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

Purpose

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.

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:

MedlinePlus related topics: HIV/AIDS Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Metamfetamine

U.S. FDA Resources

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:	December 2016
Primary Completion Date:	June 2016 (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 (Adult, Senior)
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

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


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:	July 22, 2016
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2016