Stonewall Treatment Evaluation Project (STEP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01129401
First received: May 6, 2010
Last updated: August 19, 2013
Last verified: August 2013

May 6, 2010
August 19, 2013
March 2010
December 2012   (final data collection date for primary outcome measure)
stimulant use (measured via self-report and urine toxicology screening) [ Time Frame: 3 and 6 month follow-ups ] [ Designated as safety issue: No ]
Participants will complete a self-report measure that assesses substance use during the past month. We will examine the total number of days that stimulants (cocaine, crack, or methamphetamine) were used during the past month. We will also conduct urine toxicology screening to determine whether participants test positive for cocaine or methamphetamine metabolites at each study visit. This is an objective measure of recent stimulant use (i.e., during the past 72 hours).
Same as current
Complete list of historical versions of study NCT01129401 on ClinicalTrials.gov Archive Site
sexual risk taking [ Time Frame: 3 and 6 month follow-ups ] [ Designated as safety issue: No ]
Sexual risk taking will be assessed using a measure that allows our team to examine risk as a function of HIV status, partner type (i.e., insertive or receptive), and whether the participant was under the influence of methamphetamine. Sex risk for HIV-negative men will be defined as any unprotected anal intercourse, irrespective of the HIV serostatus of sex partners. Sex risk for HIV-positive men will be defined as unprotected anal intercourse with HIV-negative or unknown serostatus partners.
Same as current
Not Provided
Not Provided
 
Stonewall Treatment Evaluation Project
Evaluation of a Harm Reduction Treatment for Methamphetamine-Using Men Who Have Sex With Men (MSM)

This treatment outcome evaluation of the Stonewall Project will recruit 150 participants to complete a face-to-face assessment visit at baseline, 3-month follow-up, and 6-month follow-up to examine treatment outcome with respect to HIV risk and substance use.

Stonewall Project clients who have initiated treatment within the past 60 days will be eligible for the outcome evaluation. 20% of clients are likely to be on parole or probation; these clients will be eligible to participate in the study.

Outcome measures that will be examined as part of the treatment outcome evaluation include: 1) self-reported substance use; 2) urine toxicology screening; and 3) sex risk taking.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Substance Abuse
  • HIV Infections
Behavioral: Stonewall Project
The Stonewall Project is an outpatient substance abuse treatment program for methamphetamine-using MSM that includes individual counseling, group counseling, and visits with a psychiatrists where indicated.
Not Provided
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
150
May 2014
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

- Participants in the outcome evaluation must have initiated services at the Stonewall Project within the past 60 days.

Exclusion Criteria:

- Inability to provide informed consent as judged by the Co-PI's and study team.

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01129401
CR08-SF-423
No
University of California, San Francisco
University of California, San Francisco
California HIV/AIDS Research Program
Principal Investigator: Adam W Carrico, Ph.D. University of California, San Francisco
Principal Investigator: William J Woods, Ph.D. University of California, San Francisco
Principal Investigator: Michael D. Siever, Ph.D. San Francisco AIDS Foundation
University of California, San Francisco
August 2013

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