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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01161485
First received: July 9, 2010
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

There is a need to identify and test effective strategies to reduce meth use and 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 and STI 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.

Condition Intervention
HIV Infections
Behavioral: HIV Testing and Counseling
Behavioral: Contingency Management
Behavioral: Strengths-based case management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduction of Drug Use and HIV Risk Among Out-of-Treatment Methamphetamine Users

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Reduction of drug use, specifically methamphetamine [ Time Frame: 12-month follow-up interview ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Improved mental health status [ Time Frame: 12-month follow-up interview ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: August 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HIV Testing and Counseling
HIV Testing and Counseling
Behavioral: HIV Testing and Counseling
A manualized individual-level model consisting of two education and counseling sessions that structurally bracket confidential HIV antibody screening.
Active Comparator: Contingency Management (CM)
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.
Behavioral: HIV Testing and Counseling
A manualized individual-level model consisting of two education and counseling sessions that structurally bracket confidential HIV antibody screening.
Behavioral: Contingency Management
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.
Experimental: CM with Strengths-based case management
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.
Behavioral: HIV Testing and Counseling
A manualized individual-level model consisting of two education and counseling sessions that structurally bracket confidential HIV antibody screening.
Behavioral: Contingency Management
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.
Behavioral: Strengths-based case management
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161485

Contacts
Contact: Karen F Corsi, ScD, MPH 303-315-0951 karen.corsi@ucdenver.edu
Contact: Channing Tate, MPH 303-315-0991 channing.tate@ucdenver.edu

Locations
United States, Colorado
Project Safe Recruiting
Denver, Colorado, United States, 80206
Contact: Channing Tate, MPH    303-315-0991    channing.tate@ucdenver.edu   
Contact: Patricia Wilkins    303-315-0992    patricia.wilkins@ucdenver.edu   
Principal Investigator: Karen F Corsi, ScD, MPH         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Karen F Corsi, ScD, MPH University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01161485     History of Changes
Other Study ID Numbers: 10-0518
Study First Received: July 9, 2010
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
HIV Infections
Treatment
Methamphetamine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Antibodies
Physiological Effects of Drugs
Central Nervous System Agents
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Adrenergic Agents
Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Methamphetamine
Immunologic Factors
Pharmacologic Actions
Central Nervous System Stimulants
Therapeutic Uses
Sympathomimetics
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014