Project MIX: Behavioral Intervention to Reduce Risk Among Substance-Using MSM
Project Mix: Behavioral Intervention to Reduce Sexual Risk Behavior of Substance-Using (Non-Injection) Men Who Have Sex With Men
5 other identifiers
interventional
1,686
1 country
6
Brief Summary
The purpose of this project is to test the efficacy of an HIV prevention behavioral intervention to reduce sexual risk for HIV infection among non-injection, substance-using men who have sex with men (SUMSM). The primary goal of the intervention is to reduce HIV transmission by reducing the incidence of unprotected anal sex while under the influence of alcohol and other drugs (AOD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Oct 2002
Longer than P75 for not_applicable hiv-infections
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedMay 20, 2024
May 1, 2024
5.9 years
September 7, 2005
May 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Decrease in the number of unprotected anal sex partners (and acts) while under the influence of AOD as reported at 3-, 6-, and 12-month follow-up assessments compared to baseline assessments.
3 months
Decrease in the number of unprotected anal sex partners (and acts) as reported at 3-, 6-, and 12-month follow-up assessments compared to baseline assessments.
3 months
Study Arms (3)
Intervention
EXPERIMENTALBehavioral discussion sessions focused on reducing substance use and sexual risk behavior
Comparison
ACTIVE COMPARATORVideo discussion on health issues unrelated to HIV prevention and substance use
Control
NO INTERVENTIONWaitlist control
Interventions
Eligibility Criteria
You may qualify if:
- be 18 years of age or older;
- self-identify as male;
- understand and read English;
- live within the metropolitan area;
- report being drunk or "buzzed" on alcohol 2 or more times or high on non-injection drugs at least once during (or two hours before) anal sex in the past six months;
- have had at least one unprotected anal sex episode in the past six months with a male partner of unknown or different HIV-status than their own (i.e., DUA)
You may not qualify if:
- report only marijuana, only Viagra or only marijuana and Viagra use during anal sex (current research shows that marijuana use is not associated with sexual risk behavior);
- report injecting drugs (eligible if only methamphetamine, steroids, hormones and/or prescribed medications) in the past six months;
- have known their HIV-positive status for less than six months (this is done to allow for psychological and behavioral adjustment following an initial HIV diagnosis and this time frame coincides with our screening window); these men (if they so desire) will be put on a wait list and contacted after 6 months have passed since their first HIV-positive test result;
- are currently involved in another HIV behavioral intervention study for MSM \[local study site identifies a list of such studies in their community at the time of the trial\];
- have a specific plan to move from the metropolitan area within the next 15 months;
- participated in the pilot phase of the project;
- other reasons that the investigators deem would make participation either detrimental to the participant or to the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gordon Manserghlead
- New York Blood Centercollaborator
- San Francisco Department of Public Healthcollaborator
- University of Illinois at Chicagocollaborator
- Health Research Associationcollaborator
Study Sites (6)
Health Research Association
Hollywood, California, 90038, United States
San Francisco Department of Public Health
San Francisco, California, 94102, United States
The University of Illinois at Chicago
Chicago, Illinois, 60607, United States
Howard Brown Health Center
Chicago, Illinois, 60613, United States
New York Blood Center
New York, New York, 10021, United States
Project Achieve
New York, New York, 10024, United States
Related Publications (1)
Mansergh G, Koblin BA, McKirnan DJ, Hudson SM, Flores SA, Wiegand RE, Purcell DW, Colfax GN; Project MIX Study Team. An intervention to reduce HIV risk behavior of substance-using men who have sex with men: a two-group randomized trial with a nonrandomized third group. PLoS Med. 2010 Aug 24;7(8):e1000329. doi: 10.1371/journal.pmed.1000329.
PMID: 20811491DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gordon Mansergh, PhD
Centers for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Project Officer/Senior Scientist
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
October 1, 2002
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
May 20, 2024
Record last verified: 2024-05