Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000441718p
Ethics application status
Not yet submitted
Date submitted
13/09/2021
Date registered
18/03/2022
Date last updated
18/03/2022
Date data sharing statement initially provided
18/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Point Of Care Hepatitis C testing and subsequent treatment uptake in Addiction Medicine residential withdrawal unit (POCAM): a pilot study
Scientific title
Point Of Care Hepatitis C testing and subsequent treatment uptake in Addiction Medicine residential withdrawal unit (POCAM): a pilot study
Secondary ID [1] 304925 0
None
Universal Trial Number (UTN)
Trial acronym
POCAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C virus 323072 0
Condition category
Condition code
Infection 320650 320650 0 0
Other infectious diseases
Public Health 320651 320651 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to evaluate the uptake and acceptability of point of care (POC) testing using the Xpert HCV VL Fingerstick test in individuals with substance dependence presenting to a residential withdrawal unit. Further, we seek to evaluate the initiation (prescription and/or dispensing) of DAA therapy in participants offered POC testing, compared to initiation among participants who have undergone standard-of-care (SOC) HCV testing at the residential withdrawal unit over a similar time period. The study will take place at Depaul House, the residential withdrawal facility attached to St Vincent's Hospital.

The intervention being examined is the Cepheid Xpert Hepatitis C (HCV) Viral Load (VL) Fingerstick test, which is run on the Cepheid GeneXpert platform.

The Cepheid GeneXpert platform 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 fingerprick and only requires 100uL of capillary blood for a test to be run. The fingerprick takes between 2 and 5 minutes to perform; it will be performed once on admission to Depaul House and again for assessment of adherence to therapy at week 4 and week 8 post commencing direct acting antiviral (DAA) as well as at 4 weeks post therapy for sustained virological response.

Duration of participation in the study will depend on need for initiation of DAA therapy; individuals that are negative on HCV VL Fingerstick will participate in the study until their test results are disclosed and have undertaken post testing questionnaire (expected to be between 1 and 2 days). Individuals that test positive on HCV VL Fingerstick will be offered commencement of DAA therapy and will be followed up for a minimum of 12 weeks: either 8 or 12 weeks of treatment depending on DAA regimen and at least a further 4 weeks to assess for sustained virological response (SVR4+).

The HCV VL fingerstick will be administered by a St Vincent’s Hospital doctor or nurse from the departments of Addiction medicine or Gastroenterology who has been undertaken the prior training of administering the HCV VL fingerstick.

Treatment adherence will be monitored through administration of questionnaires at week 4 and week 8 follow-up appointments post commencing treatment; furthermore administration of HCV VL fingerstick at week 4 and week 8 of DAA therapy will act as a further surrogate marker for treatment adherence. Attendance to these appointments will be recorded.

Other investigations offered as part of the study conform with current standard of care practice.
- At the time of venepuncture, other pathology results obtained will include a HIV test (with counseling), hepatitis A serology, hepatitis B serology, liver function test panel including ALT, AST, Albumin and bilirubin, FBE, INR and a beta-HCG where appropriate.
- FibroScan (transient elastography) allows a rapid, non-invasive evaluation of liver fibrosis via the measurement of liver stiffness. It is a performed with a participant lying supine with an ultrasound-like probe place on the skin over the liver area, typically in the right mid-axillary line. Typically the test takes around 10 minutes to perform and causes no discomfort. FibroScan is an accepted and commonly used clinical tool in the assessment of fibrosis in people with or at risk of chronic liver disease.
- Participants with a positive HCV RNA will be prescribed treatment with direct acting antiviral (DAA) therapy which will be at the discretion of the prescribing doctor. Primarily, one of two pangenotypic DAA regimens will be used (reflecting standard clinical practice). This will be done via a pharmaceutical benefits scheme (PBS) funded script, in compliance with PBS criteria and in accordance with Australasian Liver Association/Gastroenterological Society of Australia guidelines.
Intervention code [1] 321322 0
Early detection / Screening
Comparator / control treatment
The control arm will consist of a retrospective analysis of the standard of care model of hepatitis C screening and treatment at Depaul House over the preceding 12 month period. For this, admissions to Depaul House for elective substance withdrawal over a 12 month period from 1st August 2020 to 31st July 2021 will be compiled from the intake database. Data will be extracted from St Vincent’s Hospital medical records along with a search of pathology results ordered by St Vincent’s Hospital. Data collected included patient demographics, markers of patient vulnerability, substance use history, hepatitis C testing results (including date of testing and date of result availability), other pathology results as well as details of hepatitis C treatment including outcomes, rates of relapse and re-infection.
Control group
Historical

