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Addressing Psychosocial Needs and HIV Risk in Indian MSM

This study has been completed.
Sponsor:
Collaborators:
Tuberculosis Research Centre, India
Fenway Community Health
Information provided by (Responsible Party):
Steven A. Safren, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01266122
First received: November 24, 2010
Last updated: January 3, 2012
Last verified: January 2012

November 24, 2010
January 3, 2012
January 2010
November 2010   (final data collection date for primary outcome measure)
changes in HIV risk taking behavior [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.
changes in HIV risk taking behavior [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.
Complete list of historical versions of study NCT01266122 on ClinicalTrials.gov Archive Site
  • acquisition of STIs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will test for locally relevant STIs at baseline and 6 months.
  • changes in psychosocial mediators [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.
  • acquisition of STIs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    We will test for locally relevant STIs at baseline and 6 months.
  • changes in psychosocial mediators [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
    We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.
Not Provided
Not Provided
 
Addressing Psychosocial Needs and HIV Risk in Indian MSM
Addressing Psychosocial Needs and HIV Risk in Indian MSM

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • HIV/STI Risk
  • HIV/STI Incidence
Behavioral: 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.
Other Name: Psychosocial intervention for MSM in India
  • No Intervention: HIV/STI voluntary counseling and testing
    Participants enrolled in the control arm will receive study assessments only.
  • Experimental: 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.
    Intervention: Behavioral: Behavioral intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT01266122
5R21MH085314-02, 5R21MH085314-02
Yes
Steven A. Safren, Massachusetts General Hospital
Massachusetts General Hospital
  • National Institute of Mental Health (NIMH)
  • Tuberculosis Research Centre, India
  • Fenway Community Health
Principal Investigator: Steven A. Safren, PhD Massachusetts General Hospital, Boston, Massachusetts, United States
Principal Investigator: Beena E. Thomas, PhD Tuberculosis Research Centre, Chennai, India
Massachusetts General Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP