HIV Clinical Trial
— Project FIRSTOfficial title:
A Randomized Trial of an Abstinence-reinforcing Contingency Management Intervention to Suppress HIV Viral Load
Verified date | December 2020 |
Source | Albert Einstein College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 242 |
Est. completion date | August 10, 2017 |
Est. primary completion date | August 10, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein College of Medicine Division of Substance Abuse clinics | Bronx | New York |
United States | Montefiore Infectious Disease Clinic | Bronx | New York |
United States | Montefiore's Community Clinics (Montefiore Medical Group) | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HIV viral load | 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. | Viral load will be measured every 4 weeks over the 28-week follow-up period. | |
Secondary | CD4 count | 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. | CD4 count will be measured at weeks 0, 4, 20, and 28. | |
Secondary | Abstinence from opiates, oxycodone, and cocaine | 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. | Abstinence will be measured twice weekly during weeks 0-20, then every two weeks during weeks 21-28. | |
Secondary | Antiretroviral adherence | 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). | Antiretroviral adherence will be measured every 4 weeks during the 28-week follow-up period |
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