Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection Substance Abuse |
Behavioral: empowerment theory-based small group discussion Behavioral: individual resilience counseling |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
- 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 ]
| Enrollment: | 515 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | January 2014 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
empowerment theory-based small group discussion
|
Behavioral: empowerment theory-based small group discussion
four small group discussion sessions followed by one individual counseling session
|
|
Active Comparator: 2
single session individual resilience counseling
|
Behavioral: individual resilience counseling
one individual resilience counseling session
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Steven Kurtz, Ph.D., Professor, Nova Southeastern University |
| ClinicalTrials.gov Identifier: | NCT01327898 History of Changes |
| Other Study ID Numbers: | DESPR DA024579 |
| Study First Received: | March 30, 2011 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Nova Southeastern University:
|
MSM HIV/AIDS sexual risk substance use |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Substance-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013