Same-visit Hepatitis C Testing and Treatment (The QuickStart Study)
1 other identifier
interventional
1,800
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2022
Typical duration for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2021
CompletedFirst Posted
Study publicly available on registry
August 23, 2021
CompletedStudy Start
First participant enrolled
March 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedNovember 13, 2023
November 1, 2023
2.1 years
August 16, 2021
November 9, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
HCV treatment
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).
Within 12 weeks of enrolment
HCV cure
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).
HCV cure will be measured between 4 and 20 weeks post treatment completion.
Study Arms (4)
POC HCV antibody group (Arm A)
EXPERIMENTALThis 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.
POC HCV RNA group (Arm B)
EXPERIMENTALThis 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.
Test and treat group (ArmC)
EXPERIMENTALThis 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.
Control
NO INTERVENTIONThis 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.
Interventions
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 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.
Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Mediclinic Australia
Clayton South, Victoria, 3168, Australia
Innerspace
Collingwood, Victoria, 3066, Australia
Corio Community Health Centre
Corio, Victoria, 3214, Australia
Cohealth Fitzroy
Fitzroy, Victoria, 3065., Australia
Homeless Healthcare
Highgate, Western Australia, 6003, Australia
Cockburn Wellbeing
Success, Western Australia, 6164, Australia
Related Publications (2)
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.
PMID: 40607684DERIVEDDoyle 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.
PMID: 38960465DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Doyle, MBBS, PhD
Burnet Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2021
First Posted
August 23, 2021
Study Start
March 9, 2022
Primary Completion
April 1, 2024
Study Completion
June 1, 2024
Last Updated
November 13, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share
Requests for data sharing can be made to the principal investigator; further approval by the Human Research Ethics Committee may be necessary given the sensitive behaviour and risk information collected in the context of a trial of people who use drugs and hepatitis C testing.