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Trial registered on ANZCTR


Registration number
ACTRN12620000526976p
Ethics application status
Not yet submitted
Date submitted
2/04/2020
Date registered
29/04/2020
Date last updated
29/04/2020
Date data sharing statement initially provided
29/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating new, rapid point of care testing for hepatitis C in injecting drug users visiting a medically supervised injecting room.
Scientific title
Evaluation of Point Of Care Hepatitis C testing and subsequent treatment uptake in injecting drug users visiting a medically Supervised Injecting Room – a pilot study (EPOCH-SIR)
Secondary ID [1] 300901 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EPOCH-SIR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 316837 0
Condition category
Condition code
Infection 315044 315044 0 0
Other infectious diseases
Oral and Gastrointestinal 315214 315214 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
Study Design: Time series, recruiting consecutive patients over four months. In the first two months (months 1-2), patients will be assigned to the standard of care testing or comparator arm (Arm A). In the subsequent two months (months 3-4), patients will be assigned to the point of care testing or intervention arm (Arm B).
All participants with a positive HCV RNA result will be offered treatment either at the initial visit (if result available) or a later date on a subsequent visit to the medically supervised injecting room once this result is available.
The primary outcomes will be to compare the uptake and acceptability of point of care testing to the standard of care model that exists at present, and the influence this has on treatment uptake/early initiation of treatment.

The primary intervention involves point of care testing using the Cepheid Xpert HCV VL Fingerstick test. The Cepheid Xpert HCV VL test is run on the Cepheid GeneXpert platform, which is a bench top machine that performs real-time polymerase chain reaction (PCR) in a self-contained cartridge to provide a HCV RNA result within 60 minutes. It is done via fingerpick and only requires 100uL of capillary blood for a test to be run. The equipment required includes a lancet for fingerstick, minivettes 100ul to collect blood sample and transfer to cartridges, HCV VL Fingerstick cartridges and a GeneXpert 4 module system.
The testing is quick, easy and will carried out by trained members of the study team (clinical nurse, integrated hepatitis nurse, medical practitioners). The Cepheid Xpert HCV VL Fingerstick test was been shown to have both a sensitivity and specificity of up to 100%. As the test is highly accurate and is performed in a standardised manner, no specific monitoring of the fidelity of the intervention is planned. The intervention will be delivered after recruitment and consent is gained from people who inject drugs that are attending a medically supervised injecting room in Melbourne, Victoria.
Intervention code [1] 317221 0
Diagnosis / Prognosis
Intervention code [2] 317222 0
Early detection / Screening
Comparator / control treatment
Standard of care testing that presently exists for hepatitis C will act as a comparator arm. Participants will be recruited over the initial two months (months 1-2) of the study recruitment phase. Standard of care testing with venepuncture for HCV antibody, RNA, viral load and genotype will be carried out members of the study team (clinical nurse, integrated hepatitis nurse, medical practitioners). All participants recruited during the first two months of the study will undergo venepuncture in a confidential setting following presentation to the medically supervised injecting room during the first study visit
Control group
Active

Outcomes
Primary outcome [1] 323348 0
Uptake of care Xpert Hepatitis C Viral Load Fingerstick testing compared to standard of care hepatitis C testing
(Assessed by comparing the proportion of those approached willing to undergo point of care testing, as compared to standard of care testing)
Timepoint [1] 323348 0
Baseline (same visit as HCV testing offered)
Primary outcome [2] 323472 0
Acceptance of points of care Xpert Hepatitis C Viral Load Fingerstick testing compared to standard of care hepatitis C testing
(Assessed by study-specific questionnaires offered at the timepoints listed below)
Timepoint [2] 323472 0
Baseline (same visit as HCV testing offered), 4 weeks after HCV treatment initiation, 8 weeks after HCV treatment initiation (end of treatment), 12 weeks after treatment initiation (end of treatment).
Secondary outcome [1] 381622 0
The number of participants who are hepatitis C RNA negative at 12 weeks post treatment completion (sustained virological response, SVR12).
(Assessed by venepuncture of hepatitis C RNA testing at the final study visit, 12 weeks post treatment completion)
Timepoint [1] 381622 0
12 weeks post treatment completion (study week 20 or 24 deepening on duration of treatment)
Secondary outcome [2] 382017 0
Direct acting antiviral treatment prescription following point of care Xpert HCV VL Fingerstick testing compared to standard of care HCV testing.
(Assessed by the number of participants who have a prescription written by a medical practitioner on the same day as HCV RNA result, or at a subsequent time point)
Timepoint [2] 382017 0
Baseline (same visit as HCV testing offered)
Proportion of participants who are prescribed direct acting antiviral therapy on the same day as a hepatitis C RNA positive result will be recorded.
Time from hepatitis C RNA positive result to prescription of treatment will be recorded up to eight weeks post testing.
Secondary outcome [3] 382018 0
Direct acting antiviral treatment dispensing following point of care Xpert HCV VL Fingerstick testing compared to standard of care HCV testing.
(Assessed by the number of participants who have medication dispensed onsite or by a community pharmacy on the same day as HCV RNA result, or at a subsequent time point)
Timepoint [3] 382018 0
Baseline (same visit as HCV testing offered).
Proportion of participants who are dispensed direct acting antiviral therapy on the same day as a hepatitis C RNA positive result will be recorded (either on site or after filling a prescription at a community pharmacy).
Time from hepatitis C RNA positive result to dispensing of treatment will be recorded up to eight weeks post testing.

Eligibility
Key inclusion criteria
- Aged greater than or equal to 18 years;
- Present to the medically supervised injecting room during the recruitment phase of the study;
- Able to provide written informed consent;
- Consent to provide full name, contact details and Medicare number;
- Consent to multiple visits and to completion of questionnaires;
- Consent to blood sample for storage at pre-specified time points during the study;
- Not currently engaged in care for treatment of hepatitis C infection, hepatitis B or HIV;
- Fulfills study criteria for hepatitis C diagnosis to initiate treatment.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or breastfeeding at time of commencement of hepatitis C antiviral treatment;
- Clinical evidence of decompensated cirrhosis;
- Diagnosed and/or undergoing treatment for hepatocellular carcinoma;
- Awaiting liver transplantation;
- Currently engaged in care for treatment of hepatitis C infection, hepatitis B infection or HIV;
- Unable or unwilling to present to pick up ongoing DAA supply for treatment (four weekly basis);
- Receiving medications which are contra-indicated to co-administration of direct acting antiviral's or at risk of significant drug-drug interactions;
- Clients who are first time presenters or users of the medically supervised injecting room
- Clients who receive a clinical intervention for overdose whilst using the supervised injecting drug room after initially consenting to participate;
- 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
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Time series design, where all participants recruited in the first two months (months 1-2) on the study will be assigned to the comparator arm and all participants recruited in the subsequent two months (months 3-4) will be assigned to the intervention arm.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Prevalence data will be reported descriptively using number and percentage (95% CI). Descriptive statistics will be used to describe the proportion of participants who are HCV RNA positive as a proportion of participants tested. The proportion of participants screened who subsequently obtain treatment from pharmacy, complete treatment and achieve SVR12 will also be recorded. Fibrosis stage (APRI or FibroScan result) and blood test results will also be recorded.
Logistic regression will be used to identify clinical and demographic predictors (age, gender, fixed abode, fibrosis stage, pattern of injecting, treatment regimen and drug and alcohol use) of a positive diagnosis and predictors of linkage to treatment. Pearson’s Chi Square and Fisher’s exact test will be used to test association between categorical variables as appropriate, and Mann-Whitney U test for continuous variables. Two tailed tests of significance at p<0.05 will be used in all inferential tests.

This is a pilot study designed to demonstrate feasibility and acceptability. We aim to recruit 30-50 patients into each arm of the study.

