Stonewall Treatment Evaluation Project (STEP)
This study has been completed.
Sponsor:
University of California, San Francisco
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: October 23, 2014
Last verified: October 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Substance Abuse HIV Infections |
Behavioral: Stonewall Project |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of a Harm Reduction Treatment for Methamphetamine-Using Men Who Have Sex With Men (MSM) |
Resource links provided by NLM:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- 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).
Secondary Outcome Measures:
- 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.
| Enrollment: | 150 |
| Study Start Date: | March 2010 |
| Study Completion Date: | May 2014 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders 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 Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129401
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01129401 History of Changes |
| Other Study ID Numbers: | CR08-SF-423 |
| Study First Received: | May 6, 2010 |
| Last Updated: | October 23, 2014 |
| Health Authority: | United States: UCSF Committee on Human Research |
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 |
ClinicalTrials.gov processed this record on September 29, 2016