Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001578897
Ethics application status
Approved
Date submitted
21/09/2021
Date registered
18/11/2021
Date last updated
18/11/2021
Date data sharing statement initially provided
18/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Point-of-care Testing for Hepatitis C in the Priority Settings of Mental Health, Prisons and Drug & Alcohol Facilities
Scientific title
The Effect of Point-of-care Testing for Hepatitis C on Testing rates in the Priority Settings of Mental Health, Prisons and Drug & Alcohol Facilities
Secondary ID [1] 305333 0
None
Universal Trial Number (UTN)
Trial acronym
PROMPt
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 323691 0
Condition category
Condition code
Infection 321225 321225 0 0
Other infectious diseases
Public Health 321226 321226 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a novel feasibility study introducing Point of Care (POC) testing for HCV in clinics with high caseload of people at risk of HCV infection, in particular people who inject drugs (PWID). There will be concurrent activation of 3 sites enrolling over an approximate 12 month period, each from a mental health, prison & AOD setting.
POC HCV testing will be performed or overseen by PROMPt project staff in conjunction with peer workers and clinic staff who will provide fingerstick tests to participants, read the result and counsel the particiapnt about their result. Any person performing the test will undergo full training in pre & post test counselling and testing procedures.

The SD Bioline HCV POC fingerstick test will be used to detect antibodies to HCV in human whole blood, the test takes 20 minutes. Positive tests will then be reflexed to the GeneXpert HCV viral load POC fingerstick to perform a quantitative RNA assay that will provide a result from whole blood in 60 minutes.
Project staff, including peer support workers where possible will provide HCV education, pre/post test counselling and linkage to care as appropriate with the support of the lead clinician within each domain and Viral Hepatitis nurses specific to the local health network. This will all be done verbally and will take approximately 30 minutes. Study participants will not receive treatment as part of this study.
Intervention code [1] 321764 0
Early detection / Screening
Intervention code [2] 321765 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329014 0
1. Number and proportion of participants who receive a rapid POC HCV Ab test plus POC RNA test (collected from study data) as compared to previous testing rates of the clinic (collected from audit of sites previous testing rates from medical records).

Timepoint [1] 329014 0
The data will be collected and analysed post completion of the testing period.
Primary outcome [2] 329613 0
2. Number and proportion of HCV RNA positive participants who are linked to care - will be performed post test.
Timepoint [2] 329613 0
Data will be collected from clinical staff involved with the treatment of participants and from medical records. This will occur post testing.
Secondary outcome [1] 401171 0
1. Acceptability of HCV POC testing to participants in each setting.
Data will be collected during study visit using a survey. This survey was designed specifically for this study.
Timepoint [1] 401171 0
The survey will be conducted during the study visit for each HCV POCT and will take approximately 20 minutes.
Secondary outcome [2] 402048 0
2. Time period from diagnosis with POC testing through to commencing HCV treatment.
Data will be linked from study records to medical records at each site.
Timepoint [2] 402048 0
Time from POCT to commencement of treatment will be measured at the end of the testing period,
Secondary outcome [3] 402049 0
3. Number and proportion of participants who have SVR 12 testing performed - will be performed via linking medical records to study data.
Timepoint [3] 402049 0
The number and proportion of participants who have SVR12 testing performed will be conducted and the end of the POC testing period at each site.
Secondary outcome [4] 402051 0
4. Number and proportion of participants who achieve SVR 12 - will be performed via linking medical records to study data.
Timepoint [4] 402051 0
The number and proportion of participants who have achieved SVR12 will be conducted and the end of the POC testing period at each site.

Eligibility
Key inclusion criteria
Participants will be recruited from mental health, AOD and prison study sites. An opt-out approach to consent will be employed.
Inclusion criteria
1) Aged > 18 years
2) Able to provide voluntary informed consent
3) Not currently engaged in care for the treatment of hepatitis C infection.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
1) Unable or unwilling to provide informed consent or abide by the requirements of the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
1200
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 309695 0
Charities/Societies/Foundations
Name [1] 309695 0
Paul Ramsay Foundation
Country [1] 309695 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Eliminate C Australia
Address
85 Commercial Road, Melbourne
VIC, 3004, Australia
Country
Australia
Secondary sponsor category [1] 310747 0
None
Name [1] 310747 0
Address [1] 310747 0
Country [1] 310747 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309464 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 309464 0
North Terrace, Adelaide, SA, 5000.
Ethics committee country [1] 309464 0
Australia
Date submitted for ethics approval [1] 309464 0
Approval date [1] 309464 0
31/08/2020
Ethics approval number [1] 309464 0
13046

Summary
Brief summary
A key barrier to hepatitis C (HCV) diagnosis and treatment is the multi-stage process of conventional HCV testing as patients require multiple visits to pathology services and healthcare providers to obtain a HCV antibody test, then a HCV RNA test, receive the result and finally be linked into care.
This novel study aims to scale up HCV screening in the community by providing HCV point-of-care (POC) testing, liver assessment and direct referral into treatment at the priority settings of mental health, prisons and alcohol & other drugs (AOD) services. The study will investigate the benefit of providing POC HCV diagnostic testing using SD Bioline fingerstick antibody (Ab) assay and Cepheid fingerstick HCV RNA for participants who return a positive HCV Ab result. Providing same day test results and referral for treatment in one visit addresses a major barrier to HCV treatment uptake, particularly in people at high risk of HCV infection such as people who inject drugs (PWIDs).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114246 0
A/Prof David Shaw
Address 114246 0
Royal Adelaide Hospital
North Terrace, Adelaide, 5000, SA.
Country 114246 0
Australia
Phone 114246 0
+61 422113598
Fax 114246 0
Email 114246 0
[email protected]
Contact person for public queries
Name 114247 0
Dr Erin McCartney
Address 114247 0
Royal Adelaide Hospital
North Terrace, Adelaide, 5000, SA.
Country 114247 0
Australia
Phone 114247 0
+61437162362
Fax 114247 0
Email 114247 0
[email protected]
Contact person for scientific queries
Name 114248 0
Dr Erin McCartney
Address 114248 0
Royal Adelaide Hospital
North Terrace, Adelaide, 5000, SA.
Country 114248 0
Australia
Phone 114248 0
+61437162362
Fax 114248 0
Email 114248 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.