Hepatitis C Clinical Trial
Official title:
Stepped-Wedge Randomized Control Trial to Compare Integrated, Co-located, Telemedicine-based HCV Management for Individuals on Opiate Agonist Treatment Versus Usual Care Treatment of HCV of Individuals on Opiate Agonist Treatment
To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in most cases will be referral to an offsite location for HCV management. The effectiveness will be expressed through the primary patient centered and clinical outcome, achievement of viral eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.
The study will be conducted as a non-blinded stepped wedge cluster randomized controlled trial with two arms: onsite HCV management through telemedicine versus HCV management through usual care, which in most cases will be referral to an offsite liver specialist (Referral). The arm assignment will be at the cluster (clinic) level. After an initial period (6 months) in which all clinics implement the control intervention (usual care), at regular intervals (i.e., the "steps") of 6 months duration each, one group of clinics will be randomized to cross over from the Usual Care arm to the Telemedicine arm. In this way, there will be enough time for implementation and assessment of the intervention within each time period. The process continues until all clinics have crossed over to implement telemedicine, and thus all clinics contribute data to both interventions. In addition, patients will be followed for two years post-treatment cessation to assess for reinfection or relapse of HCV RNA. ;
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