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

Not Applicable

Completed

• Conditions: HIV; Opiate Dependence
• Interventions: Behavioral: Performance Feedback intervention; Behavioral: Abstinence-reinforcing contingency management intervention

• Registration Number: NCT01376570
• Lead Sponsor: Albert Einstein College of Medicine

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.

Detailed Description

Using a randomized controlled study design, the investigators will test the efficacy of an abstinence-reinforcing contingency management intervention compared with a control condition (Performance Feedback) on HIV viral load suppression. The investigators will enroll 202 opioid-dependent HIV-infected individuals who are receiving opioid agonist treatment with buprenorphine or methadone, who continue to use opiates, oxycodone or cocaine (drugs that are consistently associated with poor HIV treatment outcomes), and who are prescribed antiretroviral medication, but with suboptimal viral load suppression. The contingency management group will have the potential to receive compensation in vouchers over the 16-week intervention based on drug-free urine. Participants will be followed for 28 weeks, with research visits occurring twice weekly during the Baseline Period (weeks 1-4) and Intervention Period (weeks 5-20), then every two weeks during the Post-Intervention Period (weeks 21-28). Data sources will include blood tests (viral load and CD4 count), urine toxicology tests, questionnaires, pill counts, and medical records. The primary outcome will be change in HIV viral load, and secondary outcomes will include CD4 count, antiretroviral adherence, and abstinence.

Study Timeline

• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Study Start: 2012-06
• Primary Completion: 2017-08-10
• Study Completion: 2017-08-10
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• 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%

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Performance Feedback intervention	The Control arm will receive the performance feedback intervention.
Contingency Management arm	Abstinence-reinforcing contingency management intervention	The Contingency Management arm will receive the abstinence-reinforcing contingency management intervention.

Primary Outcome Measures

Name	Time	Method
HIV viral load	Viral load will be measured every 4 weeks over the 28-week follow-up period.	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.

Secondary Outcome Measures

Name	Time	Method
CD4 count	CD4 count will be measured at weeks 0, 4, 20, and 28.	At weeks 0, 4, 20, and 28, participants will undergo phlebotomy and CD4 count will be measured. CD4 count will be analyzed as a continuous measure and an increase of 50 cells/mm3 will be considered a clinically significant improvement.
Abstinence from opiates, oxycodone, and cocaine	Abstinence will be measured twice weekly during weeks 0-20, then every two weeks during weeks 21-28.	Participants will provide urine samples twice weekly during weeks 0-20, and every two weeks during weeks 21-28. Abstinence will be defined as having drug-free urine (no cocaine, oxycodone and opiates). Abstinence will be examined two different ways-as the proportion of drug-free urines and the number of consecutive drug-free urines. Although urine toxicology tests will be our primary data source for measuring abstinence, we will also measure addiction severity using the Addiction Severity Index.
Antiretroviral adherence	Antiretroviral adherence will be measured every 4 weeks during the 28-week follow-up period	Antiretroviral adherence will be measured using pill counts. Adherence will be analyzed as a continuous measure, defined as the proportion of pills taken (# pills taken / # pills prescribed). Mean adherence over each 4-week period will be examined. In addition, we will also analyze adherence as a dichotomous measure (e.g., perfect \[100%\] adherence or not during each 4-week period).

Trial Locations

Locations (3)

Montefiore's Community Clinics (Montefiore Medical Group); 🇺🇸 Bronx, New York, United States

Albert Einstein College of Medicine Division of Substance Abuse clinics; 🇺🇸 Bronx, New York, United States

Montefiore Infectious Disease Clinic; 🇺🇸 Bronx, New York, United States