NCT07793643

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
21mo left

Started Dec 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

August 28, 2026

Status Verified

August 1, 2026

Enrollment Period

1.8 years

First QC Date

August 22, 2026

Last Update Submit

August 26, 2026

Conditions

HEPATITIS C (HCV)

Outcome Measures

Primary Outcomes (2)

  • Medication Adherence Rate

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

    12 Weeks After Treatment Initiation

  • 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.

    4 Weeks after completion of treatment

Study Arms (1)

Medication in Hand

EXPERIMENTAL

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

Epclusa (sofosbuvir and velpatasvir)DRUG

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.

Medication in Hand

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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, platelet count \<150,000/m3, etc.)
  • Known prior liver biopsy showing cirrhosis
  • Pregnancy
  • Known or suspected Hepatocellular carcinoma
  • Followed by hospice or transplant, have a life expectancy \< 1 year
  • Chronic Kidney Disease (CKD) or on dialysis
  • Allergy to study medications
  • Patients admitted to the hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combinationSofosbuvirvelpatasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Central Study Contacts

Ronda Shea

CONTACT

859-323-5212ronda.petrey@uky.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 22, 2026

First Posted

August 28, 2026

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

August 28, 2026

Record last verified: 2026-08

Locations

US(1)