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Completed

NCT Number: NCT01442311

Directly Observed Hepatitis C Treatment in Methadone Clinics

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.

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Key information

Conditions

Hepatitis C Behavior Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Health Behavior Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Treatment Adherence and Compliance Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Einstein College of Medicine Division of Substance Abuse

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

enhanced DOT (both pegylated interferon alfa-2a and ribavirin)

Other

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.

standard DOT (PEG-DOT control arm)

Other

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.

Primary outcomes

  1. Adherence

    Time frame: 24 -48 weeks

    Adherence assessed by pill count, self-report, and medical records.

Secondary outcomes

  1. sustained viral response (SVR)

    Time frame: 24 weeks after treatment completion

  2. end of treatment response (ETR)

    Time frame: 24 - 48 weeks

  3. treatment completion

    Time frame: 24 - 48 weeks

    completion of at least 80% of planned duration of HCV treatment.

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Sep 28, 2011
Registry last updated
Jun 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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