Directly Observed Hepatitis C Treatment in Methadone Clinics

Albert Einstein College of Medicine

Status: Completed

Conditions: Medication Adherence; Hepatitis C

Treatments: Other: standard DOT (PEG-DOT control arm); Other: enhanced DOT (both pegylated interferon alfa-2a and ribavirin)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01442311

2006-224

K23DA022454-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

enhanced DOT (PEG/RBV-DOT)

Experimental group

Description:

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.

Treatment:

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

standard DOT (PEG-DOT)

Active Comparator group

Description:

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.

Treatment:

Other: standard DOT (PEG-DOT control arm)