HCV Tappt Adherence Study - Trial NCT06263829

Timeline & Enrollment

Primary Outcome

Medication adherence

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.

ICD-10 Classifications