HCV Tappt Adherence Study

February 8, 2024 updated by: University of Illinois at Chicago

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18 years of age or older
  2. Hepatitis C virus (HCV) infection (denoted by positive HCV antibody and detectable HCV RNA)
  3. Initiating oral HCV therapy with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir
  4. HCV treatment provided and managed by the clinical pharmacist at UI Health
  5. Access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access
  6. Ability to verbalize understanding of the study protocol in English
  7. Able and willing to provide informed consent in English

Exclusion Criteria:

  1. Inability to speak and read English
  2. Inability or unwillingness to adhere to the study protocol
  3. Pregnant individuals
  4. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tappt App
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.
Other: Use of Tappt App
Use of Tappt, a novel digital medication companion solution
No Intervention: Historical Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence
Time Frame: 8-12 weeks
Modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR)
8-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

American Society of Health-System Pharmacists
Synchronyx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-1580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on Use of Tappt App

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe