Clinical trial NCT01161485: Reduction of Drug Use and HIV Risk Among Out-of-Treatment Methamphetamine Users
Official title: Reduction of Drug Use and HIV Risk Among Out-of-Treatment Methamphetamine Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV Infections
Treatment
Methamphetamine
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2010-07-13
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction of drug use, specifically methamphetamine
timeFrame: 12-month follow-up interview
measure: Reduction of HIV and STI risk behaviors, specifically sex risk behaviors but also needle risk for injection drug users
timeFrame: 12-month follow-up interview
measure: Improved mental health status
timeFrame: 12-month follow-up interview
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Project Safe
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Karen F Corsi, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References: