Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06263829

HCV Tappt Adherence Study

Led by University of Illinois at Chicago · Updated on 2025-04-10

30

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

U

University of Illinois at Chicago

Lead Sponsor

S

Synchronyx

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

HCV Tappt Adherence Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Hepatitis C virus infection confirmed by positive antibody and detectable RNA
  • Starting oral HCV therapy with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir
  • Treatment provided and managed by clinical pharmacist at UI Health
  • Access to a compatible smartphone (iPhone 7 or later; Android from 2012 or later) with reliable data or Wi-Fi
  • Able to verbally understand the study protocol in English
  • Able and willing to provide informed consent in English
Not Eligible

You will not qualify if you...

  • Inability to speak and read English
  • Inability or unwillingness to follow the study protocol
  • Pregnant individuals
  • Decompensated cirrhosis (Child Turcotte Pugh Class B and C)
  • Hepatocellular carcinoma
  • Prior liver or kidney transplant
  • Adults unable or unwilling to consent
  • Individuals under 18 years old
  • Prisoners

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

UIH

Chicago, Illinois, United States, 60612

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

2

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