Reduction of Drug Use and HIV Risk Among Out-of-Treatment Methamphetamine Users

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT01161485
• Lead Sponsor: University of Colorado, Denver

Brief Summary

There is a need to identify and test effective strategies to reduce meth use and human immunodeficiency virus (HIV) risk behaviors in heterosexuals. This project will compare the efficacy of a manually-driven HIV testing and counseling (HIV T/C) intervention, with HIV T/C plus a manualized Contingency Management (CM), with HIV T/C plus CM plus a manualized Strengths-Based Case Management (CM/SBCM) model. As HIV T/C is the standard of care, the investigators are testing to determine if the investigators can enhance this standard. The specific aims and hypotheses of this protocol are:

1. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing drug use, specifically meth use. Hypothesis 1: CM/SBCM will reduce drug use more than those in CM (which will have more reduction than HIV T/C), potentially mediated through increased service utilization.

2. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing HIV and STI risk behaviors, specifically sex risk behaviors but also needle risk for injection drug users (IDUs). Hypothesis 2: CM/SBCM will have greater decreases in HIV risk behaviors than those in CM (which will have greater decreases than HIV T/C), potentially mediated through reduced drug use.

3. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on improving mental health status. Hypothesis 3: CM/SBCM will have greater improvements in mental health status than those in CM (which will have greater improvements than HIV T/C), potentially mediated through increased service utilization and reduction of drug use, and potentially moderated by baseline meth use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-12
• Study First Posted: 2010-07-13
• Study Start: 2010-08
• Primary Completion: 2015-06-13
• Study Completion: 2016-05-25
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

• 18 years of age or older
• Be competent (not too intoxicated or mentally disabled) to give informed consent at the time of the interview
• Meth use (verified through urine drug screening and a self-report of meth use of at least 4 times per month for the last 3 months)
• Self-reported sex with someone of the opposite sex in last 30 days
• Ability to provide a reliable address and phone number for contact
• Not in drug treatment in the past 30 days
• Willingness to be tested for HIV at baseline and follow-up
• Not transient and no know reason why he/she will not be available for follow-up interviews
• Not currently mandated by the criminal justice system to receive treatment based on self-report.

Exclusion Criteria

• Participation in drug treatment in the past 30 days
• Currently participating in another Project Safe study
• Pregnant or attempting to become pregnant
• Intoxicated or impaired mentally to the point that they cannot voluntarily consent to participate tin the project and/or respond to the interview

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Reduction of HIV and STI risk behaviors, specifically sex risk behaviors but also needle risk for injection drug users	12-month follow-up interview
Improved mental health status	12-month follow-up interview
Reduction of drug use, specifically methamphetamine	12-month follow-up interview

Trial Locations

Locations (1)

Project Safe; 🇺🇸 Denver, Colorado, United States