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

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.

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Key information

Conditions

HEPATITIS C (HCV) Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location contact

Patrick Grace

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

Primary outcomes

Medication Adherence Rate

Time frame: 12 Weeks After Treatment Initiation

Percentage of prescribed hepatitis C medication doses taken during the treatment period, measured using the cellular-connected smart pillbox.
Sustained Virologic Response at 4 Weeks (SVR4)

Time frame: 4 Weeks after completion of treatment

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ronda Shea

CONTACT

[email protected]

859-323-5212

Sponsors and collaborators

Lead sponsor

Patrick Grace

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Aug 28, 2026
Registry last updated: Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not yet recruiting