Understanding the Acceptability of Broadly Neutralizing Antibodies for HIV Prevention Among At-Risk Populations and Feasibility Considerations for Product Introduction in India: Protocol for a Qualitative Study.

BACKGROUND: Acceptability and preference research play a crucial role in the design, evaluation, and implementation of any new prevention product in any geographical setting. They also play a critical role in the development of clinical guidelines and policies. A wide range of acceptability studies have been conducted in diverse general and key populations for various new HIV prevention products worldwide. As clinical development strategies are being developed for clinical studies of broadly neutralizing antibodies (bNAbs) as potential HIV prevention products, appropriately tailoring them to address the type of HIV epidemic at hand would be critical for efficient uptake within in-country public health systems and decrease adoption and adherence challenges. Accomplishing this will require comprehensive acceptability and feasibility studies to inform multisectoral efforts that increase access to these products and national policies supportive of access to health care for those in most need. Thus, it is both opportune and important to undertake focused efforts toward informing product development strategies. OBJECTIVE: This study aims to understand preferences for product attributes and key behavioral factors influencing adoption and uptake of bNAb prevention products among end-users including female sex workers, men who have sex with men, transgender women, people who inject drugs, and adolescent girls and young women in India and understand the key health system and programmatic perspectives toward the introduction of bNAb prevention products from health service providers and policy makers in India. METHODS: A multisite study will be conducted in Delhi, Mumbai, and Chennai to capture the differences in perspectives among diverse end-users and key informants across the country. The study will use a multimethods design using focus group discussions, in-depth interviews, simulated behavioral experiments, and key informant interviews. A total of 30 focus group discussions, 45 in-depth interviews, 15 simulated behavioral experiments sessions, and 15 key informant interviews will be conducted across 3 sites. RESULTS: The data collected and analyzed will enable insights on which specific product attributes matter the most to the populations and why some attributes are less preferred; contextual drivers of preferences and choices at individual, interpersonal, social, and structural levels; and relative positioning of bNAb products among other potential HIV prevention products. Insights from the health service providers and policy makers will provide a critical understanding of the need perception of the potential product in the existing product landscape and what additional efforts and resources are required for potential introduction, delivery, and uptake of the bNAb products in the Indian context. CONCLUSIONS: Insights generated from the abovementioned objectives will represent perspectives of populations of interest across geographies in India, will provide an overview of the acceptability of bNAb products and the feasibility of their introduction in this region, and will inform product development strategies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47700.

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.

HIV Testing by Gender Identity Among Sexually Active Transgender-, Intersex-, and Hijra Individuals Reached Online in India.

Online outreach may be an important strategy to reach Indian gender minority (GM) populations for HIV testing. However, little is known about Indian GM populations reached online who are sexually active and their HIV testing behaviors. We conducted a secondary analysis of an India wide online cross-sectional survey to assess HIV testing and identify associated factors. The 467 GM respondents identified their gender as transgender women (29.6%), Hijra (5.1%), intersex (37%), or gender non-binary (28.3%). Overall, almost half (47.5%) had never been tested for HIV; among respondents having condomless anal sex, half (50%) reported never testing for HIV. A decreased odds of ever HIV testing was associated with being unsure how to access free testing (compared to being easy; AOR = 0.36, 95%CI 0.20, 0.63) and unaware of comfortable testing sites (AOR = 0.32, 95% CI 0.20, 0.63). Increased odds of testing were associated with identifying as Hijra (compared to transgender women; AOR = 4.07, 95%CI 1.18-16.92) and disclosing sexual behaviors to a doctor (AOR = 3.20, 95% CI 1.91, 5.46). In this GM sample recruited online, HIV testing rates were low. Online interventions are needed to engage individuals with diverse GM identities in India for linkage to accessible and acceptable HIV testing options.

Longitudinal impact of stressful life events on HIV-related risk and psychosocial problems among MSM in Chennai and Mumbai, India.

BACKGROUND: Studies show that stressful life events (SLE) (e.g., discrimination, financial problems) can lead to psychosocial problems and exacerbate condomless anal sex (CAS) without protection via pre-exposure prophylaxis (PrEP) among men who have sex with men. However, few studies have examined this relationship among men who have sex with men in India, and none have examined this longitudinally. METHODS: As a part of an HIV-prevention intervention, 608 MSM from Chennai and Mumbai, India, completed behavioral surveys at baseline, 4, 8, and 12 months. We used longitudinal generalized estimating equations (GEE) modeling to examine the relationship between SLE and its severity and subsequent psychosocial problems, CAS, and history of diagnosed sexually transmitted infection (STI). All models are adjusted for age, sexual identity, intervention arm, human immunodeficiency virus status, and recruitment city. RESULTS: The number of SLE and their corresponding perceived impact score remained consistent at each time point. In multivariable GEE models, the number of SLE was predictive of CAS, depression, and harmful drinking. Similarly, the ratio of the impact of SLE was predictive of CAS, depression, and diagnosed STI. However, harmful drinking was not predictive in this model. CONCLUSIONS: These findings provide evidence that can inform future interventions, which can be used to enhance self-acceptance, coping skills, and other forms of resiliency.

Mental health, economic well-being and health care access amid the COVID-19 pandemic: a mixed methods study among urban men who have sex with men in India.

Scant empirical research from Asia has addressed the impact of COVID-19 on sexual minority health. We aimed to explore and understand the impact of COVID-19 on income security, mental health, HIV risk and access to health services among men who have sex with men (MSM) in India. We conducted a concurrent mixed methods study from April to June 2020, including a cross-sectional survey and in-depth semi-structured interviews with MSM recruited from three non-governmental organisations providing HIV prevention services in Chandigarh, India. We examined the associations of sexual minority stressors (sexual stigma, internalised homonegativity), economic stressors, and stress due to social distancing, with depression and anxiety, HIV risk, and access to health services. Survey findings (n = 132) indicated that internalised homonegativity and stress related to social distancing were significantly associated with depressive and anxiety symptoms. Results also showed reduced access to condoms, HIV testing and counselling services. Qualitative findings (n = 10) highlighted adverse economic impacts of COVID-19, including loss of employment/wages and engaging in survival sex work, which contributed to psychological distress and HIV risk. The COVID-19 pandemic has resulted in considerable psychological and financial distress among low socioeconomic status MSM in India, including those involved in sex work - communities already marginalised in economic, family and healthcare sectors. Structural interventions to improve access to mental health and HIV services and decrease financial burden are critical to mitigate the impact of COVID-19.

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.

The cost-effectiveness of a resilience-based psychosocial intervention for HIV prevention among MSM in India.

OBJECTIVE: MSM in India are at a high risk for HIV infection given psychosocial challenges, sexual orientation stress, and stigma. We examined the cost-effectiveness of a novel resilience-based psychosocial intervention for MSM in India. DESIGN: We parameterized a validated microsimulation model (CEPAC) with India-specific data and results from a randomized trial and examined two strategies for MSM: status quo HIV care ( SQ ), and a trial-based psychosocial intervention ( INT ) focused on building resilience to stress, improving mental health, and reducing condomless anal sex (CAS). METHODS: We projected lifetime clinical and economic outcomes for MSM without HIV initially. Intervention effectiveness, defined as reduction in self-reported CAS, was estimated at 38%; cost was $49.37/participant. We used a willingness-to-pay threshold of US$2100 (2019 Indian per capita GDP) per year of life saved (YLS) to define cost-effectiveness. We also assessed the 5-year budget impact of offering this intervention to 20% of Indian MSM. RESULTS: Model projections showed the intervention would avert 2940 HIV infections among MSM over 10 years. Over a lifetime horizon, the intervention was cost-effective (ICER = $900/YLS). Results were most sensitive to intervention effectiveness and cost; the intervention remained cost-effective under plausible ranges of these parameters. Offering this intervention in the public sector would require an additional US$28 M over 5 years compared with SQ . CONCLUSION: A resilience-based psychosocial intervention integrated with HIV risk reduction counseling among MSM in India would reduce HIV infections and be cost-effective. Programs using this approach should be expanded as a part of comprehensive HIV prevention in India.

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.

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.

An eHealth Intervention for Promoting COVID-19 Knowledge and Protective Behaviors and Reducing Pandemic Distress Among Sexual and Gender Minorities: Protocol for a Randomized Controlled Trial (#SafeHandsSafeHearts).

