Stated preferences for new HIV prevention technologies among men who have sex with men in India: A discrete choice experiment.

INTRODUCTION: India has the second largest HIV epidemic in the world. Despite successes in epidemic control at the population level, a concentrated epidemic persists among gay and other men who have sex with men (MSM). However, India lags in implementation of biomedical prevention technologies, such as HIV pre-exposure prophylaxis (PrEP). In order to inform scale-up of new HIV prevention technologies, including those in the development pipeline, we assessed willingness to use oral PrEP, rectal microbicides, and HIV vaccines, and choices among product characteristics, among MSM in two major Indian cities. METHODS: A cross-sectional survey was conducted with a discrete choice experiment (DCE), an established methodology for quantitively estimating end-user preferences in healthcare. Survey participants were randomly assigned to one of three questionnaire versions, each of which included a DCE for one prevention technology. Participants were recruited using chain-referral sampling by peer outreach workers, beginning with seeds in community-based organizations and public sex environments, in Chennai and Mumbai. DCE data were analyzed using random-parameters (mixed) logit (RPL) models. RESULTS: Among participants (n = 600), median age was 25 years, with median monthly income of INR 9,000 (~US$125). Nearly one-third (32%) had completed a college degree and 82% were single/never married. A majority of participants (63%) reported condomless anal sex in the past month. The acceptability of all three products was universally high (≥90%). Across all three products, four attributes were significant predictors of acceptability-with efficacy consistently the most important attribute, and in decreasing order of preference, side-effects, dosing schedule, and venue. MSM varied in their preferences for product attributes in relation to their levels of education and income, and engagement in sex work and HIV risk behavior. CONCLUSION: This study provides empirical evidence to facilitate the integration of end users' preferences throughout design, testing, and dissemination phases of HIV prevention technologies. The findings also suggest action points and targets for interventions for diverse subgroups to support the effectiveness of combination HIV prevention among MSM in India.

Associations between water insecurity and mental health outcomes among lesbian, gay, bisexual, transgender and queer persons in Bangkok, Thailand and Mumbai, India: Cross-sectional survey findings.

Background: Water insecurity disproportionally affects socially marginalized populations and may harm mental health. Lesbian, gay, bisexual, transgender and queer (LGBTQ) persons are at the nexus of social marginalization and mental health disparities; however, they are understudied in water insecurity research. Yet LGBTQ persons likely have distinct water needs. We explored associations between water insecurity and mental health outcomes among LGBTQ adults in Mumbai, India and Bangkok, Thailand. Methods: This cross-sectional survey with a sample of LGBTQ adults in Mumbai and Bangkok assessed associations between water insecurity and mental health outcomes, including anxiety symptoms, depression symptoms, loneliness, alcohol misuse, COVID-19 stress and resilience. We conducted multivariable logistic and linear regression analyses to examine associations between water insecurity and mental health outcomes. Results: Water insecurity prevalence was 28.9% in Mumbai and 18.6% in Bangkok samples. In adjusted analyses, in both sites, water insecurity was associated with higher likelihood of depression symptoms, anxiety symptoms, COVID-19 stress, alcohol misuse and loneliness. In Mumbai, water insecurity was also associated with reduced resilience. Conclusion: Water insecurity was common among LGBTQ participants in Bangkok and Mumbai and associated with poorer well-being. Findings signal the importance of assessing water security as a stressor harmful to LGBTQ mental health.

A scoping review of lesbian, gay, bisexual, transgender, queer, and intersex (LGBTQI+) people's health in India.

Amid incremental progress in establishing an enabling legal and policy environment for lesbian, gay, bisexual, transgender and queer-identified people, and people with intersex variations (LGBTQI+) in India, evidence gaps on LGBTQI+ health are of increasing concern. To that end, we conducted a scoping review to map and synthesize the current evidence base, identify research gaps, and provide recommendations for future research. We conducted a scoping review using the Joanna Briggs Institute methodology. We systematically searched 14 databases to identify peer-reviewed journal articles published in English language between January 1, 2010 and November 20, 2021, that reported empirical qualitative, quantitative or mixed methods data on LGBTQI+ people's health in India. Out of 3,003 results in total, we identified 177 eligible articles; 62% used quantitative, 31% qualitative, and 7% mixed methods. The majority (55%) focused on gay and other men who have sex with men (MSM), 16% transgender women, and 14% both of these populations; 4% focused on lesbian and bisexual women, and 2% on transmasculine people. Overall, studies reported high prevalence of HIV and sexually transmitted infections; multilevel risk factors for HIV; high levels of mental health burden linked to stigma, discrimination, and violence victimization; and non-availability of gender-affirmative medical care in government hospitals. Few longitudinal studies and intervention studies were identified. Findings suggest that LGBTQI+ health research in India needs to move beyond the predominant focus on HIV, and gay men/MSM and transgender women, to include mental health and non-communicable diseases, and individuals across the LGBTQI+ spectrum. Future research should build on largely descriptive studies to include explanatory and intervention studies, beyond urban to rural sites, and examine healthcare and service needs among LGBTQI+ people across the life course. Increased Indian government funding for LGBTQI+ health research, including dedicated support and training for early career researchers, is crucial to building a comprehensive and sustainable evidence base to inform targeted health policies and programs moving forward.

A Smartphone-Based Pilot HIV Prevention Intervention (Sakhi) among Transgender Women who Engage in Sex Work in India: Efficacy of a Pre- and Post-Test Quasi-Experimental Trial.

Transgender women (TGW) in India, especially those who engage in sex work, are at high risk for HIV. Guided by the information-motivation-behavioral skills model and qualitative formative research findings, Sakhi (girlfriend), a 3-week smartphone-based pilot intervention consisting of short videos (one/week) and text messages (two/week), was implemented using a one-group pre- and post-test design to test its efficacy in promoting condom use and HIV testing among TGW (N = 50) who engage in sex work in Chennai. Changes in outcomes were assessed by conducting multivariable analyses using generalized estimating equations. Participants' mean age was 26 years, and the mean monthly income was INR 21700 (USD 292). About one-third completed college, and 96% were HIV-negative. Significant changes in the desired direction were observed in the primary outcomes: condom use - decrease in the engagement of condomless anal sex with male partners (12% to 2%, p < 0.05) and HIV testing - increase in intentions to undergo HIV testing every 6 months (34% to 86%, p < 0.001); and in some of the secondary outcomes: decrease in alcohol use before sex, increase in intentions to use condoms consistently and increase in the well-being score. This study demonstrated the feasibility, acceptability, and preliminary efficacy of the Sakhi intervention and warrants a larger randomized trial among diverse sub-groups in diverse settings.

Use of Smartphones for Social and Sexual Networking among Transgender Women in South India: Implications for Developing Smartphone-based Online HIV Prevention Interventions.

BACKGROUND: Smartphone use is increasing among transgender women (TGW), including those who engage in sex work. Current government-supported HIV prevention interventions focus on physical venue-based outreach among TGW, missing the opportunity to reach them through smartphone-based interventions. OBJECTIVE: We examined the use of smartphones among TGW, especially in relation to social and sexual networking, and explored their perspectives on their willingness to use smartphone-based HIV prevention interventions. MATERIALS AND METHODS: Through an exploratory descriptive-interpretive qualitative research design, we conducted 6 focus groups with a purposive sample of 30 TGW (70% in sex work) and 4 key informant in-depth interviews in Chennai and Hyderabad, India. Data were explored using framework analysis. RESULTS: Through smartphones, TGW used social media (e.g., WhatsApp and Facebook) and dating applications for socialization, meeting sexual partners, and entertainment. Low-literacy TGW used voice or video messaging. TGW expressed interest in receiving short health-related videos and text messages on HIV, mental health, and gender transition. CONCLUSION: At-risk TGW could potentially be reached through smartphone-based online health promotion interventions, but those interventions need to be holistic - moving beyond HIV.

The Impact of COVID-19 on Economic Well-being and Health Outcomes among Transgender Women in India.

Coronavirus disease 2019 (COVID-19)-related lockdowns in India have disrupted the meager sources of income of many transgender women, including those in the hijra subculture who largely rely on money from providing blessings, begging, and sex work. Many have expended savings and taken high-interest loans, contributing to psychological distress. For hijras engaged in sex work, challenges to negotiating condom use and adhering to COVID-19 protective measures increase risks for contracting HIV and COVID-19 amid decreased access to HIV services. Many transgender women face challenges accessing COVID-19-related government welfare programs as they lack legal gender identity documents. Multisectoral and transgender-competent approaches are needed to mitigate the impact of the pandemic.

Associations between sexual stigma, enacted HIV stigma, internalized HIV stigma and homonegativity, and depression: testing an extended minority stress model among men who have sex with men living with HIV in India.

Limited data is available on the associations between intersectional stigmas and mental health outcomes among men who have sex with men living with HIV (MSMLH) in India. The minority stress model postulates that sexual stigma contributes to depression through proximal stressors like internalized homonegativity (IHN). Using cross-sectional survey data from 119 MSMLH in 2015/16, we tested whether: (1) sexual stigma and enacted HIV stigma (EHS) are associated with depression; (2) their effects on depression are mediated through IHN and internalized HIV stigma (IHS); and (3) their effects on IHN are mediated through IHS. Significant direct associations were observed between scores on sexual stigma and IHS (ß = .49, 95% CI .27, .70), EHS and IHN (ß = .19, 95% CI .03, .36), and IHS and IHN (ß = .07, 95% CI .03, .12). IHS scores mediated the associations of sexual stigma with depression (ß = .17, 95% CI .07, .27) and IHN scores (ß = .04, 95% CI .004, .07). EHS was not found to be significantly associated with depression or IHN. The findings partially support the minority stress model among MSMLH and highlight the importance of addressing both sexual and HIV-related stigmas to improve mental health of MSMLH, especially by screening for and reducing IHS, IHN and depression.

Affirming and negotiating gender in family and social spaces: Stigma, mental health and resilience among transmasculine people in India.

Research on transmasculine people's health is scant globally, including in India. We explored transmasculine people's experiences in affirming their gender in family and social spaces, and how those experiences impact mental health. In 2019, we conducted four focus groups (n = 17 participants) and 10 in-depth interviews with transmasculine people in Mumbai and Chennai. Data analyses were guided by minority stress theory and the gender affirmation model. Within family, the pressure to conform to assigned gender roles and gender policing usually began in adolescence and increased over time. Some participants left parental homes due to violence. In educational settings, participants described the enforcement of gender-normative dress codes, lack of faculty support, and bullying victimisation, which led some to quit schooling. In the workplace, experiences varied depending on whether participants were visibly trans or had an incongruence between their identity documents and gender identity. Everyday discrimination experiences in diverse settings contributed to psychological distress. Amidst these challenges, participants reported resilience strategies, including self-acceptance, connecting with peers, strategic (non)disclosure, and circumventing gendered restrictions on dress and behaviour. Interventions at social-structural, institutional, family and individual levels are needed to reduce stigma and discrimination faced by transmasculine people in India and to promote their mental health.

PrEP eligibility, HIV risk perception, and willingness to use PrEP among high-risk men who have sex with men in India: A cross-sectional survey.

HIV pre-exposure prophylaxis (PrEP) is not yet included in India's national AIDS program, with demonstration projects for MSM in planning stages. In order to support PrEP roll-out for MSM, we assessed: (1) associations between guideline-informed PrEP eligibility, HIV risk perception, and perceived PrEP benefits and costs, with willingness to use PrEP (WTUP); and (2) correlates of non-WTUP among PrEP-eligible MSM. Data were collected from MSM (n = 197) sampled from cruising sites in Mumbai and Chennai. More than half (58.4%) reported inconsistent condom use with male partners, 88.3% >1 male partner, and 48.6% engaging in sex work (all past month). Overall, 76.6% reported they would "definitely use" PrEP. Among 92.9% deemed PrEP-eligible, 79.2% reported WTUP. In adjusted analyses, PrEP eligibility (aOR = 5.31, 95% CI 1.11, 25.45), medium (aOR = 2.41, 95% CI 1.03, 5.63) or high (aOR = 13.08, 95% CI 1.29, 132.27) perceived HIV risk, and greater perceived benefits (aOR = 1.13, 95% CI 1.03, 1.24) were associated with higher odds of WTUP. Among PrEP-eligible MSM, non-WTUP was associated with low HIV risk perception and lower perceived benefits. Facilitating accurate risk assessment and promoting awareness of PrEP benefits and eligibility criteria may increase PrEP uptake among MSM in India.

Willingness to Use Pre-exposure Prophylaxis (PrEP) and Preferences Among Men Who have Sex with Men in Mumbai and Chennai, India: A Discrete Choice Experiment.

Pre-exposure prophylaxis (PrEP) programs are planned for key populations in India. We examined PrEP awareness and willingness to use PrEP in order to support products and services for MSM. From December 2016 to March 2017, we conducted a survey and discrete choice experiment (DCE)-a technique to quantify the strength of participants' trade-off preferences among various product attributes-to assess willingness to use PrEP and related preferences. MSM were recruited from cruising sites and HIV prevention services in Mumbai and Chennai. DCE data were analyzed using mixed logit regression models and estimated marginal willingness-to-pay, the relative value participants' place on different PrEP attributes. Overall, 76.6% indicated willingness to use PrEP. Efficacy had the greatest effect on choice (high vs. moderate, aOR = 19.9; 95% CI 13.0-30.4), followed by dosing frequency (intermittent vs. daily regimen, aOR = 2.02; 95% CI 1.8-2.2). Participants preferred no (vs. minor) side-effects, subsidized (vs. market) price, and government (vs. private) hospitals. Findings suggest that educational and social marketing interventions should emphasize PrEP's high efficacy and minimal side effects, and programs should provide government-subsidized PrEP with choices of intermittent or daily dosing delivered by government and private hospitals/clinics in order to optimize PrEP uptake among MSM in India.

Acceptability of HIV Pre-Exposure Prophylaxis Among Transgender Women in India: A Qualitative Investigation.

Despite high HIV prevalence among transgender women (TGW) in India, there is limited exploration of pre-exposure prophylaxis (PrEP) acceptability. With PrEP licensure pending, we conducted six focus group discussions (FGDs) with diverse TGW (n = 36), and eight key informant interviews with community leaders and physicians, in Mumbai and Chennai. Data were explored using framework analysis guided by the Theoretical Framework of Acceptability. FGD participants' mean age was 26.1 years (SD = 4.8); two-thirds engaged in sex work. TGW reported low PrEP awareness, with moderate acceptability once PrEP was explained. Population-specific facilitators of PrEP acceptability included its perceived effectiveness in the context of challenges to condom use in serodiscordant relationships and forced sex encounters. PrEP was considered especially appropriate for TGW sex workers; however, barriers were anticipated in the context of hierarchical hijra (indigenous trans identity) kinship networks and gurus' (masters) potential negative reactions to PrEP use by their chelas (disciples). Positive attitudes toward high efficacy and potential covert use were tempered by TGW's concerns about high costs and adherence challenges living with parents or primary partners, and TGW sex workers' unpredictable schedules. Anticipated interactions with feminizing hormones, visible side effects, and PrEP-related stigma within TGW communities emerged as opportunity costs. PrEP implementation for TGW in India should promote comprehensive information on side effects and potential interactions with feminizing hormones, provide free or subsidized PrEP, and highlight the advantages of added protection in sex work and forced sexual encounters. Meaningful engagement with TGW kinship networks can encourage positive transgender community norms on PrEP use and mitigate multifaceted stigma.

