Stonewall Treatment Evaluation Project (STEP)
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| ClinicalTrials.gov Identifier: NCT01129401 |
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Recruitment Status
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Completed
First Posted
: May 24, 2010
Last Update Posted
: October 27, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Substance Abuse HIV Infections | Behavioral: Stonewall Project | Phase 1 Phase 2 |
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 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 |
| 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.
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- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
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
| United States, California | |
| San Francisco AIDS Foundation | |
| San Francisco, California, United States, 94103 | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94105 | |
| 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 |
Additional Information:
| 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:
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methamphetamine men who have sex with men HIV/AIDS |
Additional relevant MeSH terms:
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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 |