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HCV Test and Treat Utilizing Simplified HCV Patient Education

Primary Purpose

Hepatitis C

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cepheid POC HCV Viremia (RNA) test
HCV education from a health care provider
Glecaprevir and Pibrentasvir
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C Virus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arm Type

Active Comparator

Experimental

Arm Label

HCV Education

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of subjects who complete treatment in 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)
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)

Full Information

First Posted
October 12, 2022
Last Updated
December 20, 2022
Sponsor
Weill Medical College of Cornell University
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05582681
Brief Title
HCV Test and Treat Utilizing Simplified HCV Patient Education
Official Title
HCV Test and Treat Utilizing Simplified HCV Patient Education
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
October 2027 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HCV Education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Point of Care (POC) HCV Viremia (RNA) testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cepheid POC HCV Viremia (RNA) test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
HCV education from a health care provider
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Glecaprevir and Pibrentasvir
Other Intervention Name(s)
G/P
Intervention Description
G/P will be provided for 8 weeks.
Primary Outcome Measure Information:
Title
Number of subjects who initiated treatment within 8-week window from enrollment.
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Number of subjects who complete treatment in 8 weeks
Time Frame
Up to 8 weeks
Title
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)
Time Frame
Up to 24 weeks
Title
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)
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert S Brown, MD, MPH
Phone
646-962-5483
Email
rsb2005@med.conrell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam Gazi
Phone
646-962-5483
Email
mag4028@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Brown, MD, MPH
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix House
City
Long Island City
State/Province
New York
ZIP/Postal Code
11101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Sacco, PhD
Phone
888-671-9392
First Name & Middle Initial & Last Name & Degree
Maryam Gazi
Phone
6469625483
Email
mag4028@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Robert S Brown, MD
Facility Name
ColumbiaDoctors Midtown
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert S Brown, MD
Phone
212-326-8500
Email
rb464@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Maryam Gazi
Phone
6469625483
Email
mag4028@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Robert S Brown, MD
Facility Name
Weill Cornell Medicine Midtown Center for Treatment and Research
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Sturiano, PhD
Phone
212-764-5178
Email
chs2036@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Maryam Gazi
Phone
6469625483
Email
mag4028@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Robert S Brown, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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HCV Test and Treat Utilizing Simplified HCV Patient Education

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