Tappt App for Hepatitis C

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must be taking: Glecaprevir/pibrentasvir, Sofosbuvir/velpatasvir

Disqualifiers: Pregnancy, Decompensated cirrhosis, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it focuses on starting a new oral medication for hepatitis C, so it's best to discuss your current medications with the study team.

What data supports the effectiveness of the Tappt treatment for Hepatitis C?

Research shows that direct-acting antiviral treatments for Hepatitis C, which are similar to Tappt, have high success rates, with more than 90% of patients experiencing significant improvements. These treatments are well-tolerated and lead to better health outcomes. ^{1 2 3 4 5}

What makes the Tappt App treatment for Hepatitis C unique?

The Tappt App treatment for Hepatitis C is unique because it likely involves a digital or app-based approach, which could offer advantages in accessibility and ease of use compared to traditional drug therapies. This approach may enhance patient engagement and adherence to treatment protocols, although specific details about its mechanism or components are not provided in the available research. ^{6 7 8 9 10}

Research Team

Michelle Martin

Principal Investigator

UIH

Eligibility Criteria

This trial is for adults over 18 with hepatitis C starting oral therapy managed by a clinical pharmacist at UI Health. Participants must understand English, have access to a smartphone (iPhone 7/Android from 2012 or newer) with data/Wi-Fi, and be willing to consent.

Inclusion Criteria

Access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access

Able and willing to provide informed consent in English

I have an active Hepatitis C infection.

Exclusion Criteria

Inability to speak and read English

Inability or unwillingness to adhere to the study protocol

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants utilize the Tappt app to record adherence to oral medication for hepatitis C virus (HCV) treatment

8-12 weeks

Follow-up

Participants are monitored for sustained virologic response (SVR) and treatment completion

4 weeks

Treatment Details

Interventions

• Tappt

Trial Overview The study tests the Tappt app's effectiveness in helping patients stick to their hepatitis C medication schedule. It measures if using Tappt is as good as standard care for keeping up with meds, finishing treatment, and clearing the virus.

Participant Groups

Group I: Tappt App Experimental Treatment 1 Intervention

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.

Group II: Historical Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

American Society of Health-System Pharmacists

Collaborator

Trials

5

Recruited

330+

Synchronyx

Collaborator

Trials

1

Recruited

30+

Findings from Research

A 12-week treatment with sofosbuvir-based direct-acting antivirals (DAAs) led to significant improvements in patient-reported outcomes, including health-related quality of life and fatigue, 24 weeks after treatment in 120 patients with chronic hepatitis C from Central and West Africa.

The study highlights that patients experienced better physical and mental health post-treatment, suggesting that DAAs provide benefits beyond just eradicating the virus, which can help inform treatment providers in low-to-middle-income countries about the broader advantages of DAA therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes with direct-acting antiviral treatment for hepatitis C in West and Central Africa (TAC ANRS 12311 trial). Marcellin, F., Mourad, A., Lemoine, M., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes with direct-acting antiviral treatment for hepatitis C in West and Central Africa (TAC ANRS 12311 trial). [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Hepatitis C: How Good Are Real-Life Data and Do Generics Work. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Factors associated with success of telaprevir- and boceprevir-based triple therapy for hepatitis C virus infection. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes 12 months after hepatitis C treatment with direct-acting antivirals: Results from the PROP UP study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A comprehensive assessment of patient reported symptom burden, medical comorbidities, and functional well being in patients initiating direct acting antiviral therapy for chronic hepatitis C: Results from a large US multi-center observational study. [2019]

6. France pubmed.ncbi.nlm.nih.gov

[Which place for point-of-care screening tests in the diagnosis of hepatitis C infection among drug users?]. [2017]

7. Canada pubmed.ncbi.nlm.nih.gov

An update on the management of hepatitis C: consensus guidelines from the Canadian Association for the Study of the Liver. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

How to use virological tools for the optimal management of chronic hepatitis C. [2011]

9. Canada pubmed.ncbi.nlm.nih.gov

Advances in the Diagnosis and Monitoring of Hepatitis C Virus Infection. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Hepatitis C: controversies, strategies and challenges. [2019]