Directly Observed Hepatitis C Treatment in Methadone Clinics

Study Overview
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Brief Summary
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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.

Official Title
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Directly Observed Hepatitis C Treatment in Methadone Clinics

Conditions
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Hepatitis C, Medication Adherence

Intervention / Treatment
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* Other: enhanced DOT (both pegylated interferon alfa-2a and ribavirin)
* Other: standard DOT (PEG-DOT control arm)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enhanced DOT (PEG/RBV-DOT)<br>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: enhanced DOT (both pegylated interferon alfa-2a and ribavirin)<br>* 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.<br>|
| Active Comparator: standard DOT (PEG-DOT)<br>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. | Other: standard DOT (PEG-DOT control arm)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Adherence assessed by pill count, self-report, and medical records. | 24 -48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained viral response (SVR) |  | 24 weeks after treatment completion | 
| end of treatment response (ETR) |  | 24 - 48 weeks | 
| treatment completion | completion of at least 80% of planned duration of HCV treatment. | 24 - 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C Virus, Chronic Hepatitis C, Methadone, Injection Drug User, Adherence, Directly Observed Treatment