NCT01118416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

4.3 years

First QC Date

May 5, 2010

Last Update Submit

May 30, 2013

Conditions

Keywords

sexual risksubstance useHIVpreventioninterventionMotivational Enhancement Therapyyoung men who have sex with men

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • motivation to change club drug use and unsafe sex over 12 months

    every three months over the course of a year

Study Arms (2)

intervention condition

EXPERIMENTAL

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

Education condition

ACTIVE COMPARATOR

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

Interventions

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 conditionintervention condition

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New York, New York, 10018, United States

Location

Related Links

MeSH Terms

Conditions

CoitusSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Jeffrey T Parsons, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 5, 2010

First Posted

May 6, 2010

Study Start

June 1, 2006

Primary Completion

September 1, 2010

Study Completion

October 1, 2011

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations