4 Microbiology Department, Clinical Laboratory North Metropolitan Area, Hospital Universitari Germans Trias i Pujol. Department of Genetics and Microbiology, Autonomous University of Barcelona, Badalona, Spain
Maria Antònia Llopis
11 Clinical Laboratories Corporate Manager, Catalan Institute of Health (ICS), Barcelona, Spain
Laura Calatayud
5 Microbiology Department, Hospital Universitari de Bellvitge, Barcelona, Spain
Adriana Palom
1 Liver Unit, Hospital Universitari Vall d’Hebron, Barcelona, Spain
Ariadna Rando-Segura
2 Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
Alicia Sellés-Sánchez
6 Molecular Biology Department, Clinical Laboratory ICS Camp de Tarragona-Terres de l`Ebre Hospital Universitari Joan XXIII de Tarragona, Tarragona, Spain
Saray Mormeneo Bayo
8 Microbiology Department, Hospital Universitari Arnau de Vilanova, Lleida, Spain
Maria Mar Olga Perez Moreno
9 Microbiology Department, Hospital Universitari Verge de la Cinta de Tortosa, Tortosa, Spain
David Tabernero
2 Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
Josefina Ayats
10 Microbiology Area of the Clinical Laboratories Directorate, Catalan Institute of Health (ICS), Barcelona, Spain
Juan Carlos Quer
12 Gastroenterology Department, Hospital Universitari Joan XXIII de Tarragona, Universitat Rovira i Virgili, Tarragona, Spain
Introduction Hepatitis B virus (HBV) affects 296 million people globally, causing 780 000 annual deaths. It has been estimated that 12–43 million individuals are co-infected with hepatitis D virus (HDV). In Spain, the prevalence of HBsAg in adults is 0.22%, with an anti-HDV prevalence of 7.7%, although not extensively documented since many HBsAg-positive cases are not tested for anti-HDV. The primary objective of this project is to optimise hepatitis D care by implementing a screening programme for anti-HDV in all HBsAg-positive individuals over a 1 year period in Catalonia. Secondary objectives include evaluating hepatitis D prevalence, establishing a digital registry for all anti-HDV positive cases, testing them for HDV-RNA in a centralised laboratory and offering linkage to care.Methods and analysis This prospective study will be performed in seven hospital centres in Catalonia, which attend to more than 95% of the adult population. Approximately, 9290 HBsAg-positive individuals are expected to be screened for anti-HDV in 1 year. All anti-HDV positive samples will be sent to a centralised laboratory for HDV-RNA quantification. All individuals testing positive for anti-HDV will be registered on an electronic platform and linked to care. The registry will collect data on demographics, infection stage, risk factors, disease awareness and previous diagnoses. No additional interventions will be conducted for those with adequate follow-up.Ethics and dissemination The Vall d’Hebron Hospital Ethics Committee (PR(AG)628/2023) and the Spanish Agency of Medicines and Medical Devices approved this study. These findings will be disseminated through peer-reviewed publications and conference presentations.Trial registration study Grant number: IN-ES-980–7058.