Reducing sexual risk and promoting acceptance of men who have sex with men living with HIV in India: Outcomes and process evaluation of a pilot randomised multi-level intervention.

HIV-positive men who have sex with men (HIV+MSM) in India need culturally-relevant interventions to promote safer sex. We tested a multi-level intervention among HIV+MSM that targeted individual, interpersonal, and community factors, based on the Social-Personal and Social Ecological Models. We conducted a 2 × 2 factorial RCT with 119 HIV+MSM randomised to receive either an individual-level intervention (ILI) using motivational interviewing to promote safer sex, a community-level intervention (CLI) to strengthen community norms toward safer sex and reduce stigma among MSM communities, a multi-level intervention combining the individual- and community-level interventions (ILI + CLI), or standard-of-care control. Participants completed pre- and post-intervention assessments of a composite sexual risk score and a process evaluation to assess fidelity and satisfaction. Out of the 119 HIV+MSM, 106 (89.0%) completed pre- and post-intervention assessments. Generalised Estimating Equation models showed that both CLI (Incidence Rate Ratio [IRR] = .67, 95% CI .47 to .96) and ILI + CLI (IRR = .66, 95% CI .48 to .91) groups had a statistically significant decrease in sexual risk compared to the standard-of-care. The interventions had high levels of fidelity and satisfaction. This pilot RCT demonstrated feasibility and potential effectiveness of a multi-level intervention that addresses individual, interpersonal and community-level contributors of sexual risk among HIV+MSM.

Syndemic Classes, Stigma, and Sexual Risk Among Transgender Women in India.

Syndemic theory could explain the elevated HIV risk among transgender women (TGW) in India. Using cross-sectional data of 300 TGW in India, we aimed to: identify latent classes of four syndemic conditions (Depression-D, Alcohol use-A, Violence victimization-V, HIV-positive status), test whether syndemic classes mediate the association between stigma and sexual risk, and test whether social support and resilient coping moderate the association between syndemic classes and sexual risk. Four distinct classes emerged: (1) DAV Syndemic, (2) AV Syndemic, (3) DV Syndemic, and (4) No Syndemic. TGW in the DAV Syndemic (OR 9.80, 95% CI 3.45, 27.85, p < 0.001) and AV Syndemic classes (OR 2.74, 95% CI 1.19, 6.32, p < 0.01) had higher odds of inconsistent condom use in the past month than the No Syndemic class. Social support significantly moderated the effect of DAV Syndemic class on inconsistent condom use. DAV Syndemic was found to be a significant mediator of the effect of transgender identity stigma on sexual risk. HIV prevention programs among TGW need to: (a) incorporate multi-level multi-component interventions to address syndemic conditions, tailored to the nature of syndemic classes; (b) reduce societal stigma against TGW; and (c) improve social support to buffer the impact of syndemics on sexual risk.

"Like Holding an Umbrella Before It Rains": Acceptability of Future Rectal Microbicides Among Men Who Have Sex With Men in India-A Modified Technology Acceptance Model.

Topical rectal microbicides (RMs) are a new prevention technology in development that aims to reduce the risk of HIV acquisition from anal sex. We examined RM acceptability among men who have sex with men (MSM) in India. We conducted a qualitative exploratory study guided by a modified Technology Acceptance Model, with 10 focus groups ( n = 61) of MSM and 10 key informant interviews. Data were explored using framework analysis. RM acceptability was influenced by technological contexts: perceived usefulness of RMs, perceived ease of use of RM and applicator, and habits around condom and lubricant use; individual and interpersonal contexts: perceived relevance and preferences for product formulation and dosing frequency; and MSM community/social contexts: perceived social approval, RM-related stigma, social support. Implementation of RMs for MSM in India may be supported by multi-level interventions that engage community-based organizations in destigmatizing and distributing RMs, ideally gel-based products that enable on-demand use before sex.

