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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01376570
Recruitment Status : Active, not recruiting
First Posted : June 20, 2011
Last Update Posted : August 1, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
HIV Opiate Dependence Behavioral: Abstinence-reinforcing contingency management intervention Behavioral: Performance Feedback intervention

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of an Abstinence-reinforcing Contingency Management Intervention to Suppress HIV Viral Load
Study Start Date : June 2012
Estimated Primary Completion Date : August 10, 2017
Estimated Study Completion Date : August 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. HIV viral load [ Time Frame: 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 :
  1. CD4 count [ Time Frame: 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.

  2. 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. ]
    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.

  3. Antiretroviral adherence [ Time Frame: 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).

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376570

United States, New York
Montefiore's Community Clinics (Montefiore Medical Group)
The Bronx, New York, United States, 10451
Albert Einstein College of Medicine Division of Substance Abuse clinics
The Bronx, New York, United States, 10461
Montefiore Infectious Disease Clinic
The Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
National Institute on Drug Abuse (NIDA)
Principal Investigator: Chinazo Cunningham, MD,MS Albert Einstein College of Medicine, Inc.
More Information

Responsible Party: Chinazo Cunningham, Associate Professor of Medicine, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT01376570     History of Changes
Other Study ID Numbers: R01DA032110 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

Keywords provided by Chinazo Cunningham, Albert Einstein College of Medicine, Inc.:
Opiate dependence
Opiate replacement therapy
Cocaine-related disorders
Risk Reduction Behavior
Medication Adherence

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Opiate Alkaloids
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Analgesics, Opioid