Directly Observed Hepatitis C Treatment in Methadone Clinics
Completed · Not applicable
Conditions studied: Hepatitis C, Medication Adherence
In brief
Drug users account for a disproportionately large burden of hepatitis C virus (HCV) infection. However, HCV treatment adherence rates in drug users may be suboptimal in patients who use drugs regularly during HCV treatment. Because HCV treatment is most effective when patients adhere to at least 80% of the prescribed treatment regimen, interventions to improve HCV treatment adherence need to be developed and evaluated. The investigators designed the HCV DOT trial to test the efficacy of two versions of modified directly observed HCV therapy provided on-site at a methadone clinic. The primary objective of this trial is to determine whether enhanced DOT with both pegylated interferon alfa-2a plus ribavirin (PEG/RBV-DOT) is more efficacious than standard DOT with weekly provider-administered pegylated interferon (PEG-DOT) and self-administered ribavirin for increasing adherence and improving HCV treatment outcomes. The investigators hypothesize that PEG/RBV-DOT is associated with increased adherence and rates of sustained viral response compared with PEG-DOT.
Key facts
- Study ID
- NCT01442311
- Run by
- Albert Einstein College of Medicine
- People needed
- 80
- Starts
- 2007-10-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2015-06-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- HCV-infected
- receive HCV medical care at the methadone clinic
- plan to initiate HCV treatment on-site within the next 3 months
- psychiatrically stable as determined by HCV treatment provider and/or on-site psychiatrist
- attend the methadone clinic between three and six days per week to receive methadone
- stable dose fo methadone for two weeks prior to the baseline visit
You may not qualify if…
- unable or unwilling to provide informed consent
- currently receiving HCV treatment
- primary HCV care provider does not agree to their participation in the trial
- psychiatrically unstable
Where it is running
- Albert Einstein College of Medicine Division of Substance Abuse — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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