Clinical trial NCT01376570: Project FIRST - Financial Incentives to Reduce Substance Use and Improve Treatment
Official title: A Randomized Trial of an Abstinence-reinforcing Contingency Management Intervention to Suppress HIV Viral Load
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Opiate Dependence
Keywords: HIV
Opiate dependence
Opiate replacement therapy
Cocaine-related disorders
Risk Reduction Behavior
Medication Adherence
Motivation
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-06-20
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: HIV viral load
timeFrame: Viral load will be measured every 4 weeks over the 28-week follow-up period.
Secondary outcomes:
measure: CD4 count
timeFrame: CD4 count will be measured at weeks 0, 4, 20, and 28.
measure: Abstinence from opiates, oxycodone, and cocaine
timeFrame: Abstinence will be measured twice weekly during weeks 0-20, then every two weeks during weeks 21-28.
measure: Antiretroviral adherence
timeFrame: Antiretroviral adherence will be measured every 4 weeks during the 28-week follow-up period
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore's Community Clinics (Montefiore Medical Group)
state: New York
city: Bronx
country: United States
facility: Albert Einstein College of Medicine Division of Substance Abuse clinics
state: New York
city: Bronx
country: United States
facility: Montefiore Infectious Disease Clinic
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Chinazo Cunningham, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: