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

Albert Einstein College of Medicine logo

Albert Einstein College of Medicine

Status

Completed

Conditions

Opiate Dependence
HIV

Treatments

Behavioral: Abstinence-reinforcing contingency management intervention
Behavioral: Performance Feedback intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01376570
2010-553
R01DA032110 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

242 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

242 participants in 2 patient groups

Contingency Management arm
Experimental group
Description:
The Contingency Management arm will receive the abstinence-reinforcing contingency management intervention.
Treatment:
Behavioral: Abstinence-reinforcing contingency management intervention
Control arm
Active Comparator group
Description:
The Control arm will receive the performance feedback intervention.
Treatment:
Behavioral: Performance Feedback intervention

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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