Addressing Psychosocial Needs and HIV Risk in Indian MSM

Mass General Brigham

Status: Completed

Conditions: HIV/STI Incidence; HIV/STI Risk

Treatments: Behavioral: Behavioral intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01266122

5R21MH085314-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will develop and pilot test a combined individual and group-level behavioral HIV prevention intervention for men who have sex with men (MSM) in Chennai, India, addressing HIV risk within the context of broader psychosocial issues, including self-acceptance, substance use and social support.

Full description

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.

Enrollment: 96 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Man who has had unprotected sex with another man in past 3 months
• Resident of Tamil Nadu state, India
• Identifies as Khothi or Double-decker

Exclusion criteria

• Does not identify as a man (i.e. Hijra/ Ali/Transgendered)
• Under age 18
• Unable to complete or understand informed consent procedures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

HIV/STI voluntary counseling and testing

No Intervention group

Description:

Participants enrolled in the control arm will receive study assessments only.

Behavioral intervention

Experimental group

Description:

Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.

Treatment:

Behavioral: Behavioral intervention