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.
Brief Title
Project FIRST - Financial Incentives to Reduce Substance Use and Improve Treatment
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 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
HIV
Opiate Dependence
Eligibility 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
* 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
Inclusion 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%
* 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%
Gender
All
Gender Based
false
Keywords
HIV
Opiate dependence
Opiate replacement therapy
Cocaine-related disorders
Risk Reduction Behavior
Medication Adherence
Motivation
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01376570
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2010-553
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized Trial of an Abstinence-reinforcing Contingency Management Intervention to Suppress HIV Viral Load
Primary Outcomes
Outcome Description
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.
Outcome Measure
HIV viral load
Outcome Time Frame
Viral load will be measured every 4 weeks over the 28-week follow-up period.
Secondary Ids
Secondary Id
R01DA032110
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
CD4 count will be measured at weeks 0, 4, 20, and 28.
Outcome Measure
CD4 count
Outcome Description
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.
Outcome Time Frame
Abstinence will be measured twice weekly during weeks 0-20, then every two weeks during weeks 21-28.
Outcome Measure
Abstinence from opiates, oxycodone, and cocaine
Outcome Description
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).
Outcome Time Frame
Antiretroviral adherence will be measured every 4 weeks during the 28-week follow-up period
Outcome Measure
Antiretroviral adherence
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Deepika Slawek
Investigator Email
dslawek@montefiore.org
Investigator Phone
512-947-6438