Hepatitis C
Conditions
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.
Interventions
OTHERUse of Tappt App
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.
Sponsors
University of Illinois at Chicago
Synchronyx
American Society of Health-System Pharmacists
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence | 8-12 weeks | Modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichelle Martin
UIH
Outcome results
None listed