Effect of community-based voluntary counselling and testing on HIV incidence and social and behavioural outcomes (NIMH Project Accept; HPTN 043): a cluster-randomised trial.

BACKGROUND: Although several interventions have shown reduced HIV incidence in clinical trials, the community-level effect of effective interventions on the epidemic when scaled up is unknown. We investigated whether a multicomponent, multilevel social and behavioural prevention strategy could reduce HIV incidence, increase HIV testing, reduce HIV risk behaviour, and change social and behavioural norms. METHODS: For this phase 3 cluster-randomised controlled trial, 34 communities in four sites in Africa and 14 communities in Thailand were randomly allocated in matched pairs to receive 36 months of community-based voluntary counselling and testing for HIV (intervention group) or standard counselling and testing alone (control group) between January, 2001, and December, 2011. The intervention was designed to make testing more accessible in communities, engage communities through outreach, and provide support services after testing. Randomisation was done by a computer-generated code and was not masked. Data were collected at baseline (n=14 567) and after intervention (n=56.683) by cross-sectional random surveys of community residents aged 18-32 years. The primary outcome was HIV incidence and was estimated with a cross-sectional multi-assay algorithm and antiretroviral drug screening assay. Thailand was excluded from incidence analyses because of low HIV prevalence. This trial is registered at ClinicalTrials.gov, number NCT00203749. FINDINGS: The estimated incidence of HIV in the intervention group was 1.52% versus 1.81% in the control group with an estimated reduction in HIV incidence of 13.9% (relative risk [RR] 0.86, 95% CI 0.73-1.02; p=0.082). HIV incidence was significantly reduced in women older than 24 years (RR=0.70, 0.54-0.90; p=0.0085), but not in other age or sex subgroups. Community-based voluntary counselling and testing increased testing rates by 25% overall (12-39; p=0.0003), by 45% (25-69; p<0·0001) in men and 15% (3-28; p=0.013) in women. No overall effect on sexual risk behaviour was recorded. Social norms regarding HIV testing were improved by 6% (95% CI 3-9) in communities in the intervention group. INTERPRETATION: These results are sufficiently robust, especially when taking into consideration the combined results of modest reductions in HIV incidence combined with increases in HIV testing and reductions in HIV risk behaviour, to recommend the Project Accept approach as an integral part of all interventions (including treatment as prevention) to reduce HIV transmission at the community level. FUNDING: US National Institute of Mental Health, the Division of AIDS of the US National Institute of Allergy and Infectious Diseases, and the Office of AIDS Research of the US National Institutes of Health.

Development of methods for cross-sectional HIV incidence estimation in a large, community randomized trial.

BACKGROUND: Accurate methods of HIV incidence determination are critically needed to monitor the epidemic and determine the population level impact of prevention trials. One such trial, Project Accept, a Phase III, community-randomized trial, evaluated the impact of enhanced, community-based voluntary counseling and testing on population-level HIV incidence. The primary endpoint of the trial was based on a single, cross-sectional, post-intervention HIV incidence assessment. METHODS AND FINDINGS: Test performance of HIV incidence determination was evaluated for 403 multi-assay algorithms [MAAs] that included the BED capture immunoassay [BED-CEIA] alone, an avidity assay alone, and combinations of these assays at different cutoff values with and without CD4 and viral load testing on samples from seven African cohorts (5,325 samples from 3,436 individuals with known duration of HIV infection [1 month to >10 years]). The mean window period (average time individuals appear positive for a given algorithm) and performance in estimating an incidence estimate (in terms of bias and variance) of these MAAs were evaluated in three simulated epidemic scenarios (stable, emerging and waning). The power of different test methods to detect a 35% reduction in incidence in the matched communities of Project Accept was also assessed. A MAA was identified that included BED-CEIA, the avidity assay, CD4 cell count, and viral load that had a window period of 259 days, accurately estimated HIV incidence in all three epidemic settings and provided sufficient power to detect an intervention effect in Project Accept. CONCLUSIONS: In a Southern African setting, HIV incidence estimates and intervention effects can be accurately estimated from cross-sectional surveys using a MAA. The improved accuracy in cross-sectional incidence testing that a MAA provides is a powerful tool for HIV surveillance and program evaluation.

Social networking technologies as an emerging tool for HIV prevention: a cluster randomized trial.

BACKGROUND: Social networking technologies are an emerging tool for HIV prevention. OBJECTIVE: To determine whether social networking communities can increase HIV testing among African American and Latino men who have sex with men (MSM). DESIGN: Randomized, controlled trial with concealed allocation. (ClinicalTrials.gov: NCT01701206). SETTING: Online. PATIENTS: 112 MSM based in Los Angeles, more than 85% of whom were African American or Latino. INTERVENTION: Sixteen peer leaders were randomly assigned to deliver information about HIV or general health to participants via Facebook groups over 12 weeks. After participants accepted a request to join the group, participation was voluntary. Group participation and engagement were monitored. Participants could request a free, home-based HIV testing kit and completed questionnaires at baseline and 12-week follow-up. MEASUREMENTS: Participant acceptance of and engagement in the intervention and social network participation, rates of home-based HIV testing, and sexual risk behaviors. RESULTS: Almost 95% of intervention participants and 73% of control participants voluntarily communicated using the social platform. Twenty-five of 57 intervention participants (44%) requested home-based HIV testing kits compared with 11 of 55 control participants (20%) (difference, 24 percentage points [95% CI, 8 to 41 percentage points]). Nine of the 25 intervention participants (36%) who requested the test took it and mailed it back compared with 2 of the 11 control participants (18%) who requested the test. Retention at study follow-up was more than 93%. LIMITATION: Only 2 Facebook communities were included for each group. CONCLUSION: Social networking communities are acceptable and effective tools to increase home-based HIV testing among at-risk populations. PRIMARY FUNDING SOURCE: National Institute of Mental Health.

Sexual risk and HIV prevention behaviours among African-American and Latino MSM social networking users.

This study explores the feasibility of recruiting minority men who have sex with men Facebook users for human immunodeficiency virus (HIV) prevention studies and notes demographic and sexual risk behaviours. Facebook-registered men who have sex with men (MSM; N = 118) were recruited using online and offline methods. Participants validated Facebook-user status through using a Facebook Connect (computer science) application. Participants were primarily Latino (60.2%) and African-American (28.0%), with 33.1% using social media to find sex partners. Black MSM social networking users reported engaging in a lower frequency (coefficient = -0.48, p < 0.05) of unprotected receptive anal intercourse compared to Latino MSM. Results suggest that minority social media users can be recruited for HIV studies and that sexual risk behavioural differences exist among minority social networking users. Findings highlight the importance of incorporating technologies into population-focused HIV interventions.

Estimation of HIV incidence in a large, community-based, randomized clinical trial: NIMH project accept (HIV Prevention Trials Network 043).

BACKGROUND: National Institute of Mental Health Project Accept (HIV Prevention Trials Network [HPTN] 043) is a large, Phase III, community-randomized, HIV prevention trial conducted in 48 matched communities in Africa and Thailand. The study intervention included enhanced community-based voluntary counseling and testing. The primary endpoint was HIV incidence, assessed in a single, cross-sectional, post-intervention survey of >50,000 participants. METHODS: HIV rapid tests were performed in-country. HIV status was confirmed at a central laboratory in the United States. HIV incidence was estimated using a multi-assay algorithm (MAA) that included the BED capture immunoassay, an avidity assay, CD4 cell count, and HIV viral load. RESULTS: Data from Thailand was not used in the endpoint analysis because HIV prevalence was low. Overall, 7,361 HIV infections were identified (4 acute, 3 early, and 7,354 established infections). Samples from established infections were analyzed using the MAA; 467 MAA positive samples were identified; 29 of those samples were excluded because they contained antiretroviral drugs. HIV prevalence was 16.5% (range at study sites: 5.93% to 30.8%). HIV incidence was 1.60% (range at study sites: 0.78% to 3.90%). CONCLUSIONS: In this community-randomized trial, a MAA was used to estimate HIV incidence in a single, cross-sectional post-intervention survey. Results from this analysis were subsequently used to compare HIV incidence in the control and intervention communities. TRIAL REGISTRATION: ClinicalTrials.gov NCT00203749.

The relationship between online social networking and sexual risk behaviors among men who have sex with men (MSM).

Online social networking usage is growing rapidly, especially among at-risk populations, such as men who have sex with men (MSM). However, little research has studied the relationship between online social networking usage and sexual risk behaviors among at-risk populations. One hundred and eighteen Facebook-registered MSM (60.1% Latino, 28% African American; 11.9% other) were recruited from online (social networking websites and banner advertisements) and offline (local clinics, restaurants and organizations) venues frequented by minority MSM. Inclusion criteria required participants to be men who were 18 years of age or older, had had sex with a man in the past 12 months, were living in Los Angeles, and had a Facebook account. Participants completed an online survey on their social media usage and sexual risk behaviors. Results from a multivariable regression suggest that number of sexual partners met from online social networking technologies is associated with increased: 1) likelihood of having exchanged sex for food, drugs, or a place to stay within the past 3 months; 2) number of new partners within the past 3 months; 3) number of male sex partners within the past 3 months; and 4) frequency of engaging in oral sex within the past 3 months, controlling for age, race, education, and total number of sexual partners. Understanding the relationship between social media sex-seeking and sexual risk behaviors among at-risk populations will help inform population-focused HIV prevention and treatment interventions.

HIV surveillance in a large, community-based study: results from the pilot study of Project Accept (HIV Prevention Trials Network 043).

BACKGROUND: Project Accept is a community randomized, controlled trial to evaluate the efficacy of community mobilization, mobile testing, same-day results, and post-test support for the prevention of HIV infection in Thailand, Tanzania, Zimbabwe, and South Africa. We evaluated the accuracy of in-country HIV rapid testing and determined HIV prevalence in the Project Accept pilot study. METHODS: Two HIV rapid tests were performed in parallel in local laboratories. If the first two rapid tests were discordant (one reactive, one non-reactive), a third HIV rapid test or enzyme immunoassay was performed. Samples were designated HIV NEG if the first two tests were non-reactive, HIV DISC if the first two tests were discordant, and HIV POS if the first two tests were reactive. Samples were re-analyzed in the United States using a panel of laboratory tests. RESULTS: HIV infection status was correctly determined based on-in country testing for 2,236 (99.5%) of 2,247 participants [7 (0.37%) of 1,907 HIV NEG samples were HIV-positive; 2 (0.63%) of 317 HIV POS samples were HIV-negative; 2 (8.3%) of 24 HIV DISC samples were incorrectly identified as HIV-positive based on the in-country tie-breaker test]. HIV prevalence was: Thailand: 0.6%, Tanzania: 5.0%, Zimbabwe 14.7%, Soweto South Africa: 19.4%, Vulindlela, South Africa: 24.4%, (overall prevalence: 14.4%). CONCLUSIONS: In-country testing based on two HIV rapid tests correctly identified the HIV infection status for 99.5% of study participants; most participants with discordant HIV rapid tests were not infected. HIV prevalence varied considerably across the study sites (range: 0.6% to 24.4%). TRIAL REGISTRATION: ClinicalTrials.gov registry number NCT00203749.

HIV-related stigma, social norms, and HIV testing in Soweto and Vulindlela, South Africa: National Institutes of Mental Health Project Accept (HPTN 043).

OBJECTIVE: HIV testing is necessary to curb the increasing epidemic. However, HIV-related stigma and perceptions of low likelihood of societal HIV testing may reduce testing rates. This study aimed to explore this association in South Africa, where HIV rates are extraordinarily high. METHODS: Data were taken from the Soweto and Vulindlela, South African sites of Project Accept, a multinational HIV prevention trial. Self-reported HIV testing, stigma, and social norms items were used to study the relationship between HIV testing, stigma, and perceptions about societal testing rates. The stigma items were broken into 3 factors: negative attitudes, negative perceptions about people living with HIV, and perceptions of fair treatment for people living with HIV (equity). RESULTS: Results from a univariate logistic regression suggest that history of HIV testing was associated with decreased negative attitudes about people living with HIV/AIDS, increased perceptions that people living with HIV/AIDS experience discrimination, and increased perceptions that people with HIV should be treated equitably. Results from a multivariate logistic regression confirm these effects and suggest that these differences vary according to sex and age. Compared with people who had never tested for HIV, those who had previously tested were more likely to believe that the majority of people have tested for HIV. CONCLUSIONS: Data suggest that interventions designed to increase HIV testing in South Africa should address stigma and perceptions of societal testing.

Framing male circumcision to promote its adoption in different settings.

The effectiveness of male circumcision in preventing transmission of HIV from females to males has been established. Those who are now advocating its widespread use face many challenges in convincing policy-makers and the public of circumcision's value. We suggest that frames are a useful lens for communicating public health messages that may help promote adoption of circumcision. Frames relate to how individuals and societies perceive and understand the world. Existing frames are often hard to shift, and should be borne in mind by advocates and program implementers as they attempt to promote male circumcision by invoking new frames. Frames differ across and within societies, and advocates must find ways of delivering resonant messages that take into account prior perceptions and use the most appropriate means of communicating the benefits and value of male circumcision to different audiences.

Male circumcision and HIV prevention: looking to the future.

Now that male circumcision has been shown to have a protective effect for men against HIV infection when engaging in vaginal intercourse with HIV-infected women, the research focus needs to shift towards the operational studies that can pave the way for effective implementation of circumcision programs. Behavioral research is needed to find out how people perceive the procedure and the barriers to and facilitators of uptake. It should also assess the risk of an increase in unsafe sex after circumcision. Social research must examine cultural perceptions of the practice, in Africa and beyond, including how likely uncircumcised communities are to access surgery and what messages are needed to persuade them. Advocates of male circumcision would benefit from research on how to influence health policy-makers, how best to communicate the benefits to the public, and how to design effective delivery models.

Twenty-five years of HIV: lessons for low prevalence scenarios.

During the initial quarter century since the discovery of HIV, international response has focused on high prevalence scenarios and concentrated epidemics. Until recently, the theoretical underpinnings of HIV prevention were largely based on these responses-the assumption that inadequate responses to concentrated epidemics within low prevalence populations could rapidly lead to generalized epidemics. The limits of these assumptions for HIV prevention in low prevalence scenarios have become evident. While examples of rapid HIV diffusion in once low prevalence scenarios exist, emergence of generalized epidemics are less likely for much of the world. This paper reviews several key issues and advances in biomedical and behavioural HIV prevention to date and highlights relevance to low prevalence scenarios.

Leadership development and HIV/AIDS.

Leadership development among all sectors addressing HIV/AIDS has come to be recognized as a critically important endeavor as the HIV pandemic moves into its fourth decade. Globally, there is a tremendous need for well-trained leaders in healthcare, research, policy, programme management, activism and advocacy, especially in countries and settings with high HIV prevalence and limited human resource capacity. This article examines the growing need for HIV/AIDS leadership development, and describes and assesses a number of current initiatives that focus on leadership development in a variety of populations and settings. A series of recommendations are provided to expand the scope and impact of leadership development activities; recommendations are primarily targeted towards foundations and other funders and leadership development programme managers.

Stigma in the HIV/AIDS epidemic: a review of the literature and recommendations for the way forward.

Although stigma is considered a major barrier to effective responses to the HIV/AIDS epidemic, stigma reduction efforts are relegated to the bottom of AIDS programme priorities. The complexity of HIV/AIDS-related stigma is often cited as a primary reason for the limited response to this pervasive phenomenon. In this paper, we systematically review the scientific literature on HIV/AIDS-related stigma to document the current state of research, identify gaps in the available evidence and highlight promising strategies to address stigma. We focus on the following key challenges: defining, measuring and reducing HIV/AIDS-related stigma as well as assessing the impact of stigma on the effectiveness of HIV prevention and treatment programmes. Based on the literature, we conclude by offering a set of recommendations that may represent important next steps in a multifaceted response to stigma in the HIV/AIDS epidemic.

The next 5 years of global HIV/AIDS policy: critical gaps and strategies for effective responses.

The University of California, Los Angeles Program in Global Health performed a landscape analysis based on interviews conducted between November 2006 and February 2007 with 35 key informants from major international organizations conducting HIV/AIDS work. Institutions represented included multilateral organizations, foundations, and governmental and non-governmental organizations. The purpose of this analysis is to assist major foundations and other institutions to understand better the international HIV/AIDS policy landscape and to formulate research and development programmes that can make a significant contribution to moving important issues forward in the HIV/AIDS policy arena. Topics identified during the interviews were organized around the four major themes of the Ford Foundation's Global HIV/AIDS Initiative: leadership and leadership development; equity; accountability; and global partnerships. Key informants focused on the need for a visionary response to the HIV pandemic, the need to maintain momentum, ways to improve the scope of leadership development programmes, ideas for improving gender equity and addressing regional disparities and the needs of vulnerable populations, recommendations for strengthening accountability mechanisms among governments, foundations, and civil society and on calling for increased collaboration and partnership among key players in the global HIV/AIDS response.

Accountability in the global response to HIV: measuring progress, driving change.

Accountability implies that institutions and individuals are answerable for their commitments and responsibilities. The concept of accountability is highly relevant in the global response to HIV/AIDS because governments, donors and other actors have often failed to keep their commitments to expand funding and service delivery levels. Many governments have not been held accountable for failing to address the HIV-related needs of their populations adequately. Accountability is about more than passing judgement. Effective accountability mechanisms can be powerful tools to improve service delivery by providing constructive assessments and motivating decision makers to avoid negative external critiques. An impressive variety of HIV-related accountability projects have emerged over the past few years, the most prominent being the ongoing monitoring of government compliance with the United Nations General Assembly Special Session (UNGASS) Declaration of Commitment. Other accountability efforts are essential in order to capture perspectives and priorities outside of governments and aid agencies. Many civil society-based accountability projects are now tracking HIV policy, service delivery and funding levels. We make several suggestions to increase the impact of accountability efforts, including connecting accountability to sustained advocacy, holding multiple actors accountable, continually assessing what measures of success will be most powerful in driving improved outcomes, and supporting and building the capacity of civil society monitoring efforts. We also suggest exploring how the International AIDS Conferences could serve as an expanded platform for accountability.