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

NCT ID: NCT01376570

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-08-10

Brief Summary

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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

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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.

Conditions

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HIV Opiate Dependence

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Contingency Management arm

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

Group Type EXPERIMENTAL

Abstinence-reinforcing contingency management intervention

Intervention Type 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.

Control arm

The Control arm will receive the performance feedback intervention.

Group Type ACTIVE_COMPARATOR

Performance Feedback intervention

Intervention Type 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.

Interventions

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Abstinence-reinforcing contingency management intervention

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.

Intervention Type BEHAVIORAL

Performance Feedback intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Chinazo Cunningham

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chinazo Cunningham, MD,MS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Montefiore's Community Clinics (Montefiore Medical Group)

The Bronx, New York, United States

Site Status

Albert Einstein College of Medicine Division of Substance Abuse clinics

The Bronx, New York, United States

Site Status

Montefiore Infectious Disease Clinic

The Bronx, New York, United States

Site Status

Countries

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United States

Related Links

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https://doi.org/10.1016/j.drugalcdep.2020.108230

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

Other Identifiers

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R01DA032110

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010-553

Identifier Type: -

Identifier Source: org_study_id