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Addressing Psychosocial Needs and HIV Risk in Indian MSM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01266122
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : June 1, 2015
Last Update Posted : June 1, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
HIV/STI Risk HIV/STI Incidence Behavioral: Behavioral intervention

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Addressing Psychosocial Needs and HIV Risk in Indian MSM
Study Start Date : January 2010
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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

Outcome Measures

Primary Outcome Measures :
  1. Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant [ Time Frame: up to 6 months ]
    We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.

Secondary Outcome Measures :
  1. Acquisition of STIs - Number of Participants That Acquired STIs [ Time Frame: 6 months ]
    We will test for locally relevant STIs at baseline and 6 months.

  2. Changes in Psychosocial Mediators [ Time Frame: up to 6 months ]
    We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266122

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Fenway Community Health
Boston, Massachusetts, United States, 02215
Tuberculosis Research Centre
Chennai, Tamil Nadu, India
Sponsors and Collaborators
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
More Information

Responsible Party: Steven A. Safren, Director, Behavioral Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01266122     History of Changes
Other Study ID Numbers: 5R21MH085314-02 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2010    Key Record Dates
Results First Posted: June 1, 2015
Last Update Posted: June 1, 2015
Last Verified: May 2015

Keywords provided by Steven A. Safren, Massachusetts General Hospital:
Psychosocial problems