Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)
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ClinicalTrials.gov Identifier: NCT01327898 |
Recruitment Status
:
Completed
First Posted
: April 4, 2011
Last Update Posted
: July 25, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection Substance Abuse | Behavioral: empowerment theory-based small group discussion Behavioral: individual resilience counseling | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 515 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
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
|
- unprotected anal intercourse events outside of primary relationships [ Time Frame: 3 months ]
- unprotected anal intercourse events outside of primary relationships [ Time Frame: 6 months ]
- unprotected anal intercourse events outside of primary relationships [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327898
United States, Florida | |
NSU Research Center | |
Miami Beach, Florida, United States, 33139 | |
NSU Research Center | |
Wilton Manors, Florida, United States, 33305 |
Responsible Party: | Steven Kurtz, Ph.D., Professor, Nova Southeastern University |
ClinicalTrials.gov Identifier: | NCT01327898 History of Changes |
Other Study ID Numbers: |
DESPR DA024579 |
First Posted: | April 4, 2011 Key Record Dates |
Last Update Posted: | July 25, 2014 |
Last Verified: | July 2014 |
Keywords provided by Steven Kurtz, Ph.D., 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 |