it is
also one of t+e most convenient-to-use HIV drugs availa8le todayF .+ese trials are designed to
evaluate tenofovir3s safety and efficacy among uninfected individualsF -ide effects may differ in
HIV-negative populations# and it is not yet 0no7n if tenofovir can prevent HIV infection in +umansF
Speci"ic !rial #esigns and %./ectives
$ll t+ree of C1C3s studies are randomized# dou8le-8lind# place8o-controlled trialsF In eac+ trial# all
participants 7ill receive ris0-reduction counseling and ot+er prevention servicesF In addition# +alf
of t+e participants 7ill 8e randomly assigned to ta0e one ,!! mg tenofovir pill daily# and t+e ot+er
+alf 7ill 8e randomly assigned to ta0e one daily place8o pill (a similar ta8let 7it+out active
medication2F :eit+er researc+ers nor participants 7ill 0no7 an individual3s group assignmentF In
all# t+e studies 7ill involve ,#(!! volunteersF .+e studies are sc+eduled to 8egin in early (!!@ and
are expected to last 8et7een ( and ; yearsF
.o ensure t+at t+e studies remain on a solid scientific and et+ical foundation# all study procedures
and plans are revie7ed and approved 8y scientific and et+ical revie7 committees at C1C (called
institutional revie7 8oards# or I/Bs2# as 7ell as I/Bs esta8lis+ed 8y eac+ +ost country and
researc+ site prior to trial launc+F $dditionally# data on safety# enrollment# and efficacy 7ill 8e
revie7ed at standard intervals 8y an independent data safety and monitoring 8oard (1-&B2 for
t+e Bots7ana and .+ai trials# and 8y an independent safety revie7 committee for t+e EF-F trial# to
ensure t+at t+e researc+ is safe to continueF 1uring t+e P+ase III components# t+e 1-&B 7ill also
determine at 7+at point t+e results are conclusiveF If scientific Auestions arise during t+e course
of t+e researc+# t+ese committees 7ill meet more freAuentlyF
+otswana and !)ailand
.+e trials in Bots7ana and .+ailand are P+ase II9III safety and efficacy trialsF .+is means t+at
eac+ trial 7ill 8egin 8y examining safety alone (P+ase II2 among local HIV-uninfected participantsF
$fter participants +ave completed a pre-determined amount of follo7-up ((!! patient-years of
o8servation2# data 7ill 8e assessed 8y t+e 1-&BF If t+e 1-&B determines t+at t+e once-daily
regimen is safe for participants# t+e trials 7ill 8e expanded to assess efficacy (P+ase III2 in
addition to continued safety monitoringF
+otswana J .+e Bots7ana study is 8eing conducted in colla8oration 7it+ t+e Bots7ana
government and 7ill enroll "#(!! HIV-negative +eterosexual men and 7omen# ages "= to
(# in t+e nation3s t7o largest cities# %a8arone and *rancisto7nF Participants 7ill 8e
recruited t+roug+ a num8er of venues# including HIV voluntary counseling and testing
centers# sexually transmitted disease (-.12 and family planning clinics# yout+
organizations# and community eventsF
!)ailand J .+e .+ailand study is 8eing conducted in colla8oration 7it+ t+e Bang0o0
&etropolitan $dministration and t+e .+ailand &inistry of Pu8lic Healt+ and 7ill enroll
"#)!! HIV-negative intravenous drug users (I1Es2 at "> drug-treatment clinics in
Bang0o0F Participants 7ill 8e recruited at t+e drug treatment clinics and t+roug+ a peer
referral programF
!)e -nited States
.+e EF-F trial is a P+ase II trial designed to assess t+e clinical and 8e+avioral safety of once-daily
tenofovir among HIV-negative men 7+o +ave sex 7it+ men (&-&2F Gfficacy 7ill not 8e examined
in t+is study as a muc+ larger sample 7ould 8e reAuired to determine efficacy in t+is populationF
*ollo7ing completion of t+e safety component# data from t+is study 7ill assist in t+e design of
future studies among &-&# and 7ill provide critical information to guide t+e development of
guidelines for use# s+ould efficacy 8e demonstrated in ot+er populationsF
Enited -tates J .+e EF-F study is 8eing conducted at t7o sites in colla8oration 7it+ t+e
-an *rancisco 1epartment of Pu8lic Healt+ and t+e $I1- /esearc+ Consortium of
$tlantaF .+e study 7ill enroll ;!! HIV-negative &-& 7+o report +aving +ad anal
intercourse in t+e past "( mont+sF Participants 7ill 8e randomly assigned to one of four
