Addressing Psychosocial Needs and HIV Risk in Indian MSM

Not Applicable

Completed

• Conditions: HIV/STI Risk; HIV/STI Incidence
• Interventions: Behavioral: Behavioral intervention

• Registration Number: NCT01266122
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-24
• Results First Submitted: 2014-08-04
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-14
• Last Update Submitted: 2015-05-14
• Results First Posted: 2015-06-01
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral intervention	Behavioral intervention	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.

Primary Outcome Measures

Name	Time	Method
Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant	up to 6 months	We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.

Secondary Outcome Measures

Name	Time	Method
Acquisition of STIs - Number of Participants That Acquired STIs	6 months	We will test for locally relevant STIs at baseline and 6 months.
Changes in Psychosocial Mediators	up to 6 months	We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.

Trial Locations

Locations (3)

Fenway Community Health; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Tuberculosis Research Centre; 🇮🇳 Chennai, Tamil Nadu, India