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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 registered on ANZCTR


Registration number
ACTRN12618000657224
Ethics application status
Approved
Date submitted
11/03/2018
Date registered
24/04/2018
Date last updated
12/09/2019
Date data sharing statement initially provided
12/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Hepatitis C Testing in Pharmacy Study: uptake and frequency of positive tests
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
Secondary ID [1] 294302 0
Nil known
Universal Trial Number (UTN)
U1111-1210-7649
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus 307006 0
Condition category
Condition code
Infection 306100 306100 0 0
Other infectious diseases
Public Health 306101 306101 0 0
Health service research
Oral and Gastrointestinal 306510 306510 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
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.
Intervention code [1] 300601 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305132 0
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.
Timepoint [1] 305132 0
6 months after the pharmacy is enrolled in the study
Primary outcome [2] 305133 0
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?
Timepoint [2] 305133 0
6 months after the pharmacy is enrolled in the study
Secondary outcome [1] 344288 0
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?
Timepoint [1] 344288 0
6 months after the pharmacy is enrolled in the study
Secondary outcome [2] 344289 0
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?
Timepoint [2] 344289 0
3 months after the patient is screened
Secondary outcome [3] 344290 0
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.
Timepoint [3] 344290 0
6 months after patient was screened.

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.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previous positive hepatitis C test

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
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9673 0
New Zealand
State/province [1] 9673 0
Auckland

Funding & Sponsors
Funding source category [1] 298947 0
Government body
Name [1] 298947 0
Waitemata District Health Board
Address [1] 298947 0
Private Bag 93-503
Takapuna
AUCKLAND 0740
Country [1] 298947 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Natalie Gauld Ltd
Address
PO Box 9349
Newmarket
Auckland 1149
Country
New Zealand
Secondary sponsor category [1] 298160 0
None
Name [1] 298160 0
Address [1] 298160 0
Country [1] 298160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299884 0
Health and Disability Ethics Committee Central
Ethics committee address [1] 299884 0
HDEC
Ministry of Health
PO box 5013
Wellington
Ethics committee country [1] 299884 0
New Zealand
Date submitted for ethics approval [1] 299884 0
05/04/2018
Approval date [1] 299884 0
26/04/2018
Ethics approval number [1] 299884 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81862 0
Dr Natalie Gauld
Address 81862 0
Natalie Gauld Ltd
PO Box 9349
Newmarket
Auckland 1149
Country 81862 0
New Zealand
Phone 81862 0
+6496305683
Fax 81862 0
Email 81862 0
natalie@nataliegauld.com
Contact person for public queries
Name 81863 0
Dr Natalie Gauld
Address 81863 0
Natalie Gauld Ltd
PO Box 9349
Newmarket
Auckland 1149
Country 81863 0
New Zealand
Phone 81863 0
+6496305683
Fax 81863 0
Email 81863 0
natalie@nataliegauld.com
Contact person for scientific queries
Name 81864 0
Dr Natalie Gauld
Address 81864 0
Natalie Gauld Ltd
PO Box 9349
Newmarket
Auckland 1149
Country 81864 0
New Zealand
Phone 81864 0
+6496305683
Fax 81864 0
Email 81864 0
natalie@nataliegauld.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Highly sensitive information, and no funding available for de-identification.
What supporting documents are/will be available?
No other documents available
Summary results
No Results