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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.
Doyle, Joseph S; Heath, Katherine; Elsum, Imogen; Douglass, Caitlin; Wade, Amanda; Kasza, Jessica; Allardice, Kate; Von Bibra, Sally; Chan, Kico; Camesella, Beatriz; Guzman, Rodney; Bryant, Mellissa; Thompson, Alexander J; Stoové, Mark A; Snelling, Thomas L; Scott, Nick; Spelman, Timothy; Anderson, David; Richmond, Jacqui; Howell, Jessica; Andric, Nada; Dietze, Paul M; Higgs, Peter; Sacks-Davis, Rachel; Forbes, Andrew B; Hellard, Margaret E; Pedrana, Alisa E.
Afiliación
  • Doyle JS; Infectious Diseases, Monash University, Melbourne, Victoria, Australia joseph.doyle@burnet.edu.au.
  • Heath K; Burnet Institute, Melbourne, Victoria, Australia.
  • Elsum I; Burnet Institute, Melbourne, Victoria, Australia.
  • Douglass C; Burnet Institute, Melbourne, Victoria, Australia.
  • Wade A; Burnet Institute, Melbourne, Victoria, Australia.
  • Kasza J; Burnet Institute, Melbourne, Victoria, Australia.
  • Allardice K; Population Health, Monash University, Melbourne, Victoria, Australia.
  • Von Bibra S; Burnet Institute, Melbourne, Victoria, Australia.
  • Chan K; Burnet Institute, Melbourne, Victoria, Australia.
  • Camesella B; Burnet Institute, Melbourne, Victoria, Australia.
  • Guzman R; Burnet Institute, Melbourne, Victoria, Australia.
  • Bryant M; Burnet Institute, Melbourne, Victoria, Australia.
  • Thompson AJ; Burnet Institute, Melbourne, Victoria, Australia.
  • Stoové MA; Gastroenterology, St Vincent's Hospital, Melbourne, Victoria, Australia.
  • Snelling TL; Department of Medicine at St Vincent's Hospital, The University of Melbourne, Melbourne, Victoria, Australia.
  • Scott N; Burnet Institute, Melbourne, Victoria, Australia.
  • Spelman T; Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia.
  • Anderson D; Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
  • Richmond J; Burnet Institute, Melbourne, Victoria, Australia.
  • Howell J; Burnet Institute, Melbourne, Victoria, Australia.
  • Andric N; Burnet Institute, Melbourne, Victoria, Australia.
  • Dietze PM; Burnet Institute, Melbourne, Victoria, Australia.
  • Higgs P; Burnet Institute, Melbourne, Victoria, Australia.
  • Sacks-Davis R; Gastroenterology, St Vincent's Hospital, Melbourne, Victoria, Australia.
  • Forbes AB; HepatitisWA, Perth, Western Australia, Australia.
  • Hellard ME; Burnet Institute, Melbourne, Victoria, Australia.
  • Pedrana AE; Population Health, Monash University, Melbourne, Victoria, Australia.
BMJ Open ; 14(7): e083502, 2024 Jul 02.
Article en En | MEDLINE | ID: mdl-38960465
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Abuso de Sustancias por Vía Intravenosa / Hepatitis C / Estudios Cruzados Límite: Humans País/Región como asunto: Oceania Idioma: En Revista: BMJ Open Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Antivirales / Abuso de Sustancias por Vía Intravenosa / Hepatitis C / Estudios Cruzados Límite: Humans País/Región como asunto: Oceania Idioma: En Revista: BMJ Open Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido