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	Behavior: Discussion Group  Behavior: Video Discussion Group

Further Study Details: 

Primary Outcomes: 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.; 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.
Expected Total Enrollment:  1750

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00153361

Gordon Mansergh      404-639-6135    gmansergh@cdc.gov
Stephen A Flores      404-639-1910    sflores@cdc.gov

California
      San Francisco Department of Public Health, San Francisco,  California,  94102,  United States; Recruiting
      Health Research Association, Hollywood,  California,  90038,  United States; Recruiting
Illinois
      The University of Illinois at Chicago, Chicago,  Illinois,  60607,  United States; Recruiting
      Howard Brown Health Center, Chicago,  Illinois,  60613,  United States; Recruiting
New York
      New York Blood Center, New York,  New York,  10021,  United States; Recruiting
      Project Achieve, New York,  New York,  10024,  United States; Recruiting

Study chairs or principal investigators

Gordon Mansergh, PhD,  Principal Investigator,  US Centers for Disease Control and Prevention   

Study ID Numbers:  CDC-NCHSTP-3985; U65/CCU522209; U65/CCU922215; U65/CCU222309; U65/CCU922213
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00153361
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13