MIGrant Reflex Test HDV (MIGRED) Project
NCT Number: NCT06539052
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Hepatitis D Virus Infection
Interventions: DIAGNOSTIC_TEST: anti-HDV positive with the reflex testing methodology
Sponsor: University of Campania "Luigi Vanvitelli"
Collaborators: Gilead Sciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-12-20
Completion Date: 2026-12-20

Summary:
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.

Primary Outcome Measures: Number of anti-Delta-positive subjects connected to tertiary services., Clinical recording of referrals and confirmation of successful connection through digital medical records, 1 month|Detection rate of HDV RNA., quantitative Test RT-PCR (Reverse Transcription Polymerase Chain Reaction)., 1 month|Number of subjects evaluated for therapy., Clinical patient records and standardized medical assessments, 1 month|Prevalence of anti-Delta positivity in different demographic categories., Demographic questionnaires, 1 month|Distribution of clinical (e.g., ALT/AST levels, liver fibrosis) features based on anti-Delta positivity., Measuring instrument: Standardized laboratory tests (blood tests, virological tests) and diagnostic tools (ultrasounds, fibroscans)., 1 month|Assessment of virological (e.g., HBV viral load) features, This outcome measure will assess HBV viral load in anti-Delta positive subjects and how it varies with HDV-RNA positivity. HBV viral load will be quantified using specific and standardized virological tests.

Measurement tool: Laboratory testing for HBV viral load, such as polymerase chain reaction (PCR) quantification.

Data aggregation: Viral load data will be aggregated and presented as mean viral load, median, and distribution of viral loads in HDV-RNA positive subjects. Descriptive statistics will include minimum, maximum, means, and standard deviations, 1 month|Number of HBsAg positive subjects who are also HIV Ab positive and/or HCV Ab positive., Enzyme-Linked Immunosorbent Assay (ELISA) test for HIV Ab and HCV Ab., 1 month|Distribution of demographic characteristics (age, sex, geographical origin), This measure will assess how demographic characteristics (age, sex, geographic origin) are distributed among anti-Delta positive subjects based on HDV-RNA positivity.

* Measurement tool: Demographic questionnaires completed by participants.
* Data aggregation: Data will be aggregated by age, gender, and geographic origin, and presented in frequency tables and descriptive statistics., 1 month|Distribution of Virological Features, This measure will assess how virological features (e.g., HBV and HDV viral load) are distributed among anti-Delta positive subjects based on HDV-RNA positivity.

* Measurement tool: Laboratory testing for HDV-RNA using RT-PCR (Reverse Transcription Polymerase Chain Reaction) and virological tests for HBV viral load.
* Data Aggregation: Data will be aggregated by viral load and presented in frequency tables and descriptive statistics., 1 month|Distribution of clinical features, This measure will assess how clinical features (e.g., ALT/AST levels, liver fibrosis) are distributed among anti-Delta positive subjects based on HDV-RNA positivity.

* Measurement Tool: Standardized clinical examinations, including blood tests for ALT/AST levels and liver fibrosis assessments via fibroscan.
* Data aggregation: Data will be aggregated for each clinical parameter and presented in frequency tables and descriptive statistics., 1 month