Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM) - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:

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
Study Completion Date:	July 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 (Adult)
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327898

Locations


United States, Florida
NSU Research Center
Miami Beach, Florida, United States, 33139
NSU Research Center
Wilton Manors, Florida, United States, 33305

Sponsors and Collaborators

Nova Southeastern University

National Institute on Drug Abuse (NIDA)

More Information


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:	July 24, 2014
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 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 Chemically-Induced Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2016