HCV Test and Treat Utilizing Simplified HCV Patient Education

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis C
• Intervention / Treatment: Other: HCV education from a health care provider; Drug: Glecaprevir and Pibrentasvir; Diagnostic test: Cepheid POC HCV Viremia (RNA) test

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Robert S Brown, MD, MPH; Phone Number: 646-962-5483; Email: rsb2005@med.conrell.edu
• Study Contact Backup: Name: Jessica Siguencia; Phone Number: 646-962-5483; Email: jms4007@med.cornell.edu

Study Locations

• United States
  • New York
    • Long Island City, New York, United States, 11101
      • Recruiting
      • Phoenix House
      • Contact: Linda Sacco, PhD; Phone Number: 888-671-9392
      • Principal Investigator: Robert S Brown, MD
      • Contact: Jessica Siguencia; Phone Number: 6469625483; Email: jms4007@med.cornell.edu
    • New York, New York, United States, 10019
      • Recruiting
      • ColumbiaDoctors Midtown
      • Principal Investigator: Robert S Brown, MD
      • Contact: Robert S Brown, MD; Phone Number: 212-326-8500; Email: rb464@cumc.columbia.edu
      • Contact: Jessica Siguencia; Phone Number: 6469625483; Email: jms4007@med.cornell.edu
    • New York, New York, United States, 10036
      • Recruiting
      • Weill Cornell Medicine Midtown Center for Treatment and Research
      • Principal Investigator: Robert S Brown, MD
      • Contact: Christopher Sturiano, PhD; Phone Number: 212-764-5178; Email: chs2036@med.cornell.edu
      • Contact: Jessica Siguencia; Phone Number: 6469625483; Email: jms4007@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HCV Education; 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.	Other: HCV education from a health care provider; HCV education provided by health care provider. HCV Education will include HCV disease overview, HCV screening, treatment with G/P, and post treatment assessment and management; Drug: Glecaprevir and Pibrentasvir; G/P will be provided for 8 weeks.; Other Names: G/P
Experimental: Point of Care (POC) HCV Viremia (RNA) testing; 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.	Other: HCV education from a health care provider; HCV education provided by health care provider. HCV Education will include HCV disease overview, HCV screening, treatment with G/P, and post treatment assessment and management; Drug: Glecaprevir and Pibrentasvir; G/P will be provided for 8 weeks.; Other Names: G/P; Diagnostic test: 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 for being conducted for research use only and will not be used for HCV diagnosis or treatment decisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects who initiated treatment within 8-week window from enrollment.	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: AbbVie
• Investigators: Principal Investigator: Robert S Brown, MD, MPH, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hepatitis C Virus
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: 21-06023705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes