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

ConditionHEPATITIS C (HCV)

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age22-65

SponsorPatrick Grace

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

35 Participants

are divided into 1 treatment group

Group A: Medication in HandExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Patrick Grace

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: