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Risk Reduction Intervention for Vulnerable Young Adult Males (YMHP)

Primary Purpose

Sex, Substance Use, HIV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV prevention intervention randomized control trial
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sex focused on measuring sexual risk, substance use, HIV, prevention, intervention, Motivational Enhancement Therapy, young men who have sex with men

Eligibility Criteria

18 Years - 29 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention condition

Education condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
May 5, 2010
Last Updated
May 30, 2013
Sponsor
Hunter College of City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT01118416
Brief Title
Risk Reduction Intervention for Vulnerable Young Adult Males
Acronym
YMHP
Official Title
Risk Reduction Intervention for Vulnerable Young Adult Males
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sex, Substance Use, HIV
Keywords
sexual risk, substance use, HIV, prevention, intervention, Motivational Enhancement Therapy, young men who have sex with men

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Education condition
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
HIV prevention intervention randomized control trial
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sexual risk
Description
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).
Time Frame
every three months over the course of a year
Secondary Outcome Measure Information:
Title
motivation to change club drug use and unsafe sex over 12 months
Description
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.
Time Frame
every three months over the course of a year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey T Parsons, PhD
Organizational Affiliation
Hunter College of CUNY and Center for HIV/AIDS Educational Studies and Training
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.hunter.cuny.edu/chest/
Description
Center for HIV/AIDS Educational Studies and Training website

Learn more about this trial

Risk Reduction Intervention for Vulnerable Young Adult Males

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