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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Chinazo Cunningham, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01376570
First received: June 16, 2011
Last updated: July 15, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
HIV
Opiate Dependence
Behavioral: Abstinence-reinforcing contingency management intervention
Behavioral: Performance Feedback intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of an Abstinence-reinforcing Contingency Management Intervention to Suppress HIV Viral Load

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • HIV viral load [ Time Frame: Viral load will be measured every 4 weeks over the 28-week follow-up period. ] [ Designated as safety issue: No ]
    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:
  • CD4 count [ Time Frame: CD4 count will be measured at weeks 0, 4, 20, and 28. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Abstinence will be measured twice weekly during weeks 0-20, then every two weeks during weeks 21-28. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Antiretroviral adherence will be measured every 4 weeks during the 28-week follow-up period ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 202
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contingency Management arm
The Contingency Management arm will receive the abstinence-reinforcing contingency management intervention.
Behavioral: 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. The voucher for the first drug-free urine is worth $2.50, and with each subsequent drug-free urine, the voucher increases by $2.50. When participants have urines with opiates or cocaine, the value of the voucher is reset back to baseline ($2.50). The maximum possible earnings for achieving continued abstinence over the intervention period is $1320. The vouchers are part of the intervention, they are not participant compensation.
Active Comparator: Control arm
The Control arm will receive the performance feedback intervention.
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.

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 up to $1320 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least 18 years old
  • English or Spanish fluency
  • HIV-infected
  • Currently taking highly active antiretroviral therapy
  • receiving opioid agonist treatment with methadone or buprenorphine
  • self-reported cocaine or opioid use while receiving opioid agonist treatment in the prior month and 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 HARRT <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
  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: NCT01376570

Contacts
Contact: Chinazo Cunningham, MD, MS 718-944-3860 ccunning@montefiore.org

Locations
United States, New York
Montefiore Infectious Disease Clinic Recruiting
Bronx, New York, United States, 10467
Contact: Robert Grossberg, MD    718-920-5276    RGROSSBE@montefiore.org   
Principal Investigator: Robert Grossberg, MD         
Albert Einstein College of Medicine Division of Substance Abuse clinics Recruiting
Bronx, New York, United States, 10461
Contact: Julia Arnsten, MD    718-944-3840    jarnsten@montefiore.org   
Principal Investigator: Julia Arnsten, MD         
Montefiore's Community Clinics (Montefiore Medical Group) Recruiting
Bronx, New York, United States, 10451
Contact: Chinazo Cunningham, MD    718-944-3860    ccunning@montefiore.org   
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Chinazo Cunningham, MD,MS Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Chinazo Cunningham, Associate Professor of Medicine, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01376570     History of Changes
Other Study ID Numbers: R01DA032110
Study First Received: June 16, 2011
Last Updated: July 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
HIV
Opiate dependence
Opiate replacement therapy
Cocaine-related disorders
Risk Reduction Behavior
Medication Adherence
Motivation

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 02, 2014