We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01327898
Recruitment Status : Completed
First Posted : April 4, 2011
Last Update Posted : July 25, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infection Substance Abuse Behavioral: empowerment theory-based small group discussion Behavioral: individual resilience counseling Phase 2

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.


Study Design

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
Primary Completion Date : December 2011
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. unprotected anal intercourse events outside of primary relationships [ Time Frame: 3 months ]
  2. unprotected anal intercourse events outside of primary relationships [ Time Frame: 6 months ]
  3. unprotected anal intercourse events outside of primary relationships [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Information from the National Library of Medicine

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


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
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