Risk Reduction Intervention for Vulnerable Young Adult Males

HIV Clinical Trial

— YMHP  

Official title:

Risk Reduction Intervention for Vulnerable Young Adult Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118416
• Other study ID #: R01DA020366
• Status: Completed
• Phase: N/A
• First received: May 5, 2010
• Last updated: May 30, 2013
• Start date: June 2006
• Est. completion date: October 2011

Study information

• Verified date: May 2013
• Source: Hunter College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: October 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Sex
• Substance Use

Intervention

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.

Locations

Country	Name	City	State
United States	Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hunter College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual risk	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).	every three months over the course of a year	No
Secondary	motivation to change club drug use and unsafe sex over 12 months	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.	every three months over the course of a year	No

External Links

•   Center for HIV/AIDS Educational Studies and Training website