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

HIV Infections Clinical Trial

Official title:

Project Mix: Behavioral Intervention to Reduce Sexual Risk Behavior of Substance-Using (Non-Injection) Men Who Have Sex With Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153361
• Other study ID #: CDC-NCHSTP-3985
• Secondary ID: U65/CCU522209U65
• Status: Completed
• Phase: N/A
• Start date: October 2002
• Est. completion date: September 2008

Study information

• Verified date: May 2024
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1686
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Discussion Group

• Video Discussion Group

Locations

Country	Name	City	State
United States	Howard Brown Health Center	Chicago	Illinois
United States	The University of Illinois at Chicago	Chicago	Illinois
United States	Health Research Association	Hollywood	California
United States	New York Blood Center	New York	New York
United States	Project Achieve	New York	New York
United States	San Francisco Department of Public Health	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
Gordon Mansergh	Health Research Association, New York Blood Center, San Francisco Department of Public Health, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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