Evaluation of HepCure Toolkit to Improve Harvoni Adherence

Completed · Not applicable

Conditions studied: Hepatitis C, Medication Adherence

In brief

There is limited data outside of clinical trials on adherence to once daily ledipasvir/sofosbuvir regimens. Many patients present with known barriers to medication adherence including untreated psychiatric illness and substance use disorders, cognitive impairment, and low health literacy. The goal of this study is to evaluate the baseline level of adherence to ledipasvir/sofosbuvir in a real-world clinic population and compare this to the level of adherence in patients provided with additional adherence support. Medication adherence in this study will be evaluated using AdhereTech, a wireless pill monitoring device that measures the dosage and time a medication was taken. Using cellular technology, AdhereTech can be used passively to collect data on when a medication is taken, when a refill is needed, and how often the bottle is opened. AdhereTech also can be used actively to monitor adherence and provide feedback to subjects using the device. When actively monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up, sounding chimes, and sending phone/text/email alerts to remind patients to take their medication (see attached PowerPoint presentation). HepCure is a web-based tool kit in the form of a dashboard for medical providers (MDs and NPs) and an application (or "app") for patients. The app allows patients to become active participants in their treatment by enabling them to set medication reminders, record doses taken, and communicate their adherence to their medical provider using the provider dashboard.

Key facts

Study ID

NCT02740556

Run by

Icahn School of Medicine at Mount Sinai

People needed

71

Starts

2016-02-01

Expected to finish

2019-03-31

Last updated by the study team

2020-03-23

Who can join

Age: 21 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Individuals with diminished mental capacity who are unable to give informed consent
• Prisoners
• Participants who do not speak or write in English as a primary language
• Participants who are unable to speak and read English
• Participants who are expected to have difficult with regular access to smart phone device.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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