Addressing Psychosocial Needs and HIV Risk in Indian MSM

NCT ID: NCT01266122

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-11-30

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.

Conditions

HIV/STI Risk; HIV/STI Incidence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

HIV/STI voluntary counseling and testing

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Behavioral intervention

Intervention Type: BEHAVIORAL

The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk.

Interventions

Behavioral intervention

The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk.

Intervention Type: BEHAVIORAL

Other Intervention Names

Psychosocial intervention for MSM in India

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Tuberculosis Research Centre, India

OTHER_GOV

Sponsor Role: collaborator

Fenway Community Health

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Steven A. Safren

Director, Behavioral Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven A. Safren, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital, Boston, Massachusetts, United States

Beena E. Thomas, PhD

Role: PRINCIPAL_INVESTIGATOR

Tuberculosis Research Centre, Chennai, India

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Fenway Community Health

Boston, Massachusetts, United States

Tuberculosis Research Centre

Chennai, Tamil Nadu, India

Countries

United States; India

References

O'Cleirigh C, Safren SA, Taylor SW, Goshe BM, Bedoya CA, Marquez SM, Boroughs MS, Shipherd JC. Cognitive Behavioral Therapy for Trauma and Self-Care (CBT-TSC) in Men Who have Sex with Men with a History of Childhood Sexual Abuse: A Randomized Controlled Trial. AIDS Behav. 2019 Sep;23(9):2421-2431. doi: 10.1007/s10461-019-02482-z.

Reference Type: DERIVED

PMID: 30993478 (View on PubMed)

Other Identifiers

5R21MH085314-02

Identifier Type: NIH

Identifier Source: secondary_id

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5R21MH085314-02

Identifier Type: NIH

Identifier Source: org_study_id

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