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Risk Reduction Intervention for Vulnerable Young Adult Males (YMHP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01118416
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : June 3, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Sex Substance Use HIV Behavioral: HIV prevention intervention randomized control trial

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Risk Reduction Intervention for Vulnerable Young Adult Males
Study Start Date : June 2006
Primary Completion Date : September 2010
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01118416


Locations
United States, New York
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
New York, New York, United States, 10018
Sponsors and Collaborators
Hunter College of City University of New York
Investigators
Principal Investigator: Jeffrey T Parsons, PhD Hunter College of CUNY and Center for HIV/AIDS Educational Studies and Training
More Information

Additional Information:
Responsible Party: Jeffrey T. Parsons, Professor, Hunter College
ClinicalTrials.gov Identifier: NCT01118416     History of Changes
Other Study ID Numbers: R01DA020366 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Jeffrey T. Parsons, Hunter College:
sexual risk
substance use
HIV
prevention
intervention
Motivational Enhancement Therapy
young men who have sex with men