Eliminating hepatitis C on the Balearic Islands, Spain: a protocol for an intervention study to test and link people who use drugs to treatment and care.

Introduction: The hepatitis C virus (HCV) is a highly infectious and deadly disease, affecting some 58 million people worldwide. Of the 1.13 million people living in the Balearic Islands, Spain, about 1350 individuals have untreated HCV. Of these, about 1120 (83%) are estimated to be people who use drugs (PWUD), who are one of the key at-risk groups for HCV infection globally. Carrying out micro-elimination approaches focused on this population is crucial to achieve the WHO goal of eliminating HCV by 2030. Thus, the primary objective of this study is to validate a model of care that simplifies the screening and linkage to HCV care pathways for PWUD on the Balearic Islands.
Methods and Analysis: This intervention study will be implemented across 17 sites, in 4 different settings: addiction service centres (n=12), non-governmental organisation centres (n=3), a mobile methadone unit and a prison, with an estimated 3725 participants. Together with the healthcare staff at each centre, the intervention protocols will be adapted, focusing on four phases: recruitment and testing; linkage to care; treatment for those who test positive; and monitoring of sustained virological response 12 weeks after treatment and reinfection. The primary outcomes will be the number of tested and treated individuals and the secondary outcomes will include individuals lost at each step in the cascade of care. Descriptive analysis and multivariable logistic regression of the data will be undertaken.
Ethics and Dissemination: The Hospital Clínic Barcelona, Spain, Ethics Committee approved this study on 18 February 2021 (HCB/2020/2018). Findings will be disseminated through peer-reviewed publications, conference presentations and social media. The results of this study could provide a model for targeting PWUD for HCV testing and treatment in the rest of Spain and in other settings, helping to achieve the WHO HCV elimination goal.
Competing Interests: Competing interests: JVL reports grants, personal fees, and other from AbbVie and Gilead Sciences, personal fees from CEPHEID, GSK, Intercept and Janssen, and grants and personal fees from MSD, outside the submitted work. MB reports advisory fees from Gilead Sciences, Abbvie, GlaxoSmithKline and Assembly Biosciences and speaker fees from Gilead Sciences and Abbvie, outside of the submitted work. AV, AH, CAP, MV-R, AR, JMA, AM, AP, ET and FB have no competing interest to declare.
(© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)