Project FIRST - Financial Incentives to Reduce Substance Use and Improve Treatment (Project FIRST)
|ClinicalTrials.gov Identifier: NCT01376570|
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : April 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Opiate Dependence||Behavioral: Abstinence-reinforcing contingency management intervention Behavioral: Performance Feedback intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||242 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376570
|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|
|Principal Investigator:||Chinazo Cunningham, MD,MS||Albert Einstein College of Medicine, Inc.|