BACKGROUND: Existing data on COVID-19 disparities among vulnerable populations portend excess risk for lesbian, gay, bisexual, transgender (LGBT) and other persons outside of heteronormative and cisgender identities (ie, LGBT+). Owing to adverse social determinants of health, including pervasive HIV and sexual stigma, harassment, violence, barriers in access to health care, and existing health and mental health disparities, sexual and gender minorities in India and Thailand are at disproportionate risk for SARS-CoV-2 infection and severe disease. Despite global health disparities among LGBT+ populations, there is a lack of coordinated, community-engaged interventions to address the expected excess burden of COVID-19 and public health-recommended protective measures. OBJECTIVE: We will implement a randomized controlled trial (RCT) to evaluate the effectiveness of a brief, peer-delivered eHealth intervention to increase COVID-19 knowledge and public health-recommended protective behaviors, and reduce psychological distress among LGBT+ people residing in Bangkok, Thailand, and Mumbai, India. Subsequent to the RCT, we will conduct exit interviews with purposively sampled subgroups, including those with no intervention effect. METHODS: SafeHandsSafeHearts is a 2-site, parallel waitlist-controlled RCT to test the efficacy of a 3-session, peer counselor-delivered eHealth intervention based on motivational interviewing and psychoeducation. The study methods, online infrastructure, and content were pilot-tested with LGBT+ individuals in Toronto, Canada, before adaptation and rollout in the other contexts. The primary outcomes are COVID-19 knowledge (index based on US Centers for Disease Control and Prevention [CDC] items), protective behaviors (index based on World Health Organization and US CDC guidelines), depression (Patient Health Questionnaire-2), and anxiety (Generalized Anxiety Disorder-2). Secondary outcomes include loneliness, COVID-19 stress, and intended care-seeking. We will enroll 310 participants in each city aged 18 years and older. One-third of the participants will be cisgender gay, bisexual, and other men who have sex with men; one-third will be cisgender lesbian, bisexual, and other women who have sex with women; and one-third will be transfeminine, transmasculine, and gender nonbinary people. Participants will be equally stratified in the immediate intervention and waitlist control groups. Participants are mainly recruited from online social media accounts of community-based partner organizations. They can access the intervention on a computer, tablet, or mobile phone. SafeHandsSafeHearts involves 3 sessions delivered weekly over 3 successive weeks. Exit interviews will be conducted online with 3 subgroups (n=12 per group, n=36 in each city) of purposively selected participants to be informed by RCT outcomes and focal populations of concern. RESULTS: The RCT was funded in 2020. The trials started recruitment as of August 1, 2021, and all RCT data collection will likely be completed by January 31, 2022. CONCLUSIONS: The SafeHandsSafeHearts RCT will provide evidence about the effectiveness of a brief, peer-delivered eHealth intervention developed for LGBT+ populations amid the COVID-19 pandemic. If the intervention proves effective, it will provide a basis for future scale-up in India and Thailand, and other low- and middle-income countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT04870723; https://clinicaltrials.gov/ct2/show/NCT04870723. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34381.

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.

Strengthening resilience to reduce HIV risk in Indian MSM: a multicity, randomised, clinical efficacy trial.

BACKGROUND: Men who have sex with men (MSM) in India are extremely marginalised and stigmatised, and therefore experience immense psychosocial stress. As current HIV prevention interventions in India do not address mental health or resilience to these stressors, we aimed to evaluate a resilience-based psychosocial intervention in the context of HIV and sexually transmitted infection (STI) prevention. METHODS: We did a multicity, randomised, clinical efficacy trial in Chennai (governmental tuberculosis research institute) and Mumbai (non-governmental organisation for MSM), India. Inclusion criteria were MSM, aged 18 years or older, who were at risk of HIV acquisition or transmission, defined as having any of the following in the 4 months before screening: anal sex with four or more male partners (protected or unprotected), diagnosis of an STI, history of transactional sex activity, or condomless anal sex with a man who was of unknown HIV status or serodiscordant. Participants were required to speak English, Tamil (in Chennai), or Hindi (in Mumbai) fluently. Eligible individuals were randomly assigned (1:1) to either a resilience-based psychosocial HIV prevention intervention, consisting of group (four sessions) and individual (six sessions) counselling alongside HIV and STI voluntary counselling and testing, or a standard-of-care control comprising voluntary counselling and testing alone. The primary outcomes were number of condomless anal sex acts with male partners during the past month (at baseline and 4 months, 8 months, and 12 months after randomisation), and incident bacterial STIs (at 12 months after randomisation). Resilience-related mediators included self-esteem, self-acceptance, and depression. Recruitment is now closed. This trial is registered with ClinicalTrials.gov, NCT02556294. FINDINGS: Between Sept 4, 2015, and June 28, 2018, we enrolled 608 participants; 305 (50%) were assigned to the psychosocial intervention condition and 303 (50%) were assigned to the control condition. 510 (84%) of 608 men completed an assessment at 4 months after randomisation, 483 (79%) at 8 months, and 515 (85%) at 12 months. 512 (99%) of 515 men had STI data from the 12-month assessment. The intervention condition had a 56% larger reduction in condomless anal sex acts (95% CI 35-71; p<0·0001) from baseline to 4-month follow-up, 72% larger reduction (56-82; p<0·0001) from baseline to 8-month follow-up, and 72% larger reduction (53-83; p<0·0001) from baseline to 12-month follow-up, compared with the standard-of-care control condition (condition by time interaction; χ2=40·29, 3 df; p<0·0001). Improvements in self-esteem and depressive symptoms both mediated 9% of the intervention effect on condomless anal sex acts. Bacterial STI incidence did not differ between study conditions at 12-month follow-up. INTERPRETATION: A resilience-based psychosocial intervention for MSM at risk of HIV acquisition or transmission in India was efficacious in reducing condomless anal sex acts, with evidence for mediation effects in two key target resilience variables. HIV prevention programmes for MSM in India should address mental health resilience to augment reductions in the risk of sexually transmitted HIV. FUNDING: National Institute of Mental Health.

Geographic and behavioral differences associated with sexually transmitted infection prevalence among Indian men who have sex with men in Chennai and Mumbai.

India has one of the largest numbers of men who have sex with men (MSM) globally; however, geographic data on sexually transmitted infection (STI) prevalence and associations with sexual behavior are limited. Six-hundred and eight MSM in Chennai and Mumbai underwent screening for a behavioral trial and were assessed for bacterial STIs (syphilis, chlamydia, gonorrhea), HIV, and past-month self-reported condomless anal sex (CAS). Mumbai (37.8%) had a greater prevalence of any STI than Chennai (27.6%) (prevalence ratio [PR] = 1.37, 95% CI: 1.09, 1.73). This pattern also emerged for gonorrhea and chlamydia separately but not syphilis. Conversely, Mumbai MSM reported lower rates of CAS (mean = 2.2) compared to Chennai MSM (mean = 14.0) (mean difference = -11.8, 95% CI: -14.6, -9.1). The interaction of city by CAS on any STI prevalence (PR = 2.09, 95% CI: 1.45, 3.01, p < .0001) revealed that in Chennai, higher rates of CAS were not associated with STI prevalence, but in Mumbai they were (PR = 2.49, 95% CI: 1.65, 3.76, p < .0001). The higher prevalence of bacterial STIs but lower frequency of CAS in Mumbai (versus Chennai), along with the significant interaction of CAS with city on STI rates, suggests that there are either differences in disease burden or differences by city with respect to self-reported assessment of CAS. Regardless, the high prevalence rates of untreated STIs and condomless sex among MSM suggest the need for additional prevention intervention efforts for MSM in urban India.

An Internet-Based, Peer-Delivered Messaging Intervention for HIV Testing and Condom Use Among Men Who Have Sex With Men in India (CHALO!): Pilot Randomized Comparative Trial.

BACKGROUND: Leveraging internet-based communication tools (eg, messaging apps, SMS text messaging, and email) may be an effective avenue for delivery of HIV prevention messages to men who have sex with men (MSM) in India, but there are limited models for such internet-based interventions. OBJECTIVE: The CHALO! pilot was an online educational and behavioral intervention aimed to determine the feasibility, acceptability, and preliminary impact of a peer-delivered, internet-based messaging intervention for HIV testing and consistent condom use for MSM in India. The messages addressed barriers to HIV testing and condom use and were theoretically based on the information-motivation-behavioral skills model. METHODS: Between February and March 2015, we recruited, enrolled, and randomized 244 participants via online advertisements on mobile dating apps and Facebook. Eligible men (18 years or older, sexually active with other men, and self-reported HIV-negative or unknown status) were randomized to receive educational and motivational messages framed as either approach (ie, a desirable outcome to be achieved) or avoidance (an undesirable outcome to be avoided) over 12 weeks via internet-based messaging platforms. Participants completed online surveys at baseline and immediately postintervention. RESULTS: Participants were similar across arms with respect to sociodemographic and behavioral characteristics. Over 82.0% (200/244) of participants were retained (ie, viewed final messages), and 52.3% (130/244) of them completed the follow-up survey. Of those completing the follow-up survey, 82.3% (107/130) liked or strongly liked participating in CHALO!. The results showed a significant increase in self-reported HIV testing in the past 6 months from baseline to follow-up (41/130, 31.5% to 57/130, 43.8%; P=.04). When including those who reported intentions to test, this percentage increased from 44.6% (58/130) at baseline to 65.4% (85/130) at follow-up (P<.01). When examining intentions to test among those without prior HIV testing, intentions increased from 32% (16/50) of the sample at baseline to 56% (28/50) of the sample at follow-up (P=.02). Condom use during anal sex did not significantly change from baseline to follow-up. HIV testing and condom use did not significantly differ between approach and avoidance conditions at follow-up. CONCLUSIONS: As one of the first studies of an online HIV prevention intervention for Indian MSM, CHALO! was feasible to implement by a community-based organization, was acceptable to participants, and demonstrated potential to improve HIV testing rates.

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.

Information, Motivation, and Self-Efficacy Among Men Who Have Sex With Men and Transgender Women in the State of Maharashtra, India.

BACKGROUND: India's National AIDS Control Programme calls for, among other things, targeted behavioral interventions that address determinants contributing to new infections among men who have sex with men (MSM) and hijras (transgender women). AIM: To determine if the information-motivation-behavioral skills model was transferable to an Indian context. METHODS: We recruited 442 MSM and 7 hijras into an online cross-sectional study that asked questions about condom use knowledge, motivation, self-efficacy, and sexual behavior. Structural equation modeling was used to test the overall information-motivation-behavioral skills structure. RESULTS: Condom use and HIV risk knowledge did not significantly predict condom use self-efficacy or having condomless anal sex with more than one male partner in the past 3 months, and knowledge was not significantly correlated with attitudes toward barebacking. Despite this, the final structural model explained 14.4% of the variance in condom use self-efficacy and 20.0% of the variance in risky sexual behavior. Overall fit of the model was good: χ2(201, N = 447) = 445.002, p < .0001, root mean square error of approximation = .052, 90% CI [.046, .059], comparative fit index = .989, Tucker-Lewis Index = .987. CONCLUSION: The public health response to India's HIV epidemic is currently different than in the West due to differences in medication access and public health infrastructure. As Indian MSM and hijras learn more about the effectiveness of viral suppression and hopefully have greater access to preexposure prophylaxis, researchers should monitor for changing attitudes toward condoms and be prepared to collaborate with the public health infrastructure in order to develop interventions that reinforce positive attitudes toward condom use.

Humanizing an Invisible Population in India: Voices from Bisexual Men Concerning Identity, Life Experiences, and Sexual Health.

Research examining the sexual identities, behaviors, and experiences of bisexual men outside of Western contexts (including in India) is limited. Individuals who self-identify as bisexual due to their orientation toward partners of more than one gender face distinct psychosocial challenges relative to exclusively heterosexual, gay/lesbian, or other individuals. We conducted four focus group discussions (n = 22) and in-depth interviews (n = 50) with self-identified bisexual men (age 18 years and older) who were recruited from the metropolitan area of Mumbai, India, between June and August 2013. We triangulated and analyzed focus group and interview data using standard qualitative research techniques. Findings from our study suggest that multiple factors influence the sexual experiences of self-identified bisexual men in Mumbai, including contexts of sexual interactions, sexual positioning, and the gender of sexual partners. Participants described cultural meaning systems and psychosocial dynamics that regulate bisexual identity development, disclosure, and sexual decision making with male, female, and other partners. Secrecy, discretion, and sexual pleasure also influenced sexual behaviors and relationships. Although Western sexual identity categories are not necessarily equivalent in the Indian context, it is interesting and important to note that a number of individuals in India continue to use the identity label of "bisexual." Before developing interventions to meet unique sexual health needs of bisexual men, it is crucial to understand how these men perceive themselves, reconcile the ordinary aspects of their lives with their sexuality, and structure their relationships with partners.

A randomized clinical efficacy trial of a psychosocial intervention to strengthen self-acceptance and reduce HIV risk for MSM in India: study protocol.

BACKGROUND: Men who have sex with men (MSM) in India are a key group at risk for HIV acquisition and transmission. They are also an extremely marginalized and stigmatized population, facing immense psychosocial stressors including, but not limited to, stigma, homophobia, discrimination, criminalization, low self-esteem, low self-acceptance, distress, and, as a result, high rates of mental health problems. Although these multi-level psychosocial problems may put MSM at high risk for HIV acquisition and transmission, currently HIV prevention interventions in India do not address them. This paper describes the design of a psychosocial intervention to reduce HIV risk for MSM in India. METHODS: Funded by the National Institute of Mental Health, this study is a two-arm randomized clinical efficacy trial of a self-acceptance based psychosocial HIV prevention intervention, informed by the minority stress model and syndemic theory, that was developed with extensive community-based formative work and input from the Indian MSM community and key informants who are knowledgeable about the experiences faced by MSM in India. Participants are MSM in Chennai and Mumbai who endorsed recent sexual behaviors placing them at high risk for HIV/sexually transmitted infection (STI) acquisition and transmission. Enrolled participants are equally randomized to either 1) the experimental condition, which consists of four group and six individual counseling sessions and includes standard of care HIV/STI testing and counseling, or 2) the standard of care condition, which includes HIV/STI testing and counseling alone. The primary outcomes are changes in the frequency of condomless anal sex acts and STI incidence (syphilis seropositivity and urethral, rectal, and pharyngeal gonorrhea and chlamydia infection. Major study assessment visits occur at baseline, 4-, 8-, and 12-months. DISCUSSION: HIV prevention interventions that address the psychosocial stressors faced by MSM in India are needed; this study will examine the efficacy of such an intervention. If the intervention is successful, it may be able to reduce the national HIV/AIDS burden in India while empowering a marginalized and highly stigmatized group. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02556294 , registered 22 September 2015.

Recommendations for the Development of a Mobile HIV Prevention Intervention for Men Who Have Sex With Men and Hijras in Mumbai: Qualitative Study.

BACKGROUND: As Internet and mobile phone use expands in India, there is an opportunity to develop mobile health (mHealth) interventions for marginalized populations, including men who have sex with men (MSM) and hijras (transgender women), hesitant to access traditional health care systems. OBJECTIVE: The purpose of this study was to determine if an mHealth intervention was acceptable to MSM and hijras living in Mumbai, and if so, what features would be useful in targeting the prevention of HIV acquisition and to increase the quality of life among persons living with HIV/AIDS. METHODS: Data from 4 focus groups with MSM and interviews with 4 hijras, 10 health service providers, and 8 mHealth developers were thematically analyzed. RESULTS: Once the need for an mHealth intervention was confirmed, comments about features were organized into 3 themes: content, interface, and retention. Content subthemes included providing sex education for younger community members, providing information about STIs, and providing information and social support for persons living with HIV. Interface subthemes included presenting content using pictures; using videos to present stories of role models; using push notifications for testing, appointment, and medication reminders; using geolocation to link to just-in-time services; and using telemedicine to increase access to health service providers and community services. The 5 retention subthemes included keeping it fun, using gaming mechanics, developing content in regional languages, protecting confidentiality, and linking to social networking apps. CONCLUSIONS: These findings may help inform mHealth development in India.

Substance Use, Mental Health, HIV Testing, and Sexual Risk Behavior Among Men Who Have Sex With Men in the State of Maharashtra, India.

Among 433 men who have sex with men in Maharashtra, India who completed an online survey, 23% reported hazardous drinking, 12% illicit substance, and 9% polysubstance use. The overall prevalence of depression and intimate partner violence (IPV) were 58% and 56%, respectively. Participants engaging in hazardous drinking had more sexual partners and were less likely to be married to women. Participants reporting illicit substance use or polysubstance use were more likely to have been out, had more sexual partners, or experienced IPV. Those reporting illicit substance use were more likely to engage in condomless anal sex. Based on our findings, we suggest that public health interventions integrate HIV, substance use, and mental health services.