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NCT Number: NCT01129401

Stonewall Treatment Evaluation Project

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.

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Key information

Conditions

Substance Abuse Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Homosexuality Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexual Behavior Sexuality Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

San Francisco AIDS Foundation, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stonewall Project

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • California HIV/AIDS Research Program

Registry information

Official study title

Evaluation of a Harm Reduction Treatment for Methamphetamine-Using Men Who Have Sex With Men (MSM)

Acronym: STEP

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
May 24, 2010
Registry last updated
Oct 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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