NCT01266122

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

June 1, 2015

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

10 months

First QC Date

November 24, 2010

Results QC Date

August 4, 2014

Last Update Submit

May 14, 2015

Conditions

HIV/STI RiskHIV/STI Incidence

Keywords

HIVPsychosocial problemsMSMIndia

Outcome Measures

Primary Outcomes (1)

  • Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant

    We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.

    up to 6 months

Secondary Outcomes (2)

  • Acquisition of STIs - Number of Participants That Acquired STIs

    6 months

  • Changes in Psychosocial Mediators

    up to 6 months

Study Arms (2)

HIV/STI voluntary counseling and testing

NO INTERVENTION

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

Behavioral intervention

EXPERIMENTAL

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

Interventions

Behavioral interventionBEHAVIORAL

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.

Also known as: Psychosocial intervention for MSM in India
Behavioral intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Fenway Community Health

Boston, Massachusetts, 02215, United States

Location

Tuberculosis Research Centre

Chennai, Tamil Nadu, India

Location

Related Publications (1)

  • 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.

    PMID: 30993478DERIVED

MeSH Terms

Interventions

Behavior TherapyPsychosocial Interventiondimethyl sulfone

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Steven Safren
Organization
Behavioral Medicine Service, Massachusetts General Hospital
ssafren@partners.org
617-724-0817

Study Officials

  • Steven A. Safren, PhD

    Massachusetts General Hospital, Boston, Massachusetts, United States

    PRINCIPAL INVESTIGATOR

  • Beena E. Thomas, PhD

    Tuberculosis Research Centre, Chennai, India

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Behavioral Medicine

Study Record Dates

First Submitted

November 24, 2010

First Posted

December 24, 2010

Study Start

January 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

June 1, 2015

Results First Posted

June 1, 2015

Record last verified: 2015-05

Locations

IN(1)US(2)