Directly Observed Hepatitis C Treatment in Methadone Clinics
Hepatitis C, Medication Adherence
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C Virus, Chronic Hepatitis C, Methadone, Injection Drug User, Adherence, Directly Observed Treatment
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Albert Einstein College of Medicine Division of Substance Abuse
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
enhanced DOT (PEG/RBV-DOT)
standard DOT (PEG-DOT)
Subjects randomized to the PEG/RBV-DOT arm receive weekly provider-administered pegylated interferon alfa-2a injections plus modified directly observed ribavirin therapy. We describe this as modified because ribavirin ingestion is observed at the methadone window three to six days per week based on the participants' methadone pick-up schedule, and only one of two daily doses is observed.
Subjects randomized to the Peg-DOT arm receive standard on-site treatment (weekly provider-administered pegylated interferon alfa-2a injections) and self-administered twice-daily oral ribavirin. Subjects in the PEG-DOT arm are dispensed monthly medication bottles of ribavirin, and ingest the ribavirin at home.