Risk Reduction Intervention for Vulnerable Young Adult Males

NCT ID: NCT01118416

Last Updated: 2013-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Sex Substance Use HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HIV prevention intervention randomized control trial

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

HIV prevention intervention randomized control trial

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hunter College of City University of New York

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey T. Parsons

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey T Parsons, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.hunter.cuny.edu/chest/

Center for HIV/AIDS Educational Studies and Training website

Other Identifiers

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R01DA020366

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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