Directly Observed Hepatitis C Treatment in Methadone Clinics

Hepatitis C Clinical Trial

Official title:

Directly Observed Hepatitis C Treatment in Methadone Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442311
• Other study ID #: 2006-224
• Secondary ID: K23DA022454-01A1
• Status: Completed
• Phase: N/A
• First received: September 27, 2011
• Last updated: June 25, 2015
• Start date: October 2007
• Est. completion date: March 2013

Study information

• Verified date: June 2015
• Source: Albert Einstein College of Medicine of Yeshiva University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Medication Adherence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine Division of Substance Abuse	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine of Yeshiva University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Adherence assessed by pill count, self-report, and medical records.	24 -48 weeks	No
Secondary	sustained viral response (SVR)		24 weeks after treatment completion	No
Secondary	end of treatment response (ETR)		24 - 48 weeks	No
Secondary	treatment completion	completion of at least 80% of planned duration of HCV treatment.	24 - 48 weeks	No