Trial Outcomes & Findings for Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM (NCT NCT00137631)

NCT ID: NCT00137631

Last Updated: 2010-06-24

Results Overview

Sexual activities with casual male partners in past 3 months (i.e., any unprotected insertive or receptive anal sex)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 341 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2010-06-24

Participant Flow

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

Participant milestones

Measure	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)
Overall Study STARTED	164	174
Overall Study Complete 3-month Follow-up	120	125
Overall Study Completed 6-month Follow-up	127	133
Overall Study COMPLETED	127	133
Overall Study NOT COMPLETED	37	41

Reasons for withdrawal

Measure	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)
Overall Study Lost to Follow-up	37	41

Baseline Characteristics

Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM

Baseline characteristics by cohort

Measure	Many Men, Many Voices (3MV) Intervention n=164 Participants Receive 6-session intervention immediately after baseline assessment and randomization	Wait List Comparison n=174 Participants Receive intervention after 6-month delay (wait list control group)	Total n=338 Participants Total of all reporting groups
Age Continuous	29.5 years STANDARD_DEVIATION 9.1 • n=5 Participants	29.7 years STANDARD_DEVIATION 9.5 • n=7 Participants	29.6 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Sex: Female, Male Male	164 Participants n=5 Participants	174 Participants n=7 Participants	338.0 Participants n=5 Participants
Region of Enrollment United States	164 participants n=5 Participants	174 participants n=7 Participants	338.0 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Sexual activities with casual male partners in past 3 months (i.e., any unprotected insertive or receptive anal sex)

Outcome measures

Measure	Many Men, Many Voices (3MV) Intervention n=127 Participants Receive 6-session intervention immediately after baseline assessment and randomization	Wait List Comparison n=133 Participants Receive intervention after 6-month delay (wait list control group)
Any Unprotected Anal Intercourse (UAI) With Casual Partners	2.0 Number of episodes Standard Deviation 5.6	6.2 Number of episodes Standard Deviation 22.7

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Many Men, Many Voices (3MV) Intervention n=126 Participants Receive 6-session intervention immediately after baseline assessment and randomization	Wait List Comparison n=133 Participants Receive intervention after 6-month delay (wait list control group)
Number of Participants Reporting HIV Testing Behavior	69 participants	58 participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Many Men, Many Voices (3MV) Intervention n=127 Participants Receive 6-session intervention immediately after baseline assessment and randomization	Wait List Comparison n=133 Participants Receive intervention after 6-month delay (wait list control group)
Number of Participants Reporting Sexually Transmitted Disease (STD) Testing Behavior	43 participants	43 participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Many Men, Many Voices (3MV) Intervention n=127 Participants Receive 6-session intervention immediately after baseline assessment and randomization	Wait List Comparison n=133 Participants Receive intervention after 6-month delay (wait list control group)
Number of Episodes of Insertive Unprotected Anal Intercourse (UAI) With Casual Partners	1.1 number of episodes Standard Deviation 3.4	4.5 number of episodes Standard Deviation 18.6

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Many Men, Many Voices (3MV) Intervention n=127 Participants Receive 6-session intervention immediately after baseline assessment and randomization	Wait List Comparison n=133 Participants Receive intervention after 6-month delay (wait list control group)
Number of Episodes of Receptive Unprotected Anal Intercourse (UAI) With Casual Partners	0.9 number of episodes Standard Deviation 3.3	1.7 number of episodes Standard Deviation 6.8

Adverse Events

Many Men, Many Voices (3MV) Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait List Comparison

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leo Wilton, PhD

Department of Human Development, State University of New York at Binghamton

Phone: 607-777-9215

Email: lwilton@binghamton.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60