ClinicalTrials.gg
Not yet recruitingNCT07793643Updated Aug 28, 2026

AI-Powered Hepatitis C Single-Encounter Test-and-Treat

A Phase 4 interventional study of Epclusa (sofosbuvir and velpatasvir) in HEPATITIS C (HCV), sponsored by Patrick Grace. Not yet recruiting at 1 site in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Patrick Grace · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
22 Years to 65 Years
Sex
All
01

Study summary

This study will evaluate a single-visit approach to hepatitis C treatment in patients seen in the emergency department. Participants with hepatitis C will receive rapid testing and, if eligible, hepatitis C medication before leaving the emergency department. The study will also use a smart pillbox, an AI-powered virtual agent, and community health worker support to help participants take their medication as prescribed. Participants will have follow-up visits and testing to assess medication adherence and whether the hepatitis C infection is cured.

02

Conditions studied

  • HEPATITIS C (HCV)

Browse trials for

03

In context

Hepatitis C

1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.

This study's planned enrollment of 35 is below the median of 72 across 1,223 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

This is the only study on the registry with Patrick Grace as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 22-65 years old, presenting to the Emergency Department (ED) who are undergoing antibody testing as part of universal screening
  • Patients to be discharged from the ED or ED Observational units

Exclusion criteria

Exclusion Criteria:

  • Capacity to Consent
  • Emergency Severity Index (ESI) Level one (high acuity patients)
  • Known noninvasive serologic tests above proprietary cutoffs indicating cirrhosis (example - FibroSure, Enhanced Liver Fibrosis Test, etc.)
  • Known clinical evidence of cirrhosis (egliver nodularity and/or splenomegaly on imaging, count \<150,000/m3, etc.)
  • Known prior liver showing cirrhosis

    •Pregnancy

  • Known or suspected Hepatocellular carcinoma
  • Followed by hospice or transplant, have a \< 1 year
  • Chronic Kidney Disease (CKD) or on dialysis
  • Allergy to study medications
  • Patients admitted to the hospital
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Medication in Hand

    Participants will receive hepatitis C treatment during the emergency department visit, along with medication adherence support using a cellular-connected smart pillbox, an artificial intelligence-powered virtual agent, and community health worker support. Participants will be followed through treatment completion and follow-up testing.

    Drug: Epclusa (sofosbuvir and velpatasvir)

Interventions

  • DrugEpclusa (sofosbuvir and velpatasvir)

    Participants who test positive for hepatitis C will receive sofosbuvir/velpatasvir treatment before discharge from the Emergency Department. The first month of medication will be provided by the study, with subsequent treatment coordinated through the clinical team and specialty pharmacy.

06

What researchers measure

Primary outcomes

  1. Medication Adherence Rate

    Percentage of prescribed hepatitis C medication doses taken during the treatment period, measured using the cellular-connected smart pillbox.

    Time frame: 12 Weeks After Treatment Initiation

  2. Sustained Virologic Response at 4 Weeks (SVR4)

    Percentage of participants who achieved a sustained virologic response, indicating hepatitis C cure, at 4 weeks after completion of treatment.

    Time frame: 4 Weeks after completion of treatment

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07793643
Lead sponsor
Patrick Grace
Responsible party
Patrick Grace (Associate Professor, University of Kentucky) — Sponsor-investigator
First posted
Aug 28, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Sep 1, 2028 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Aug 28, 2026

Study contacts

Ronda Shea
Contact
ronda.petrey@uky.edu
859-323-5212

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion