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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: Contingency Management; Behavioral: HIV Testing and Counseling; Behavioral: Strengths-based case management

Study type: Interventional

Funder types: Other

Identifiers

NCT01161485

10-0518

Details and patient eligibility

About

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.

Enrollment: 502 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

502 participants in 3 patient groups

HIV Testing and Counseling

Active Comparator group

Description:

HIV Testing and Counseling

Treatment:

Behavioral: HIV Testing and Counseling

Contingency Management (CM)

Active Comparator group

Description:

Contingency management is based on Skinner's principles of operant conditioning in behavioral psychology, dating back to the 1930s (Skinner 1938). The basis of this model is that behavior is learned and reinforced by environmental contingencies that reward or punish.

Treatment:

Behavioral: Contingency Management

Behavioral: HIV Testing and Counseling

CM with Strengths-based case management

Experimental group

Description:

Strengths-based case management (SBCM) is a specific type of case management that is based on the following principles: 1) clients are most successful when they identify and use their strengths, abilities, and assets; 2) goal-setting is guided by the clients' perceptions of their own needs; 3) the client-case manager relationship is promoted as essential; 4) a creative approach to the use of the community will lead to the discovery of needed resources; and 5) case management is conducted in the community.

Treatment:

Behavioral: Strengths-based case management

Behavioral: Contingency Management

Behavioral: HIV Testing and Counseling