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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05713136




Registration number
NCT05713136
Ethics application status
Date submitted
17/01/2023
Date registered
6/02/2023
Date last updated
3/07/2024

Titles & IDs
Public title
The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
Scientific 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
Secondary ID [1] 0 0
VHCRP2203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Diagnostic Test: Point-of-Care Testing

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


Treatment: Devices: Diagnostic Test: Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 weeks from enrolment
Secondary outcome [1] 0 0
To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Timepoint [1] 0 0
Recruitment phase
Secondary outcome [2] 0 0
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Timepoint [2] 0 0
Recruitment phase
Secondary outcome [3] 0 0
To evaluate the HCV antibody prevalence among people tested.
Timepoint [3] 0 0
Recruitment phase
Secondary outcome [4] 0 0
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;
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
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;
Timepoint [6] 0 0
52 weeks
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
52 weeks
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
52 weeks

Eligibility
Key inclusion criteria
* Provide informed consent
* = 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Is unable or unwilling to provide informed consent

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
40000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
ACT Justice Health - Canberra
Recruitment hospital [2] 0 0
Justice Health and Forensic Mental Health Network - Sydney
Recruitment hospital [3] 0 0
Queensland Injectors Health Network Ltd - Bowen Hills
Recruitment hospital [4] 0 0
West Moreton Hospital and Health Service - Brisbane
Recruitment hospital [5] 0 0
Lotus Glen Correctional Centre - Cairns
Recruitment hospital [6] 0 0
Townsville Correctional Centre - Townsville
Recruitment hospital [7] 0 0
Woodford Correctional Centre - Woodford
Recruitment hospital [8] 0 0
South Australian Prison Health Service - Adelaide
Recruitment hospital [9] 0 0
Hepatitis South Australia - Hackney
Recruitment hospital [10] 0 0
Tasmanian Prison Service - Hobart
Recruitment hospital [11] 0 0
St Vincent's Hospital (Melbourne) - Melbourne
Recruitment hospital [12] 0 0
WA Department of Justice - Perth
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
4006 - Bowen Hills
Recruitment postcode(s) [4] 0 0
- Brisbane
Recruitment postcode(s) [5] 0 0
- Cairns
Recruitment postcode(s) [6] 0 0
4810 - Townsville
Recruitment postcode(s) [7] 0 0
- Woodford
Recruitment postcode(s) [8] 0 0
- Adelaide
Recruitment postcode(s) [9] 0 0
5069 - Hackney
Recruitment postcode(s) [10] 0 0
- Hobart
Recruitment postcode(s) [11] 0 0
- Melbourne
Recruitment postcode(s) [12] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Flinders University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05713136
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
David Silk, BSc
Address 0 0
Country 0 0
Phone 0 0
+61293850900
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05713136