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
Location: See all (12) locations...
Intervention Type: Device
Study Type: Observational
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 participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Provide informed consent

• ≥ 18 years of age.

Locations
Other Locations
Australia
South Australian Prison Health Service
NOT_YET_RECRUITING
Adelaide
Queensland Injectors Health Network Ltd
RECRUITING
Bowen Hills
West Moreton Hospital and Health Service
RECRUITING
Brisbane
Lotus Glen Correctional Centre
RECRUITING
Cairns
ACT Justice Health
NOT_YET_RECRUITING
Canberra
Hepatitis South Australia
NOT_YET_RECRUITING
Hackney
Tasmanian Prison Service
NOT_YET_RECRUITING
Hobart
St Vincent's Hospital (Melbourne)
RECRUITING
Melbourne
WA Department of Justice
NOT_YET_RECRUITING
Perth
Justice Health and Forensic Mental Health Network
RECRUITING
Sydney
Townsville Correctional Centre
NOT_YET_RECRUITING
Townsville
Woodford Correctional Centre
RECRUITING
Woodford
Contact Information
Primary
David Silk, BSc
dsilk@kirby.unsw.edu.au
+61293850900
Backup
Stephanie Davey, BSc
sdavey@kirby.unsw.edu.au
+61293481404
Time Frame
Start Date: 2023-01-25
Estimated Completion Date: 2027-01
Participants
Target number of participants: 40000
Treatments
People at risk of HCV acquisition
Clinic staff will offer HCV point-of-care testing to participants as they access services. Testing will be performed using point-of-care HCV RNA testing
Related Therapeutic Areas
Sponsors
Collaborators: Flinders University
Leads: Kirby Institute

This content was sourced from clinicaltrials.gov

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