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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Behavioral: HIV Testing and Counseling; Behavioral: Contingency Management; Behavioral: Strengths-based case management	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	502 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Reduction of Drug Use and HIV Risk Among Out-of-Treatment Methamphetamine Users
Study Start Date :	August 2010
Actual Primary Completion Date :	June 13, 2015
Actual Study Completion Date :	May 25, 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Reduction of drug use, specifically methamphetamine [ Time Frame: 12-month follow-up interview ]
2. 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 ]
3. Improved mental health status [ Time Frame: 12-month follow-up interview ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Colorado
Project Safe
Denver, Colorado, United States, 80218

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator:	Karen F Corsi, ScD, MPH	University of Colorado, Denver

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT01161485 History of Changes
Other Study ID Numbers:	10-0518
First Posted:	July 13, 2010
Last Update Posted:	January 20, 2017
Last Verified:	January 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by University of Colorado, Denver:

HIV Infections; Treatment; Methamphetamine

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Methamphetamine; Central Nervous System Stimulants; Physiological Effects of Drugs	Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Uptake Inhibitors