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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
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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
From August 2005 through November 2006, People of Color in Crisis Inc. recruited potential participants from venues throughout New York City.

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
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)

Participant Flow:   Overall Study
    Many Men, Many Voices (3MV) Intervention     Wait List Comparison  
STARTED     164     174  
Complete 3-month Follow-up     120     125  
Completed 6-month Follow-up     127 [1]   133 [2]
COMPLETED     127     133  
NOT COMPLETED     37     41  
Lost to Follow-up                 37                 41  
[1] 7 participants who were lost to follow-up at 3-months were retained at 6-months
[2] 8 participants who were lost to follow-up at 3-months were retained at 6-months



  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
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


  More Information