Risk Reduction Intervention for Vulnerable Young Adult Males

Not Applicable

Completed

• Conditions: Sex; Substance Use; HIV

• Registration Number: NCT01118416
• Lead Sponsor: Hunter College of City University of New York

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-06
• Primary Completion: 2010-09
• Study Completion: 2011-10
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 317

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sexual risk	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 Outcome Measures

Name	Time	Method
motivation to change club drug use and unsafe sex over 12 months	every three months over the course of a year	The following factors assessed at baseline will predict club drug use and unsafe sex over the 12-month outcome period: baseline severity of club drug use, baseline severity of other substance use, motivation, decisional balance, and self-efficacy.

Trial Locations

Locations (1)

Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY; 🇺🇸 New York, New York, United States