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.
Brief Title
Directly Observed Hepatitis C Treatment in Methadone Clinics
Categories
Completion Date
Completion Date Type
Actual
Conditions
Hepatitis C
Medication Adherence
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Hepatitis C Virus
Chronic Hepatitis C
Methadone
Injection Drug User
Adherence
Directly Observed Treatment
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01442311
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2006-224
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Directly Observed Hepatitis C Treatment in Methadone Clinics
Primary Outcomes
Outcome Description
Adherence assessed by pill count, self-report, and medical records.
Outcome Measure
Adherence
Outcome Time Frame
24 -48 weeks
Secondary Ids
Secondary Id
K23DA022454-01A1
Secondary Outcomes
Outcome Time Frame
24 weeks after treatment completion
Outcome Measure
sustained viral response (SVR)
Outcome Time Frame
24 - 48 weeks
Outcome Measure
end of treatment response (ETR)
Outcome Description
completion of at least 80% of planned duration of HCV treatment.
Outcome Time Frame
24 - 48 weeks
Outcome Measure
treatment completion
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alain Litwin
Investigator Email
alitwin@montefiore.org
Investigator Phone
718-920-5946