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
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...
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BMJ Publishing Group
2024-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/7/e083502.full |
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| author | Andrew B Forbes Jessica Kasza Thomas L Snelling David Anderson Joseph S Doyle Peter Higgs Margaret E Hellard Nick Scott Alisa E Pedrana Alexander J Thompson Jessica Howell Timothy Spelman Beatriz Camesella Imogen Elsum Kico Chan Mark A Stoové Paul M Dietze Mellissa Bryant Katherine Heath Rodney Guzman Caitlin Douglass Amanda Wade Kate Allardice Sally Von Bibra Jacqui Richmond Nada Andric Rachel Sacks‐Davis |
| author_facet | Andrew B Forbes Jessica Kasza Thomas L Snelling David Anderson Joseph S Doyle Peter Higgs Margaret E Hellard Nick Scott Alisa E Pedrana Alexander J Thompson Jessica Howell Timothy Spelman Beatriz Camesella Imogen Elsum Kico Chan Mark A Stoové Paul M Dietze Mellissa Bryant Katherine Heath Rodney Guzman Caitlin Douglass Amanda Wade Kate Allardice Sally Von Bibra Jacqui Richmond Nada Andric Rachel Sacks‐Davis |
| author_sort | Andrew B Forbes |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-e78a8ff3a766436ca40eda23df6e0411 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-e78a8ff3a766436ca40eda23df6e04112025-08-20T03:01:06ZengBMJ Publishing GroupBMJ Open2044-60552024-07-0114710.1136/bmjopen-2023-083502Same-visit hepatitis C testing and treatment to accelerate cure among people who inject drugs (the QuickStart Study): a cluster randomised cross-over trial protocolAndrew B Forbes0Jessica Kasza1Thomas L Snelling2David Anderson3Joseph S Doyle4Peter Higgs5Margaret E Hellard6Nick Scott7Alisa E Pedrana8Alexander J Thompson9Jessica Howell10Timothy Spelman11Beatriz Camesella12Imogen Elsum13Kico Chan14Mark A Stoové15Paul M Dietze16Mellissa Bryant17Katherine Heath18Rodney Guzman19Caitlin Douglass20Amanda Wade21Kate Allardice22Sally Von Bibra23Jacqui Richmond24Nada Andric25Rachel Sacks‐Davis26Biostatistics Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia3 Population Health, Monash University, Melbourne, Victoria, AustraliaMenzies School of Health Research and Charles Darwin University, Darwin, Northern Territory, AustraliaDepartment of Biochemistry and Molecular Biology, University of Calgary Cumming School of Medicine, Calgary, Alberta, CanadaBurnet Institute, Melbourne, Victoria, Australia1 Disease Elimination, Burnet Institute, Melburne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia2 School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia4 Gastroenterology, St Vincent`s Hospital, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, AustraliaSchool of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, AustraliaBurnet Institute, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia2 Burnet Institute, Melbourne, Victoria, Australia8 HepatitisWA, Perth, Western Australia, Australia2 Burnet Institute, Melbourne, Victoria, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/14/7/e083502.full |
| spellingShingle | Andrew B Forbes Jessica Kasza Thomas L Snelling David Anderson Joseph S Doyle Peter Higgs Margaret E Hellard Nick Scott Alisa E Pedrana Alexander J Thompson Jessica Howell Timothy Spelman Beatriz Camesella Imogen Elsum Kico Chan Mark A Stoové Paul M Dietze Mellissa Bryant Katherine Heath Rodney Guzman Caitlin Douglass Amanda Wade Kate Allardice Sally Von Bibra Jacqui Richmond Nada Andric Rachel Sacks‐Davis 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/14/7/e083502.full |
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