Recruitment
Recruitment status
Not yet 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 in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305352 0
Hospital
Name [1] 305352 0
Gastroenterology Department, St Vincent's Hospital Melbourne
Address [1] 305352 0
Department of Gastroenterology, SVHM
Level 4 Daly Wing
35 Victoria Pde
Fitzroy, Victoria 3065
Country [1] 305352 0
Australia
Primary sponsor type
Hospital
Name
Gastroenterology Department, St Vincent's Hospital Melbourne
Address
Department of Gastroenterology, SVHM
Level 4 Daly Wing
35 Victoria Pde
Fitzroy, Victoria 3065
Country
Australia
Secondary sponsor category [1] 305755 0
None
Name [1] 305755 0
None
Address [1] 305755 0
None
Country [1] 305755 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305684 0
St Vincent’s Hospital Melbourne Human Research Ethics Committee D
Ethics committee address [1] 305684 0
Research Governance Unit
Level 5, Building E (Aikenhead Building)
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 305684 0
Australia
Date submitted for ethics approval [1] 305684 0
06/05/2020
Approval date [1] 305684 0
Ethics approval number [1] 305684 0

Summary
Brief summary
The aims of this study are to evalute the uptake and acceptability of point fo care testing for hepatitis C using the Xpert Hepatitis C (HCV) Viral Load (VL) Fingerstick test, as compared to standard of care HCV testing in persons who inject drugs presenting to the medically supervised injecting room in Richmond, Victoria. We also seek to evaluate if point of care testing increases the rates of initiation of HCV treatment.
Participants will be those persons over the age of 18 years who inject drugs that visit the medically supervised injecting room in Richmond, Victoria.
The study will be a time series design, with two arms, conducted over ten months. The recruitment phase will be a total of four months, with each arm (standard of care, point of care) recruiting for a consecutive period of two months. Participants recruited in the first two months (months 1-2) will undergo standard of care testing for HCV. Participants recruited in the subsequent two months (months 3-4) will undergo point of care testing with Xpert HCV VL Fingerstick. Participants who return a positive HCV RNA result, suggestive of chronic hepatitis C infection, will be offered treatment with direct acting antiviral therapy. Participants will be followed up throughout the treatment course at four-weekly intervals, at end of treatment and at 12 weeks post treatment completion to assess for sustained virological response (SVR12).
Participants will also complete questionnaires at enrolment, following HCV testing and at each follow up visit to assess acceptability of point of care testing, as compared to standard of care testing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101218 0
Prof Alexander Thompson
Address 101218 0
Department of Gastroenterology, SVHM
Level 4 Daly Wing
35 Victoria Pde
Fitzroy, VIC 3065
Country 101218 0
Australia
Phone 101218 0
+61 3 92313590
Fax 101218 0
Email 101218 0
alexander.thompson@svha.org.au
Contact person for public queries
Name 101219 0
Dr Michael MacIsaac
Address 101219 0
Department of Gastroenterology, SVHM
Level 4 Daly Wing
35 Victoria Pde
Fitzroy, VIC 3065
Country 101219 0
Australia
Phone 101219 0
+61 3 9231 2211
Fax 101219 0
Email 101219 0
michael.macisaac@svha.org.au
Contact person for scientific queries
Name 101220 0
Dr Michael MacIsaac
Address 101220 0
Department of Gastroenterology, SVHM
Level 4 Daly Wing
35 Victoria Pde
Fitzroy, VIC 3065
Country 101220 0
Australia
Phone 101220 0
+61 3 9231 2211
Fax 101220 0
Email 101220 0
michael.macisaac@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Available immediately following publication, ending 5 years following main results publication
Available to whom?
Due to the sensitive nature of the data to be collected and privacy/confidentiality concerns, individual participant data will only be made available on a case by case basis at the discretion of the principal investigators.
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Due to the sensitive nature of the data to be collected and privacy/confidentiality concerns, individual participant data will only be made available on a case by case basis at the discretion of the principal investigators. A designated principal investigator can be contacted via email (michael.macisaac@svha.org.au) or telephone (+613 9231 2211)
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7494 0
Study protocol
Citation [1] 7494 0
Link [1] 7494 0
Email [1] 7494 0
michael.macisaac@svha.org.au
Other [1] 7494 0
Attachment [1] 7494 0
Type [2] 7495 0
Informed consent form
Citation [2] 7495 0
Link [2] 7495 0
Email [2] 7495 0
michael.macisaac@svha.org.au
Other [2] 7495 0
Attachment [2] 7495 0
Type [3] 7496 0
Ethical approval
Citation [3] 7496 0
Link [3] 7496 0
Email [3] 7496 0
michael.macisaac@svha.org.au
Other [3] 7496 0
Attachment [3] 7496 0
Summary results
No Results