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The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset - Trial NCT05713136

Access comprehensive clinical trial information for NCT05713136 through Pure Global AI's free database. This phase not specified trial is sponsored by Kirby Institute and is currently Not yet recruiting. The study focuses on Hepatitis C. Target enrollment is 40000 participants.

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Trial Details
ClinicalTrials.gov โ€ข NCT05713136
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The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection - HCV Antibody Testing Minimal Dataset

Study Focus

Hepatitis C

Diagnostic Test: Point-of-Care Testing

Observational

device

Sponsor & Location

Kirby Institute

Timeline & Enrollment

N/A

Mar 01, 2023

Dec 31, 2025

40000 participants

Primary Outcome

To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing.

Summary

This is an observational cohort study. Participants will be recruited from settings that
 provide services to people with a risk factor for the acquisition of HCV infection.
 Participants will attend a single visit to have HCV point-of-care testing. Participants who
 have not previously received HCV treatment will have a point-of-care HCV antibody test,
 followed by reflex point-of-care HCV RNA test if positive. Those who have a history of HCV
 treatment will proceed straight to point-of-care HCV RNA testing. Participants will not
 receive treatment as a part of this study. Participants who are HCV RNA positive will receive
 treatment via standard of care. The purpose of this study is to look at the effect of
 finger-stick point-of-care hepatitis C testing, to see if it increases the number of tests,
 diagnoses, and treatments for people with a risk factor of having hepatitis C in Australia.

ICD-10 Classifications

Acute hepatitis C
Chronic viral hepatitis C
Viral hepatitis
Chronic viral hepatitis
Unspecified viral hepatitis

Data Source

ClinicalTrials.gov

NCT05713136

Device Trial