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 ]

Measure Type Primary
Measure Title Any Unprotected Anal Intercourse (UAI) With Casual Partners
Measure Description Sexual activities with casual male partners in past 3 months (i.e., any unprotected insertive or receptive anal sex)
Time Frame 6 months  
Safety Issue No  

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)

Measured Values
    Many Men, Many Voices (3MV) Intervention     Wait List Comparison  
Number of Participants Analyzed  
[units: participants]
  127     133  
Any Unprotected Anal Intercourse (UAI) With Casual Partners  
[units: Number of episodes]
Mean ± Standard Deviation
  2.0  ± 5.6     6.2  ± 22.7  


Statistical Analysis 1 for Any Unprotected Anal Intercourse (UAI) With Casual Partners
Groups [1] All groups
Method [2] negative binomial regression
P Value [3] < 0.05
Rate Ratio [4] 0.58
95% Confidence Interval ( 0.33 to 1.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Primary
Measure Title Number of Participants Reporting HIV Testing Behavior
Measure Description No text entered.
Time Frame 6 months  
Safety Issue No  

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)

Measured Values
    Many Men, Many Voices (3MV) Intervention     Wait List Comparison  
Number of Participants Analyzed  
[units: participants]
  126     133  
Number of Participants Reporting HIV Testing Behavior  
[units: participants]
  69     58  


Statistical Analysis 1 for Number of Participants Reporting HIV Testing Behavior
Groups [1] All groups
Method [2] generalized estimating equations
P Value [3] < 0.05
Odds Ratio (OR) [4] 1.33
95% Confidence Interval ( 1.05 to 1.68 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Primary
Measure Title Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior
Measure Description No text entered.
Time Frame 6 months  
Safety Issue No  

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)

Measured Values
    Many Men, Many Voices (3MV) Intervention     Wait List Comparison  
Number of Participants Analyzed  
[units: participants]
  127     133  
Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior  
[units: participants]
  43     43  


Statistical Analysis 1 for Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior
Groups [1] All groups
Method [2] Mixed Models Analysis
P Value [3] < 0.05
Odds Ratio (OR) [4] 1.17
95% Confidence Interval ( 0.69 to 1.98 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Primary
Measure Title Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners
Measure Description No text entered.
Time Frame 6 months  
Safety Issue No  

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)

Measured Values
    Many Men, Many Voices (3MV) Intervention     Wait List Comparison  
Number of Participants Analyzed  
[units: participants]
  127     133  
Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners  
[units: number of episodes]
Mean ± Standard Deviation
  1.1  ± 3.4     4.5  ± 18.6  


Statistical Analysis 1 for Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners
Groups [1] All groups
Method [2] generalized estimating equations
P Value [3] < 0.05
Rate Ratio [4] 0.49
95% Confidence Interval ( 0.28 to 0.87 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Primary
Measure Title Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners
Measure Description No text entered.
Time Frame 6 months  
Safety Issue No  

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)

Measured Values
    Many Men, Many Voices (3MV) Intervention     Wait List Comparison  
Number of Participants Analyzed  
[units: participants]
  127     133  
Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners  
[units: number of episodes]
Mean ± Standard Deviation
  0.9  ± 3.3     1.7  ± 6.8  


Statistical Analysis 1 for Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners
Groups [1] All groups
Method [2] generalized estimating equations
P Value [3] < 0.05
Rate Ratio [4] 0.80
95% Confidence Interval ( 0.42 to 1.53 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.




  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