HCV Tappt Adherence Study

The goal of this non-inferiority clinical trial is to evaluate the efficacy of Tappt, a novel digital medication companion solution, among individuals with hepatitis C virus (HCV) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting.

* The primary aim is to assess the non-inferiority of Tappt with medication adherence, treatment completion, sustained virologic response (SVR) assessment, and SVR achievement rates. * The secondary aim is to assess the efficacy of Tappt at enabling pharmacists to personalize treatment and management decision based on participants' reported barriers to adherence, care, and SVR achievement.

Participants will download and utilize the Tappt app to record adherence to oral medication. For the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR). MTSR is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period.

Upon study completion, a retrospective matched control will be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UIH

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years of age or older
Hepatitis C virus (HCV) infection (denoted by positive HCV antibody and detectable HCV RNA)
Initiating oral HCV therapy with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir
HCV treatment provided and managed by the clinical pharmacist at UI Health
Access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access
Ability to verbalize understanding of the study protocol in English
Able and willing to provide informed consent in English

Exclusion criteria

Inability to speak and read English
Inability or unwillingness to adhere to the study protocol
Pregnant individuals
Decompensated cirrhosis (Child Turcotte Pugh Class B and C); hepatocellular carcinoma; prior liver or kidney transplant

No patient will be excluded because of gender, race or ethnic origin.

The following populations will be excluded from the study:

Adults 18 years of age and older who are unable or unwilling to consent
Individuals less than 18 years old
Pregnant individuals
Prisoners

Treatment and study plan

Use of Tappt App

Other

Use of Tappt, a novel digital medication companion solution. Upon study completion, a retrospective matched control may be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm.

Primary outcomes

Medication adherence

Time frame: 8-12 weeks

Modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR)

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

American Society of Health-System Pharmacists
Synchronyx

Registry information

Official study title

Effectiveness of a Novel Smart Tag Technology in a Pharmacy-Led Setting to Improve Adherence, Patient-Centered Care and Outcomes in HCV

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Feb 16, 2024
Registry last updated: Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed