Addressing Psychosocial Needs and HIV Risk in Indian MSM

MSM in India are at increased risk for HIV in a stigmatizing environment that includes
discrimination and violence. There is a need for evidence-based MSM HIV prevention
interventions that address HIV risk in the context of these psychosocial issues. This study
consists of formative qualitative work followed by the development and testing of a pilot
behavioral HIV prevention intervention for MSM in Chennai, India. Study goals are to
maximize intervention feasibility and acceptability, estimate an effect size for a power
analysis, and prepare for a full-scale trial to follow.

PHASE 1-Intervention Development. This phase involved the collection of formative data
through MSM focus groups and key informant interviews to develop a subsequent pilot
behavioral intervention.

PHASE 2-Open Pilot. Following Phase 1, the team conducted an open-phase non-randomized pilot
of the intervention. Enrollment involved a baseline assessment that included an
interviewer-administered behavioral assessment and voluntary counseling and testing for HIV
and the STIs, syphilis, gonorrhea and chlamydia. Eleven MSM in Chennai then completed 6
group sessions and 4 individual sessions over 3 months. A follow-up behavioral assessment
was administered upon completion of all sessions, and 6 months after baseline participants
were again administered the questionnaire and HIV/STI testing.

PHASE 3-Pilot Randomized Controlled Trial. The study is currently in Phase 3, and the data
articulated in this registry is for Phase 3. We are now conducting a pilot randomized
controlled trial (RCT) of the intervention among 6 "batches" of 8 MSM in each group (n=48).
Comparison groups (n=48) will receive the same baseline assessment and voluntary HIV/STI
counseling and testing as the intervention groups. Based on Phase 2 findings, the
intervention groups will meet for 4 group sessions and 4 individual sessions. Those assigned
to receive the comparison condition will not receive these sessions. Participants complete
the assessments approximately 3 months after randomization, and again 3 months after that.