Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 16, 2011
July 15, 2012
June 2012
March 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01376570 on ClinicalTrials.gov Archive Site
  • 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).
  • 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 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 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).
Not Provided
Not Provided
 
Project FIRST - Financial Incentives to Reduce Substance Use and Improve Treatment
A Randomized Trial of an Abstinence-reinforcing Contingency Management Intervention to Suppress HIV Viral Load

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Opiate Dependence
  • 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.
  • 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.
  • Experimental: Contingency Management arm
    The Contingency Management arm will receive the abstinence-reinforcing contingency management intervention.
    Intervention: Behavioral: Abstinence-reinforcing contingency management intervention
  • Active Comparator: Control arm
    The Control arm will receive the performance feedback intervention.
    Intervention: Behavioral: Performance Feedback intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
202
June 2016
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Chinazo Cunningham, MD, MS 718-944-3860 ccunning@montefiore.org
United States
 
NCT01376570
R01DA032110
Yes
Chinazo Cunningham, Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Chinazo Cunningham, MD,MS Albert Einstein College of Medicine of Yeshiva University
Albert Einstein College of Medicine of Yeshiva University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP