MIGrant Reflex Test HDV (MIGRED) Project

Our research team has executed a robust strategy to improve viral hepatitis detection and linkage to care in migrants, contributing to the improvement of knowledge on the clinical and virological future of viral hepatitis in this population difficult to reach and manage. Our hypothesis is that the extension of our model to three other large university clinical centers operating in southern Italy and the use of HDV reflex testing for HBsAg-positive subjects will allow the implementation of knowledge on prevalence of HDV in migrants living in southern Italy and coming from HDV endemic areas. Precisely, the investigators will involve the Department of Infectious Diseases of the University of Bari, that of the University of Catanzaro and that of the University of Palermo with expertise in the management of infectious diseases in the migratory context and with whom the investigators have previously collaborated in other areas. It is expected to enroll at least 7500 patients. The project will last 18 months. Diagnosis and treatment of HDV infection in migrants will reduce the circulation of HDV in low endemic regions such as our region. Follow-up of HDV-infected individuals and reducing the rate of new infections among migrants will reduce the number of people who will experience complications related to HDV infection, such as decompensated liver cirrhosis and carcinoma hepatocellular. All this will determine benefits for the Italian public health system.

NCT Number	NCT06539052
Lead Sponsor	University of Campania Luigi Vanvitelli Collaborators: Gilead Sciences
Conditions	Hepatitis D Virus Infection
Enrollment	7,500 participants
Start Date	2024-12-20
Primary Completion	2026-06-20 (estimated)
Study Completion	2026-12-20 (estimated)
Updated on ClinicalTrials.gov	2024-12-18