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Trial registered on ANZCTR
Registration number
ACTRN12618000657224
Ethics application status
Approved
Date submitted
11/03/2018
Date registered
24/04/2018
Date last updated
16/12/2022
Date data sharing statement initially provided
12/09/2019
Date results information initially provided
16/12/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Hepatitis C Testing in Pharmacy Study: uptake and frequency of positive tests
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Scientific title
Hepatitis C Virus Screening in Community Pharmacy: A pilot study to ascertain uptake, frequency of positive tests, and numbers lost to follow-up
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Secondary ID [1]
294302
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Nil known
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Universal Trial Number (UTN)
U1111-1210-7649
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus
307006
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Condition category
Condition code
Infection
306100
306100
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0
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Other infectious diseases
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Public Health
306101
306101
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0
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Health service research
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Oral and Gastrointestinal
306510
306510
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Selected community pharmacies will offer screening for hepatitis C virus to people with risk factors for hepatitis C virus. They will then provide lab test forms for anyone with a positive test, and a referral to their general practitioner.
The screening will be a finger prick test taking up to 20 mins for results to come through. It will be administered by pharmacists in a private consulting room with the consumer alone or with their support people if preferred.
No strategies will be used to monitor adherence, fidelity
The researchers at the DHB will follow positive tests on the lab testing and treatment information available to medical practitioners to ascertain outcomes.
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Intervention code [1]
300601
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Early detection / Screening
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Is screening for hepatitis C virus in NZ community pharmacies feasible?
Feedback from pharmacies (who will be asked if they think it is feasible and would want to continue) and overall numbers screened, number of pharmacies screening high numbers, and proportions of people who are screened and positive, and proportions of those positive who get treatment., e.g. if all pharmacies or most pharmacies recruited few to no patients or everyone screened did not have hepatitis C, or most of those positive did not go on to have treatment, it is not feasible. The researchers will be assessing it qualitatively with the overall picture rather than specific quantities alone.
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Assessment method [1]
305132
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Timepoint [1]
305132
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3 months after the study is completed.
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Primary outcome [2]
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What proportion of people screened for hepatitis C virus in selected NZ pharmacies receive a positive result within 20 minutes with the point of care screening test by pharmacists of finger prick blood?
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Assessment method [2]
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Timepoint [2]
305133
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3 months after the study is completed
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Secondary outcome [1]
344288
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What proportion of people with positive Hepatitis C screening results in pharmacy then receive a positive result with RNA testing on a sample of whole blood through the community laboratory diagnostic testing facility used in Auckland, as ascertained through the lab test information available to doctors and checked by the medical doctors on the research team?
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Assessment method [1]
344288
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Timepoint [1]
344288
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6 months after the study ends
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Secondary outcome [2]
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What proportion of people with positive hepatitis C screening from the point of care test and fingerprick test in the pharmacy do not have the recommended RNA test of blood at the community diagnostic testing laboratory facility in Auckland, as seen where the patient's test results are viewed by the medical doctors on the research team and no test is reported?
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Assessment method [2]
344289
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Timepoint [2]
344289
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6 months after the study is completed
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Secondary outcome [3]
344290
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What proportion of positive hepatitis C screenings are treated and receive sustained viral response (SVR)? This will be assessed through the shared laboratory and pharmaceutical records available to the medical doctors in the research team which will show if the drug was provided and if the SVR occured.
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Assessment method [3]
344290
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Timepoint [3]
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Up to 8 months after the study finishes
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Eligibility
Key inclusion criteria
Pharmacies in the West Auckland area, 5 of which have needle exchange and/or methadone services, 2 of which do not. Pharmacies will be selected purposively to provide good geographical range, some with longer opening hours, and one in a mall if possible.
Inclusion criteria for patients, NZ residents who:
• ever had a tattoo or body piercing using unsterile equipment
• ever injected drugs
• had a blood transfusion before 1992
• ever lived or had medical treatment in a high-risk country (e.g. Pakistan, Egypt, developing countries in Africa and Asia, Eastern Europe including Russia)
• have ever been in prison
• were been born to a mother with hepatitis C, or
• are 35 to 69 years old.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Previous positive hepatitis C test
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Descriptive statistics. Analysis plan is to report total numbers screened by each pharmacy, total number (and proportion) positive of all screened, and by pharmacy, total number (and proportion) of all positives getting an RNA test; total number (and proportion) of all positives having a positive RNA test; total number (and proportion ) of all positive RNA tests having treatment; total number and proportion of all those screened who received treatment. total number (and proportion) of all positives having a positive RNA test; total number (and proportion ) of all those having treatment who achieved SVR.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/2018
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Actual
25/07/2018
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Date of last participant enrolment
Anticipated
30/10/2019
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Actual
2/11/2019
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Date of last data collection
Anticipated
31/01/2020
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Actual
4/03/2020
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Sample size
Target
350
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Accrual to date
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Final
192
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Recruitment outside Australia
Country [1]
9673
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New Zealand
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State/province [1]
9673
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Auckland
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Funding & Sponsors
Funding source category [1]
298947
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Government body
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Name [1]
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Waitemata District Health Board
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Address [1]
298947
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Private Bag 93-503
Takapuna
AUCKLAND 0740
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Country [1]
298947
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New Zealand
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Primary sponsor type
Commercial sector/Industry
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Name
Natalie Gauld Ltd
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Address
PO Box 9349
Newmarket
Auckland 1149
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
298160
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Address [1]
298160
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Country [1]
298160
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299884
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Health and Disability Ethics Committee Central
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Ethics committee address [1]
299884
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HDEC
Ministry of Health
PO box 5013
Wellington
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Ethics committee country [1]
299884
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New Zealand
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Date submitted for ethics approval [1]
299884
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05/04/2018
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Approval date [1]
299884
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26/04/2018
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Ethics approval number [1]
299884
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Summary
Brief summary
In this pilot study, selected pharmacies in the Waitemata District Health Board area will offer Hepatitis C screening for people with risk factors for hepatitis C virus. We will find out the feasibility of doing this. We want to know how many people pharmacy screen, the numbers of positives found, and numbers going on to have positive RNA results, treatment and cure. We will ascertain the risk factors of people being tested, age and ethnicity, and the pharmacists considerations of how feasible this work is. Informed consent will be obtained.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Natalie Gauld
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Address
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Natalie Gauld Ltd
PO Box 9349
Newmarket
Auckland 1149
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Country
81862
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New Zealand
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Phone
81862
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+6496305683
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Fax
81862
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Email
81862
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[email protected]
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Contact person for public queries
Name
81863
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Dr Natalie Gauld
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Address
81863
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Natalie Gauld Ltd
PO Box 9349
Newmarket
Auckland 1149
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Country
81863
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New Zealand
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Phone
81863
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+6496305683
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Fax
81863
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Email
81863
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[email protected]
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Contact person for scientific queries
Name
81864
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Dr Natalie Gauld
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Address
81864
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Natalie Gauld Ltd
PO Box 9349
Newmarket
Auckland 1149
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Country
81864
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New Zealand
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Phone
81864
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+6496305683
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Fax
81864
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Email
81864
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Highly sensitive information, and no funding available for de-identification.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Gauld, N.; Perry, J.; Jackson, C.; Gane, E. Feasib...
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More Details
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Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Feasibility and outcomes of a hepatitis C screening programme in community pharmacies.
2020
N.B. These documents automatically identified may not have been verified by the study sponsor.
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