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

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. ETHICS AND DISSEMINATION: The study was approved by University of Tasmania's Human Research Ethics Committee (Protocol ID: 18418) on 17 December 2019. Results of the project will be presented in scientific meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04510246. TRIAL PROGRESSION: The study commenced recruitment in September 2020 and end of study expected December 2021.

Exploring hepatitis C virus testing and treatment engagement over time in Melbourne, Australia: a study protocol for a longitudinal cohort study (EC-Experience Cohort study).

INTRODUCTION: The advent of direct acting antiviral therapy for hepatitis C virus (HCV) means the elimination of HCV is possible but requires sustained effort to achieve. Between 2016 and 2019, 44% of those living with HCV were treated in Australia. However, treatment uptake has declined significantly. In Australia, people who inject drugs (PWID) are the population most at risk of HCV acquisition. Eliminating HCV in Australia will require nuanced understanding of the barriers to HCV treatment experienced by PWID and tailored interventions to address these barriers. The EC-Experience Cohort study aims to explore the barriers and enablers reported by PWID to engagement in HCV care. METHODS AND ANALYSIS: The EC-Experience Cohort study is a prospective cohort of PWID, established in Melbourne, Australia in 2018. Participants are assigned into three study groups: (1) those not currently engaged in HCV testing; (2) those diagnosed with HCV but not currently engaged in treatment and (3) those completed treatment. Participants complete a total of four interviews every 6 months across an 18-month study period. Predictors of experience of key outcome events along the HCV care cascade will be explored over time. ETHICS AND DISSEMINATION: Ethical approval for the EC-Experience Cohort study was obtained by the Alfred Hospital Ethics Committee in Melbourne, Australia (Project Number: HREC/16/Alfred/164). All eligible participants are assessed for capacity to consent and partake in a thorough informed consent process. Results from the EC-Experience Cohort study will be disseminated via national and international scientific and public health conferences and peer-reviewed journal publications. Data from the EC-Experience Cohort study will improve the current understanding of the barriers to HCV care for PWID and guide the tailoring of service provision for specific subgroups. Understanding the barriers and how to increase engagement in care of PWID is critical to achieve HCV elimination goals.