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

NCT ID: NCT00153361

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1686 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2008-09-30

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).

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Behavioral discussion sessions focused on reducing substance use and sexual risk behavior

Group Type: EXPERIMENTAL

Discussion Group

Intervention Type: BEHAVIORAL

Comparison

Video discussion on health issues unrelated to HIV prevention and substance use

Group Type: ACTIVE_COMPARATOR

Video Discussion Group

Intervention Type: BEHAVIORAL

Control

Waitlist control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Discussion Group

Intervention Type: BEHAVIORAL

Video Discussion Group

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

New York Blood Center

OTHER

Sponsor Role: collaborator

San Francisco Department of Public Health

OTHER_GOV

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Health Research Association

OTHER

Sponsor Role: collaborator

Gordon Mansergh

FED

Sponsor Role: lead

Responsible Party

Gordon Mansergh

Project Officer/Senior Scientist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gordon Mansergh, PhD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

Health Research Association

Hollywood, California, United States

San Francisco Department of Public Health

San Francisco, California, United States

The University of Illinois at Chicago

Chicago, Illinois, United States

Howard Brown Health Center

Chicago, Illinois, United States

New York Blood Center

New York, New York, United States

Project Achieve

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20811491 (View on PubMed)

Other Identifiers

U65/CCU522209

Identifier Type: -

Identifier Source: secondary_id

U65/CCU922215

Identifier Type: -

Identifier Source: secondary_id

U65/CCU222309

Identifier Type: -

Identifier Source: secondary_id

U65/CCU922213

Identifier Type: -

Identifier Source: secondary_id

CDC-NCHSTP-3985

Identifier Type: -

Identifier Source: org_study_id