HEPATITIS C (HCV)
Conditions
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.
Interventions
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.
Sponsors
Patrick Grace
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence Rate | 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) | 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. |
Countries
United States
Contacts
CONTACTRonda Shea
Outcome results
None listed