Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals

The study is a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite HCV management through telemedicine versus HCV management through usual care, referral to an offsite hepatitis specialist (Referral). The arm assignment is at the cluster (clinic) level. After an initial period (9 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 9 months duration each, one group of clinics is randomized to cross over from the Usual Care arm to the Telemedicine arm. The process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. In addition, patients cured of HCV are followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA.

Inclusion criteria

• HCV antibody detected
• Ability and willingness of subject or legal representative to provide written informed consent.
• 18 years of age
• A minimum of 12-month enrollment in the opiate agonist treatment program
• Likely to be adherent to the therapeutic regimen
• Covered by medical insurance

Exclusion criteria

• Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.
• <18 years of age
• < 12 months enrolled in an opiate agonist treatment program.
• Non-compliance with therapeutic regimen defined as three consecutive missed appointments that will result in a discussion between the principal investigator at the site and the study participant to determine the reason for the missed appointments. Continuation in the study for the participant will be assessed on a case-by-case basis between the study PI and the site PI.
• Lack of medical insurance coverage
• Ineligibility for HCV treatment
• Active treatment for HCV at the time of the study enrollment