Directly Observed Hepatitis C Treatment in Methadone Clinics
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 27, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJune 26, 2015
June 1, 2015
5.4 years
September 27, 2011
June 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence
Adherence assessed by pill count, self-report, and medical records.
24 -48 weeks
Secondary Outcomes (3)
sustained viral response (SVR)
24 weeks after treatment completion
end of treatment response (ETR)
24 - 48 weeks
treatment completion
24 - 48 weeks
Study Arms (2)
enhanced DOT (PEG/RBV-DOT)
EXPERIMENTALSubjects 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)
ACTIVE COMPARATORSubjects 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albert Einstein College of Medicine Division of Substance Abuse
The Bronx, New York, 10461, United States
Related Publications (1)
Litwin AH, Berg KM, Li X, Hidalgo J, Arnsten JH. Rationale and design of a randomized controlled trial of directly observed hepatitis C treatment delivered in methadone clinics. BMC Infect Dis. 2011 Nov 12;11:315. doi: 10.1186/1471-2334-11-315.
PMID: 22078241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Litwin, MD, MPH
Albert Einstein College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2011
First Posted
September 28, 2011
Study Start
October 1, 2007
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
June 26, 2015
Record last verified: 2015-06