HEPATITIS C (HCV)Phase 4NCT07793643
AI-Powered Hepatitis C Single-Encounter Test-and-Treat
A Phase 4 study testing Epclusa (sofosbuvir and velpatasvir) in people with HEPATITIS C (HCV), run by Patrick Grace at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- HEPATITIS C (HCV)
- What is being tested?
- Epclusa (sofosbuvir and velpatasvir)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kentucky
Lexington, Kentucky, 40506
Patrick Grace, patrick.grace@uky.edu
About this study
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.
- Conditions
- HEPATITIS C (HCV)
- Being tested
- Epclusa (sofosbuvir and velpatasvir)
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Epclusa (sofosbuvir and velpatasvir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Adherence Rate
Percentage of prescribed hepatitis C medication doses taken during the treatment period, measured using the cellular-connected smart pillbox.
Measured: 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.
Measured: 4 Weeks after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEPATITIS C (HCV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patrick Grace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Patrick Grace, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793643
- Sponsor's protocol ID
- 107575
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Powered Hepatitis C Single-Encounter Test-and-Treat
- ClinicalTrials.gov ID
- NCT07793643
- Acronym / sponsor ID
- 107575
- Conditions
- HEPATITIS C (HCV)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Patrick GraceUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medication in Hand | Experimental | Drug: Epclusa (sofosbuvir and velpatasvir)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. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epclusa (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. | Drug | Medication in Hand |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
Related trials for HEPATITIS C (HCV)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epclusa (sofosbuvir and velpatasvir) in people with HEPATITIS C (HCV), run by Patrick Grace at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronda Shea (859-323-5212, ronda.petrey@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Rate (time frame: 12 Weeks After Treatment Initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.