Clinical trial NCT05713136: The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis C
Keywords: Point-of-Care
Rapid Diagnostic Testing
HCV
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
Collaborators: name: Flinders University
First posted: 2023-02-06
Enrollment: 40000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be included from settings that provide services to people with a risk factor for the acquisition of HCV infection, including drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, homelessness services, and other appropriate settings nationally. It is anticipated that approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.

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 participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.


Eligibility criteria: Inclusion Criteria:

* Provide informed consent
* ≥ 18 years of age.

Exclusion Criteria:

* Is unable or unwilling to provide informed consent

Primary outcomes:
measure: 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.
timeFrame: 12 weeks from enrolment
Secondary outcomes:
measure: To evaluate the proportion of people who accept point-of-care testing among those offered testing.
timeFrame: Recruitment phase
measure: To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
timeFrame: Recruitment phase
measure: To evaluate the HCV antibody prevalence among people tested.
timeFrame: Recruitment phase
measure: To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;
timeFrame: 52 weeks
measure: To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.
timeFrame: 52 weeks
measure: To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;
timeFrame: 52 weeks
measure: To evaluate the proportion of participants who achieve an SVR following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment
timeFrame: 52 weeks
measure: To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.
timeFrame: 52 weeks
measure: To evaluate the cost of point-of-care HCV antibody testing prior to reflex HCV RNA testing compared to direct point-of-care HCV RNA testing and standard of care.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: ACT Justice Health
state: Australian Capital Territory
city: Sydney
country: Australia
facility: Justice Health and Forensic Mental Health Network
state: New South Wales
city: Bowen Hills
country: Australia
facility: Queensland Injectors Health Network Ltd
state: Queensland
city: Brisbane
country: Australia
facility: West Moreton Hospital and Health Service
state: Queensland
city: Cairns
country: Australia
facility: Lotus Glen Correctional Centre
state: Queensland
city: Townsville
country: Australia
facility: Townsville Correctional Centre
state: Queensland
city: Woodford
country: Australia
facility: Woodford Correctional Centre
state: Queensland
city: Adelaide
country: Australia
facility: South Australian Prison Health Service
state: South Australia
city: Hackney
country: Australia
facility: Hepatitis South Australia
state: South Australia
city: Hobart
country: Australia
facility: Tasmanian Prison Service
state: Tasmania
city: Melbourne
country: Australia
facility: St Vincent's Hospital (Melbourne)
state: Victoria
city: Perth
country: Australia
facility: WA Department of Justice
state: Western Australia
Study officials:
References: