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: May 14, 2015
Last verified: May 2015
Results First Received: August 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: HIV/STI Risk
HIV/STI Incidence
Intervention: Behavioral: Behavioral intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HIV/STI Voluntary Counseling and Testing Participants enrolled in the control arm will receive study assessments only.
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 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.


Participant Flow:   Overall Study
    HIV/STI Voluntary Counseling and Testing     Behavioral Intervention  
STARTED     48     48  
COMPLETED     42     42  
NOT COMPLETED     6     6  
Lost to Follow-up                 6                 6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HIV/STI Voluntary Counseling and Testing Participants enrolled in the control arm will receive study assessments only.
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 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.

Total Total of all reporting groups

Baseline Measures
    HIV/STI Voluntary Counseling and Testing     Behavioral Intervention     Total  
Number of Participants  
[units: participants]
  48     48     96  
Age  
[units: years]
Mean (Standard Deviation)
  29.7  (8.1)     28.4  (6.9)     29  (7.5)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     48     48     96  



  Outcome Measures
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1.  Primary:   Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant   [ Time Frame: up to 6 months ]

2.  Secondary:   Acquisition of STIs - Number of Participants That Acquired STIs   [ Time Frame: 6 months ]

3.  Secondary:   Changes in Psychosocial Mediators   [ Time Frame: up to 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Steven Safren
Organization: Behavioral Medicine Service, Massachusetts General Hospital
phone: 617-724-0817
e-mail: ssafren@partners.org


No publications provided


Responsible Party: Steven A. Safren, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01266122     History of Changes
Other Study ID Numbers: 5R21MH085314-02, 5R21MH085314-02
Study First Received: November 24, 2010
Results First Received: August 4, 2014
Last Updated: May 14, 2015
Health Authority: United States: Federal Government