An interventional study of enhanced DOT (both pegylated interferon alfa-2a and ribavirin) and standard DOT (PEG-DOT control arm) in Hepatitis C and Medication Adherence, sponsored by Albert Einstein College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-26.
Sponsored by Albert Einstein College of Medicine · Not applicable, Interventional, and Treatment
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 80 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Albert Einstein College of Medicine is the lead sponsor of 199 studies on the registry; 21 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 35 (80%) have results posted.
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Exclusion Criteria:
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)
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)
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.
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.
Adherence
Adherence assessed by pill count, self-report, and medical records.
Time frame: 24 -48 weeks
sustained viral response (SVR)
Time frame: 24 weeks after treatment completion
end of treatment response (ETR)
Time frame: 24 - 48 weeks
treatment completion
completion of at least 80% of planned duration of HCV treatment.
Time frame: 24 - 48 weeks
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Albert Einstein College of Medicine