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Randomised controlled trial of active case management to link hepatitis C notifications to treatment in Tasmania, Australia: a study protocol


Marukutira, T and Moore, KP and Hellard, M and Richmond, J and Turner, K and Pedrana, AE and Melody, S and Johnston, F and Owen, L and Van Den Boom, W and Scott, N and Thompson, A and Iser, D and Spelman, T and Veitch, M and Stoove, MA and Doyle, J, Randomised controlled trial of active case management to link hepatitis C notifications to treatment in Tasmania, Australia: a study protocol, BMJ Open, 12, (3) pp. 1-7. ISSN 2044-6055 (2022) [Refereed Article]

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DOI: doi:10.1136/bmjopen-2021-056120


Introduction: By subsidising access to direct acting antivirals (DAAs) for all people living with hepatitis C (HCV) in 2016, Australia is positioned to eliminate HCV as a public health threat. However, uptake of DAAs has declined over recent years and new initiatives are needed to engage people living with HCV in care. Active follow-up of HCV notifications by the health department to the notifying general practitioner (GP) may increase treatment uptake. In this study, we explore the impact of using hepatitis C notifications systems to engage diagnosing GPs and improve patient access to treatment.

Methods and analysis: This study is a randomised controlled trial comparing enhanced case management of HCV notifications with standard of care. The intervention includes phone calls from a department of health (DoH) specialist HCV nurse to notifying GPs and offering HCV management support. The level of support requested by the GP was graded in complexity: level 1: HCV information only; level 2: follow-up testing advice; level 3: prescription support including linkage to specialist clinicians and level 4: direct patient contact. The study population includes all GPs in Tasmania who notified HCV diagnosis to the DoH between September 2020 and December 2021. The primary outcome is proportion of HCV cases who initiate DAAs after 12 weeks of HCV notification to the health department. Secondary outcomes are proportion of HCV notifications that complete HCV RNA testing, treatment workup and treatment completion. Multiple logistic regression modelling will explore factors associated with the primary and secondary outcomes. The sample size required to detect a significant difference for the primary outcome is 85 GPs in each arm with a two-sided alpha of 0.05% and 80% power.

Item Details

Item Type:Refereed Article
Keywords:epidemiology; public health; virology
Research Division:Health Sciences
Research Group:Epidemiology
Research Field:Disease surveillance
Objective Division:Health
Objective Group:Clinical health
Objective Field:Treatment of human diseases and conditions
UTAS Author:Johnston, F (Professor Fay Johnston)
ID Code:155611
Year Published:2022
Deposited By:Menzies Institute for Medical Research
Deposited On:2023-03-02
Last Modified:2023-03-02

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