Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)

NCT ID: NCT01327898

Last Updated: 2014-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2014-07-31

Brief Summary

The specific aims of the 5-year study are to: 1) describe the nature and extent of substance use and sexual risk behaviors in a sample of 500 sexually active, substance using, not-in-treatment men who have sex with men (MSM) in urban South Florida (Miami/Ft. Lauderdale); 2) identify the independent covariates of baseline substance abuse and sexual risks; 3) evaluate, through random assignment of participants, the relative effectiveness of two intervention conditions in reducing sexual risks and substance use, as measured at 3-, 6-, and 12-month follow-up assessments: a) an innovative five-session risk reduction intervention derived from psychological empowerment theory titled Project GOAL; and, b) an enhanced community standard-of-care HIV counseling Comparison Condition.

Detailed Description

Although recent meta-analyses of the HIV prevention intervention literature have demonstrated that behavioral interventions reduce sexual risk-taking among men who have sex with men (MSM), interventions for not-in-treatment substance using MSM are lacking. Consequently, and based upon overwhelming evidence that substance use is a primary driver of HIV infection among urban MSM, public health authorities have identified the development of efficacious interventions for substance using MSM as a concern of the highest priority. The proposed study aims to test a new intervention based upon psychological empowerment theory that, in preliminary field tests, produced high levels of acceptability and participation, as well as large reductions in sexual risks and substance use, among a sample of ethnically-diverse, high risk, substance using, HIV+ and -negative MSM. The intervention to be tested is based upon a theory of MSM health risk behaviors that posits that urban gay "fast lane" subcultures present risk environments - including lack of integration with the larger society, normative hypersexuality and substance use, homophobia, sexual competitiveness, and an emphasis on entertainment and escapism - that become problematic for a sizable minority of MSM who live in them.

The proposed project responds directly to the calls by public health authorities for the development of efficacious risk reduction interventions for substance using MSM. South Florida consistently ranks in the top three MSAs nationwide in HIV and AIDS incidence and prevalence. South Florida is also a well-known migration point for MSM of extraordinarily diverse backgrounds with high rates of non-injection drug use. This setting provides an excellent context for testing an innovative intervention among high risk substance using MSM who are in need of HIV prevention services.

Conditions

HIV Infection; Substance Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

empowerment theory-based small group discussion

Group Type: EXPERIMENTAL

empowerment theory-based small group discussion

Intervention Type: BEHAVIORAL

four small group discussion sessions followed by one individual counseling session

2

single session individual resilience counseling

Group Type: ACTIVE_COMPARATOR

individual resilience counseling

Intervention Type: BEHAVIORAL

one individual resilience counseling session

Interventions

empowerment theory-based small group discussion

four small group discussion sessions followed by one individual counseling session

Intervention Type: BEHAVIORAL

individual resilience counseling

one individual resilience counseling session

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ongoing substance use and ongoing unprotected anal intercourse with men

Exclusion Criteria

• past twelve month participation in HIV prevention intervention or drug treatment; no current working telephone number and residential address; no intention to remain in in South Florida for next 12 months; newly diagnosed with HIV infection in the past 6 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

Steven Kurtz, Ph.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NSU Research Center

Miami Beach, Florida, United States

NSU Research Center

Wilton Manors, Florida, United States

Countries

United States

Other Identifiers

DESPR DA024579

Identifier Type: -

Identifier Source: org_study_id