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

HIV Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327898
• Other study ID #: DESPR DA024579
• Status: Completed
• Phase: Phase 2
• First received: March 30, 2011
• Last updated: July 24, 2014
• Start date: November 2008
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: July 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infection
• Substance Abuse

Intervention

Behavioral:
• empowerment theory-based small group discussion
four small group discussion sessions followed by one individual counseling session
• individual resilience counseling
one individual resilience counseling session

Locations

Country	Name	City	State
United States	NSU Research Center	Miami Beach	Florida
United States	NSU Research Center	Wilton Manors	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	unprotected anal intercourse events outside of primary relationships		3 months	No
Primary	unprotected anal intercourse events outside of primary relationships		6 months	No
Primary	unprotected anal intercourse events outside of primary relationships		12 months	No