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HCV Test and Treat Utilizing Simplified HCV Patient Education

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05582681
Collaborator
AbbVie (Industry)
200
Enrollment
3
Locations
2
Arms
58.6
Anticipated Duration (Months)
66.7
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Cepheid POC HCV Viremia (RNA) test
  • Other: HCV education from a health care provider
  • Drug: Glecaprevir and Pibrentasvir
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
HCV Test and Treat Utilizing Simplified HCV Patient Education
Actual Study Start Date :
Nov 11, 2022
Anticipated Primary Completion Date :
Oct 1, 2027
Anticipated Study Completion Date :
Oct 1, 2027

Arms and Interventions

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.

    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.

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of subjects who initiated treatment within 8-week window from enrollment. [Up to 8 weeks]

    Secondary Outcome Measures

    1. Number of subjects who complete treatment in 8 weeks [Up to 8 weeks]

    2. 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]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix House Long Island City New York United States 11101
    2 ColumbiaDoctors Midtown New York New York United States 10019
    3 Weill Cornell Medicine Midtown Center for Treatment and Research New York New York United States 10036

    Sponsors and Collaborators

    • Weill Medical College of Cornell University
    • AbbVie

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT05582681
    Other Study ID Numbers:
    • 21-06023705
    First Posted:
    Oct 17, 2022
    Last Update Posted:
    Dec 21, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Weill Medical College of Cornell University
    Hepatitis C Virus
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis

    Study Results

    No Results Posted as of Dec 21, 2022