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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05042544




Registration number
NCT05042544
Ethics application status
Date submitted
20/08/2021
Date registered
13/09/2021
Date last updated
13/09/2021

Titles & IDs
Public title
The National Australian HCV Point-of-Care Testing Program
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
Secondary ID [1] 0 0
VHCRP2101
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]
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. In settings with high anticipated HCV antibody prevalence (>15%; e.g. drug treatment, prisons, needle and syringe programs), people who have previously been told they have HCV infection, or people who have previously received HCV treatment, testing will be performed using point-of-care HCV RNA testing. In settings with a low anticipated HCV antibody prevalence (<15%; e.g. mental health, homelessness), testing will be performed using point-of-care HCV antibody testing and if positive, point-of-care HCV RNA testing will be performed.


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
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. - HCV treatment
Timepoint [1] 0 0
12 Weeks from enrolment
Secondary outcome [1] 0 0
1. To evaluate the proportion of people who accept point-of-care testing among those offered testing. - Accepting testing
Timepoint [1] 0 0
Recruitment phase
Secondary outcome [2] 0 0
2. To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested. - Prevalence
Timepoint [2] 0 0
Recruitment phase
Secondary outcome [3] 0 0
3. To evaluate the time to HCV treatment uptake among people who receive treatment. - Time to treatment
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
4. 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. - Initiation of treatment
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
5. To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment. - Completion of treatment
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
6. To evaluate the proportion of participants who achieve an SVR (defined as HCV RNA below the lower limit of quantitation at post treatment week 12). - SVR
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
7. 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. - HCV negative
Timepoint [7] 0 0
52 weeks

Eligibility
Key inclusion criteria
1. Provided informed consent.

2. = 18 years of age.

3. Have a risk factor for the acquisition of HCV infection (including current or past
injecting drug use, previous incarceration, HIV infection, receiving blood products
prior to 1990, having a tattoo or piercing in an unregulated environment, a
needle-stick injury, or a mother with HCV).

OR:

4. Are attending a service caring for people with risk factors for the acquisition of HCV
infection (e.g. drug treatment clinics, needle and syringe programs, prisons, mobile
outreach services, community health services, mental health services, and homelessness
services).
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
a. Is unable or unwilling to provide informed consent or abide by the requirements of the
study.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Directions - Canberra
Recruitment hospital [2] 0 0
Hepatitis ACT - Canberra
Recruitment hospital [3] 0 0
Western NSW LHD - Bathurst
Recruitment hospital [4] 0 0
North and Mid North Coast LHD - Port Macquarie
Recruitment hospital [5] 0 0
Sydney Medically Supervised Injecting Centre - Sydney
Recruitment hospital [6] 0 0
NSLHD - Sydney
Recruitment hospital [7] 0 0
WSLHD Drug Health - Sydney
Recruitment hospital [8] 0 0
South West Sydney LHD - Sydney
Recruitment hospital [9] 0 0
Metro North Hospital and Health Service - Brisbane
Recruitment hospital [10] 0 0
Queensland Injectors Health Network - Brisbane
Recruitment hospital [11] 0 0
Micah Projects - Brisbane
Recruitment hospital [12] 0 0
Cairns Sexual Health Service - Cairns
Recruitment hospital [13] 0 0
Kombi Clinic - Inala
Recruitment hospital [14] 0 0
Metro South Addiction Services - Inala ADS - Inala
Recruitment hospital [15] 0 0
Darling Downs Hospital and Health Service - Toowoomba
Recruitment hospital [16] 0 0
Central Adelaide Local Health Network - Adelaide
Recruitment hospital [17] 0 0
Drug and Alcohol Services South Australia - Adelaide
Recruitment hospital [18] 0 0
North Adelaide Local Health Network - Adelaide
Recruitment hospital [19] 0 0
South Adelaide Local Health Network - Adelaide
Recruitment hospital [20] 0 0
Peer Based Harm Reduction WA - Perth
Recruitment hospital [21] 0 0
Kirketon Road Centre - Sydney
Recruitment postcode(s) [1] 0 0
2606 - Canberra
Recruitment postcode(s) [2] 0 0
2612 - Canberra
Recruitment postcode(s) [3] 0 0
2795 - Bathurst
Recruitment postcode(s) [4] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [5] 0 0
2011 - Sydney
Recruitment postcode(s) [6] 0 0
2065 - Sydney
Recruitment postcode(s) [7] 0 0
2151 - Sydney
Recruitment postcode(s) [8] 0 0
2170 - Sydney
Recruitment postcode(s) [9] 0 0
4000 - Brisbane
Recruitment postcode(s) [10] 0 0
4006 - Brisbane
Recruitment postcode(s) [11] 0 0
4101 - Brisbane
Recruitment postcode(s) [12] 0 0
4870 - Cairns
Recruitment postcode(s) [13] 0 0
4077 - Inala
Recruitment postcode(s) [14] 0 0
4350 - Toowoomba
Recruitment postcode(s) [15] 0 0
5000 - Adelaide
Recruitment postcode(s) [16] 0 0
5069 - Adelaide
Recruitment postcode(s) [17] 0 0
5112 - Adelaide
Recruitment postcode(s) [18] 0 0
5168 - Adelaide
Recruitment postcode(s) [19] 0 0
6230 - Perth
Recruitment postcode(s) [20] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country

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). Participants will attend a single visit to
have their HCV RNA status tested and complete a self-administered survey. 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/show/NCT05042544
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 C 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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05042544