Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)
Primary Purpose
HIV Infection, Substance Abuse
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
empowerment theory-based small group discussion
individual resilience counseling
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infection focused on measuring MSM, HIV/AIDS, sexual risk, substance use
Eligibility 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
Sites / Locations
- NSU Research Center
- NSU Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
empowerment theory-based small group discussion
single session individual resilience counseling
Outcomes
Primary Outcome Measures
unprotected anal intercourse events outside of primary relationships
unprotected anal intercourse events outside of primary relationships
unprotected anal intercourse events outside of primary relationships
Secondary Outcome Measures
Full Information
NCT ID
NCT01327898
First Posted
March 30, 2011
Last Updated
July 24, 2014
Sponsor
Nova Southeastern University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01327898
Brief Title
Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Southeastern University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Substance Abuse
Keywords
MSM, HIV/AIDS, sexual risk, substance use
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
515 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
empowerment theory-based small group discussion
Arm Title
2
Arm Type
Active Comparator
Arm Description
single session individual resilience counseling
Intervention Type
Behavioral
Intervention Name(s)
empowerment theory-based small group discussion
Intervention Description
four small group discussion sessions followed by one individual counseling session
Intervention Type
Behavioral
Intervention Name(s)
individual resilience counseling
Intervention Description
one individual resilience counseling session
Primary Outcome Measure Information:
Title
unprotected anal intercourse events outside of primary relationships
Time Frame
3 months
Title
unprotected anal intercourse events outside of primary relationships
Time Frame
6 months
Title
unprotected anal intercourse events outside of primary relationships
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
NSU Research Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
NSU Research Center
City
Wilton Manors
State/Province
Florida
ZIP/Postal Code
33305
Country
United States
12. IPD Sharing Statement
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Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)
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