HCV Tappt Adherence Study

NCT06263829 | Recruiting

• 1 other identifier: 2023-1580
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Medication adherence

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

  8-12 weeks

Study Arms (2)

Tappt App

EXPERIMENTAL

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

Historical Control

NO INTERVENTION

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.

Interventions

Use of Tappt App OTHER

Use of Tappt, a novel digital medication companion solution

Tappt App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Synchronyx: collaborator
• American Society of Health-System Pharmacists: collaborator

Study Sites (1)

UIH

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

• Michelle Martin

  UIH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 16, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)