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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
The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.
Trial website
https://clinicaltrials.gov/study/NCT05248555
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/NCT05248555