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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05016609
Registration number
NCT05016609
Ethics application status
Date submitted
16/08/2021
Date registered
23/08/2021
Date last updated
13/11/2023
Titles & IDs
Public title
Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)
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Scientific title
Same-visit Hepatitis C Testing and Treatment to Accelerate Cure Among People Who Inject Drugs: a Cluster Randomised Control Trial (The QuickStart Study)
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Secondary ID [1]
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HREC/64731/Alfred-2020-217547
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Universal Trial Number (UTN)
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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
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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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
Treatment: Devices - OraQuick HCV Antibody test (OraSure Technologies, Inc)
Treatment: Devices - Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
Treatment: Drugs - Sofosbuvir/Velpatasvir (Gilead)
Experimental: POC HCV antibody group (Arm A) - This group will receive POC HCV antibody testing via fingerprick using the OraQuick HCV antibody test (OraSure) in addition to the standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. Follow up and management of any treatment will be through usual standard-of-care. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire.
Experimental: POC HCV RNA group (Arm B) - This group will receive POC HCV antibody testing using the OraQuick HCV antibody test. Participants in this group who return a positive POC HCV antibody result will receive POC HCV viral load testing via fingerstick using the Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid) in addition to the standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. Follow up and management of any treatment will be through usual standard-of-care. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire.
Experimental: Test and treat group (ArmC) - This group will receive POC HCV antibody testing using the OraQuick HCV antibody test. Participants in this group who return a positive POC HCV antibody result will be provided a starter pack of HCV treatment (epclusa). POC tests results will be confirmed through standard-of-care whole-blood conventional laboratory-based HCV PCR viral load testing. HCV RNA positive participants will continue treatment. Participants in this group will also fill out a short behavioural questionnaire and a clinical questionnaire.
No Intervention: Control - This group will receive the standard of care for HCV testing and treatment. Participants in this group will fill out a short behavioural questionnaire and a clinical questionnaire.
Treatment: Devices: OraQuick HCV Antibody test (OraSure Technologies, Inc)
The OraQuick HCV test is a point of care antibody test for detecting HCV antibodies in fingerstick blood. The test takes 20 minutes to provide a result. Appropriate pre- and post-test counselling will be provided to participants.
Treatment: Devices: Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)
Xpert® HCV VL Fingerstick is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human venous and capillary fingerstick EDTA whole blood. Only participants who return a reactive OraQuick HCV Antibody test will be offered the Xpert® HCV VL Fingerstick test. Appropriate pre- and post-test counselling will be provided to participants.
Treatment: Drugs: Sofosbuvir/Velpatasvir (Gilead)
Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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HCV treatment
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Assessment method [1]
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The number of participants who start HCV treatment in each of the intervention arms (Arm A, Arm B or Arm C) within 12 weeks of enrolment, compared with standard care testing and treatment (Control Arm).
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Timepoint [1]
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Within 12 weeks of enrolment
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Primary outcome [2]
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HCV cure
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Assessment method [2]
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The number of participants who achieve HCV cure in each of the intervention arms (Arm A, Arm B or Arm C), compared with standard care testing and treatment (Control Arm).
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Timepoint [2]
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HCV cure will be measured between 4 and 20 weeks post treatment completion.
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Eligibility
Key inclusion criteria
- current or former PWID (i.e., injected drugs at least once)
- aged 18 years or over
- attending a participating PHC for any reason
- no previous treatment with DAAs for HCV
- failed interferon based treatment for HCV in the past (i.e., did not achieve cure)
- Medicare eligible
- able to speak and understand English
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Minimum age
18
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
- women known to be currently pregnant or who are breastfeeding
- individuals self-reporting to be currently engaged in treatment for HCV
- unable to provide informed consent
- tested for HCV in the past 3 months
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Study design
Purpose of the study
Health Services Research
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Allocation to intervention
Randomised controlled 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2024
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Actual
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Sample size
Target
1800
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Mediclinic Australia - Clayton South
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Recruitment hospital [2]
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Innerspace - Collingwood
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Recruitment hospital [3]
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Corio Community Health Centre - Corio
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Recruitment hospital [4]
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Cohealth Fitzroy - Fitzroy
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Recruitment hospital [5]
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Homeless Healthcare - Highgate
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Recruitment hospital [6]
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Cockburn Wellbeing - Success
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Recruitment postcode(s) [1]
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3168 - Clayton South
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Recruitment postcode(s) [2]
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3066 - Collingwood
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Recruitment postcode(s) [3]
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3214 - Corio
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Recruitment postcode(s) [4]
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3065. - Fitzroy
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Recruitment postcode(s) [5]
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6003 - Highgate
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Recruitment postcode(s) [6]
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6164 - Success
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Funding & Sponsors
Primary sponsor type
Other
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Name
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The QuickStart study aims to assess the impact of three models of HCV care on HCV treatment
uptake and cure among people who inject drugs. Rapid point-of-care (POC) HCV testing and
test-and-treat strategies will be utilised in primary health care settings across Australia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05016609
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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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Joseph Doyle, MBBS, PhD
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Address
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Burnet Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Caitlin Douglass, BHSc(Hons)
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Address
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Country
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Phone
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+61404707275
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05016609
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