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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05248555




Registration number
NCT05248555
Ethics application status
Date submitted
12/12/2021
Date registered
21/02/2022
Date last updated
13/06/2024

Titles & IDs
Public title
The National Australian HCV Point-of-Care Testing Program - 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 - Minimal Dataset
Secondary ID [1] 0 0
VHCRP2104
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
Diagnosis / Prognosis - 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.


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

Outcomes
Primary outcome [1] 0 0
The proportion of HCV infected participants who initiate HCV treatment at 12 weeks
Timepoint [1] 0 0
12 Weeks from enrolment
Secondary outcome [1] 0 0
The proportion of participants who accept point-of-care testing
Timepoint [1] 0 0
2 years from recruitment commencement
Secondary outcome [2] 0 0
The prevalence of HCV infection amongst study participants tested
Timepoint [2] 0 0
2 years from recruitment commencement
Secondary outcome [3] 0 0
To evaluate the time to HCV treatment uptake among HCV RNA positive participants
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
To evaluate proportion of HCV RNA positive participants who initiate HCV treatment
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
To evaluate the proportion of participants who complete HCV (DAA) treatment
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
To evaluate the proportion of participants who achieve an SVR
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
To evaluate the proportion of participants who are HCV RNA negative at 12 months
Timepoint [7] 0 0
52 weeks

Eligibility
Key inclusion criteria
* = 18 years of age.
* Received point-of-care HCV testing.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Nil

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
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
40000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Justice Health and Forensic Mental Health Network - Sydney
Recruitment hospital [2] 0 0
Lotus Glen Correctional Centre - Cairns
Recruitment hospital [3] 0 0
Hepatitis Queensland - Coorparoo
Recruitment hospital [4] 0 0
West Moreton Hospital and Health Service - Ipswich
Recruitment hospital [5] 0 0
Townsville Correctional Centre - Townsville
Recruitment hospital [6] 0 0
Woodford Correctional Centre - Woodford
Recruitment hospital [7] 0 0
South Australian Prison Health Service - Marden
Recruitment hospital [8] 0 0
Mount Gambier Priosn - Mount Gambier
Recruitment hospital [9] 0 0
St Vincent's Correctional Health Services - Fitzroy
Recruitment hospital [10] 0 0
Medically Supervised Injecting Room - Melbourne
Recruitment hospital [11] 0 0
Geo Healthcare - The Geo Group Australia Pty Ltd - Ravenhall
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Cairns
Recruitment postcode(s) [3] 0 0
4151 - Coorparoo
Recruitment postcode(s) [4] 0 0
- Ipswich
Recruitment postcode(s) [5] 0 0
- Townsville
Recruitment postcode(s) [6] 0 0
- Woodford
Recruitment postcode(s) [7] 0 0
5070 - Marden
Recruitment postcode(s) [8] 0 0
5290 - Mount Gambier
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3000 - Melbourne
Recruitment postcode(s) [11] 0 0
3023 - Ravenhall

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
Trial website
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
dsilk@kirby.unsw.edu.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05248555