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Project MIX: Behavioral Intervention to Reduce Risk Among Substance-Using MSM

This study has been completed.
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00153361
First received: September 7, 2005
Last updated: January 6, 2010
Last verified: January 2010
History of Changes
  Purpose

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).


Condition Intervention
HIV Infections
 Behavioral: Discussion Group
Behavioral: Video Discussion Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Project Mix: Behavioral Intervention to Reduce Sexual Risk Behavior of Substance-Using (Non-Injection) Men Who Have Sex With Men

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1750
Study Start Date: October 2002
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Men who have sex with men (MSM) continue to be the largest risk category for incident and prevalent cases of HIV and AIDS in the U.S. Studies of MSM have established an association between alcohol and other drug (AOD) use and risky sexual behaviors. Although studies have assessed and confirmed the association of AOD use and unsafe sex, few have focused specifically on reducing sexual risk of SUMSM.

Sexual risk reduction interventions for MSM identified in the published scientific literature have demonstrated that they are generally effective at reducing sexual risk behaviors among MSM. However, none of these interventions specifically targeted non-injecting SUMSM. Thus, a gap exists in prevention efforts to reduce HIV transmission among SUMSM.

The primary aim of the Project Mix overall is to develop and evaluate a practical intervention strategy that is specifically tailored to the needs of non-injecting SUMSM. The intent of the intervention is to decrease the number of unprotected anal sex partners (and acts) while under the influence of AOD and in general.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00153361

Locations
United States, California
Health Research Association
Hollywood, California, United States, 90038
San Francisco Department of Public Health
San Francisco, California, United States, 94102
United States, Illinois
The University of Illinois at Chicago
Chicago, Illinois, United States, 60607
Howard Brown Health Center
Chicago, Illinois, United States, 60613
United States, New York
New York Blood Center
New York, New York, United States, 10021
Project Achieve
New York, New York, United States, 10024
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Gordon Mansergh, PhD Centers for Disease Control and Prevention
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gordon Mansergh/Senior Behavioral Scientist, CDC
ClinicalTrials.gov Identifier: NCT00153361     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3985, U65/CCU522209, U65/CCU922215, U65/CCU222309, U65/CCU922213
Study First Received: September 7, 2005
Last Updated: January 6, 2010
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
HIV Seronegativity
HIV

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013