Outcomes
Primary outcome [1] 328463 0
Acceptability of POC testing with the Xpert HCV VL Fingerstick test
Acceptability will be assessed through a participant questionnaire post administration of Fingerstick test which will includes 5-point Likert scale
Timepoint [1] 328463 0
6 months post-intervention commencement
Primary outcome [2] 328464 0
Composite primary outcome of DAA treatment prescription and dispensing following Xpert HCV VL Fingerstick testing compared to SOC HCV testing.
Assessed by comparing SOC testing documentation from retrospective withdrawal unit admission, pharmacy records with POCAM documentation and pharmacy records.
Timepoint [2] 328464 0
3 months post-intervention commencement
Secondary outcome [1] 399090 0
Composite secondary outcome of prevalence of HCV Ab and HCV RNA positivity amongst the study population
Assessed by review of the participants' medical records of laboratory results taken during their withdrawal unit admission.
Timepoint [1] 399090 0
1 week post initial HCV testing
Secondary outcome [2] 399091 0
The number of participants who receive a POC Xpert HCV VL Fingerstick result on the same day as testing
Assessed by audit of study database which will document timing of HCV VL Fingerstick administration and timing of result communication.
Timepoint [2] 399091 0
Within 24 hours post HCV testing
Secondary outcome [3] 399092 0
The average time to treatment initiation of DAAs following a positive Xpert HCV VL Fingerstick result, compared to SOC HCV testing
Assessed by audit of study database which will document timing of HCV VL Fingerstick administration and timing of DAA commencement
Timepoint [3] 399092 0
From time of positive test to time of treatment initiation.
Secondary outcome [4] 399093 0
The composite endpoint of the number that are prescribed and dispensed DAA treatment during their residential withdrawal stay among participants who are HCV RNA positive,
Assessed by audit of study database which will document timing of DAA commencement along with review of pharmacy records for dispensing during withdrawal unit stay stay.
Timepoint [4] 399093 0
At time of discharge from residential withdrawal unit.
Secondary outcome [5] 399094 0
Uptake of DAA therapy during admission in patients suitable for study
Assessed by audit of study database
Timepoint [5] 399094 0
At time of discharge from residential withdrawal unit.
Secondary outcome [6] 399095 0
The number of participants who commence DAA therapy who return at week 4 and/or week 8 (if applicable) for ongoing treatment
Assessed by audit of study database which will document treatment attendances by participants on DAA therapy.
Timepoint [6] 399095 0
4 and 8 weeks post DAA treatment commencement
Secondary outcome [7] 399096 0
The number of participants who complete DAA therapy
Assessed by audit of study database, participant questionnaire's at treatment and post-treatment attendances and pharmacy records.
Timepoint [7] 399096 0
8 to 12 weeks post DAA therapy commencement depending on DAA regimen.
Secondary outcome [8] 399097 0
Rates of negativity of end of treatment HCV PCR
End of treatment HCV PCR will be assessed with either POC VL fingerstick or peripheral blood sample at participant's preference.
Timepoint [8] 399097 0
8 to 12 weeks post commencement of DAA therapy depending on DAA regimen.
Secondary outcome [9] 399099 0
Composite outcome of relapse or re-infection rates
Assessed by review of medical records of HCV PCR samples taken either as peripheral blood sample or using POC VL fingerstick post treatment completion.
Timepoint [9] 399099 0
6 months post intervention commencement
Secondary outcome [10] 399100 0
Client perceptions of screening process
Client perception of screening process will be assessed through a participant questionnaire post administration of Fingerstick test which will includes 5-point Likert scale
Timepoint [10] 399100 0
1 week post intervention commencement
Secondary outcome [11] 407141 0
Client perceptions of treatment process
Client perception of treatment process will be assessed through a participant questionnaire post administration of Fingerstick test which will includes 5-point Likert scale
Timepoint [11] 407141 0
6 months post intervention commencement

Eligibility
Key inclusion criteria
Inclusion criteria are:
• Admitted to the St Vincent’s Hospital residential withdrawal unit, Depaul House, during the recruitment phase of the study;
• Willing and able to provide written informed consent;
• Consent to completion of questionnaires;
• Consent to a venous blood sample for routine blood tests;
• Not currently engaged in care for treatment of hepatitis C infection;
• Fulfils study criteria for HCV diagnosis to initiate treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who meet any of the following criteria will not be included in the study:
• Inability or unwillingness to provide informed consent
• Pregnant or breastfeeding at time of commencement of HCV antiviral treatment;
• Decompensated liver disease
• Creatinine clearance <30 mL/min
• History of solid organ transplant
• Diagnosed and/or undergoing treatment for hepatocellular carcinoma;
• Awaiting liver transplantation;
• Currently engaged in care for treatment of hepatitis C infection or HIV
• Use of prohibited concomitant medications

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
The control arm will consist of a retrospective analysis of the standard of care model of hepatitis C screening and treatment at Depaul House over the preceding 12 month period.

For this, admissions to Depaul House for elective substance withdrawal over a 12 month period from 1st January 2021 to 31st December 2021 were compiled from the intake database. Data was then extracted from St Vincent’s Hospital medical records along with a search of pathology results ordered by St Vincent’s Hospital. Data collected included patient demographics, markers of patient vulnerability, substance use history, hepatitis C testing results (including date of testing and date of result availability), other pathology results as well as details of hepatitis C treatment including outcomes, rates of relapse and re-infection.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
HCV prevalence will be determined by proportion of study participants with a positive HCV RNA test. The proportion of individuals commencing HCV treatment will be defined as the number of participants who received at least one dose of HCV treatment amongst all study participants who returned a positive HCV RNA result during the study. SVR4+ will be determined either using the Xpert HCV VL Fingerstick test or SOC qualitative HCV RNA by venepuncture in those that have undergone HCV treatment.

Given this is a pilot study for the implementation of POC testing, interpretation of findings will be primarily descriptive. Categorical data will be presented as frequencies and continuous data will be presented as medians with interquartile range. Logistic regression will be used to identify clinical, sociodemographic and behavioural predictors (age, gender, fixed abode, fibrosis stage, injecting behaviours, treatment regimen and drug and alcohol use) of a positive diagnosis and predictors of linkage to treatment. Comparisons will be made using Pearson’s chi2/fisher exact for categorical data and Mann-Whitney U test for continuous variables. Two tailed tests of significance at p<0.05 will be used in all inferential tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20512 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 35289 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 309305 0
Hospital
Name [1] 309305 0
St Vincent's Hospital Melbourne
Country [1] 309305 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 310278 0
None
Name [1] 310278 0
None
Address [1] 310278 0
None
Country [1] 310278 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 309135 0
St Vincent's Hospital Melbourne Human Research Ethics Committee D
Ethics committee address [1] 309135 0
Ethics committee country [1] 309135 0
Australia
Date submitted for ethics approval [1] 309135 0
25/03/2022
Approval date [1] 309135 0
Ethics approval number [1] 309135 0

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

Contacts
Principal investigator
Name 113106 0
Prof Alex Thompson
Address 113106 0
St Vincent's Hospital Melbourne
41 Victoria Parade Fitzroy VIC 3065
Country 113106 0
Australia
Phone 113106 0
+61 409 954 350
Fax 113106 0
Email 113106 0
[email protected]
Contact person for public queries
Name 113107 0
James Williams
Address 113107 0
St Vincent's Hospital Melbourne
41 Victoria Parade Fitzroy VIC 3065
Country 113107 0
Australia
Phone 113107 0
+61 439 319 757
Fax 113107 0
+61 3 9231 2642
Email 113107 0
[email protected]
Contact person for scientific queries
Name 113108 0
James Williams
Address 113108 0
St Vincent's Hospital Melbourne
41 Victoria Parade Fitzroy VIC 3065
Country 113108 0
Australia
Phone 113108 0
+61 439 319 757
Fax 113108 0
+61 3 9231 2642
Email 113108 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
13178Study protocol  [email protected] 382512-(Uploaded-13-09-2021-13-19-49)-Study-related document.docx
13181Informed consent form  [email protected] 382512-(Uploaded-13-09-2021-13-20-50)-Study-related document.docx



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.