Stonewall Treatment Evaluation Project

HIV Infections Clinical Trial

— STEP  

Official title:

Evaluation of a Harm Reduction Treatment for Methamphetamine-Using Men Who Have Sex With Men (MSM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129401
• Other study ID #: CR08-SF-423
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 6, 2010
• Last updated: October 23, 2014
• Start date: March 2010
• Est. completion date: May 2014

Study information

• Verified date: October 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: UCSF Committee on Human Research
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Substance Abuse

Intervention

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.

Locations

Country	Name	City	State
United States	San Francisco AIDS Foundation	San Francisco	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	California HIV/AIDS Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stimulant use (measured via self-report and urine toxicology screening)	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).	3 and 6 month follow-ups	No
Secondary	sexual risk taking	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.	3 and 6 month follow-ups	No

External Links

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