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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV Testing and Counseling
Contingency Management
Strengths-based case management
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV Infections, Treatment, Methamphetamine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Project Safe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

HIV Testing and Counseling

Contingency Management (CM)

CM with Strengths-based case management

Arm Description

HIV Testing and Counseling

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.

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.

Outcomes

Primary Outcome Measures

Reduction of drug use, specifically methamphetamine
Reduction of HIV and STI risk behaviors, specifically sex risk behaviors but also needle risk for injection drug users
Improved mental health status

Secondary Outcome Measures

Full Information

First Posted
July 9, 2010
Last Updated
January 18, 2017
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT01161485
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 13, 2015 (Actual)
Study Completion Date
May 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Infections, Treatment, Methamphetamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV Testing and Counseling
Arm Type
Active Comparator
Arm Description
HIV Testing and Counseling
Arm Title
Contingency Management (CM)
Arm Type
Active Comparator
Arm 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.
Arm Title
CM with Strengths-based case management
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
HIV Testing and Counseling
Intervention Description
A manualized individual-level model consisting of two education and counseling sessions that structurally bracket confidential HIV antibody screening.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Intervention Description
In voucher-based CM programs, drug users who submit urine samples that are negative for specified drugs are reinforced with vouchers. Based on operant conditioning, CM rewards those who comply with the targeted behavior and does not reward when compliance is not achieved. In this study a mid-value reinforcement CM schedule will be used in order to balance community cost concerns with the need to show comparative efficacy in reducing meth use and concomitant sex risk behaviors in a largely unstudied risk group. Participants in the CM arm will be asked to come to the study site three times a week to leave a urine sample, get the result, and will then be offered a voucher if their urine is clean and given brief verbal feedback.
Intervention Type
Behavioral
Intervention Name(s)
Strengths-based case management
Intervention 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. It differs from more traditional case management models that emphasize resource brokerage and client advocacy in its recognition that only the individual can change his/her behavior.
Primary Outcome Measure Information:
Title
Reduction of drug use, specifically methamphetamine
Time Frame
12-month follow-up interview
Title
Reduction of HIV and STI risk behaviors, specifically sex risk behaviors but also needle risk for injection drug users
Time Frame
12-month follow-up interview
Title
Improved mental health status
Time Frame
12-month follow-up interview

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen F Corsi, ScD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Project Safe
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States

12. IPD Sharing Statement

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

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