Evaluating a digital medication companion for hepatitis C treatment adherence
Effectiveness of a Novel Smart Tag Technology in a Pharmacy-Led Setting to Improve Adherence, Patient-Centered Care and Outcomes in HCV
This study is testing a new app called Tappt to see if it helps people with hepatitis C stick to their medication better than usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06263829 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy of Tappt, a digital medication companion app, in improving medication adherence among individuals starting oral therapy for hepatitis C. Participants will use the app to track their medication intake, and the study will measure adherence rates, treatment completion, and sustained virologic response (SVR) outcomes. The trial also seeks to empower pharmacists to tailor treatment based on reported barriers to adherence. The primary focus is on determining whether Tappt is as effective as standard care in achieving these outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed hepatitis C infection who are beginning oral antiviral therapy.
Not a fit: Patients with severe liver disease, such as decompensated cirrhosis or those who cannot communicate in English, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance medication adherence and treatment outcomes for patients with hepatitis C.
How similar studies have performed: Other studies have shown promise in using digital health solutions to improve medication adherence, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- Uih — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Martin — Uih
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.