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

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Patrick Grace
Study ID
NCT07793643
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • HEPATITIS C (HCV)

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Dec 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Medication Adherence Rate [ Time Frame: 12 Weeks After Treatment Initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Patrick Grace
[email protected]

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By research site
University of Kentucky· Lexington, KY

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