ObjectivesBroad international guidelines and studies in the context of individual clinical trials highlight the centrality of community stakeholder engagement in conducting ethically rigorous HIV prevention trials. We explored and identified challenges and facilitators for community stakeholder engagement in biomedical HIV prevention trials in diverse global settings. Our aim was to assess and deepen the empirical foundation for priorities included in the GPP guidelines and to highlight challenges in implementation that may merit further attention in subsequent GPP iterations.MethodsFrom 2008–2012 we conducted an embedded, multiple case study centered in Thailand, India, South Africa and Canada. We conducted in-depth interviews and focus groups with respondents from different trial-related subsystems: civil society organization representatives, community advocates, service providers, clinical trialists/researchers, former trial participants, and key HIV risk populations. Interviews/focus groups were recorded, and coded using thematic content analysis. After intra-case analyses, we conducted cross-case analysis to contrast and synthesize themes and sub-themes across cases. Lastly, we applied the case study findings to explore and assess UNAIDS/AVAC GPP guidelines and the GPP Blueprint for Stakeholder Engagement.ResultsAcross settings, we identified three cross-cutting themes as essential to community stakeholder engagement: trial literacy, including lexicon challenges and misconceptions that imperil sound communication; mistrust due to historical exploitation; and participatory processes: engaging early; considering the breadth of “community”; and, developing appropriate stakeholder roles. Site-specific challenges arose in resource-limited settings and settings where trials were halted.ConclusionsThis multiple case study revealed common themes underlying community stakeholder engagement across four country settings that largely mirror GPP goals and the GPP Blueprint, as well as highlighting challenges in the implementation of important guidelines. GPP guidance documents could be strengthened through greater focus on: identifying and addressing the community-specific roots of mistrust and its impact on trial literacy activities; achieving and evaluating representativeness in community stakeholder groups; and addressing the impact of power and funding streams on meaningful engagement and independent decision-making.

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This paper estimates the marginal willingness-to-pay for attributes of a hypothetical HIV vaccine using discrete choice modeling.We use primary data from 326 respondents from Bangkok and Chiang Mai, Thailand, in 2008-2009, selected using purposive, venue-based sampling across two strata. Participants completed a structured questionnaire and full rank discrete choice modelling task administered using computer-assisted personal interviewing. The choice experiment was used to rank eight hypothetical HIV vaccine scenarios, with each scenario comprising seven attributes (including cost) each of which had two levels. The data were analyzed in two alternative specifications: (1) best-worst; and (2) full-rank, using logit likelihood functions estimated with custom routines in Gauss matrix programming language.In the full-rank specification, all vaccine attributes are significant predictors of probability of vaccine choice. The biomedical attributes of the hypothetical HIV vaccine (efficacy, absence of VISP, absence of side effects, and duration of effect) are the most important attributes for HIV vaccine choice. On average respondents are more than twice as likely to accept a vaccine with 99% efficacy, than a vaccine with 50% efficacy. This translates to a willingness to pay US$383 more for a high efficacy vaccine compared with the low efficacy vaccine.Knowledge of the relative importance of determinants of HIV vaccine acceptability is important to ensure the success of future vaccination programs. Future acceptability studies of hypothetical HIV vaccines should use more finely-grained biomedical attributes, and could also improve the external validity of results by including more levels of the cost attribute.

Rectal microbicides (RMs) may offer substantial benefits in expanding HIV prevention options for key populations. From April to August 2013, we conducted Tablet-Assisted Survey Interviewing, including a discrete choice experiment, with participants recruited from gay entertainment venues and community-based organizations in Chiang Mai and Pattaya, Thailand. Among 408 participants, 74.5 % were young men who have sex with men, 25.5 % transgender women, with mean age = 24.3 years. One-third (35.5 %) had ≤9th grade education; 63.4 % engaged in sex work. Overall, 83.4 % reported they would definitely use a RM, with more than 2-fold higher odds of choice of a RM with 99 versus 50 % efficacy, and significantly higher odds of choosing gel versus suppository, intermittent versus daily dosing, and prescription versus over-the-counter. Sex workers were significantly more likely to use a RM immediately upon availability, with greater tolerance for moderate efficacy and daily dosing. Engaging key populations in assessing RM preferences may support biomedical research and evidence-informed interventions to optimize the effectiveness of RMs in HIV prevention.

High HIV prevalence among men who have sex with men (MSM) and transgender women in Thailand suggest a vital need for targeted interventions. We conducted a cross-sectional survey to examine and compare sexual risk behaviors, and demographic and behavioral correlates of risk, among MSM and transgender women recruited from gay entertainment venue staff and community-based organization (CBO) participants. We used venue-based sampling across nine sites in Bangkok and Chiang Mai. Among 260 participants (57.3% gay-identified, 26.9% heterosexual/bisexual-identified, 15.8% transgender; mean age=26.7 years), nearly one-fifth (18.5%) reported unprotected anal sex (UAS), half (50.4%) sex in exchange for money, and one-fifth (20.0%) STI diagnosis (past year). Nearly one-fourth (23.1%) reported oral erectile dysfunction medication use and nearly one-fifth (19.2%) illicit drug use (past 3 months). Overall, 43.1% indicated that healthcare providers exhibited hostility towards them. Gay entertainment venue staff were significantly more likely to self-identify as heterosexual/bisexual (versus gay or transgender female), and to have less than high school degree education, higher monthly income, to have engaged in sex in exchange for money, sex with women and unprotected vaginal sex, but were significantly less likely to have engaged in UAS than CBO participants. Targeted interventions for younger MSM and transgender women, for non gay-identified men, and strategies to address structural determinants of risk, including low education and discrimination from healthcare providers, may support HIV prevention among MSM and transgender women, and serve broader national HIV prevention efforts in Thailand.