India has the world's third largest HIV epidemic1, and given the population size, one of the largest, if not the largest, populations of men who have sex with men (MSM) in the world. MSM in India have an estimated seroprevalence of 14.7%. HIV prevention efforts for MSM in India are limited to condom distribution and HIV education, with no existing efficacy trials of interventions and therefore no evidenced- based interventions this population. They are hidden, stigmatized, and face considerable psychosocial stressors, including pressure to marry, which increases the risk for HIV transmission to their wives. Preliminary studies. This proposal is the culmination of our ongoing, successful >10-year community- based research collaboration with two NGOs dedicated to HIV prevention among MSM, Sahodaran (Chennai) and The Humsafar Trust (Mumbai), and investigators from the India Council of Medical Research (ICMR), National Institute for Research in Tuberculosis (NIRT) in Chennai. We have, in every phase of the development of this proposal (and throughout each of our preliminary studies), engaged the community in developing the research ideas, forming the program of research, designing / refining the studies, and disseminating the results to inform next-steps. Preliminary studies include: 1) documenting the exceptionally high rates of distress / mental health problems in MSM in Mumbai2, 2) documenting, in Chennai, the high prevalence of HIV and sexual risk, and the important surrounding psychosocial context3-5, 3) conducting a three-phased Indo-U.S. sponsored R21 including extensive formative work from CABs, focus groups with representative MSM, and key informant interviews to develop our self-acceptance based model of self care in the context of pervasive stigma and discrimination facing Indian MSM. We field tested and then conducted a feasibility pilot RCT (with CAB feedback throughout) of the resulting intervention comparing it to HIV voluntary counseling and testing (VCT) alone. This field test and pilot RCT showed high participant acceptability and feasibility of study procedures, and success reducing HIV sexual risk behavior. Design. MSM in Chennai and Mumbai will be randomized to either: 1) a self-acceptance based HIV sexual risk reduction intervention and HIV/STI VCT, or 2) HIV/STI VCT. Those randomized to the experimental intervention will receive 4 group sessions focused on building self-acceptance, social support and HIV risk reduction skills and 6 individual sessions focused on personalized HIV risk reduction plans and, as needed, prevention case management. Participants will be followed for one year, with STI incidence and HIV risk behavior as primary outcomes and psychosocial mediators secondary. Cost effectiveness of the intervention will be calculated compared to HIV/STI VCT alone, considering individual and public health benefits as well as downstream cost-savings due to infections averted.
India is the home to one of the largest, if not the largest populations of MSM in the world, and these men face enormous and unique psychosocial challenges and HIV risk. Currently, prevention efforts for MSM in India mainly involve condom distribution and HIV education;none have addressed the unique cultural and psychosocial context for this population, none have been tested in an RCT powered to examine efficacy, and there is no evidence base for NGOs to draw upon for interventions to help this population in need. A successful intervention for increasing self-acceptance and reducing HIV risk has the potential to decrease significant psychosocial distress, offset new HIV infections, and thus decrease the burden of HIV/AIDS nationally in India, and globally, given the size of the MSM population in India.
