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

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ClinicalTrials.gov Identifier: NCT00137631
Recruitment Status : Completed
First Posted : August 30, 2005
Results First Posted : May 14, 2010
Last Update Posted : June 24, 2010
Sponsor:
Collaborator:
University of Rochester
Information provided by:
Centers for Disease Control and Prevention

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Conditions HIV Infections
Sexually Transmitted Diseases
Intervention Behavioral: Many Men, Many Voices (3MV)
Enrollment 341

Recruitment Details From August 2005 through November 2006, People of Color in Crisis Inc. recruited potential participants from venues throughout New York City.
Pre-assignment Details  
Arm/Group Title Many Men, Many Voices (3MV) Intervention Wait List Comparison
Hide Arm/Group Description Receive 6-session intervention immediately after baseline assessment and randomization Receive intervention after 6-month delay (wait list control group)
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title Many Men, Many Voices (3MV) Intervention Wait List Comparison Total
Hide Arm/Group Description Receive 6-session intervention immediately after baseline assessment and randomization Receive intervention after 6-month delay (wait list control group) Total of all reporting groups
Overall Number of Baseline Participants 164 174 338
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 174 participants 338 participants
29.5  (9.1) 29.7  (9.5) 29.6  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 174 participants 338 participants
Female
0
   0.0%
0
   0.0%
0.0
Male
164
 100.0%
174
 100.0%
338.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 164 participants 174 participants 338 participants
164 174 338
1.Primary Outcome
Title Any Unprotected Anal Intercourse (UAI) With Casual Partners
Hide Description Sexual activities with casual male partners in past 3 months (i.e., any unprotected insertive or receptive anal sex)
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Many Men, Many Voices (3MV) Intervention Wait List Comparison
Hide Arm/Group Description:
Receive 6-session intervention immediately after baseline assessment and randomization
Receive intervention after 6-month delay (wait list control group)
Overall Number of Participants Analyzed 127 133
Mean (Standard Deviation)
Unit of Measure: Number of episodes
2.0  (5.6) 6.2  (22.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Many Men, Many Voices (3MV) Intervention, Wait List Comparison
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method negative binomial regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.58
Confidence Interval 95%
0.33 to 1.01
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Reporting HIV Testing Behavior
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Many Men, Many Voices (3MV) Intervention Wait List Comparison
Hide Arm/Group Description:
Receive 6-session intervention immediately after baseline assessment and randomization
Receive intervention after 6-month delay (wait list control group)
Overall Number of Participants Analyzed 126 133
Measure Type: Number
Unit of Measure: participants
69 58
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Many Men, Many Voices (3MV) Intervention, Wait List Comparison
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method generalized estimating equations
Comments Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.33
Confidence Interval 95%
1.05 to 1.68
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Many Men, Many Voices (3MV) Intervention Wait List Comparison
Hide Arm/Group Description:
Receive 6-session intervention immediately after baseline assessment and randomization
Receive intervention after 6-month delay (wait list control group)
Overall Number of Participants Analyzed 127 133
Measure Type: Number
Unit of Measure: participants
43 43
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Many Men, Many Voices (3MV) Intervention, Wait List Comparison
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.17
Confidence Interval 95%
0.69 to 1.98
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Many Men, Many Voices (3MV) Intervention Wait List Comparison
Hide Arm/Group Description:
Receive 6-session intervention immediately after baseline assessment and randomization
Receive intervention after 6-month delay (wait list control group)
Overall Number of Participants Analyzed 127 133
Mean (Standard Deviation)
Unit of Measure: number of episodes
1.1  (3.4) 4.5  (18.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Many Men, Many Voices (3MV) Intervention, Wait List Comparison
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method generalized estimating equations
Comments Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.49
Confidence Interval 95%
0.28 to 0.87
Estimation Comments [Not Specified]
5.Primary Outcome
Title Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Many Men, Many Voices (3MV) Intervention Wait List Comparison
Hide Arm/Group Description:
Receive 6-session intervention immediately after baseline assessment and randomization
Receive intervention after 6-month delay (wait list control group)
Overall Number of Participants Analyzed 127 133
Mean (Standard Deviation)
Unit of Measure: number of episodes
0.9  (3.3) 1.7  (6.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Many Men, Many Voices (3MV) Intervention, Wait List Comparison
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method generalized estimating equations
Comments Tests intervention efficacy over all study periods (baseline, 3-months, and 6-months)
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.80
Confidence Interval 95%
0.42 to 1.53
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Many Men, Many Voices (3MV) Intervention Wait List Comparison
Hide Arm/Group Description Receive 6-session intervention immediately after baseline assessment and randomization Receive intervention after 6-month delay (wait list control group)
All-Cause Mortality
Many Men, Many Voices (3MV) Intervention Wait List Comparison
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Many Men, Many Voices (3MV) Intervention Wait List Comparison
Affected / at Risk (%) Affected / at Risk (%)
Total   0/164 (0.00%)   0/174 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Many Men, Many Voices (3MV) Intervention Wait List Comparison
Affected / at Risk (%) Affected / at Risk (%)
Total   0/164 (0.00%)   0/174 (0.00%) 
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.
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
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 ( Other Grant/Funding Number: Centers for Disease Control and Prevention )
First Submitted: August 26, 2005
First Posted: August 30, 2005
Results First Submitted: March 10, 2010
Results First Posted: May 14, 2010
Last Update Posted: June 24, 2010