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 :
Completed
First Posted : June 20, 2011
Last Update Posted : April 20, 2018
|
Sponsor:
Albert Einstein College of Medicine, Inc.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Chinazo Cunningham, Albert Einstein College of Medicine, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 | Phase |
|---|---|---|
| HIV Opiate Dependence | Behavioral: Abstinence-reinforcing contingency management intervention Behavioral: Performance Feedback intervention | Not Applicable |
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.
| 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 |
| Actual Primary Completion Date : | August 10, 2017 |
| Actual Study Completion Date : | August 10, 2017 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Opioid addiction
MedlinePlus related topics:
HIV/AIDS
| 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. 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. |
|
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. |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- 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).
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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
Locations
| United States, New York | |
| Montefiore's Community Clinics (Montefiore Medical Group) | |
| Bronx, New York, United States, 10451 | |
| Albert Einstein College of Medicine Division of Substance Abuse clinics | |
| Bronx, New York, United States, 10461 | |
| Montefiore Infectious Disease Clinic | |
| Bronx, New York, United States, 10467 | |
Sponsors and Collaborators
Albert Einstein College of Medicine, Inc.
National Institute on Drug Abuse (NIDA)
Investigators
| Principal Investigator: | Chinazo Cunningham, MD,MS | Albert Einstein College of Medicine, Inc. |
| 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: |
2010-553 R01DA032110 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 20, 2011 Key Record Dates |
| Last Update Posted: | April 20, 2018 |
| Last Verified: | April 2018 |
Keywords provided by Chinazo Cunningham, Albert Einstein College of Medicine, Inc.:
|
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 Cocaine Opiate Alkaloids Anesthetics, Local Anesthetics 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 Narcotics Analgesics |