study armsF .7o arms 7ill receive eit+er tenofovir or place8o immediately# 7+ile t+e ot+er
t7o arms 7ill receive eit+er tenofovir or place8o after nine mont+s of enrollmentF .+is
design 7ill allo7 researc+ers to compare ris0 8e+aviors among t+ose ta0ing a daily pill
and t+ose not ta0ing pillsF
0ducation and 0nrollment o" !rial Participants
Enderstanding t+e potential impact of a daily drug regimen on HIV ris0 8e+aviors 7ill 8e critical#
s+ould tenofovir prove effective in reducing HIV transmissionF One of t+e greatest ris0s# as efforts
progress to identify ne7 8iomedical approac+es# is t+at individuals at ris0 7ill reduce t+eir use of
proven HIV prevention strategiesF It 7ill t+erefore 8e crucial to reinforce proven 8e+avioral
prevention strategies# 8ot+ 7it+in and 8eyond t+ese trialsF $ll t+ree trials 7ill ta0e multiple steps to
address t+is issue during t+e education and enrollment of trial participants and t+roug+ ongoing
participant counselingF
*irst# it is critical to ensure t+at participants understand t+at trial participation may not protect
t+em from HIV infectionJeit+er 8ecause t+ey may receive a place8o or 8ecause t+ey may
receive tenofovir# t+e efficacy of 7+ic+ remains unprovenF .+is and ot+er 0ey aspects of t+e trial#
including t+e potential ris0s and 8enefits of participation# are explained to potential volunteers in
dept+ in t+e language of t+eir c+oice# prior to t+eir enrollmentF .o ensure participants fully
understand all aspects of t+eir participation# all volunteers 7ill 8e reAuired to pass a
compre+ension test prior to providing 7ritten informed consentF -tudy participants are also free to
7it+dra7 from t+e trial at any time and for any reasonF
Risk1Reduction *ounseling and %t)er Prevention and !reatment
Services
.o assist participants in eliminating or reducing HIV ris0 8e+aviors# extensive counseling 7ill 8e
provided at eac+ study visit# and more often if neededF .+e interactive counseling to 8e provided
+as proven effective in reducing t+e ris0 of HIV and ot+er -.1s in multiple populations# including
past participants of similar HIV prevention trialsF Participants 7ill also 8e offered free condoms
and -.1 testing and treatment to reduce t+eir ris0 for HIV infectionF $dditionally# in .+ailand#
participanting iI1Es 7ill 8e offered follo7-up in a met+adone drug treatment program and receive
8leac+ and instructions on +o7 to use it to clean needlesF Consistent 7it+ .+ai government policy#
sterile syringes 7ill not 8e provided# 8ut are 7idely availa8le in .+ailand 7it+out a prescription
and at lo7 cost (one sterile syringe and one needle cost a8out @ 8a+t# or a8out D!F"(2F
H+ile participants 7ill li0ely 8e at lo7er ris0 as a result of t+ese prevention services# some
individuals 7ill engage in 8e+avior t+at places t+em at ris0 for HIV infectionF .o ensure t+at
participants 7+o are infected during t+e trial are Auic0ly referred to t+e 8est availa8le medical and
psyc+osocial services# participants 7ill receive free rapid HIV testing at every visitF .+is regular
HIV testing 7ill also +elp guard against t+e development of drug-resistant virus# as tenofovir 7ill
8e immediately discontinued 7+en infection is detectedF
Participants 7+o 8ecome infected 7ill receive confirmatory testing for infection# post-test ris0-
reduction and support counseling# and +elp enrolling in local HIV care programsF Bot+ .+ailand
and Bots7ana +ave antiretroviral treatment and HIV care programs in place at minimal or no cost
to patientsF In t+e Enited -tates# participants 7ill 8e referred to local +ealt+ care providers or
pu8lic programs for needed medical and social servicesF
.o +elp guide treatment decisions and to determine if prior exposure to tenofovir +as any effect
on t+e course of disease# participants 7ill 8e follo7ed for an additional "( mont+s follo7ing
infection# and testing 7ill 8e provided for viral load# C1; count# and HIV resistance mutationsF
Because resistance to tenofovir is relatively uncommon among HIV-infected individuals using t+e
drug for treatment# researc+ers 8elieve t+at t+e pro8a8ility of participants eit+er 8ecoming
infected 7it+# or developing# drug-resistant virus during t+e trial 7ill 8e lo7F Ho7ever# resistance
testing 7ill provide important data on t+e degree to 7+ic+ any resistance occursF
Monitoring "or Side 0""ects
.+e +ealt+ of participants 7ill 8e closely monitored t+roug+out t+e trial# and participants 7ill 8e
lin0ed to any necessary medical care as neededF In addition to sc+eduled revie7s of safety data
8y t+e 1-&B# 8ot+ clinical and 8e+avioral safety 7ill 8e closely monitored on an ongoing 8asisF
$lt+oug+ tenofovir +as an excellent safety profile# potential medical ris0s include minor side
effects suc+ as nausea# ras+ and gastrointestinal effects# as 7ell as t+e potential for rare 8ut
more serious effects# suc+ as damage to 0idney function or reductions in 8one densityF Careful
monitoring 7ill 8e provided using la8oratory testing for any 8iological a8normalities (suc+ as
elevated creatinine or decreased p+osp+orus2# so t+at tenofovir can 8e promptly discontinued if
serious concerns are identifiedF C1C 7ill 7or0 7it+ partners in eac+ community to ensure t+at
care is provided if tenofovir results in any +ealt+ pro8lems during t+e trialF
*ommunit$ 'nvolvement
C1C +as and 7ill continue to 7or0 closely 7it+ community partners at eac+ researc+ site to
ensure active community participation during t+e planning and implementation of t+ese trialsF
+otswana J In Bots7ana# community advisory 8oards +ave 8een esta8lis+ed at eac+
site# 7+ic+ include representatives from local governments (elected and traditional2# as
7ell as community mem8ers and representatives from 0ey sta0e+older organizationsF
.+ese groups 7ill provide input to researc+ers t+roug+out t+e trialF Participant advisory
8oards 7ill also 8e set up 7+en t+e trial 8eginsF
!)ailand J In .+ailand# a community relations clu8# made up of intravenous drug users#
t+eir family mem8ers# and representatives of local community organizations# meets
regularly and provides advice to study staff on all aspects of study design and
implementationF
-nited States J In t+e Enited -tates# 8ot+ sites +ave esta8lis+ed active community
advisory 8oards t+at are consulted regularly a8out study procedures and educational
materials for potential participantsF &em8ers of t+ese 8oards 7ill provide ongoing advice
t+roug+out t+e trialsF
In addition to t+e regular input received 8y t+ese esta8lis+ed committees# 8roader outreac+ and
consultations 7it+ advocates and community-8ased organizations representing populations at
ris0 for HIV are 8eing +eld# as needed# to address current and future plans for HIV prevention
researc+ and programsF
2e3t Steps in &'( Prevention
$s 7e move for7ard 7it+ our searc+ for ne7 HIV prevention strategies# it 7ill 8e critical to
determine +o7 t+ese approac+es can 8est 8e integrated into existing programs# s+ould t+ey
prove effective in reducing ris0F Because no strategy 7ill 8e "!!B effective in preventing HIV
infection# future impact 7ill ultimately 8e determined 8y +o7 effectively strategies are used in
com8ination to provide t+e greatest protection to individuals at ris0F C1C# in colla8oration 7it+ t+e
Horld Healt+ Organization# t+e :ational Institutes of Healt+# ot+er researc+ organizations# and
community sta0e+olders 7orld7ide# is developing plans to Auic0ly respond to emerging data from
t+ese and ot+er HIV prevention trialsF .+ese colla8orations 7ill +elp guide t+e development of
future policies and programs t+at can most effectively reduce t+e toll of HIV and $I1-F
Reducing HIV Transmission From Mother-to-Child: An Opt-Out
Approach to HIV Screening
The chance that HIV infection is transmitted from a mother who is HIV infected to her child during
pregnancy can be reduced to 2 percent or less (fewer than 2 out of every 100). This is possible
because of better medicines available to treat HIV. But frst, the pregnant woman and her doctor
must know if she is infected with HIV.
What do we know?
New information gathered shows that a number of women across the United States are
not getting tested for HIV during pregnancy.
Studies show that more women are tested when the HIV test is included in the standard
group of tests that all pregnant women receive routinely.
Since 1995, CDC has recommended all pregnant women be tested for HIV and, if found
to be infected, ofered treatment for themselves to improve their health and to prevent
passing the virus to their infant.
4)at !esting Approac)es Are Availa.le5
In t+e :ovem8er "@# (!!(# Morbidity and Mortality Weekly Report (MMWR)# C1C pu8lis+ed
information on recent prenatal HIV testing rates in t+e Enited -tates and CanadaF .+e report
loo0ed at HIV prenatal testing rates 7+en different testing approac+es 7ere usedF .+ere are t7o
7ays to do voluntary HIV testing6
%pt1in6
Pregnant 7omen are given pre-HIV test counselingF
.+ey must agree to getting an HIV test# usually in 7ritingF
%pt1out6
Pregnant 7omen are told t+at an HIV test 7ill 8e included in t+e standard group
of prenatal tests (t+at is to say# tests given to all pregnant 7omen2# and t+at t+ey
may decline t+e testF
Enless t+ey decline# t+ey 7ill receive an HIV testF
-tatistics pu8lis+ed in t+e MMWR s+o7ed t+at in eig+t states using t+e opt-in approac+ in "=-
"# testing rates ranged from (@B to )BF In .ennessee# 7+ic+ uses an opt-out approac+# t+e
testing rate 7as =@BF .+is and ot+er information on prenatal HIV testing suggests t+at# of t+e
voluntary approac+es to prenatal HIV testing# more 7omen are tested 7it+ t+e opt-out approac+F
4)ic) Approac) #oes *#* Recommend5
C1C recommends t+e opt-out approac+# 7+ic+ 7ould ma0e t+e HIV test a part of t+e group of
tests t+at all pregnant 7omen receive routinelyF -tudies s+o7 t+at t+e opt-out approac+ can
Increase testing rates among pregnant 7omen
Increase t+e num8er of HIV-infected 7omen 7+o are offered treatment# and
/educe HIV transmission to t+eir 8a8ies during 8irt+F
&ow is %pt1%ut 'mplemented in t)e &ealt) *are Setting5
Opt-Out +as t+ree steps for +ealt+ care providers to follo7 to put t+is approac+ into practice (C1C
recommends all t+ree steps26
.ell all pregnant 7omen t+at an HIV test 7ill 8e performed as part of t+e standard group
of tests for pregnant 7omenF
.ell t+em t+at t+ey may decline t+is testF
%ive t+em information a8out +o7 to prevent HIV transmission during pregnancy and
a8out treatment for pregnant 7omen 7+o are HIV positiveF
.+e opt-out approac+ offers t+e 8est c+ance t+at pregnant 7omen 7ill routinely 8e tested for HIV
during pregnancy and# if needed# during la8or and deliveryF If a 7oman is HIV positive# 0no7ing
+er HIV status 7ill reduce t+e c+ance t+at s+e 7ill pass t+e virus to +er c+ildF /educing t+e
transmission of HIV from mot+er to c+ild is a success story# 8ut preventing it entirely +as not yet
8een ac+ievedF Implementation of t+e opt-out approac+ is a step to reac+ing t+is goalF

Additional 'n"ormation
*or more detailed information on t+e /evised /ecommendations for HIV
-creening of Pregnant Homen# please refer to t+e Morbidity and Mortality
Weekly Report (MMWR) of :ovem8er # (!!"# at
+ttp699777FcdcFgov9mm7r9previe79mm7r+tml9rr@!"a(F+tm# or reAuest a
copy from t+e :ational Prevention Information :et7or0 at (=!!2 ;@=-@(,"F

For more in"ormation6
*#*7s 2ational Prevention 'n"ormation 2etwork
1180014981921 or www:cdcnpin:org
*#*1'2F%
118001*#*1'2F% ;221466<
!!=6 118881221648
'n 0nglis), en 0spa>ol
24 &ours?#a$
*act -+eet for Pu8lic Healt+ Personnel6
Male @ate3 *ondoms
and Se3uall$ !ransmitted #iseases
In Cune (!!!# t+e :ational Institutes of Healt+ (:IH2# in colla8oration 7it+ t+e
Centers for 1isease Control and Prevention (C1C2# t+e *ood and 1rug
$dministration (*1$2# and t+e Enited -tates $gency for International
1evelopment (E-$I12# convened a 7or0s+op to evaluate t+e pu8lis+ed evidence
esta8lis+ing t+e effectiveness of latex male condoms in preventing -.1s#
including HIVF $ summary report from t+at 7or0s+op 7as completed in Culy (!!"
(+ttp699777FniaidFni+Fgov9 dmid9stds9condomreportFpdf2F .+is fact s+eet is 8ased
on t+e :IH 7or0s+op report and additional studies t+at 7ere not revie7ed in t+at
report or 7ere pu8lis+ed su8seAuent to t+e 7or0s+op (see 4Condom
Gffectiveness5 for additional references2F &ost epidemiologic studies comparing
rates of -.1 transmission 8et7een condom users and non-users focus on
penile-vaginal intercourseF
/ecommendations concerning t+e male latex condom and t+e prevention of
sexually transmitted diseases (-.1s2# including +uman immunodeficiency virus
(HIV2# are 8ased on information a8out +o7 different -.1s are transmitted# t+e
p+ysical properties of condoms# t+e anatomic coverage or protection t+at
condoms provide# and epidemiologic studies of condom use and -.1 ris0F
!)e surest wa$ to avoid transmission o" se3uall$ transmitted diseases is to
a.stain "rom se3ual intercourse, or to .e in a long1term mutuall$
monogamous relations)ip wit) a partner w)o )as .een tested and $ou
know is unin"ected:
For persons w)ose se3ual .e)aviors place t)em at risk "or S!#s, correct
and consistent use o" t)e male late3 condom can reduce t)e risk o" S!#
transmission: &owever, no protective met)od is 100 percent e""ective, and
condom use cannot guarantee a.solute protection against an$ S!#:
Furt)ermore, condoms lu.ricated wit) spermicides are no more e""ective
t)an ot)er lu.ricated condoms in protecting against t)e transmission o"
&'( and ot)er S!#s: 'n order to ac)ieve t)e protective e""ect o" condoms,
t)e$ must .e used correctl$ and consistentl$: 'ncorrect use can lead to
condom slippage or .reakage, t)us diminis)ing t)eir protective e""ect:
'nconsistent use, e:g:, "ailure to use condoms wit) ever$ act o" intercourse,
can lead to S!# transmission .ecause transmission can occur wit) a
single act o" intercourse:
4)ile condom use )as .een associated wit) a lower risk o" cervical cancer,
t)e use o" condoms s)ould not .e a su.stitute "or routine screening wit)
Pap smears to detect and prevent cervical cancer:
Sexually Transmitted Diseases, Including HI
Sexually transmitted diseases, including HIV
!atex condoms, "#en used consistently and correctly, are #ig#ly e$$ecti%e in
pre%enting transmission o$ HI, t#e %irus t#at causes &IDS' In addition, correct
and consistent use o$ latex condoms can reduce t#e risk o$ ot#er sexually
transmitted diseases (STDs), including disc#arge and genital ulcer diseases'
W#ile t#e e$$ect o$ condoms in pre%enting #uman papilloma%irus (H() in$ection
is unkno"n, condom use #as been associated "it# a lo"er rate o$ cer%ical
cancer, an H()associated disease'
.+ere are t7o primary 7ays t+at -.1s can 8e transmittedF Human
immunodeficiency virus (HIV2# as 7ell as gonorr+ea# c+lamydia# and
tric+omoniasis K t+e disc+arge diseases K are transmitted 7+en infected semen
or vaginal fluids contact mucosal surfaces (eFgF# t+e male uret+ra# t+e vagina or
cervix2F In contrast# genital ulcer diseases K genital +erpes# syp+ilis# and
c+ancroid K and +uman papillomavirus are primarily transmitted t+roug+ contact
7it+ infected s0in or mucosal surfacesF
@a.orator$ studies +ave demonstrated t+at latex condoms provide an
essentially impermea8le 8arrier to particles t+e size of -.1 pat+ogensF
!)eoretical .asis "or protection: Condoms can 8e expected to provide different
levels of protection for various sexually transmitted diseases# depending on
differences in +o7 t+e diseases are transmittedF Because condoms 8loc0 t+e
disc+arge of semen or protect t+e male uret+ra against exposure to vaginal
secretions# a greater level of protection is provided for t+e disc+arge diseasesF $
lesser degree of protection is provided for t+e genital ulcer diseases or HPV
8ecause t+ese infections may 8e transmitted 8y exposure to areas# eFgF# infected
s0in or mucosal surfaces# t+at are not covered or protected 8y t+e condomF
0pidemiologic studies see0 to measure t+e protective effect of condoms 8y
comparing rates of -.1s 8et7een condom users and nonusers in real-life
settingsF 1eveloping suc+ measures of condom effectiveness is c+allengingF
Because t+ese studies involve private 8e+aviors t+at investigators cannot
o8serve directly# it is difficult to determine accurately 7+et+er an individual is a
condom user or 7+et+er condoms are used consistently and correctlyF ?i0e7ise#
it can 8e difficult to determine t+e level of exposure to -.1s among study
participantsF .+ese pro8lems are often compounded in studies t+at employ a
4retrospective5 design# eFgF# studies t+at measure 8e+aviors and ris0s in t+e pastF
$s a result# o8served measures of condom effectiveness may 8e inaccurateF
&ost epidemiologic studies of -.1s# ot+er t+an HIV# are c+aracterized 8y t+ese
met+odological limitations# and t+us# t+e results across t+em vary 7idely--ranging
from demonstrating no protection to demonstrating su8stantial protection
associated 7it+ condom useF .+is inconclusiveness of epidemiologic data a8out
condom effectiveness indicates t+at more researc+ is needed--not t+at latex
condoms do not 7or0F *or HIV infection# unli0e ot+er -.1s# a num8er of carefully
conducted studies# employing more rigorous met+ods and measures# +ave
demonstrated t+at consistent condom use is a +ig+ly effective means of
preventing HIV transmissionF
$not+er type of epidemiologic study involves examination of -.1 rates in
populations rat+er t+an individualsF -uc+ studies +ave demonstrated t+at 7+en
condom use increases 7it+in population groups# rates of -.1s decline in t+ese
groupsF Ot+er studies +ave examined t+e relations+ip 8et7een condom use and
t+e complications of sexually transmitted infectionsF *or example# condom use
+as 8een associated 7it+ a decreased ris0 of cervical cancer K an HPV
associated diseaseF
.+e follo7ing includes specific information for HIV# disc+arge diseases# genital
ulcer diseases and +uman papillomavirus# including information on la8oratory
studies# t+e t+eoretical 8asis for protection and epidemiologic studiesF
HI * &IDS
HIV, the virus that causes AIDS
!atex condoms, "#en used consistently and correctly, are #ig#ly e$$ecti%e in
pre%enting t#e sexual transmission o$ HI, t#e %irus t#at causes &IDS'
$I1- is# 8y far# t+e most deadly sexually transmitted disease# and considera8ly
more scientific evidence exists regarding condom effectiveness for prevention of
HIV infection t+an for ot+er -.1sF .+e 8ody of researc+ on t+e effectiveness of
latex condoms in preventing sexual transmission of HIV is 8ot+ compre+ensive
and conclusiveF In fact# t+e a8ility of latex condoms to prevent transmission of
HIV +as 8een scientifically esta8lis+ed in 4real-life5 studies of sexually active
couples as 7ell as in la8oratory studiesF
@a.orator$ studies +ave demonstrated t+at latex condoms provide an
essentially impermea8le 8arrier to particles t+e size of -.1 pat+ogensF
!)eoretical .asis "or protection: ?atex condoms cover t+e penis and provide
an effective 8arrier to exposure to secretions suc+ as semen and vaginal fluids#
8loc0ing t+e pat+7ay of sexual transmission of HIV infectionF
0pidemiologic studies t+at are conducted in real-life settings# 7+ere one
partner is infected 7it+ HIV and t+e ot+er partner is not# demonstrate
conclusively t+at t+e consistent use of latex condoms provides a +ig+ degree of
protectionF
Disc#arge Diseases, Including
+onorr#ea, ,#lamydia, and Tric#omoniasis
Discharge diseases, other than HIV
!atex condoms, "#en used consistently and correctly, can reduce t#e risk o$
transmission o$ gonorr#ea, c#lamydia, and tric#omoniasis'
%onorr+ea# c+lamydia# and tric+omoniasis are termed disc+arge diseases
8ecause t+ey are sexually transmitted 8y genital secretions# suc+ as semen or
vaginal fluidsF HIV is also transmitted 8y genital secretionsF
@a.orator$ studies +ave demonstrated t+at latex condoms provide an
essentially impermea8le 8arrier to particles t+e size of -.1 pat+ogensF
!)eoretical .asis "or protection: .+e p+ysical properties of latex condoms
protect against disc+arge diseases suc+ as gonorr+ea# c+lamydia# and
tric+omoniasis# 8y providing a 8arrier to t+e genital secretions t+at transmit -.1-
causing organismsF
0pidemiologic studies t+at compare infection rates among condom users and
nonusers provide evidence t+at latex condoms can protect against t+e
transmission of c+lamydia# gonorr+ea and tric+omoniasisF Ho7ever# some ot+er
epidemiologic studies s+o7 little or no protection against t+ese infectionsF &any
of t+e availa8le epidemiologic studies 7ere not designed or conducted in 7ays
t+at allo7 for accurate measurement of condom effectiveness against t+e
disc+arge diseasesF &ore researc+ is needed to assess t+e degree of protection
latex condoms provide for disc+arge diseases# ot+er t+an HIVF
+enital -lcer Diseases and Human (apilloma%irus
Genital ulcer diseases and HPV infections
+enital ulcer diseases and H( in$ections can occur in bot# male or $emale
genital areas t#at are co%ered or protected by a latex condom, as "ell as in
areas t#at are not co%ered' ,orrect and consistent use o$ latex condoms can
reduce t#e risk o$ genital #erpes, syp#ilis, and c#ancroid only "#en t#e in$ected
area or site o$ potential exposure is protected' W#ile t#e e$$ect o$ condoms in
pre%enting #uman papilloma%irus in$ection is unkno"n, condom use #as been
associated "it# a lo"er rate o$ cer%ical cancer, an H()associated disease'
%enital ulcer diseases include genital +erpes# syp+ilis# and c+ancroidF .+ese
diseases are transmitted primarily t+roug+ 4s0in-to-s0in5 contact from
sores9ulcers or infected s0in t+at loo0s normalF HPV infections are transmitted
t+roug+ contact 7it+ infected genital s0in or mucosal surfaces9fluidsF %enital
ulcer diseases and HPV infection can occur in male or female genital areas t+at
are# or are not# covered (protected 8y t+e condom2F
@a.orator$ studies +ave demonstrated t+at latex condoms provide an
essentially impermea8le 8arrier to particles t+e size of -.1 pat+ogensF
!)eoretical .asis "or protection: Protection against genital ulcer diseases and
HPV depends on t+e site of t+e sore9ulcer or infectionF ?atex condoms can only
protect against transmission 7+en t+e ulcers or infections are in genital areas
t+at are covered or protected 8y t+e condomF .+us# consistent and correct use of
latex condoms 7ould 8e expected to protect against transmission of genital ulcer
diseases and HPV in some# 8ut not all# instancesF
0pidemiologic studies t+at compare infection rates among condom users and
nonusers provide evidence t+at latex condoms can protect against t+e
transmission of syp+ilis and genital +erpesF Ho7ever# some ot+er epidemiologic
studies s+o7 little or no protectionF &any of t+e availa8le epidemiologic studies
7ere not designed or conducted in 7ays t+at allo7 for accurate measurement of
condom effectiveness against t+e genital ulcer diseasesF :o conclusive studies
+ave specifically addressed t+e transmission of c+ancroid and condom use#
alt+oug+ several studies +ave documented a reduced ris0 of genital ulcers in
settings 7+ere c+ancroid is a leading cause of genital ulcersF &ore researc+ is
needed to assess t+e degree of protection latex condoms provide for t+e genital
ulcer diseasesF
H+ile some epidemiologic studies +ave demonstrated lo7er rates of HPV
infection among condom users# most +ave notF It is particularly difficult to study
t+e relations+ip 8et7een condom use and HPV infection 8ecause HPV infection
is often intermittently detecta8le and 8ecause it is difficult to assess t+e
freAuency of eit+er existing or ne7 infectionsF &any of t+e availa8le
epidemiologic studies 7ere not designed or conducted in 7ays t+at allo7 for
accurate measurement of condom effectiveness against HPV infectionF
$ num8er of studies# +o7ever# do s+o7 an association 8et7een condom use and
a reduced ris0 of HPV-associated diseases# including genital 7arts# cervical
dysplasia and cervical cancerF .+e reason for lo7er rates of cervical cancer
among condom users o8served in some studies is un0no7nF HPV infection is
8elieved to 8e reAuired# 8ut not 8y itself sufficient# for cervical cancer to occurF
Co-infections 7it+ ot+er -.1s may 8e a factor in increasing t+e li0eli+ood t+at
HPV infection 7ill lead to cervical cancerF &ore researc+ is needed to assess t+e
degree of protection latex condoms provide for 8ot+ HPV infection and HPV-
associated disease# suc+ as cervical cancerF
Preventing +cc"#ational
HIV Transission to
Healthcare Personnel
As of December )""*, occupational e'posure to HIV has resulted in 7H documented
cases of HIV seroconversion among healthcare personnel :HC,; in the 3nited $tates. o
prevent transmission of HIV to healthcare personnel in the workplace, the Centers for
Disease Control and ,revention :CDC; offers the following recommendations.
,reventive Strategies
Healthcare personnel should assume that the blood and other body fluids from all patients
are potentially infectious. hey should therefore follow infection control precautions at
all times.
hese precautions includeE
the routine use of barriers :such as gloves and-or goggles; when anticipating
contact with blood or body fluids
washing hands and other skin surfaces immediately after contact with blood or
body fluids, and
the careful handling and disposing of sharp instruments during and after use.
$afety devices have been developed to help prevent needle%stick in6uries. If used
properly, these types of devices may reduce the risk of e'posure to HIV. 4any
percutaneous in6uries are related to sharps disposal. $trategies for safer disposal,
including safer design of disposal containers and placement of containers, are being
developed.
Although the most important strategy for reducing the risk of occupational HIV
transmission is to prevent occupational e'posures, plans for poste'posure management of
health care personnel should be in place. CDC has issued guidelines for the management
of HC, e'posures to HIV and recommendations for poste'posure prophyla'is
:,1,;E Updated U.S. Public Health Service Guidelines for the Management of
Occupational Exposures to H!" H#!" and H$! and %ecommendations for Postexposure
Prophylaxis :Iune )#, )""*;.
hese guidelines outline a number of considerations in determining whether or not
healthcare personnel should receive ,1, and in choosing the type of ,1, regimen. 0or
most HIV e'posures that warrant ,1,, a basic =%week, two%drug :there are several
options; regimen is recommended. 0or HIV e'posures that pose an increased risk of
transmission :based on the infection status of the source and the type of e'posure;, a
three%drug regimen may be recommended. $pecial circumstances such as a delayed
e'posure report, unknown source person, pregnancy in the e'posed person, resistance of
the source virus to antiviral agents, and to'icity of ,1, regimens are also discussed in the
guidelines. Bccupational e'posures should be considered urgent medical concerns.
B"ilding Better Prevention Progras for Healthcare Personnel
Continued work in the following areas is needed to reduce the risk of occupational HIV
transmission to healthcare personnelE
Adinistrative efforts0 All healthcare organi(ations should train HC, in infection
control procedures and on the importance of reporting occupational e'posures. hey
should develop a system to monitor reporting and management of occupational
e'posures.
Develo# and #roote the "se of safet$ devices0 1ffective and competitively priced
devices engineered to prevent sharps in6uries are needed for HC, who fre/uently come
into contact with potentially HIV%infected blood and other body fluids. ,roper and
consistent use of such safety devices should be evaluated.
%onitor the effects of P!P0 4ore data are needed on the safety and acceptability of
different regimens of ,1,, particularly those regimens that include new antiretroviral
agents. 0urthermore, improved communication prior to treatment about possible side
effects and close follow%up of HC, receiving treatment are needed to increase
compliance with the ,1,.
!or "ore infor"ation###
CDC,IN-+.
*%!""%CDC%I>0B :)<)%=C<C;
DE *%!!!%)<)%C<=!
In 1nglish, en 1spaFol
)= Hours-Day
CDC National Prevention Inforation Net/or3.
,.B. 2o' C""<
9ockville, 4aryland )"!=#%C""<
*%!""%=7!%7)<*
Internet Reso"rces.
&"idelines.
3pdated 3.$. ,ublic Health $ervice ?uidelines for the 4anagement of Bccupational
1'posures to H2V, HCV, and HIV and 9ecommendations for ,oste'posure ,rophyla'is
National Center for HIV, STD, and TB Prevention, CDC.
httpE--www.cdc.gov-nchstp-od-nchstp.html
Division of HIV/AIDS Prevention, CDC.
httpE--www.cdc.gov-hiv
Division of Healthcare 4"alit$ Prootion, CDC.
httpE--www.cdc.gov-ncidod-hip
National Prevention Inforation Net/or3.
httpE--www.cdcnpin.org