Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)
NCT ID: NCT05016609
Last Updated: 2023-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1800 participants
INTERVENTIONAL
2022-03-09
2024-06-30
Brief Summary
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Detailed Description
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Each site will participate in a control comparison period in addition to one of three interventions. The three interventions involve:
A) A rapid HCV antibody test using a fingerprick sample and for anybody subsequently diagnosed with hepatitis C, management and treatment will be according to standard of care.
B) A rapid HCV antibody test followed by a POC HCV RNA test for those who return a reactive antibody result. Both these will use a fingerprick sample and for anybody diagnosed with hepatitis C, management and treatment will be according to standard of care.
C) A rapid HCV antibody test using a fingerprick sample and for participants who return a reactive result, an initial starter pack of DAA prior to a confirmed HCV RNA diagnosis.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
Sofosbuvir/Velpatasvir (Gilead)
Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir.
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.
No interventions assigned to this group
Interventions
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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.
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.
Sofosbuvir/Velpatasvir (Gilead)
Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* individuals self-reporting to be currently engaged in treatment for HCV
* unable to provide informed consent
* tested for HCV in the past 3 months
18 Years
ALL
Yes
Sponsors
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Macfarlane Burnet Institute for Medical Research and Public Health Ltd
OTHER
Responsible Party
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Principal Investigators
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Joseph Doyle, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Burnet Institute
Locations
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Mediclinic Australia
Clayton South, Victoria, Australia
Innerspace
Collingwood, Victoria, Australia
Corio Community Health Centre
Corio, Victoria, Australia
Cohealth Fitzroy
Fitzroy, Victoria, Australia
Homeless Healthcare
Highgate, Western Australia, Australia
Cockburn Wellbeing
Success, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Heath K, Guzman R, Elsum I, Wade AJ, Allardice K, Kasza J, Bryant M, Thompson AJ, Stoove M, Snelling T, Scott N, Spelman T, Anderson DA, Richmond J, Howell J, Andric N, Dietze P, Higgs P, Sacks-Davis R, Forbes A, Hellard ME, Pedrana AE, Doyle JS. Balancing Efficiency and Accuracy in Hepatitis C Rapid Antibody Testing: Insights From a Cluster Randomised Crossover Trial. J Viral Hepat. 2025 Aug;32(8):e70043. doi: 10.1111/jvh.70043.
Doyle JS, Heath K, Elsum I, Douglass C, Wade A, Kasza J, Allardice K, Von Bibra S, Chan K, Camesella B, Guzman R, Bryant M, Thompson AJ, Stoove MA, Snelling TL, Scott N, Spelman T, Anderson D, Richmond J, Howell J, Andric N, Dietze PM, Higgs P, Sacks-Davis R, Forbes AB, Hellard ME, Pedrana AE. Same-visit hepatitis C testing and treatment to accelerate cure among people who inject drugs (the QuickStart Study): a cluster randomised cross-over trial protocol. BMJ Open. 2024 Jul 2;14(7):e083502. doi: 10.1136/bmjopen-2023-083502.
Other Identifiers
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HREC/64731/Alfred-2020-217547
Identifier Type: -
Identifier Source: org_study_id
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