Community Screening and Management of Hepatitis B, C and Delta in the Mongolian Population Living in France

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorHospices Civils de Lyon

About this trial

In Mongolia, mortality from hepatocellular carcinoma (HCC) is one of the highest in the world. Viral hepatitis is the main cause of HCC: the prevalence of hepatitis B (HBV) estimated at 11% In Mongolia, hepatitis C (HCV) at 8.5%, and hepatitis Delta (HDV) at 40-60% in HBV-infected patients. Viral hepatitis are essentially asymptomatic and therefore require systematic screening for diagnosis. Once a diagnosis of chronic viral infection has been established, specific therapies are available to reduce the morbidity and mortality of these patients. A study carried out in California in the Mongolian community found an HBV prevalence of 9.7% and positive HDV serology in 41% of these patients.

There is a large Mongolian community in France, estimated at between 5,000 and 6,000 patients. Although the majority of these patients are covered by French social security; however, access to care and screening for viral hepatitis often remain difficult and insufficient for migrant or vulnerable populations in France The aim of this study is to screen the Mongolian community in France for viral hepatitis, and then initiate a program of care and treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Mongolian people

Over 15 years of age

Living in France

Majors agree to participate or minors whose parental guardians agree to their child's participation in the study

Disqualifiers

People already followed for viral hepatitis, treated or not treated

Persons deprived of their liberty by a judicial or administrative decision

Adults subject to a legal protection measure (guardianship, curators)

People participate in any interventional research except routine care research (old regulation) and category 2 research that does not interfere with the primary endpoint analysis

Trial design

Design model

Single group

Treatments tested in this trial

  • Community screening for hepatitis B, C and delta in the Mongolian population living in France

    Diagnostic test

    Screening will be organised in 11 centres in France, with 1 to 3 screening sessions per centre: patients will be informed of these screening sessions by the Mongolian Embassy in France, social networks and communities. During this screening visit, Rapid Diagnostic Orientation Test (RDOT) will be carried out to screen for HBV and HCV. If the RDOT is negative for both viruses, an information on transmission and prevention of viral infection will be given. If the RDOT is positive, confirmation of these tests by blood sampling will be organized and complementary biology (ASAT, ALAT, GGT, PAL, bilirubin total, bilirubin conjugated). If HBV RDOT positive, additional tubes will be collected for centralized analysis at the end of the study (VHD DNA, VHD genotyping, fibrotest and LCR1/2 test). Once these confirmatory tests have been carried out, the patient will be referred to a hepatology consultation.

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Screening groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients positive for hepatitis B, hepatitis C and hepatitis D.

Number of patients with positive HBsAg (for HBV), positive serum HCV viral load (for HCV) and serum positive Delta viral load (for HDV) compared with all patients screened.

Time frame
Visit 2 (Day 0 to Mounth 4)

Secondary outcomes

1

Cascade of care for this screening strategy

Number of people tested positive for HBV, HCV or HDV who had a serological test, virological and elastometric evaluation, and hepatology consultation

Time frame
12 months after positive TROD screening
2

Information on preventing viral hepatitis

Number of Mongolian people attending the information and prevention session offered on each screening day

Time frame
Baseline
3

Characterisation of liver fibrosis in patients with chronic viral hepatitis

Evaluation of hepatic fibrosis using biological test by FibroTest

Time frame
Day 1 or up to 4 months
4

Characterisation of liver fibrosis in patients with chronic viral hepatitis

Evaluation of hepatic fibrosis using elastometry and biological test by FibroTest

Time frame
Liver fibrosis will be assessed by elastometry and a FibroTest blood test, carried out according to the procedures of each centre, either during screening or at the specialist consultation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: