HCV Test and Treat Utilizing Simplified HCV Patient Education

NCT05582681 | Terminated Phase 4

• 1 other identifier: 21-06023705
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatitis C

Keywords

Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• Number of subjects who initiated treatment within 8-week window from enrollment.

  Up to 8 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

HCV Education

ACTIVE COMPARATOR

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; Drug: Glecaprevir and Pibrentasvir

Point of Care (POC) HCV Viremia (RNA) testing

EXPERIMENTAL

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.

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

Interventions

Cepheid POC HCV Viremia (RNA) test DIAGNOSTIC_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.

Point of Care (POC) HCV Viremia (RNA) testing

HCV education from a health care provider OTHER

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

HCV Education; Point of Care (POC) HCV Viremia (RNA) testing

Glecaprevir and Pibrentasvir DRUG

G/P will be provided for 8 weeks.

Also known as: G/P

HCV Education; Point of Care (POC) HCV Viremia (RNA) testing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• AbbVie: collaborator

Study Sites (3)

Phoenix House

Long Island City, New York, 11101, United States

Location

ColumbiaDoctors Midtown

New York, New York, 10019, United States

Location

Weill Cornell Medicine Midtown Center for Treatment and Research

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Robert S Brown, MD, MPH

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label, phase 4 randomized trial to assess test and treat strategy with simplified video-based patient education versus standard of care referral with health care provider delivered patient education.

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 17, 2022
• Study Start: November 11, 2022
• Primary Completion: November 22, 2024
• Study Completion: November 22, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)