HCV Test and Treat Utilizing Simplified HCV Patient Education

Hepatitis C Clinical Trial

Official title:

HCV Test and Treat Utilizing Simplified HCV Patient Education

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05582681
• Other study ID #: 21-06023705
• Status: Recruiting
• Phase: Phase 4
• Start date: November 11, 2022
• Est. completion date: October 2027

Study information

• Verified date: March 2024
• Source: Weill Medical College of Cornell University
• Contact: Robert S Brown, MD, MPH
• Phone: 646-962-5483
• Email: rsb2005[@]med.conrell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

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.

Locations

Country	Name	City	State
United States	Phoenix House	Long Island City	New York
United States	ColumbiaDoctors Midtown	New York	New York
United States	Weill Cornell Medicine Midtown Center for Treatment and Research	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects who initiated treatment within 8-week window from enrollment.		Up to 8 weeks
Secondary	Number of subjects who complete treatment in 8 weeks		Up to 8 weeks
Secondary	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
Secondary	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