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Clinical Trials/NCT01118416
NCT01118416
Completed
N/A

Risk Reduction Intervention for Vulnerable Young Adult Males

Hunter College of City University of New York1 site in 1 country317 target enrollmentJune 2006

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sex
Sponsor
Hunter College of City University of New York
Enrollment
317
Locations
1
Primary Endpoint
Sexual risk
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The primary aim of this study is to test a brief 4-session risk reduction intervention, based on Motivational Enhancement Therapy (MET) to reduce the co-occurrence of club drug use and sexual risk taking behaviors among non-treatment seeking young men who have sex with men (YMSM) in NYC.

Detailed Description

This study is a randomized clinical trial. A sample of 300 non-treatment seeking YMSM (ages 18-24) who report risky sex and club drug use in the past 90 days are being enrolled using active and passive community-based recruitment strategies in NYC. After baseline assessment, participants are being randomly assigned to one of two study arms: a Brief Risk Reduction Intervention Condition - a four session MET intervention piloted for feasibility and acceptability among YMSM, designed to increase readiness to change club drug use and unprotected sex; or an Education Comparison Condition - four sessions of facilitated education regarding the effects of club drugs and unprotected sex. Participants undergo follow-up assessments 3, 6, 9, and 12 months after baseline.

Registry
clinicaltrials.gov
Start Date
June 2006
End Date
October 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Hunter College of City University of New York
Responsible Party
Principal Investigator
Principal Investigator

Jeffrey T. Parsons

Professor

Hunter College of City University of New York

Eligibility Criteria

Inclusion Criteria

  • At least 5 days of drug use (cocaine, ketamine, ecstasy, methamphetamine, or GHB) in the past 90 days;
  • At least 1 instance of unprotected anal sex in the past 90 days;
  • Biological male;
  • HIV-negative;
  • Residential stability;
  • Ability to communicate in written English.

Exclusion Criteria

  • Unstable, serious psychiatric symptoms;
  • Currently suicidal/homicidal;
  • Evidence of gross cognitive impairment;
  • Reports current enrollment in a drug or HIV related intervention or research study.

Outcomes

Primary Outcomes

Sexual risk

Time Frame: every three months over the course of a year

Participants in the MET condition will report greater reductions in the number of unprotected anal intercourse acts and in the proportion of days of club drug use than those in the education comparison condition at the end of the intervention period (3 months) and will maintain greater reductions in the number of unprotected anal intercourse acts and the proportion of days of club drug use than those in the education comparison condition at the three follow-up assessments (6, 9, and 12 months).

Secondary Outcomes

  • motivation to change club drug use and unsafe sex over 12 months(every three months over the course of a year)

Study Sites (1)

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