Directly Observed Hepatitis C Treatment in Methadone Clinics

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01442311
First received: September 27, 2011
Last updated: June 25, 2015
Last verified: June 2015
  Purpose
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.

Condition Intervention
Hepatitis C
Medication Adherence
Other: enhanced DOT (both pegylated interferon alfa-2a and ribavirin)
Other: standard DOT (PEG-DOT control arm)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Directly Observed Hepatitis C Treatment in Methadone Clinics

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • Adherence [ Time Frame: 24 -48 weeks ] [ Designated as safety issue: No ]
    Adherence assessed by pill count, self-report, and medical records.


Secondary Outcome Measures:
  • sustained viral response (SVR) [ Time Frame: 24 weeks after treatment completion ] [ Designated as safety issue: No ]
  • end of treatment response (ETR) [ Time Frame: 24 - 48 weeks ] [ Designated as safety issue: No ]
  • treatment completion [ Time Frame: 24 - 48 weeks ] [ Designated as safety issue: No ]
    completion of at least 80% of planned duration of HCV treatment.


Enrollment: 80
Study Start Date: October 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: enhanced DOT (PEG/RBV-DOT)
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/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.
Active Comparator: standard DOT (PEG-DOT)
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-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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442311

Locations
United States, New York
Albert Einstein College of Medicine Division of Substance Abuse
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Alain Litwin, MD, MPH Albert Einstein College of Medicine of Yeshiva University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01442311     History of Changes
Other Study ID Numbers: 2006-224  K23DA022454-01A1 
Study First Received: September 27, 2011
Last Updated: June 25, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Hepatitis C Virus
Chronic Hepatitis C
Methadone
Injection Drug User
Adherence
Directly Observed Treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2a
Methadone
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents

ClinicalTrials.gov processed this record on August 30, 2016