Risk Reduction Intervention for Vulnerable Young Adult Males - Full Text View

Purpose

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.

Condition	Intervention
Sex Substance Use HIV	Behavioral: HIV prevention intervention randomized control trial

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Risk Reduction Intervention for Vulnerable Young Adult Males

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Hunter College:

Primary Outcome Measures:

Sexual risk [ Time Frame: every three months over the course of a year ] [ Designated as safety issue: No ]
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:

motivation to change club drug use and unsafe sex over 12 months [ Time Frame: every three months over the course of a year ] [ Designated as safety issue: No ]
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.

Enrollment:	317
Study Start Date:	June 2006
Estimated Study Completion Date:	October 2011
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: intervention condition Participants randomized to the intervention condition will undergo 4 one-hour sessions of motivational interviewing (MI), during which their sexual risk taking and substance use patterns will be discussed with a trained counselor with the goal of reducing instances of unprotected anal sex and substance use.	Behavioral: HIV prevention intervention randomized control trial 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.
Active Comparator: Education condition Participants randomized to the education condition will undergo 4 one-hour sessions during which they will view video segments and discuss sexual risk taking and substance use with a health educator, with the goal of reducing instances of unprotected anal sex and substance use by making informed decisions.	Behavioral: HIV prevention intervention randomized control trial 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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 29 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118416

Locations

United States, New York
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
New York, New York, United States, 10001

Sponsors and Collaborators

Hunter College

Investigators

Principal Investigator:

Jeffrey T Parsons, PhD

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

More Information

Additional Information:

Center for HIV/AIDS Educational Studies and Training website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jeffrey T. Parsons/Principal Investigator, Hunter College of the City University of New York and Center for HIV/AIDS Educational Studies and Training
ClinicalTrials.gov Identifier:	NCT01118416 History of Changes
Other Study ID Numbers:	R01DA20366
Study First Received:	May 5, 2010
Last Updated:	June 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Hunter College:

sexual risk
substance use
HIV
prevention

intervention
Motivational Enhancement Therapy
young men who have sex with men

ClinicalTrials.gov processed this record on May 22, 2013

Risk Reduction Intervention for Vulnerable Young Adult Males (YMHP)