Directly Observed Hepatitis C Treatment in Methadone Clinics

NACompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Hepatitis CMedication Adherence
Interventions
OTHER

enhanced DOT (both pegylated interferon alfa-2a and ribavirin)

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.

OTHER

standard DOT (PEG-DOT control arm)

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.

Trial Locations (1)

10461

Albert Einstein College of Medicine Division of Substance Abuse, The Bronx

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Albert Einstein College of Medicine

OTHER

NCT01442311 - Directly Observed Hepatitis C Treatment in Methadone Clinics | Biotech Hunter | Biotech Hunter