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Background: Reversing declining rates of people initiating and completing hepatitis C (HCV) treatment, observed in many countries, is needed to achieve global HCV elimination goals. Providing financial incentives to increase HCV testing and treatment uptake among people at-risk of or living with HCV infection could be an effective intervention. We conducted a systematic review to assess evidence regarding the effectiveness of financial incentives to improve engagement and progression through the HCV care cascade., Methods: We searched MEDLINE, PubMed and EMBASE for studies published from January 2013 to January 2023 that evaluated financial incentives offered to people living with and at-risk of HCV to increase HCV antibody and or RNA testing, linkage to care, treatment initiation, treatment adherence, treatment completion, and sustained viral load (SVR) testing. Open-label randomised controlled trials (RCTs), controlled non-randomised studies, cohort or observation studies and mixed-methods studies were included, whereas literature reviews, case series and studies which did not report data were excluded., Results: We identified 1,278 studies, with 21 included after full-text screening (14,913 participants); three randomised controlled trials and 18 non-randomised studies. Studies evaluated incentives aimed at improving test uptake (n = 11), engagement in care (n = 13), treatment initiation (n = 8), adherence (n = 3), completion (n = 3) and attainment of SVR (n = 5). Findings provided inconclusive evidence for the effectiveness of incentives in improving engagement in the HCV cascade of care. Determining incentive effectiveness to improve care cascade engagement was limited by low quality study designs, heterogeneity in type (cash or voucher), value (US$5 to $600) and cascade stage being incentivised. No randomised controlled trials assessed the effectiveness of incentives to promote HCV testing, and none showed an impact on treatment uptake. In non-randomised studies (observational comparative), some evidence suggested that incentives promoted HCV testing, but evidence of their role in promoting linkage to care, HCV treatment adherence and treatment completion were mixed., Conclusion: Currently, there lacks high-quality evidence evaluating whether financial incentives improve HCV testing and treatment outcomes. Future research should seek to standardise methodologies, compare incentive types and values to enhance engagement in HCV care, and determine factors that support incentives effectiveness., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: MWT has received investigator-initiated research funding, speakers honoraria and consultant fees from Gilead Sciences for activities unrelated to this work. AP has received investigator-initiated research funding from Gilead Sciences and AbbVie and consultant fees from Gilead Sciences for activities unrelated to this work. JSD and MEH receives funding from Gilead Sciences and Abbvie for investigator-initiated research, unrelated to the submitted work. MS has received investigator-initiated research funding from Gilead Sciences and AbbVie and consultant fees from Gilead Sciences for activities unrelated to this work. Burnet Institute receives funding support (outside this study) from the Victorian Government Operational Infrastructure Fund., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: To achieve the World Health Organization hepatitis C virus (HCV) elimination targets, it is essential to increase access to treatment. Direct-acting antiviral (DAA) treatment can be provided in primary healthcare services (PHCS), improving accessibility, and, potentially, retention in care. Here, we describe our protocol for assessing the effectiveness of providing DAAs in PHCS, and the impact on the HCV care cascade. In addition, we reflect on the challenges of conducting a model of care study during a period of unprecedented change in HCV care and treatment., Methods: Consenting patients with HCV infection attending 13 PHCS in Australia or New Zealand are randomized to receive DAA treatment at the local tertiary institution (standard care arm), or their PHCS (intervention arm). The primary endpoint is the proportion commenced on DAAs and cured. Treatment providers at the PHCS include: hepatology nurses, primary care practitioners, or, in two sites, a specialist physician. All PHCS offer opioid substitution therapy., Discussion: The Prime Study is the first real-world, randomized, model of care study exploring the impact of community provision of DAA therapy on HCV-treatment uptake and cure. Although the study has faced challenges unique to this period of time characterized by changing treatment and service delivery, the data gained will be of critical importance in shaping health service policy that enables the elimination of HCV., Trial Registration: ClinicalTrials.gov , ID: NCT02555475 . Registered on 15 September 2015.