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Trial registered on ANZCTR


Registration number
ACTRN12619001087145
Ethics application status
Approved
Date submitted
16/07/2019
Date registered
6/08/2019
Date last updated
6/08/2019
Date data sharing statement initially provided
6/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing patients visiting a general practice suspected of having Influenza using an in-home test for influenza vs. PCR gold-standard test
Scientific title
Testing the flu@home test (QuickVue lateral flow test for influenza and RDT application) for patients with an influenza-like illness visiting a general practitioner vs. PCR gold-standard test for influenza.
Secondary ID [1] 298748 0
Nil known.
Universal Trial Number (UTN)
U1111-1237-0688
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
influenza-like illness 313681 0
influenza 313682 0
Condition category
Condition code
Infection 312096 312096 0 0
Other infectious diseases
Public Health 312172 312172 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adults who present to a general practitioner with an influenza-like illness and are swabbed for surveillance purposes are given the opportunity the participate in this study if they have an Android or iOS smartphone or tablet. The patient will take the self-test home. The test consists of the QuickVue test for influenza A and B, and the flu@home app. The QuickVue test is a lateral flow test. It requires the patient to take a nasal swab and elute the swab into the test tube with the reagents provided, and put a test strip into the test tube. If positive, a pink line will appear on the test strip. All instructions for performing the test are guided by the app. The app will also ask the patient to answer questions about symptom history and risk factors, and also ask the patient to take a photo of the test strip once completed. This, combined with the QuickVue test, will give them an accurate result in approximately 20 minutes, via the app. This result will be compared to the gold-standard PCR result (from surveillance data), the results of which are provided to their GP within 24 hours of receipt of the sample at the lab.

The app data are matched up to the PCR data via a unique barcode identification number. For the first 4 weeks of the study these data are continually analysed by the flu@home team and used to develop an optimal algorithm which incorporates the PCR data, photograph, and patient survey data to provide the patient with a highly accurate result.
Intervention code [1] 315016 0
Diagnosis / Prognosis
Comparator / control treatment
PCR test is the gold-standard test. ALL patients will undergo PCR test, as well as the flu@home test. The PCR is undertaken by the GP for surveillance purposes as part of the Australian Sentinel Practices Research Network (ASPREN), The GP performs a nasopharyngeal, deep nasal or throat swab on the patient. The sample is sent to SA Pathology via Australia Post.
Control group
Active

Outcomes
Primary outcome [1] 320741 0
Diagnosis of influenza from the flu@home test.
Timepoint [1] 320741 0
The test itself takes approximately 15 minutes to perform. Patients must complete the test within 7 days of symptom onset.
Secondary outcome [1] 372706 0
Comparison of flu@home result to the gold-standard PCR test via sensitivity / specificity analysis.
Timepoint [1] 372706 0
We will receive the PCR result approximately 1 week after the GP consultation. Results will be matched via a unique 8 digit number.

Eligibility
Key inclusion criteria
Must be swabbed for surveillance purposes (ie. present to an ASPREN GP or nurse practitioner with an influenza-like illness i.e. fever, cough and fatigue).
Must have an Android or iOS smartphone or tablet.
Must be 18 year or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children.
People without an influenza-like illness who aren't swabbed for surveillance purposes.
People without an Android or iOS smartphone or tablet.

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
26/07/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
1200
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303305 0
Charities/Societies/Foundations
Name [1] 303305 0
The Bill and Melinda Gates Foundation
Country [1] 303305 0
United States of America
Primary sponsor type
University
Name
The University of Adelaide
Address
The Discipline of General Practice,
The University of Adelaide
South Australia 5005
Country
Australia
Secondary sponsor category [1] 303326 0
University
Name [1] 303326 0
The University of Washington
Address [1] 303326 0
UW School of Medicine
1959 NE Pacific St, Seattle, WA 98195
Country [1] 303326 0
United States of America
Secondary sponsor category [2] 303329 0
Charities/Societies/Foundations
Name [2] 303329 0
Audere
Address [2] 303329 0
255 S King St Ste 9-104
Seattle, WA 98104
Country [2] 303329 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303839 0
The University of Adelaide HREC
Ethics committee address [1] 303839 0
Ethics committee country [1] 303839 0
Australia
Date submitted for ethics approval [1] 303839 0
30/04/2019
Approval date [1] 303839 0
09/07/2019
Ethics approval number [1] 303839 0
H-2019-116

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94982 0
Prof Nigel Stocks
Address 94982 0
The Discipline of General Practice
The University of Adelaide
SA 5005
Country 94982 0
Australia
Phone 94982 0
+61 88313 3462
Fax 94982 0
Email 94982 0
[email protected]
Contact person for public queries
Name 94983 0
Monique Chilver
Address 94983 0
The Discipline of General Practice
The University of Adelaide
SA 5005
Country 94983 0
Australia
Phone 94983 0
+61 88313 3463
Fax 94983 0
Email 94983 0
[email protected]
Contact person for scientific queries
Name 94984 0
Monique Chilver
Address 94984 0
The Discipline of General Practice
The University of Adelaide
SA 5005
Country 94984 0
Australia
Phone 94984 0
+61 88313 3463
Fax 94984 0
Email 94984 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3138Study protocolWe are the process of writing up the study protocol for publication in a peer-reviewed journal.  



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.