HCV Test and Treat Utilizing Simplified HCV Patient Education

Weill Cornell Medicine (WCM)

Status and phase: Terminated; Phase 4

Conditions: Hepatitis C

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05582681

21-06023705

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

HCV Education

Active Comparator group

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.

Treatment:

Other: HCV education from a health care provider

Drug: Glecaprevir and Pibrentasvir

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

Experimental group

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.

Treatment:

Diagnostic Test: Cepheid POC HCV Viremia (RNA) test

Other: HCV education from a health care provider

Drug: Glecaprevir and Pibrentasvir