Stonewall Treatment Evaluation Project (STEP)

This study has been completed.

Sponsor:

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

History of Changes

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:	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:

MedlinePlus related topics: HIV/AIDS Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Metamfetamine

U.S. FDA Resources

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 ]
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 ]
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)
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

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, see Learn About Clinical Studies.

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:

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
Study First Received:	May 6, 2010
Last Updated:	October 23, 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

ClinicalTrials.gov processed this record on June 23, 2017

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