HCV Test and Treat Utilizing Simplified HCV Patient Education

Phase 4

Terminated

• Conditions: Hepatitis C
• Interventions: Diagnostic Test: Cepheid POC HCV Viremia (RNA) test; Other: HCV education from a health care provider; Drug: Glecaprevir and Pibrentasvir

• Registration Number: NCT05582681
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The study hypothesis is that the test and treat model utilizing video-based patient education will have higher rates of hepatitis C virus (HCV) treatment initiation and treatment completion.

Detailed Description

Viral hepatitis C (HCV) represents a major public health concern and is associated with significant morbidity and mortality. HCV screening and treatment among people who use drugs is challenging due to barriers leading to loss within HCV care cascades at most centers providing addiction care.

One critical element that would improve access to HCV therapy would be a test, educate and treat system, where people obtain drug on the same day as they are confirmed as Hepatitis C viremic.

Study Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-17
• Study Start: 2022-11-11
• Primary Completion: 2024-11-22
• Study Completion: 2024-11-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Point of Care (POC) HCV Viremia (RNA) testing	Glecaprevir and Pibrentasvir	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.
HCV Education	Glecaprevir and Pibrentasvir	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.
Point of Care (POC) HCV Viremia (RNA) testing	Cepheid POC HCV Viremia (RNA) test	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.
Point of Care (POC) HCV Viremia (RNA) testing	HCV education from a health care provider	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.
HCV Education	HCV education from a health care provider	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.

Primary Outcome Measures

Name	Time	Method
Number of subjects who initiated treatment within 8-week window from enrollment.	Up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Number of subjects who complete treatment in 8 weeks	Up to 8 weeks
Sustained Viral Response 12 weeks post dosing (SVR12) (<lower limit of quantification (LLOQ) of HCV RNA in at 12 weeks post treatment with window up to 24 weeks after end of treatment)	Up to 24 weeks
SVR12 (<LLOQ of HCV RNA in at 12 weeks post treatment with window up to 24 weeks after end of treatment) from real world evidence post-marketing observational study (RWE PMOS) efficacy G/P9 (compare test and treat arm with PMOS SVR12 result)	Up to 24 weeks

Trial Locations

Locations (3)

Phoenix House; 🇺🇸 Long Island City, New York, United States

ColumbiaDoctors Midtown; 🇺🇸 New York, New York, United States

Weill Cornell Medicine Midtown Center for Treatment and Research; 🇺🇸 New York, New York, United States