Ignite Creation Date:
2024-05-06 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05713136
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-01-17
Brief Title:
The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
Sponsor:
Kirby Institute
Organization:
Kirby Institute
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus before providing a diagnostic test for Hepatitis C infection can increase testing diagnosis and treatment in Adults Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection The main question it aims to answer is
What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis
Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C Participants who know they have been infected with Hepatitis C in the past and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit
No treatment is provided as a part of this study participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation A review of the participants records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered
What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis
Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C Participants who know they have been infected with Hepatitis C in the past and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit
No treatment is provided as a part of this study participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation A review of the participants records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None