Directly Observed Hepatitis C Treatment in Methadone Clinics

Not Applicable

Completed

• Conditions: Hepatitis C; Medication Adherence
• Interventions: Other: enhanced DOT (both pegylated interferon alfa-2a and ribavirin); Other: standard DOT (PEG-DOT control arm)

• Registration Number: NCT01442311
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enhanced DOT (PEG/RBV-DOT)	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.
standard DOT (PEG-DOT)	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.

Primary Outcome Measures

Name	Time	Method
Adherence	24 -48 weeks	Adherence assessed by pill count, self-report, and medical records.

Secondary Outcome Measures

Name	Time	Method
end of treatment response (ETR)	24 - 48 weeks
treatment completion	24 - 48 weeks	completion of at least 80% of planned duration of HCV treatment.
sustained viral response (SVR)	24 weeks after treatment completion

Trial Locations

Locations (1)

Albert Einstein College of Medicine Division of Substance Abuse; 🇺🇸 Bronx, New York, United States