Behavior Change Interventions to Prevent HIV among Women Living in Low and Middle Income Countries

We conducted a systematic review of behavioral change interventions to prevent the sexual transmission of HIV among women and girls living in lowand middle-income countries. PubMed/MEDLINE, Web of Science, the Cochrane Library, and other databases and bibliographies were systematically searched for trials using randomized or quasiexperimental designs to evaluate behavioral interventions with HIV infection as an outcome. We identified 12 analyses for inclusion reporting on nine unique interventions. Interventions varied widely in intensity, duration, and delivery as well as by target population. Only two analyses showed a significant protective effect on HIV incidence among women and only three of eleven analyses that measured behavioral outcomes reduced any measure of HIVrelated risk behavior. Ongoing research is needed to determine whether behavior change interventions can be incorporated as independent efficacious components in HIV prevention packages for women or simply as complements to biomedical prevention strategies. AUTHOR’S NOTE An earlier version of this manuscript was published in AIDS & Behavior in December 2009. Since that time, we identified an additional study meeting the inclusion criteria and have included it in this version (van Griensven et al.). ACKNOWLEDGEMENTS This work was supported by the International Initiative for Impact Evaluation (3ie). We are grateful to Dr. Temina Madon for helpful comments on the manuscript and Dr. Nick Jewell for statistical advice. 2 INTRODUCTION Globally, women and girls are exceptionally vulnerable to HIV infection. Although women represent about half of all people living with HIV, in Sub-Saharan Africa where the pandemic is concentrated, women comprise 59 percent of people living with HIV infection. Young women become susceptible to HIV at an early age –– in some areas the prevalence of infection among women between 15-24 years is more than twice that of young men. 2 Women living in lower income countries are particularly at risk, as extreme poverty and other structural factors such as gender inequities, lack of education, and violence reduce their ability to control health outcomes or access HIV-related information and services. HIV prevention efforts in women have been hampered by the generally disappointing results of biomedical prevention trials. Candidate female-controlled biomedical prevention strategies, such as cervical barriers and microbicides, have not yet shown efficacy in randomized trials. Thus, prevention focuses mainly on male-controlled prevention methods such as male circumcision and condoms. Male circumcision, although highly effective at preventing female-to-male sexual transmission, has yet to be shown to directly reduce women’s risk of infection (although reductions in HIV prevalence will indirectly benefit women). 9 Male and female condoms are effective at preventing sexual transmission of HIV but both require male partner knowledge and consent. 11 Finally, although improved diagnosis and treatment of sexually transmitted infections (STI) may be an important strategy to reduce HIV transmission and deleterious effects of other STIs, women in the poorest parts of the world may not have access to or utilize sexual and reproductive health services. Thus, in the absence of an effective vaccine or alternative female-controlled biomedical prevention method, HIV prevention efforts for women currently focus on the mainstay of prevention strategies – behavior change. Behavioral strategies to prevent the sexual transmission of HIV include programs that aim to delay age of sexual debut, decrease the number of sexual partners and concurrent partnerships, increase the proportion of protected sexual acts, increase acceptance of voluntary counseling and testing (VCT), and improve adherence to successful biomedical prevention strategies, such as condom use. These interventions can focus on the individual, peer, couple, group, family, institution, or the community. In addition, they vary widely in duration, intensity, and delivery. In order to produce measureable population-level changes in HIV infection, behavioral interventions need to produce change in enough people for a sufficient time to impact transmission dynamics. Behavioral interventions targeting men who have sex with men, sexually transmitted disease clinic patients, heterosexual African Americans, sexually experienced adolescents in the United States, and people living with HIV are effective in reducing self-reported sexual risk behaviors. In addition, meta-analytic reviews suggest that interventions that are targeted to specific race or gender groups, include skills training, and that are based on behavioral theory demonstrate efficacy, again, when measured by self-report (for review of meta-analyses, see Noar 2008). Despite numerous behavior change interventions that have been evaluated since the beginning of the HIV epidemic more than 25 years ago, there is a notable paucity of data on the direct effect of such interventions on HIV incidence. Examining HIV infection as the outcome in efficacy trials is critical for several reasons. Most obviously, because the ultimate objective of such interventions is to prevent new HIV infections, evaluating the effect on HIV incidence is the only way to measure program impact directly. Furthermore, reported sexual behaviors can be subject to reporting and recall bias and may be inconsistent with what is known about population-level HIV infection prevalence. 23 Although greater resources are often needed to conduct evaluation trials with HIV infection as the endpoint, they are generally acceptable to study participants and have been utilized in several large randomized trails of behavioral interventions. 3 To date, no reviews have been conducted that summarize the effect of behavioral interventions for HIV prevention in women and girls in the developing world. Recently, the results of several large randomized trials of the effect of behavioral interventions on HIV incidence have been published, the data from which now permit a more focused review of these trials for HIV prevention in women. Given the increased risk of HIV incidence among women and girls 1-3 our goal was to systematically review and summarize behavioral change interventions to prevent the sexual transmission of HIV among women and girls living in lowand middle-income countries. METHODS The review was conducted using the following methods, as set out in the study protocol (McCoy et al., 2009). Search Strategy We searched PubMed/MEDLINE, PsycInfo, the Cochrane Library including the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, Sociological Abstracts, the National Library of Medicine Gateway, African Index Medicus, the Regional Index for Latin America and the Caribbean (Virtual Health Library) and IndMed (the regional database for Indian biomedical journals) for articles and abstracts meeting our inclusion criteria as of March 2, 2009. There were no language restrictions to the search. We developed a customized search strategy for each database relying on the database’s controlled vocabulary or index (e.g., medical subject headings (MeSH)) or free text terms. In most cases, search strategies combined terms for (1) HIV infection, (2) behavior or counseling, (3) prevention, and (4) study design restrictions (randomized controlled designs or quasiexperimental). In PubMed/MEDLINE, we searched for clinical trials using an adapted version of Cochrane’s “Highly Sensitive Search Strategy” for identifying randomized controlled trials. The search strategy is presented in Appendix A. To limit publication bias and identify unpublished studies, we searched the Current Controlled Trials Register, the International Clinical Trials Registry Platform Search Portal, clinicaltrials.gov, and Computer Retrieval of Information on Scientific Projects (CRISP) to identify unpublished studies meeting the inclusion criteria. We conducted a cited reference search with all articles selected for detailed review, scanned reference lists of eligible articles and reviews, and searched the electronic conference proceedings of recent HIV/AIDSrelated conferences (Conference on Retroviruses and Opportunistic Infections, International Society for STD Research annual meetings, and International AIDS Society annual meetings). We communicated with HIV prevention experts about our search and solicited published or unpublished references from them that might meet the inclusion criteria. We contacted three study authors who provided additional information about the trials (including effect estimates among women ). Trial Selection Eligible trials were those that 1) were published in 1990 or after; 2) used randomized controlled designs (individual or community) or quasi-experimental prospective designs with a control group; 3) evaluated behavioral interventions focusing on sexual transmission of HIV; 4) were conducted in lowand middle-income countries as defined by the World Bank; 5) were conducted either entirely in women or reported gender-stratified effect estimates (either in the manuscript or shared by study authors); and 6) reported HIV incidence or cumulative risk in the intervention and comparison arms or an overall relative measure of 4 effect (e.g., incidence rate ratios (IRR), risk ratios (RR)). Although effect estimates adjusted for confounders were preferred, analyses with only unadjusted (“crude”) estimates were eligible for inclusion. Crude estimates might represent intent-to-treat estimates in the case of randomized trials, or unadjusted measures of effect in controlled observational studies. We first examined the citations from the literature search to eliminate obviously ineligible studies (e.g., those conducted in men, in high-income countries, pertaining to intravenous transmission, or inappropriate article types such as reviews or commentaries). Abstracts were specifically searched fo