Reduction of Drug Use and HIV Risk Among Out-of-Treatment Methamphetamine Users
This study is currently recruiting participants.
Verified October 2012 by University of Colorado, Denver
Sponsor:
University of Colorado, Denver
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
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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:
- 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 and STI 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.
| 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
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 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 Amphetamine HIV Antibodies Sympathomimetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors Immunologic Factors |
ClinicalTrials.gov processed this record on May 19, 2013