Evaluation of PEPFAR (2013) / Chapter Skim
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5 Prevention
5 Prevention
Pages 163-236
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From page 163... ...
In this chapter a brief overview of the evolution of HIV prevention science is followed by an overview of PEPFAR's programmatic targets and funding for prevention and then discussions about the prevention of sexual transmission, including prevention for people who engage in sex work and prevention for men who have sex with men; prevention of mother-to-child transmission (PMTCT) ; prevention for people who inject drugs; and a limited assessment of PEPFAR's efforts in the areas of blood and medical injection safety.
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From page 164... ...
; • populations and HIV-risk exposure behaviors (heterosexual men and women, men who have sex with men, transgender persons, people who inject drugs, HIV serodiscordant couples, pregnant women, young people, sex workers, etc.) ; • unit- or level-targeted (individual, couple, network, community)
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From page 165... ...
. In the 1990s evidence emerged supporting the effectiveness of harm reduction strategies as a way to prevent HIV transmission among people who inject drugs.
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From page 166... ...
. These included • behavioral change programs to reduce sexual risk behaviors and be havioral prevention programs specifically targeted to HIV-positive individuals; • harm reduction services for people who inject drugs; • antiretroviral prophylaxis for PMTCT; • universal safety precautions, blood safety practices, and infection control in health care settings; • identification and treatment of STIs in addition to HIV; • HIV counseling and testing; and • policy reforms (such as those to reduce the vulnerability of women and girls or to expand access to effective prevention strategies)
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From page 167... ...
Both the ways in which HIV is transmitted -- predominantly through sexual intercourse and illicit drug injection -- and the social attitudes about people identified as most vulnerable -- including men who have sex with men, sex workers, people who inject drugs, individuals with multiple or concurrent sex partners, young women, and HIV serodiscordant couples -- have contributed to stigmatization (Avert.org, n.d.)
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From page 168... ...
, and the earmark was removed in the 2008 reauthorization legislation. The requirement was amended to state that prevention program portfolios should include a balanced funding approach within their prevention of sexual transmission activities.4 Additionally, in countries with generalized epidemics, a justification was required if programs promoting abstinence, delay of sexual debut, monogamy, fidelity, and partner reduction constituted less than 50 percent of funds spent on prevention of sexual transmission.5 2 Supra, note 1 at §301(a)
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From page 169... ...
. Although PMTCT remains a central pillar of prevention programming, the PEPFAR portfolio has since broadened to include a more diverse array of strategies for people vulnerable to sexual and druguse-related HIV transmission.
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From page 170... ...
This affects both general programming for the prevention of sexual transmission and even more so, programming to meet the prevention needs of marginalized populations at elevated risk for HIV infection. As one stakeholder interviewed for this evaluation noted: "I think one of the great challenges for PEPFAR has been on the one hand, professing to be evidence driven and interested in best practice and standards for HIV prevention, treatment, and care and at the same time, being constrained by the very real politi cal realities of the U.S.
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From page 171... ...
PREVENTION OF SEXUAL TRANSMISSION Background More than 85 percent of new HIV infections are estimated to be sexually acquired (Abdool Karim et al., 2007; Gouws et al., 2006)
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From page 172... ...
. There is very little known about the coverage of individual and mass media behavior change education programming, but in 26 countries with generalized epidemics reporting to UNAIDS, less than half of young women reported comprehensive knowledge of HIV transmission and prevention (UNAIDS, 2012b)
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From page 173... ...
The 2003 PEPFAR authorizing legislation highlighted the "ABC model" -- Abstinence, Be faithful, and correct and consistent Condom use -- as a successful approach to the prevention of sexual transmission of HIV.8 It instructed PEPFAR to support "programs and efforts that are designed or intended to impart knowledge with the exclusive purpose of helping individuals avoid behaviors that place them at risk of HIV infection," which included delay of sexual debut, fidelity and monogamy, abstinence, reduction of casual sexual partnering, and condoms.9 The 2008 reauthorization legislation expanded the scope of program activities, incorporating additional approaches, such as health education for serodiscordant couples, and structural interventions to address sexual transmission risk from vulnerabilities related to gender and age.10 In addition to the legislative directives, PEPFAR's portfolio of HIV prevention activities is also driven by guidance documents -- directives specifying what can and should be supported with PEPFAR resources -- that are fundamental to operationalizing programmatic targets and goals. A general discussion on the role of Office of the U.S.
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From page 174... ...
-- even with the newly released guidance and considerations for a given country or setting. Although PEPFAR indicators specifically mention people who inject drugs, MSM, and sex workers (OGAC, 2009c)
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. PEPFAR also supports prevention activities for specific populations at elevated risk, including men who have sex with men, sex workers, and people who inject drugs and their sexual partners (OGAC, 2009b)
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From page 176... ...
A review of annual PEPFAR Country Operational Plans from the countries selected for visits for this evaluation revealed that in most countries, there has been at least one activity supported within each of the modalities listed above. Interviewees in nearly all countries visited described the implementation of a broad array of interventions intended to prevent sexual transmission of HIV.
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From page 177... ...
. Interviewees described efforts across partner countries to incorpo rate VMMC into their prevention portfolios and to scale up services (196-12-PCGOV; 116-4-USG; 116-12-PCNGO; 166-4-USG; 272-12-USNGO; 272-17-USG; 272-25-USG; 461-3-USG; 461-8-PCGOV; 934-10-PCGOV)
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From page 178... ...
. Effects of PEPFAR's Prevention of Sexual Transmission Efforts The committee attempted an assessment of PEPFAR's activities for prevention of sexual transmission using program monitoring data reported annually to OGAC by PEPFAR mission teams.
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; the two process measures for behavior change activities described above were essentially maintained. There are currently six NGIs, listed in Box 5-2, that attempt to monitor PEPFAR efforts related to prevention of sexual transmission of HIV (OGAC, 2009c)
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. Data Limitations for the Assessment of Prevention of Sexual Transmission While the annual increases in the number of individuals reached by each type of outreach activity are notable, the two process measures pre
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From page 181... ...
To better understand the effectiveness of its programs for behavior change to prevent sexual transmission, PEPFAR will require more information on the populations in need and a clearer approach to assessing the link between having been reached by a prevention message and a resultant change in sexual risk behavior. Stakeholders interviewed by the evaluation committee echoed this assessment.
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From page 182... ...
PEPFAR is currently supporting several trials on the effectiveness of combination prevention approaches that address multiple modes of HIV transmission; with respect to sexual transmission, these include biomedical and some limited behavioral interventions (NCV-31-USG) (Essex and DeGruttola, 2012; Kerrigan and Sweat, 2012)
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From page 183... ...
. Given that sexual transmission is the primary global driver of HIV infection, effective interventions to address sexual transmission will need to be a central component of any comprehensive national response.
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From page 184... ...
Sex Workers Background Among the populations at elevated risk included within PEPFAR's prevention of sexual transmission efforts are people who engage in sex work. Sex work, which is sometimes referred to as "transactional sex," describes a wide variety of activities depending on local context.
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From page 185... ...
Global AIDS Coordinator to work "with partner countries in which the HIV/AIDS epidemic is prevalent among individuals involved in commercial sex acts to establish, as a national priority, national prevention programs, including education, voluntary testing, and counseling, and referral systems that link HIV/AIDS programs with programs to eradicate trafficking in persons and support alternatives to prostitution."20 The application of the law to U.S.-based organizations has been challenged in court, and, under the most recent ruling, the U.S. Court of Appeals for the Second Circuit held that the pledge requirement infringes on the First Amendment rights of the plaintiff-appellee nongovernmental organizations (NGOs)
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From page 186... ...
. It is also worth noting that in some partner country settings there are high rates of injection drug use among sex workers, and there are efforts to provide them PEPFAR-supported services for people who inject drugs.
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From page 187... ...
. In many cases it was also emphasized that individuals may belong to multiple populations at elevated risk; in particular, sex workers who also inject drugs and MSM who are engaged in sex work were identified as populations with distinct needs (240-9-USG; 331-7-PCNGO; 396-27-PCGOV; 396-37-USNGO; 196-25-PCNGO)
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From page 188... ...
. Interviewees lamented the lack of reliable population size estimates, and the high mobility of this population, in addition to discrimination and stigma, were noted as contributing to the limited availability of epidemiological data on sex workers in general and, in particular, on sex workers with overlapping risk, especially people who inject drugs and MSM (166-5-USG; 396-24-USNGO; 2409-USG; 331-7-PCNGO; 396-37-USNGO)
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From page 189... ...
There are some examples of success as a result of PEPFAR-supported activities for this popu lation, and increased flexibility for prevention programming with the elimination of the budget earmark for abstinence and be faith ful programs in PEPFAR II has enabled country programs to more readily plan activities for sex workers. Consequences of the Legislative Limitation on PEPFAR Funds A major issue that is often raised in relation to PEPFAR's efforts for sex workers is the legislative limitation on providing funding to any group or organization that does not have a policy explicitly opposing prostitution and sex trafficking.22 Although PEPFAR has supported programs and partner organizations in efforts for sex workers, nonetheless there is concern that the legislative limitation on funding has been an impediment to PEPFAR's work on prevention of HIV transmission for this population (NCV-22-USNGO; NCV-24-USNGO)
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From page 190... ...
These efforts have been restricted even though their inclusion would not necessitate a direct link to promoting the legalization of prostitution. This exclusion is seen by a range of stakeholders in the global health community as impeding access to HIV services for sex workers and as a missed opportunity for PEPFAR to more effectively contribute to the HIV response in partner countries and to the reduction of HIV transmission (Brennan Center for Justice, 2012; CHANGE, 2008; Evertz, 2010; Law Students for Reproductive Justice, 2012; UNDP, 2012)
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From page 191... ...
, behavior change campaigns (331-14-USG; 166-5USG) , support for prevention programs for male sex workers (196-25-PCNGO)
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From page 192... ...
. As with all populations at elevated risk, the needs of MSM cut across not only prevention programming but also other categories of services supported by PEPFAR, including access to HIV care and treatment.
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From page 193... ...
. When prolonged breast feeding occurs for 18 to 24 months, an estimated 12 percent of HIV infection occurs prior to 36 weeks gestation, 29 percent from 36 weeks 1,000 900 Aged <13 years Diagnosis, Number 800 Aged ≥13 years 700 600 500 400 300 200 100 0 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Year of Diagnosis FIGURE 5-2 AIDS diagnoses among perinatally infected persons, 1985–2010, in the United States and six U.S.-dependent areas.
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From page 194... ...
. WHO Recommendations to Prevent MTCT of HIV In 2010 WHO revised its 2006 guidelines for PMTCT and the care of mothers and recommended initiation of ART for all HIV-infected pregnant women with CD4 counts below 350/mm3 (from below 200/mm3 in 2006)
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From page 195... ...
. The subsequent scale-up in global resources contributed to an increase in PMTCT coverage, and in 2010 an estimated 35 percent of pregnant women in low- and middleincome countries received HIV testing and counseling, with coverage of counseling and testing for pregnant women increasing from an estimated 35 percent to 42 percent between 2009 and 2010 in sub-Saharan Africa (WHO, 2011)
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From page 196... ...
PEPFAR was directed to support countries to reach "80 percent of pregnant women for prevention and treatment of mother-to-child transmission of HIV in countries in which the United States is implementing HIV/AIDS programs by 2013" and to promote "infant feeding options and treatment protocols that meet the most recent criteria established by the World Health Organization."28 PEPFAR's PMTCT activities have evolved with the changing evidence base, and PEPFAR has endorsed the adaptation of the updated 2010 WHO PMTCT guidelines described above into their programming (OGAC, 2011c)
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From page 197... ...
. In order to accomplish these goals, PEPFAR not only supports efforts in partner countries but also works in concert with international partners, such as through its support of the UNICEF Inter-Agency Task Team and through PEPFAR's contribution to the 2011 Global Plan Towards the Elimination of New HIV Infections Among Children by 2015 and Keeping Their Mothers Alive (OGAC, 2011c; UNAIDS, 2011)
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From page 198... ...
The annual figures for PEPFAR coverage alone were obtained by dividing PEPFAR's programmatic indicator for pregnant women who received ARV prophylaxis for PMTCT (OGAC indicator 1.3) by the same UNGASS indicator 100% 90% Percentage of HIV+ Pregnant Women 80% Who Received PMTCT Services 70% 60% 50% 40% 30% 20% 10% 0% 2006 2007 2008 2009 NaƟonal Coverage 20.9% 28.6% 42.7% 46.6% Inclusive of PEPFAR PEPFAR Coverage 9.6% 17.1% 24.6% 33.2% FIGURE 5-4 PEPFAR's contribution to PMTCT coverage, 2006 to 2009 (aggregate data from 31 countries)
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From page 199... ...
. Estimated and observed results from several studies conducted in PEPFAR partner countries have demonstrated not only successful efforts to scale up PMTCT services, but also a positive impact of PMTCT on the reduction of HIV transmission to infants, including in operational settings.
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From page 200... ...
Even with the major increase over time in the number of pregnant women receiving services, the data in Figure 5-4 and Table 5-4 also show that overall coverage for PMTCT is still well below what is needed in PEPFAR partner countries. Overall coverage of PMTCT services from all actors in the response was less than 50 percent in 2009 in the 31 countries under review, which is well below PEPFAR's stated goal of supporting the provision of ARV prophylaxis for PMTCT for 85 percent of eligible women by 2013.
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From page 201... ...
Interviewees offered a variety of potential solutions for addressing the limitations in PMTCT access. Interviewees in multiple countries noted the approach of creating demand for PMTCT services through communication and behavior change messaging, which has been supported by PEPFAR (240-19-USACA; 331-43-USG; 636-16-USG)
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From page 202... ...
. Interviewees in several different partner countries described the integration of PMTCT activities into other health service delivery platforms.
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From page 203... ...
Several interviewees cited the challenges of integration of PMTCT services (240-24-USG; 587-2-USG; 587-5-PCGOV; 196-8-ML; 636-9-USACA; 461-18-USG)
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From page 204... ...
HIV transmission among people who inject drugs occurs primarily through the sharing of used needles and other injection equipment contaminated with HIV, although sexual transmission between drug users and their partners -- who may or may not themselves be injectors -- is also common and of concern. Because injection drug use is illegal nearly everywhere, it is difficult to measure the prevalence of this behavior, which limits the ability to determine the prevalence (and incidence)
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From page 205... ...
. MAT has been shown to be effective in reducing the extent and frequency of injection and in reducing HIV risk behaviors among people who inject drugs (IOM, 2007b)
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From page 206... ...
The strategy consisted of tailoring existing prevention of sexual transmission activities and counseling and testing activities to people who inject drugs; supporting substance abuse programs, including medication-assisted treatment; and providing individuals with comprehensive HIV treatment services (OGAC, 2006d)
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From page 207... ...
Of the 15 original focus countries, 6 described activities that included efforts, beyond improved measurement, for people who inject drugs in their Country Operational Plan narratives in at least 1 year during the first phase of PEPFAR (PEPFAR/Kenya, 2006; PEPFAR/Mozambique, 2006; PEPFAR/Nigeria, 2006; PEPFAR/South Africa, 2006; PEPFAR/Tanzania, 2006; PEPFAR/ Vietnam, 2006)
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From page 208... ...
. Importance of the National Policy Context for Efforts for Prevention for People Who Inject Drugs The policy environment, which includes the USG policies described above, as well as a partner country's own laws and policies related to drug users, has been a crucial driver of the response to HIV in PEPFARsupported countries where transmission among people who inject drugs is a major driver of the epidemic.
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From page 209... ...
The committee's ability to interpret effect sizes or health impacts from these data was extremely limited, but in the future, should this indicator continue to be collected consistently, PEPFAR should be able to assess trends in the scale-up of its opioid-substitution therapy services and to evaluate the impact of this important component of the HIV response. Declining HIV prevalence among people who inject drugs was described by interviewees in PEPFAR partner countries (196-12-PCGOV; 542-6-ML; 396-12-USG)
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From page 210... ...
Despite these successes, services for people who inject drugs remain inadequate in many countries in which PEPFAR works. Interviewees noted remaining unmet need for harm reduction services (196-13-OGOV; NCV-24-USNGO)
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From page 211... ...
The authorizing legislation included "assistance to ensure a safe blood supply and sterile medical equipment"30 among the prevention activities supported by the program, and the 2008 reauthorization legislation reiterated support for these prevention areas.31 PEPFAR has never released guidance specific to either topic, but the first Five-Year Global HIV/AIDS strategy identified blood and injection safety as two critical components of the prevention portfolio that should be rapidly scaled up (OGAC, 2004b)
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. In the first 5 years of implementation, PEPFAR's program monitoring indicators tracked the number of activities related to improving blood safety, but did not measure outcomes on blood safety at the programmatic level.
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From page 213... ...
Initially, voluntary HIV testing programs were primarily intended to increase the number of people aware of their HIV status and to serve as an entry point for counseling and prevention services, both for those who were HIV-positive and for those who were HIV-negative, with the aim of reducing HIV transmission and infection. With the introduction of more widespread care and treatment services, HIV testing now serves as a crucial gateway for enrolling those who are HIV-positive into services for HIV treatment, care and support, and for the prevention of vertical HIV transmission, while still functioning to provide counseling and an entry point to prevention services (Marum et al., 2012)
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From page 214... ...
, and interview data were most robust on the role of testing within PEPFAR for linking individuals who test HIV-positive to ART and other care and treatment services. Therefore, the primary discussion of PEPFAR's achievements and ongoing challenges in counseling and testing can be found in Chapter 6, "Care and Treatment." ANALYSIS OF PREVENTION IMPACT PEPFAR's support for the scale-up of HIV prevention activities across prevention modalities has been an achievement and a contribution to the response to the epidemic in partner countries.
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From page 215... ...
