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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 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

Locations
United States
Illinois
UIH
RECRUITING
Chicago
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 30
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Illinois at Chicago
Collaborators: American Society of Health-System Pharmacists, Synchronyx

This content was sourced from clinicaltrials.gov