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

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

This study has been completed.

Study NCT00137631 Information provided by Centers for Disease Control and Prevention

First Received on August 26, 2005. Last Updated on June 23, 2010 History of Changes

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
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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)

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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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)

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 ]

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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5. Primary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

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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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:

Wilton L, Herbst JH, Coury-Doniger P, Painter TM, English G, Alvarez ME, Scahill M, Roberson MA, Lucas B, Johnson WD, Carey JW. Efficacy of an HIV/STI prevention intervention for black men who have sex with men: findings from the Many Men, Many Voices (3MV) project. AIDS Behav. 2009 Jun;13(3):532-44. Epub 2009 Mar 9.

Other Publications:

Coury-Doniger P, Wilton L, Herbst JH, Painter TM. HIV prevention interventions for black MSM. Am J Public Health. 2010 Feb;100(2):198. Epub 2009 Dec 17. No abstract available.

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