NCT05582681

HCV Test and Treat Utilizing Simplified HCV Patient Education

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-11
• Primary completion: 2024-11-22
• Completion: 2024-11-22
• First posted: 2022-10-17
• Last updated: 2025-02-27

Locations

3 sites across 1 country: United States