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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Kurtz, Ph.D., Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT01327898
First received: March 30, 2011
Last updated: March 7, 2014
Last verified: March 2014

March 30, 2011
March 7, 2014
November 2008
December 2011   (final data collection date for primary outcome measure)
  • unprotected anal intercourse events outside of primary relationships [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • unprotected anal intercourse events outside of primary relationships [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • unprotected anal intercourse events outside of primary relationships [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01327898 on ClinicalTrials.gov Archive Site
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Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)
Not Provided

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infection
  • Substance Abuse
  • Behavioral: empowerment theory-based small group discussion
    four small group discussion sessions followed by one individual counseling session
  • Behavioral: individual resilience counseling
    one individual resilience counseling session
  • Experimental: 1
    empowerment theory-based small group discussion
    Intervention: Behavioral: empowerment theory-based small group discussion
  • Active Comparator: 2
    single session individual resilience counseling
    Intervention: Behavioral: individual resilience counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
515
July 2014
December 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01327898
DESPR DA024579
Yes
Steven Kurtz, Ph.D., Nova Southeastern University
Nova Southeastern University
National Institute on Drug Abuse (NIDA)
Not Provided
Nova Southeastern University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP