Evaluation of Wirelessly Observed Therapy to Optimize Adherence in Patients With Hepatitis C and Increased Risk for Nonadherence to Treatment

• A subject must meet ALL of the following criteria to be considered for enrollment into this study:

‣ Adults (≥18 years old) who are diagnosed with hepatitis C deemed chronic by the investigator

⁃ Candidate for treatment for oral direct acting agent for hepatitis C such as fixed-dose velpatasvir and sofosbuvir; fixed-dose ledipasvir and sofosbuvir; or fixed-dose glecaprevir and pibrentasvir with insurance coverage for therapy. Subjects may take other medicines that will not be co-encapsulated (e.g. ribavirin)

⁃ One of more of the following risk factors for nonadherence:

• Active alcohol or substance abuse (positive urine drug screen, illicit use in past 3 months, and/or in opioid substitution program), OR

∙ Patient reported history of hospitalization within past 2 years for a psychiatric comorbidity, OR

∙ Evidence of nonadherence to medications (e.g. self-report or refill history indicative of nonadherence), OR

∙ History of at least one missed clinic visit for hepatitis management, OR

∙ Patient-reported history of one or more transportation barriers (e.g. burden due to time and/or distance or lack of access to regular transportation) to healthcare access, which creates a risk for missed or delayed care

⁃ Study subject has daily access to a telephone for communicating with the study personnel and study personnel contacting the study subject

⁃ Ability to read and understand the instructions for the study.

⁃ Willingness to adhere to all study procedures (both onsite and offsite), including troubleshooting of the product by a third-party, if needed.

⁃ Capacity to and willing to provide informed consent. All subjects must have a signed informed consent document prior to participating in this study

⁃ Currently owns and uses a smart phone or tablet, or has capacity to learn use of study mobile device as determined by investigator.

⁃ Adequate data connectivity at home via cellular service and/or access to a secure wireless internet (WiFi) network with the proficiency to connect a mobile device to the WiFi network.

∙ Note: None of the five individual sub-criteria (i.e., 3a, 3b, 3c, 3d, or 3e) alone may be used to qualify more than approximately 20% of the total study population for randomization. For example, 3d may be used to qualify no more than 20% of the study population for randomization without an additional sub-criteria also being met (e.g., 3d + 3a). The data center will monitor the use of these five enrolment sub-criteria, and study sites will be notified when qualification for enrollment may no longer be based upon meeting only a specific one of the five sub-criteria alone (e.g., 3d alone).