Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM (3MV)

This study has been completed.
Sponsor:
Collaborator:
University of Rochester
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00137631
First received: August 26, 2005
Last updated: June 23, 2010
Last verified: April 2010
Results First Received: March 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Conditions: HIV Infections
Sexually Transmitted Diseases
Intervention: Behavioral: Many Men, Many Voices (3MV)

  Participant Flow


  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.
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Reporting Groups
  Description
Many Men, Many Voices (3MV) Intervention Receive 6-session intervention immediately after baseline assessment and randomization
Wait List Comparison Receive intervention after 6-month delay (wait list control group)
Total Total of all reporting groups

Baseline Measures
    Many Men, Many Voices (3MV) Intervention     Wait List Comparison     Total  
Number of Participants  
[units: participants]
  164     174     338  
Age  
[units: years]
Mean ± Standard Deviation
  29.5  ± 9.1     29.7  ± 9.5     29.6  ± 9.3  
Gender  
[units: participants]
     
Female     0     0     0  
Male     164     174     338  
Region of Enrollment  
[units: participants]
     
United States     164     174     338  



  Outcome Measures
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1.  Primary:   Any Unprotected Anal Intercourse (UAI) With Casual Partners   [ Time Frame: 6 months ]

2.  Primary:   Number of Participants Reporting HIV Testing Behavior   [ Time Frame: 6 months ]

3.  Primary:   Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior   [ Time Frame: 6 months ]

4.  Primary:   Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners   [ Time Frame: 6 months ]

5.  Primary:   Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners   [ Time Frame: 6 months ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Leo Wilton, PhD
Organization: Department of Human Development, State University of New York at Binghamton
phone: 607-777-9215
e-mail: lwilton@binghamton.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Executive Director, People of Color in Crisis, Inc.
ClinicalTrials.gov Identifier: NCT00137631     History of Changes
Other Study ID Numbers: CDC-NCHSTP-CCU224517, U65/CCU224517-01
Study First Received: August 26, 2005
Results First Received: March 10, 2010
Last Updated: June 23, 2010
Health Authority: United States: Federal Government