Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05042544
Ethics application status
Date submitted
20/08/2021
Date registered
13/09/2021
Date last updated
13/06/2024

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 - This is an observational cohort study. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. Participants will attend a single visit to receive point-of-care HCV testing and complete a self-administered survey. Testing will be performed using point-of-care HCV antibody testing (results within 1-20 minutes, depending on the test) and if positive, HCV RNA testing will be performed. Participants who have previously had HCV infection or previously received HCV treatment will be tested using point-of-care HCV RNA testing. Participants will not receive treatment as a part of this study. Participants who are HCV RNA detectable will be linked to standard of care for any other clinical assessments and treatment initiation.


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 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 time to HCV treatment uptake among HCV RNA detectable participants following HCV RNA testing
Timepoint [3] 0 0
52 weeks
Secondary outcome [4] 0 0
To evaluate the proportion of HCV RNA detectable participants who initiate HCV treatment at 12 months (52 weeks) following detectable finger-stick point-of-care HCV RNA testing.
Timepoint [4] 0 0
52 weeks
Secondary outcome [5] 0 0
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
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) following a detectable HCV RNA test result.
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 (52 weeks) following a detectable HCV RNA test.
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
To evaluate the cost-effectiveness of different testing strategies
Timepoint [8] 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
Sex
Both males and females
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2022
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)
ACT,NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Hepatitis ACT - Canberra
Recruitment hospital [2] 0 0
Western NSW LHD - Bathurst
Recruitment hospital [3] 0 0
Far West LHD - Broken Hill
Recruitment hospital [4] 0 0
Maari Ma Health Aboriginal Corporation - Broken Hill
Recruitment hospital [5] 0 0
Galambila Aboriginal Health Service - Coffs Harbour
Recruitment hospital [6] 0 0
Central Coast LHD - Gosford
Recruitment hospital [7] 0 0
Armajun Health Service Aboriginal Corporation - Inverell
Recruitment hospital [8] 0 0
Rekindling the Spirit Health Service - Lismore
Recruitment hospital [9] 0 0
Nepean Blue Mountains LHD - Penrith
Recruitment hospital [10] 0 0
North and Mid North Coast LHD - Port Macquarie
Recruitment hospital [11] 0 0
Walhallow Aboriginal Corporation - Quirindi
Recruitment hospital [12] 0 0
Bulgarr Ngaru Medical Aboriginal Corporation - South Grafton
Recruitment hospital [13] 0 0
Kirketon Road Centre - Sydney
Recruitment hospital [14] 0 0
NSLHD - Sydney
Recruitment hospital [15] 0 0
WSLHD Drug Health - Sydney
Recruitment hospital [16] 0 0
South West Sydney LHD - Sydney
Recruitment hospital [17] 0 0
Hepatitis NSW - Sydney
Recruitment hospital [18] 0 0
NSW Users and AIDS Association - Sydney
Recruitment hospital [19] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [20] 0 0
SESLHD Community and Mental Health POCT Allicance (SCAMPA) - Sydney
Recruitment hospital [21] 0 0
SESLHD Drug Health - Sydney
Recruitment hospital [22] 0 0
Storr Liver Clinic (Westmead Hospital) - Sydney
Recruitment hospital [23] 0 0
Sydney Local Health District - Sydney
Recruitment hospital [24] 0 0
Murrumbidgee & Southern LHD - Wagga Wagga
Recruitment hospital [25] 0 0
Hunter New England LHD - Waratah
Recruitment hospital [26] 0 0
ISLHD Drug and Alcohol Service - Wollongong
Recruitment hospital [27] 0 0
ADSCA - Alice Springs Hospital - Alice Springs
Recruitment hospital [28] 0 0
Alcohol and Harm Reduction Biala - Brisbane
Recruitment hospital [29] 0 0
Micah Projects - Brisbane
Recruitment hospital [30] 0 0
Cairns Sexual Health Service - Cairns
Recruitment hospital [31] 0 0
Hepatitis QLD - Coorparoo
Recruitment hospital [32] 0 0
Kombi Clinic - Inala
Recruitment hospital [33] 0 0
Metro South Addiction Services - Inala ADS - Inala
Recruitment hospital [34] 0 0
Ipswich AODS - Ipswich
Recruitment hospital [35] 0 0
Ipswich Sexual Health and BBV Service, West Moreton Health - Ipswich
Recruitment hospital [36] 0 0
OneBridge - Maroochydore
Recruitment hospital [37] 0 0
Central Adelaide Local Health Network - Adelaide
Recruitment hospital [38] 0 0
Drug and Alcohol Services South Australia - Adelaide
Recruitment hospital [39] 0 0
North Adelaide Local Health Network - Adelaide
Recruitment hospital [40] 0 0
South Adelaide Local Health Network - Adelaide
Recruitment hospital [41] 0 0
Hepatitis SA - Hackney
Recruitment hospital [42] 0 0
Pangula Mannamurna Aboriginal Corporation - Mount Gambier
Recruitment hospital [43] 0 0
Clinic 60 (Sexual Health Services) - Hobart
Recruitment hospital [44] 0 0
Moreton Group Rural Health - New Town
Recruitment hospital [45] 0 0
Western Health - Footscray
Recruitment hospital [46] 0 0
Eastern Health - Melbourne
Recruitment hospital [47] 0 0
St Vincent's Hospital (Melbourne) - Melbourne
Recruitment hospital [48] 0 0
Youth Projects - The Living Room - Melbourne
Recruitment hospital [49] 0 0
Latrobe Community Health Service Liited - Morwell
Recruitment hospital [50] 0 0
Peer Based Harm Reduction Bunbury - Bunbury
Recruitment hospital [51] 0 0
South Terrace Clinic - Fremantle Hospital - Fremantle
Recruitment hospital [52] 0 0
Peer Based Harm Reduction WA - Perth
Recruitment hospital [53] 0 0
Hepatitis WA - Perth
Recruitment hospital [54] 0 0
Next Step East Perth - Perth
Recruitment hospital [55] 0 0
Next Step Fremantle - Perth
Recruitment hospital [56] 0 0
Next Step Warwick - Perth
Recruitment postcode(s) [1] 0 0
2612 - Canberra
Recruitment postcode(s) [2] 0 0
2795 - Bathurst
Recruitment postcode(s) [3] 0 0
- Broken Hill
Recruitment postcode(s) [4] 0 0
- Coffs Harbour
Recruitment postcode(s) [5] 0 0
2250 - Gosford
Recruitment postcode(s) [6] 0 0
- Inverell
Recruitment postcode(s) [7] 0 0
- Lismore
Recruitment postcode(s) [8] 0 0
- Penrith
Recruitment postcode(s) [9] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [10] 0 0
- Quirindi
Recruitment postcode(s) [11] 0 0
- South Grafton
Recruitment postcode(s) [12] 0 0
2010 - Sydney
Recruitment postcode(s) [13] 0 0
2065 - Sydney
Recruitment postcode(s) [14] 0 0
2151 - Sydney
Recruitment postcode(s) [15] 0 0
2170 - Sydney
Recruitment postcode(s) [16] 0 0
- Sydney
Recruitment postcode(s) [17] 0 0
- Wagga Wagga
Recruitment postcode(s) [18] 0 0
- Waratah
Recruitment postcode(s) [19] 0 0
- Wollongong
Recruitment postcode(s) [20] 0 0
- Alice Springs
Recruitment postcode(s) [21] 0 0
4000 - Brisbane
Recruitment postcode(s) [22] 0 0
4101 - Brisbane
Recruitment postcode(s) [23] 0 0
4870 - Cairns
Recruitment postcode(s) [24] 0 0
- Coorparoo
Recruitment postcode(s) [25] 0 0
4077 - Inala
Recruitment postcode(s) [26] 0 0
4305 - Ipswich
Recruitment postcode(s) [27] 0 0
4560 - Maroochydore
Recruitment postcode(s) [28] 0 0
5000 - Adelaide
Recruitment postcode(s) [29] 0 0
5069 - Adelaide
Recruitment postcode(s) [30] 0 0
5112 - Adelaide
Recruitment postcode(s) [31] 0 0
5168 - Adelaide
Recruitment postcode(s) [32] 0 0
5069 - Hackney
Recruitment postcode(s) [33] 0 0
- Mount Gambier
Recruitment postcode(s) [34] 0 0
- Hobart
Recruitment postcode(s) [35] 0 0
- New Town
Recruitment postcode(s) [36] 0 0
3011 - Footscray
Recruitment postcode(s) [37] 0 0
3128 - Melbourne
Recruitment postcode(s) [38] 0 0
- Melbourne
Recruitment postcode(s) [39] 0 0
3840 - Morwell
Recruitment postcode(s) [40] 0 0
6230 - Bunbury
Recruitment postcode(s) [41] 0 0
- Fremantle
Recruitment postcode(s) [42] 0 0
6230 - Perth
Recruitment postcode(s) [43] 0 0
- 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 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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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