HCV Test and Treat Utilizing Simplified HCV Patient Education

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2024-11-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

HCV education from a health care provider

Intervention Type 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

Glecaprevir and Pibrentasvir

Intervention Type DRUG

G/P will be provided for 8 weeks.

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.

Group Type EXPERIMENTAL

Cepheid POC HCV Viremia (RNA) test

Intervention Type 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.

HCV education from a health care provider

Intervention Type 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

Glecaprevir and Pibrentasvir

Intervention Type DRUG

G/P will be provided for 8 weeks.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type OTHER

Glecaprevir and Pibrentasvir

G/P will be provided for 8 weeks.

Intervention Type DRUG

Other Intervention Names

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G/P

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes