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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03231930




Registration number
NCT03231930
Ethics application status
Date submitted
25/06/2017
Date registered
27/07/2017

Titles & IDs
Public title
Rapid Point-of-care Testing for Hepatitis C in Community Clinics (RAPID-EC) Pilot Study
Scientific title
Rapid Point-of-care Testing for Hepatitis C in Community Clinics (RAPID-EC) Pilot Study
Secondary ID [1] 0 0
HREC/16/Alfred/165
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
Interventional
Description of intervention(s) / exposure
Treatment: Devices - OraQuick HCV Ab test
Treatment: Devices - Xpert HCV viral load test

Experimental: Intervention group - Rapid point of care testing will be done using the OraQuick HCV Ab test and the Xpert HCV RNA viral load test. All participants will undergo rapid point of care testing for hepatitis C antibodies using the OraQuick test with oral fluid, followed by point of care testing for the detection of hepatitis C virus RNA using the Cepheid Xpert HCV viral load test on the GeneXpert system. Participants who are found to have current HCV infection will be worked up for treatment at the clinic and referred to appropriate practitioners for HCV treatment. As these tests are not yet licensed for diagnostic use in Australia, confirmatory testing using standard laboratory tests will be performed for all participants.


Treatment: Devices: OraQuick HCV Ab test
The OraQuick HCV point of care test involves the collection of oral fluid and provides an accurate result in approximately 20 minutes. The test involves a clinic nurse or community health worker providing pre-test counselling, then providing an oral swab to study participants, then reading the result and counselling the participant about their HCV antibody test result.

Treatment: Devices: Xpert HCV viral load test
The Cepheid Xpert HCV RNA test (Xpert® HCV Viral Load test) is a reverse transcriptase polymerase-based chain reaction amplification technology (RT-PCR) and provides an accurate HCV RNA load within 2 hours (105 minutes), using a serum sample.

This test will be performed for participants who have a positive OraQuick HCV antibody result.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants at high risk for HCV infection who receive a HCV rapid point-of-care antibody test
Timepoint [1] 0 0
6 months after commencing recruitment.
Secondary outcome [1] 0 0
Number of participants with a positive HCV antibody test who receive a rapid point-of-care RNA test
Timepoint [1] 0 0
6 months after commencing recruitment.
Secondary outcome [2] 0 0
Number of participants with a positive HCV RNA test who attend their appointment with the doctor for treatment
Timepoint [2] 0 0
6 months after commencing recruitment.
Secondary outcome [3] 0 0
Number of participants who obtain DAA therapy (ie medication is picked up from pharmacy)
Timepoint [3] 0 0
Six months post completion of recruitment
Secondary outcome [4] 0 0
Number of participants who achieve sustained virological response at 12 weeks post treatment (SVR12)
Timepoint [4] 0 0
Six months post completion of recruitment

Eligibility
Key inclusion criteria
* Aged =18 years;
* Attendance for any reason at either the primary health care services participating in the study
* Not currently engaged in care for treatment of hepatitis C infection, and not received a diagnosis of hepatitis C infection (with positive HCV RNA) in the preceding 3 months;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnancy or breastfeeding at time of HCV antiviral treatment;
* Evidence of any condition, therapy, laboratory abnormality or other circumstance (current or prior) that may confound the study's results, or interfere with participation for the full duration of the study, such that it is not in the best interest of the participant.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/05/2018
Sample size
Target
Accrual to date
Final
174
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Innerspace - Collingwood
Recruitment hospital [2] 0 0
Health Works - Footscray
Recruitment hospital [3] 0 0
North Richmond Community Health - Richmond
Recruitment postcode(s) [1] 0 0
3066 - Collingwood
Recruitment postcode(s) [2] 0 0
3011 - Footscray
Recruitment postcode(s) [3] 0 0
3121 - Richmond

Funding & Sponsors
Primary sponsor type
Other
Name
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Margaret Hellard, MBBS,PhD
Address 0 0
Burnet Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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



Results not provided in https://clinicaltrials.gov/study/NCT03231930