Project FIRST - Financial Incentives to Reduce Substance Use and Improve Treatment

NCT01376570 | Completed DMC

• 2 other identifiers: 2010-553R01DA032110
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 3

Brief Summary

This study will test whether contingency management (monetary vouchers contingent on abstinence from drugs) that reinforces one behavior (achieving abstinence from drugs) leads to improved outcomes in other related behaviors (achieving HIV viral load suppression). In a randomized controlled trial, the investigators propose to test whether an abstinence-reinforcing contingency management intervention improves viral load suppression in HIV-infected drug users.

Conditions

HIV; Opiate Dependence

Keywords

HIV; Opiate dependence; Opiate replacement therapy; Cocaine-related disorders; Risk Reduction Behavior; Medication Adherence; Motivation

Outcome Measures

Primary Outcomes (1)

• HIV viral load

  Every 4 weeks participants will undergo phlebotomy to measure HIV viral load. Viral load will be analyzed as a continuous measure (log10 copies/ml). In secondary analyses, viral load will be analyzed dichotomously, as undetectable (\<45 copies/ml) or not.

  Viral load will be measured every 4 weeks over the 28-week follow-up period.

Secondary Outcomes (3)

• CD4 count

  CD4 count will be measured at weeks 0, 4, 20, and 28.

• Abstinence from opiates, oxycodone, and cocaine

  Abstinence will be measured twice weekly during weeks 0-20, then every two weeks during weeks 21-28.

• Antiretroviral adherence

  Antiretroviral adherence will be measured every 4 weeks during the 28-week follow-up period

Study Arms (2)

Contingency Management arm

EXPERIMENTAL

The Contingency Management arm will receive the abstinence-reinforcing contingency management intervention.

Behavioral: Abstinence-reinforcing contingency management intervention

Control arm

ACTIVE COMPARATOR

The Control arm will receive the performance feedback intervention.

Behavioral: Performance Feedback intervention

Interventions

Abstinence-reinforcing contingency management intervention BEHAVIORAL

The contingency management intervention consists of participants receiving vouchers exchangeable for goods and services contingent on achieving abstinence. When participants are abstinent (urine is free of cocaine, oxycodone and opiates), they will receive a voucher. If participants are not abstinent (cocaine or oxycodone or opiates are in the urine), they will not receive a voucher. The value of vouchers increases with continued evidence of abstinence. When participants have urines with opiates or cocaine, the value of the voucher is reset. The vouchers are part of the intervention, they are not participant compensation.

Contingency Management arm

Performance Feedback intervention BEHAVIORAL

Participants will receive performance feedback about their drug use. The research team will provide informational slips of paper indicating results of urine tests and will congratulate participants when urines are drug-free or encourage participants to stop using cocaine and/or opiates when urines are not drug-free.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years old
• English or Spanish fluency
• HIV-infected
• Currently taking highly active antiretroviral therapy
• a) opioid use disorder and receiving opioid agonist treatment with methadone or buprenorphine, or b) cocaine use disorder
• urine toxicology positive for cocaine, oxycodone, or opioids during the run-in period
• detectable viral load while prescribed highly active antiretroviral therapy in the prior 6 months
• self-reported adherence to HAART \<100%

You may not qualify if:

• inability to give informed consent
• inability to follow the research protocol (e.g., visits twice weekly)
• frequent hospitalizations (\>2) in the prior 6 months
• currently with a chronic pain condition in which the participant has been prescribed opioid analgesics for longer than the past month

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Montefiore's Community Clinics (Montefiore Medical Group)

The Bronx, New York, 10451, United States

Location

Albert Einstein College of Medicine Division of Substance Abuse clinics

The Bronx, New York, 10461, United States

Location

Montefiore Infectious Disease Clinic

The Bronx, New York, 10467, United States

Location

Related Links

• Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial

MeSH Terms

Conditions

Opioid-Related Disorders; Cocaine-Related Disorders; Risk Reduction Behavior; Medication Adherence

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Chinazo Cunningham, MD,MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 20, 2011
• Study Start: June 1, 2012
• Primary Completion: August 10, 2017
• Study Completion: August 10, 2017
• Last Updated: December 3, 2020

Record last verified: 2020-12

Locations

US (3)