For other modalities, such as VMMC and certain elements of harm reduction approaches for people who inject drugs, the committee was able to document PEPFAR's support for the scale-up of specific activities related to these interventions. The committee also anticipates that in the future PEPFAR's program-monitoring system will provide some estimates of intervention outputs and coverage, which will allow for reasonable conclusions to be drawn about the expected prevention impact of such interventions, although the committee was limited in doing so at this time because the relevant indicators were only recently added.
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From page 216... ...
Although there is strong foundational knowledge to support the principles and the design of these interventions, the persistent gaps in the field include a lack of knowledge on what the appropriate measures are for meaningfully tracking scale-up and coverage of behavioral and structural interventions; a lack of established and agreedupon behavior change outcome measures and proxy outcome measures; an insufficient understanding of the effectiveness of these interventions when implemented at scale in producing changes in outcomes; and a lack of knowledge about how the rates of change in behavioral and proxy outcomes are associated with rates of change in HIV transmission. This is an area in which PEPFAR, given the scale of its programs and its commitment to implementation research, has an opportunity to contribute to much-needed ongoing research and development for assessing behavioral and structural interventions, building on the methodological approaches that are currently available and in use.
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From page 217... ...
Several approaches, each with its own limitations, have been developed to model the impact of prevention activities and to estimate HIV infections averted, including coverage-based modeling, behavior-based modeling, and disease modeling (Heaton et al., 2008)
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From page 218... ...
. At the completion of the first phase of PEPFAR in 2008, the program estimated that its support for PMTCT activities had averted nearly 240,000 infant HIV infections (PEPFAR, 2008)
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From page 219... ...
trial was initiated to determine whether a woman's daily application vaginal gel or taking a daily tablet containing either 1 percent tenofovir or Truvada®33 would be effective methods of preventing sexual transmission of HIV. Following a midterm review, the tenofovir arms of the intervention were discontinued due to a lack of evidence of effectiveness; however, the evaluation of Truvada was maintained, and results are expected to be released in 2013 (Microbicide Trials Network, 2012b)
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From page 220... ...
and thus reduced viral load, and several studies analyzing the relationship between viral load and heterosexual transmission have found that reduced viral load was associated with reduced HIV transmission among serodiscordant couples (Attia et al., 2009; Donnell et al., 2010; Quinn et al., 2000)
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From page 221... ...
For example, a recent retrospective cohort analysis in China included more than 38,000 serodiscordant heterosexual couples and analyzed the annual rate of HIV infection in the HIV-negative partners, stratified by whether the HIV-positive partner had received ART or was treatment-naïve. The authors found a 26 percent relative reduction in HIV transmission for the cohort receiving treatment (Jia et al., 2012)
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From page 222... ...
Although PEPFAR has articulated a commitment to overarching goals for prevention, it lacks clear target outcomes and objectives across all prevention modalities; this is especially the case for behavioral and structural interventions for prevention of sexual transmission, the primary global driver of HIV infection. To achieve its overall goal of reducing new infec tions and stopping the spread of the epidemic, PEPFAR will need a more comprehensive and balanced approach, with greater clarity in its operational guidance and mechanisms to support the develop ment, implementation, monitoring, and evaluation of prevention portfolios in country programs that are aligned with the drivers of epidemics and the needs for prevention services.
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From page 223... ...
The prevention re sponse should prioritize the reduction of sexual transmission, which is the primary driver of most HIV infections, while main taining support for interventions targeted at other modes of trans mission. The response should incorporate an approach balanced among biomedical, behavioral, and structural interventions that is informed by epidemiological data and intervention effectiveness evidence.
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From page 224... ...
2009. Sexual transmission of HIV according to viral load and antiretroviral therapy: Systematic review and meta-analysis.
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2005. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: The ANRS 1265 Trial.
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From page 226... ...
policy restric tions for HIV programs aimed at commercial sex workers. Washington, DC: CHANGE.
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2010. Prevention of HIV infection for people who inject drugs: Why individual, structural, and combination approaches are needed.
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2008. Estimating the number of HIV infections averted: An approach and issues.
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2012. Antiretroviral therapy to prevent HIV transmission in serodiscordant couples in China (2003-11)
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2005a. ABC guidance #1 for United States government in-country staff and imple menting partners applying the ABC approach to preventing sexually-transmitted HIV infections within the President's Emergency Plan for AIDS Relief.
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2011a. Guidance for the prevention of sexually transmitted HIV infections.
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2012. Prevention of sexually trans mitted HIV infections through the President's Emergency Plan for AIDS Relief: A history of achievements and lessons learned.
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2012. Integrating prevention of mother-to child HIV transmission programs to improve uptake: A systematic review.
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2011. Global plan towards the elimination of new HIV infections among children by 2015 and keeping their mothers alive.
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2006. Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: towards universal access.
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