MIGrant Reflex Test HDV (MIGRED) Project
ConditionHepatitis D Virus Infection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Campania Luigi Vanvitelli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All migrants, documents or undocumented migrants, and low-income refugees belonging to the infectious disease centers of the university centers participating in the project will be enrolled. aged > 18 years subjects who have given informed consent to carry out blood sampling and for the collection of epidemiological data
Disqualifiers
all migrants < 18 years of age who have not given informed consent for the collection of the blood sample and/or epidemiological data.
Trial population
HDV reflex testing is already performed in specific regions (Spain, France, Brazil, Sweden, Canada), but not at the national level. There are few data on the applicability of this methodology in migrants coming from HDV endemic areas therefore we think that testing this model in this population is useful. The diagnosis and treatment of HDV infection in migrants will reduce the circulation of HDV in low endemic regions such as our region. The follow up of subjects with HDV infection and the reduction in the rate of new infections among migrants, will reduce the number of people who will present complications related to HDV infection, such as decompensated liver cirrhosis and hepatocellular carcinoma. All this will determine benefits to the Italian public health system.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
anti-HDV positive with the reflex testing methodology
Diagnostic testRate of screening for HBsAg in all migrants attending to one of the center participating to the project rate of screening for anti-Delta in all HBsAg patients identified rate of anti-Delta-positivity in HBsAg-positive subjects rate of linkage-to-care at one of the infectious disease center participating to the project rate of HDV-RNA testing in all anti-Delta positive subjects rate of treatment for HDV in all HDV-RNA-positive subjects Rate of screening for HIV Ab in all migrants attending to one of the center participating to the project Rate of screening for HCV Ab in all migrants attending to one of the center participating to the project.
Treatment groups
7,500 Participants
are divided into 1 treatment groupGroup A: migrants1 intervention
Trial outcomes
Primary outcomes
1
Number of anti-Delta-positive subjects connected to tertiary services.
Clinical recording of referrals and confirmation of successful connection through digital medical records
Time frame
1 month2
Detection rate of HDV RNA.
quantitative Test RT-PCR (Reverse Transcription Polymerase Chain Reaction).
Time frame
1 month3
Number of subjects evaluated for therapy.
Clinical patient records and standardized medical assessments
Time frame
1 month4
Prevalence of anti-Delta positivity in different demographic categories.
Demographic questionnaires
Time frame
1 monthLocations
Sponsors and contacts
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University of Campania Luigi Vanvitelli
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: