Evaluation of HepCure Toolkit to Improve Harvoni Adherence

Summary

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.

Conditions

• Hepatitis C
• Medication Adherence

Interventions

OTHER

HepCure ToolKit

HepCure is a web-based tool kit in the form of a dashboard for providers and an application (or "app") for patients. The app allows patients to become active participants in their treatment by enabling them to enter prescribed treatment, add medications to "Pill Box," log doses, visualize adherence, and includes several additional resources.

DEVICE

AdhereTech Active Features

AdhereTech, a wireless pill monitoring device that measures the dosage and time a medication was taken. It is a HIPAA-compliant, FDA-registered Class I medical device. 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.

OTHER

AdhereTech Passive Monitoring

AdhereTech passively monitors adherence (no chimes or reminders)

Sponsors & Collaborators

• Gilead Sciences

  collaborator INDUSTRY

• Icahn School of Medicine at Mount Sinai

  lead OTHER

Principal Investigators

• Jeffrey J Weiss, PhD, MS · Icahn School of Medicine at Mount Sinai

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2019-03-31

Completion

2019-03-31

Countries

• United States

Study Locations