Understanding How Sexual and Gender Minority Stigmas Influence Depression Among Trans Women and Men Who Have Sex with Men in India.

PURPOSE: Few studies have assessed how sexual and gender minority stigmas affect the mental health of trans women and self-identified men who have sex with men (MSM) in India, populations with a high HIV burden. We tested whether social support and resilient coping act as mediators of the effect of sexual and gender minority stigmas on depression as proposed by Hatzenbuehler's psychological mediation framework, or as moderators based on Meyer's minority stress theory. METHODS: We conducted a cross-sectional survey among trans women (n = 300) and MSM (n = 300) recruited from urban and rural sites in India. Standardized scales were used to measure depression (outcome variable), transgender identity stigma/MSM stigma (predictor variables), and social support and resilient coping (tested as moderators and parallel mediators). The mediation and moderation models were tested separately for trans women and MSM, using Hayes' PROCESS macro in SPSS. RESULTS: Participants' mean age was 29.7 years (standard deviation 8.1). Transgender identity stigma and MSM stigma were significant predictors (significant total and direct effects) of depression, as were social support and resilient coping. Among trans women and MSM, social support and resilient coping mediated (i.e., significant specific indirect effects), but did not moderate, the effect of stigma on depression, supporting the psychological mediation framework. CONCLUSION: Sexual and gender minority stigmas are associated with depression, with social support and resilient coping as mediators. In addition to stigma reduction interventions at the societal level, future interventions should focus on improving social support and promoting resilience among trans women and MSM in India.

Syndemics of depression, alcohol use, and victimisation, and their association with HIV-related sexual risk among men who have sex with men and transgender women in India.

We examined the presence and co-occurrence of psychosocial health conditions (depression, frequent alcohol use, and victimisation) among men who have sex with men (MSM) and transgender (TG) women in India, and their cumulative association with sexual risk. A survey questionnaire was administered among a convenience sample of 600 participants (MSM = 300; TG women = 300) recruited through six non-governmental organisations in four states. Prevalences of the number of psychosocial health conditions among MSM were: none = 31.3%, one = 43%, two = 20%, and three = 5.7%; and among TG women: none = 9%; one = 35.33%, two = 38.33%, and three = 17.33%. In bivariate and multivariate models, these conditions were positively and additively related to sexual risk, providing evidence for a syndemic of psychosocial health conditions among MSM and TG women and their synergistic effect on sexual risk. In addition to the number of syndemic conditions, resilient coping and social support were significant predictors of sexual risk among MSM and TG women, respectively. HIV preventive interventions in India should screen for and address co-occurring psychosocial health conditions - experiences of violence, mental health issues, and alcohol use - among MSM and TG women.

Barriers and facilitators to voluntary HIV testing uptake among communities at high risk of HIV exposure in Chennai, India.

In India, increasing uptake of voluntary HIV testing among 'core risk groups' is a national public health priority. While HIV testing uptake has been studied among key populations in India, limited information is available on multi-level barriers and facilitators to HIV testing, and experiences with free, publicly available testing services, among key populations. We conducted 12 focus groups (n = 84) and 12 key informant interviews to explore these topics among men who have sex with men, transgender women, cisgender female sex workers, and injecting drug users in the city of Chennai. We identified inter-related barriers at social-structural, health-care system, interpersonal, and individual levels. Barriers included HIV stigma, marginalised-group stigma, discrimination in health-care settings, including government testing centres, and fears of adverse social consequences of testing HIV positive. Facilitators included outreach programmes operated by community-based/non-governmental organisations, accurate HIV knowledge and risk perception for HIV, and access to drug dependence treatment for injecting drug users. Promoting HIV testing among these key populations requires interventions at several levels: reducing HIV-related and marginalised-group stigma, addressing the fears of consequences of testing, promoting pro-testing peer and social norms, providing options for rapid and non-blood-based HIV tests, and ensuring non-judgmental and culturally competent HIV counselling and testing services.

Acceptability of HIV Pre-Exposure Prophylaxis (PrEP) and Implementation Challenges Among Men Who Have Sex with Men in India: A Qualitative Investigation.

This qualitative study explored the acceptability of HIV pre-exposure prophylaxis (PrEP) among MSM in India, and identified facilitators and barriers to future PrEP uptake. In 2014, we conducted 10 focus groups (n=61) among a purposive sample of diverse MSM recruited through community-based organizations in Chennai and Mumbai, and 10 key informant interviews with community leaders and health care providers. Participants' mean age was 26.1 years (SD 4.8); 62% completed secondary education, and 42% engaged in sex work. No focus group participants had heard of PrEP, but once explained, most reported they would likely use it. PrEP was alternately perceived as a 'back-up plan', a condom substitute, or a burden with concurrent condom use. Facilitators were potential for covert use, sex without condoms, and anxiety-less sex. Potential barriers emerged around stigma associated with PrEP use, fear of disclosures to one's family, wife, or male steady partner, and being labeled as HIV-positive or promiscuous by peers. Preferences emerged for intermittent rather than daily PrEP use, injectable PrEP, and free or subsidized access through community organizations or government hospitals. Key informants expressed additional concerns about risk compensation, non-adherence, and impact on ART availability for treatment. Demonstration projects are needed in India to support PrEP implementation tailored for at-risk MSM. Educational interventions for MSM should address concerns about PrEP effectiveness, side effects, and mitigate risk compensation. Community engagement may facilitate broad acceptability and challenge stigma around PrEP use. Importantly, provision of free or subsidized PrEP is necessary to making implementation feasible among low socioeconomic status MSM in India.

Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study.

OBJECTIVES: Broad 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. METHODS: From 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. RESULTS: Across 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. CONCLUSIONS: This 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.

Willingness to participate in HIV vaccine trials among men who have sex with men in Chennai and Mumbai, India.

INTRODUCTION: Men who have sex with men (MSM) are at disproportionately high risk for HIV in India and would benefit greatly from a safe and effective HIV vaccine. We assessed willingness to participate (WTP) in HIV vaccine trials and the impact of various trial characteristics on WTP among MSM in Mumbai and Chennai. METHODS: We used venue-based time-space sampling to recruit MSM at cruising sites and drop-in centers at community-based organizations. Structured survey interviews assessed sociodemographics, WTP and the impact of 10 trial characteristics on WTP. We tested for differences in WTP by sociodemographics and trial characteristics, and sociodemographic differences in the impact of trial characteristics on WTP. RESULTS: Among 400 participants (median age=25 years), 46.9% identified as kothi, 40.0% panthi/double-decker, 13.0% gay/bisexual; 29.0% had primary school education or less; and 40.0% had monthly income <=5000 INR (∼3USD/day). Overall, 48.1% reported being definitely willing to participate. Posttrial availability of an efficacious vaccine was the highest rated (90.98 on 100-point scale) trial characteristic, followed by availability of free medical treatment (90.79), life insurance (89.84) and side effects (79.81). Distance to the trial site, side effects, financial incentive, life insurance and free medical care had significant impacts on WTP, with differential importance of trial characteristics by sexual identity, education, income and living arrangement. CONCLUSION: The prioritization of trial-related financial and healthcare provisions, including access to an efficacious vaccine posttrial, among MSM in India indicates the importance of trials providing such services, as well as the value of formative research in identifying key concerns among participating communities in resource-limited settings. The significant impact of trial characteristics on WTP suggests that providing trial benefits deemed fair and important, addressing logistical concerns, and supporting educational interventions to mitigate vaccine fears may support recruitment of MSM in India in fairly and ethically conducted HIV vaccine trials.