Risk Reduction for Urban Substance Using Men Who Have Sex With Men (MSM)
1 other identifier
interventional
515
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 25, 2014
July 1, 2014
3.1 years
March 30, 2011
July 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
unprotected anal intercourse events outside of primary relationships
3 months
unprotected anal intercourse events outside of primary relationships
6 months
unprotected anal intercourse events outside of primary relationships
12 months
Study Arms (2)
1
EXPERIMENTALempowerment theory-based small group discussion
2
ACTIVE COMPARATORsingle session individual resilience counseling
Interventions
four small group discussion sessions followed by one individual counseling session
Eligibility Criteria
You may qualify if:
- ongoing substance use and ongoing unprotected anal intercourse with men
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
NSU Research Center
Miami Beach, Florida, 33139, United States
NSU Research Center
Wilton Manors, Florida, 33305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 4, 2011
Study Start
November 1, 2008
Primary Completion
December 1, 2011
Study Completion
July 1, 2014
Last Updated
July 25, 2014
Record last verified: 2014-07