HCV Test and Treat Utilizing Simplified HCV Patient Education
Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C Virus
Eligibility Criteria
Inclusion Criteria:
- Men and women age greater or equal to18 at study entry or emancipated minors over greater or equal to 16 to less or equal 70 years at study entry
- HCV antibody positive
- HCV treatment naïve (no prior treatment with an approved or investigational anti HCV medication)
Exclusion Criteria:
- Current or history of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry
- History of hepatocellular carcinoma (HCC)
- Any history of active Hepatitis B or positive HBsAg positive test
- HCV RNA undetectable
Sites / Locations
- Phoenix HouseRecruiting
- ColumbiaDoctors MidtownRecruiting
- Weill Cornell Medicine Midtown Center for Treatment and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
HCV Education
Point of Care (POC) HCV Viremia (RNA) testing
The intervention of HCV education will be performed at the addiction care setting for video- based patient education. Health care provide delivered patient education is the standard of care referral approach. HCV Education will include HCV disease overview, HCV screening, taking Glecaprevir/Pibrentasivir (G/P), and post study drug assessment and management. Participants may be randomized to either the video-based patient education or the HCV delivered patient education.
All participants will have standardized laboratory assessments for HCV Viremia (RNA testing) as well as Cepheid POC HCV Viremia (RNA) test. The Cepheid Xpert HCV Viral Load (VL) Fingerstick assay is a test designed for the quantitation (amount) of Hepatitis C Virus (HCV) DNA in human whole blood. The HCV RNA result will be compared to standardized laboratory assessment for HCV Viremia. The Cepheid test is being conducted for research use only and will not be used for HCV diagnosis or treatment decisions.