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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called Tappt, designed to help people with hepatitis C track their medication use. The goal is to determine if the app can improve adherence to treatment plans and aid in successfully clearing the virus. The trial will compare the outcomes of app users with past records of those who did not use it. Individuals with hepatitis C who are beginning specific oral treatments and own a smartphone may be suitable candidates for this study. As an unphased trial, this study allows participants to contribute to innovative research that may enhance treatment adherence for others with hepatitis C.

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 prior data suggests that the Tappt app is safe for individuals with hepatitis C?

Research has shown that digital tools like the Tappt app are generally easy for people to use. One study on a digital program for treating hepatitis C (HCV) found that it helped people take their medication regularly without causing major side effects. This suggests that using a digital app like Tappt is likely safe for participants.

Other studies on telemedicine for HCV have successfully used similar digital methods. These methods made treatment more accessible and improved patient engagement in their care. This evidence suggests that the Tappt app can safely help manage HCV treatment, assisting users in maintaining their medication regimen while reducing risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tappt App because it offers a new way to enhance treatment adherence for Hepatitis C patients. Unlike traditional treatments that rely solely on patient discipline to follow medication schedules, the Tappt App uses a technology-driven approach by allowing patients to scan tags to track their medication intake. This innovative method not only helps patients stay on track with their medication regimen but also provides real-time data that can potentially improve treatment outcomes and ensure higher rates of sustained virologic response (SVR).

What evidence suggests that the Tappt app is effective for improving medication adherence in hepatitis C patients?

Research has shown that treatments for Hepatitis C, known as direct-acting antivirals, are effective for over 90% of patients, helping most eliminate the virus. One study found that 91% of patients completed their treatment with successful results. In this trial, participants in the Tappt App arm will use the app to ensure timely medication intake, which is crucial for these treatments to be effective. By aiding adherence to medication schedules, Tappt aims to support similar positive outcomes in Hepatitis C treatment. ^{5 6 7 8 9}

Who Is on the Research Team?

Michelle Martin

Principal Investigator

UIH

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-hepatitis-c-6-2024-4847c

Tappt App 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9257498/

Outcomes of a Pharmacist-Led Hepatitis C Virus Treatment ... Of the 203 HCV treatment applications, 87% (n = 176) of patients were approved for treatment, 91% (n = 161) of whom completed treatment. Of the 161 patients who ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0955395924002469

Financial incentives to increase engagement across the ... We conducted a systematic review to assess evidence regarding the effectiveness of financial incentives to improve engagement and progression through the HCV ...

4. researchgate.net researchgate.net/publication/386025856_A_precision_randomized_trial_to_evaluate_the_impact_of_tailored_hepatitis_C_treatment_adherence_support_on_HCV_treatment_outcomes_among_people_who_inject_drugs_in_India_Design_and_Baseline_Characteris

Design and Baseline Characteristics of the STOP-C Trial All received 12 weeks of oral direct-acting antiviral therapy. The primary outcome is sustained virologic response 12 weeks after treatment ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6694728/

A Mobile Health Intervention to Improve Hepatitis C ... Four primary outcomes will be examined: undergoing HCV testing, linking to HCV medical care, initiating HCV treatment, and achieving a sustained ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11806898/

Peer-assisted telemedicine hepatitis-C treatment for ... This low-barrier model makes space for PWUD to receive HCV treatment, regardless of drug use.

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2816706

Integrated Hepatitis C–Opioid Use Disorder Care Through ... This study discusses whether facilitated telemedicine for hepatitis C treatment increases cure rates compared with standard-of-care referral ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11437394/

Lessons Learned from a Mobile Telehealth HCV Testing and ... In this commentary, we discuss lessons learned delivering telehealth on a mobile unit, important factors for consideration when designing a mobile intervention.

9. researchgate.net researchgate.net/publication/341057741_Impact_of_a_digital_medicine_programme_on_hepatitis_C_treatment_adherence_and_efficacy_in_adults_at_high_risk_for_non-adherence

Impact of a digital medicine programme on hepatitis C ... Aims To conduct a prospective, single‐arm, open‐label study across the United States to assess the impact of DMP on adherence and efficacy in ...