Risk Reduction Intervention for Vulnerable Young Adult Males

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.

Completed

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Key information

Conditions

Sex Behavior Chemically-Induced Disorders Coitus HIV Mental Disorders Sexual Behavior Substance Use Substance-Related Disorders

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY

New York, 10018, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIV prevention intervention randomized control trial

Behavioral

Substance using HIV-negative young MSM who engage in sexual risk are randomized to either a motivational interviewing or an education condition to reduce sexual risk and drug use.

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Registry information

Acronym: YMHP

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2011
First posted: May 6, 2010
Registry last updated: Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed