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Stonewall Treatment Evaluation Project (STEP)

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ClinicalTrials.gov Identifier: NCT01129401
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : October 27, 2014
Sponsor:
Collaborator:
California HIV/AIDS Research Program
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Substance Abuse HIV Infections Behavioral: Stonewall Project Phase 1 Phase 2

Detailed 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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Harm Reduction Treatment for Methamphetamine-Using Men Who Have Sex With Men (MSM)
Study Start Date : March 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : May 2014

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Arms and Interventions
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Arm Intervention/treatment
Stonewall Project Participants 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.


Outcome Measures
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Primary Outcome Measures :
  1. stimulant use (measured via self-report and urine toxicology screening) [ Time Frame: 3 and 6 month follow-ups ]
    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).


Secondary Outcome Measures :
  1. sexual risk taking [ Time Frame: 3 and 6 month follow-ups ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129401


Locations
United States, California
San Francisco AIDS Foundation
San Francisco, California, United States, 94103
University of California, San Francisco
San Francisco, California, United States, 94105
Sponsors and Collaborators
University of California, San Francisco
California HIV/AIDS Research Program
Investigators
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
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01129401     History of Changes
Other Study ID Numbers: CR08-SF-423
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014

Keywords provided by University of California, San Francisco:
methamphetamine
men who have sex with men
HIV/AIDS

Additional relevant MeSH terms:
HIV Infections
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chemically-Induced Disorders
Mental Disorders
Methamphetamine
 Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors