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Risk Reduction Intervention for Vulnerable Young Adult Males (YMHP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Hunter College
ClinicalTrials.gov Identifier:
NCT01118416
First received: May 5, 2010
Last updated: June 21, 2011
Last verified: June 2011
History of Changes

May 5, 2010
June 21, 2011
June 2006
September 2010   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01118416 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Risk Reduction Intervention for Vulnerable Young Adult Males
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Sex
  • Substance Use
  • HIV
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.
  • 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.
    Intervention: Behavioral: HIV prevention intervention randomized control trial
  • 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.
    Intervention: Behavioral: HIV prevention intervention randomized control trial
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
317
October 2011
September 2010   (final data collection date for primary outcome measure)

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.
Male
18 Years to 29 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01118416
R01DA20366
Yes
Jeffrey T. Parsons/Principal Investigator, Hunter College of the City University of New York and Center for HIV/AIDS Educational Studies and Training
Hunter College
Not Provided
Principal Investigator: Jeffrey T Parsons, PhD Hunter College of CUNY and Center for HIV/AIDS Educational Studies and Training
Hunter College
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP