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. 2024 Jul 2;14(7):e083502.
doi: 10.1136/bmjopen-2023-083502.

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

Joseph S Doyle  1   2 , Katherine Heath  2 , Imogen Elsum  2 , Caitlin Douglass  2 , Amanda Wade  2 , Jessica Kasza  3 , Kate Allardice  2 , Sally Von Bibra  2 , Kico Chan  2 , Beatriz Camesella  2 , Rodney Guzman  2 , Mellissa Bryant  2 , Alexander J Thompson  4   5 , Mark A Stoové  2 , Thomas L Snelling  6   7 , Nick Scott  2 , Timothy Spelman  2 , David Anderson  2 , Jacqui Richmond  2 , Jessica Howell  2   4 , Nada Andric  8 , Paul M Dietze  2   3 , Peter Higgs  2   9 , Rachel Sacks-Davis  2 , Andrew B Forbes  3 , Margaret E Hellard  2   3 , Alisa E Pedrana  2   3
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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

Joseph S Doyle et al. BMJ Open. .

Abstract

Introduction: Despite universal access to government-funded direct-acting antivirals (DAAs) in 2016, the rate of hepatitis C treatment uptake in Australia has declined substantially. Most hepatitis C is related to injecting drug use; reducing the hepatitis C burden among people who inject drugs (PWID) is, therefore, paramount to reach hepatitis C elimination targets. Increasing DAA uptake by PWID is important for interrupting transmission and reducing incidence, as well as reducing morbidity and mortality and improving quality of life of PWID and meeting Australia's hepatitis C elimination targets.

Methods and analysis: A cluster randomised cross-over trial will be conducted with three intervention arms and a control arm. Arm A will receive rapid hepatitis C virus (HCV) antibody testing; arm B will receive rapid HCV antibody and rapid RNA testing; arm C will receive rapid HCV antibody testing and same-day treatment initiation for HCV antibody-positive participants; the control arm will receive standard of care. The primary outcomes will be (a) the proportion of participants with HCV commencing treatment and (b) the proportion of participants with HCV achieving cure. Analyses will be conducted on an intention-to-treat basis with mixed-effects logistic regression models.

Ethics and dissemination: The study has been approved by the Alfred Ethics Committee (number HREC/64731/Alfred-2020-217547). Each participant will provide written informed consent. Reportable adverse events will be reported to the reviewing ethics committee. The findings will be presented at scientific conferences and published in peer-reviewed journals.

Trial registration number: NCT05016609.

Trial progression: The study commenced recruitment on 9 March 2022 and is expected to complete recruitment in December 2024.

Keywords: Hepatology; INFECTIOUS DISEASES; Public health.

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Conflict of interest statement

Competing interests: JSD, MH and AP report investigator-iniated funding to their institution from Gilead Sciences, AbbVie and Merck. JSD reports honoraria to his institution from Gilead Sciences and AbbVie.

Figures

Figure 1
Figure 1
(A) Sequence of events in arm A: rapid HCV antibody testing followed by standard of care. (B) Sequence of events in arm B: rapid HCV antibody±rapid HCV RNA followed by standard of care. (C) Sequence of events in arm C: rapid HCV antibody followed by same-day treatment with DAAs. (D) Sequence of events in the control arm: standard of care. DAAs, direct-acting antivirals; HCV, hepatitis C virus.
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