Project FIRST - Financial Incentives to Reduce Substance Use and Improve Treatment
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/22/2018 |
| Start Date: | June 2012 |
| End Date: | August 10, 2017 |
A Randomized Trial of an Abstinence-reinforcing Contingency Management Intervention to Suppress HIV Viral Load
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.
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.
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.
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.
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
We found this trial at
3
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