Stonewall Treatment Evaluation Project (STEP)
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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: | Allocation: Non-Randomized 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) |
- 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).
- 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.
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
-
Behavioral: Stonewall Project
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 |
| Genders 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.
Contacts and Locations| Contact: Adam W Carrico, Ph.D. | 415-597-4992 | adam.carrico@ucsf.edu |
| United States, California | |
| University of California, San Francisco | Recruiting |
| San Francisco, California, United States, 94105 | |
| Contact: Adam W Carrico, Ph.D. 415-597-4992 adam.carrico@ucsf.edu | |
| Principal Investigator: Adam W Carrico, Ph.D. | |
| San Francisco AIDS Foundation | Recruiting |
| San Francisco, California, United States, 94103 | |
| Contact: Adam W. Carrico, Ph.D. 415-597-4992 adam.carrico@ucsf.edu | |
| 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:
No publications provided
| 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 8, 2012 |
| 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 Acquired Immunodeficiency Syndrome 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 Slow Virus Diseases Mental Disorders Methamphetamine Amphetamine |
Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013