Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
7500 participants
OBSERVATIONAL
2024-12-20
2026-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Our research group performed a valid strategy to improve the detection for viral hepatitis and the link to care in migrants, contributing to the improvement of knowledge on clinical and virological futures of viral hepatitis in this population difficult to reach and to manage \[1-3\]. Our hypothesis is that the extension of our model in other three large university clinical centers operating in southern Italy and the use of the HDV reflex testing for HBsAg-positive individuals will allow to implement the knowledge on the HDV prevalence in migrants living in southern Italy and coming from endemic areas for HDV. 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 migrant and with which the investigators previously collaborated in other setting.The investigators performed a retrospective and prospective multicenter project lasting 18 months involving the 4 largest University clinical Centers for Infectious Diseases (ID) in southern Italy:
Departments of ID of the University of Napoli L.Vanvitelli (project coordinator), of the University of Bari, of the University of Catanzaro and of the University Palermo.
At this time they are not involved in any other projects involving screening and linkage to care of HDV infection.
Each of these tertiary center is associated to 1st level clinical centers, that are centers of general practice clinics attended mainly by migrants for low back pain, headache, itching, cough, hypertension and allergy symptoms. These first-level centers are linked with the Italian humanitarian organizations which welcome needy migrants. The organization of these clinics involves the presence of a physhycian expert in the management of infectious diseases in migrants, a nurse and a cultural mediator. This last figure is fundamental in explaining the epidemiological, clinical and collective health reasons that make it necessary to screen for hepatitis viruses which are endemic in their areas of origin.
Screening process All sample of migrants relating to the infectious diseases clinic of the centers participating in the project will be collected.
To improve the rate of enrollment, the physicians, with the help of cultural mediators, will explain to the what are the main sexually and parenterally transmitted infectious diseases endemic in their countries of origin and will be information on the routes of transmission of theses. The information/education will be done through brochures with pictures and explanations translated into English, French and Swahili. The migrants, who agreed to join the project, signed an informed consent written in the immigrant's own language and filled out an anonymous questionnaire administered by the research investigators with the assistance of a cultural mediator on the demographic data, date of immigration, socioeconomic status (level of education), religion, cohabitation details, sexual orientation and practices including condom use, history of HBV vaccination, surgery, dental care, tattooing, body piercing, use of drugs, blood transfusion, tribal rituals, abortion and information on previously documented personal and family infections of HBV, HDV, HCV and HIV. The data relating to the epidemiological characteristics will collected in an electronic database.
A blood sample will be collected. The cultural mediator will support the clinicians and the nurses who will collect the blood sample to ensure that the migrant fully and freely understands the reasons of the screening.
An epidemiological data sheet will be associated with the blood sample. Every center will carry out HBsAg testing on the blood samples collected. The HBsAg positivity will be the trigger to start the HDV reflex testing cascade: in the same blood sample testing positive for HBsAg, anti-HDV will be tested; in cases of anti-HDV positivity the same serum sample will be collected to test HDV RNA.
HDV RNA will be performed at the molecular biology laboratory of the Department of ID of the University of Naples (project coordinator) according to standard methods. Once a month, the samples tested anti-HDV positive with the reflex testing methodology will be carried on dry ice at a controlled temperature to the reference center for the virological tests. For subjects with positive HDV viremia the investigators will proceed for HDV genotyping on the same serum sample.
The same sample will also be tested for HIV and HCV, any positivity will be communicated to the reference.
All HBsAg-positive subjects will be linked to the tertiary centers. The cultural mediator will accompany the migrants testing positive to the screening to stage the liver disease and to start the therapeutic management of subjects with HBV infection and HBV HDV co-infection according to international guidelines.
In the Retrospective phase of the project about 2000 stored samples of migrant enrolled in a previous study will be re-tested for HBsAG, HCV Ab and HIV ab. In the same blood sample testing positive for HBsAg, anti-HDV will be tested; in cases of anti-HDV positivity the same serum sample will be collected to test HDV RNA.
In the regions of southern Italy where the project will take place, that is Campania, Apulia, Calabria and Sicily, approximately 128,000 migrants arrived from January 2023 until September 2023 (https://data2.unhcr.org/en/situations/mediterranean). In consideration of the economic availability of the project the investigators aim to evaluate approximately 7,500 migrants. the investigators hypothesize to enroll 7500 migrants. Of these 7500, the investigators hypothesize that about 4500 have already been screened for HBsAg, HCV Ab, HIV Ab, while 3000 must been screened for these viruses. The project will last 18 months and for all 7500 enrolled migrants will be carried out HBsAg, HIV Ab and HCV Ab screening. Samples positive for HBsAg will be tested for HDV at the same time as the positive result of HBsAg. Considering a prevalence of HBsAg-positivity of 10% in migrant population, the investigators hypothesize to identify 750 HBsAg-positive subjects. Considering that the prevalence of HDV in HBsAg positive subjects in Africa is estimated of approximately 9%, the investigators hypothesize to identify 68 anti-HDV positive subjects.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
migrants
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.
All HBsAg-positive subjects will be linked to the tertiary centers. The cultural mediator will accompany the migrants testing positive to the screening to stage the liver disease and to start the therapeutic management of subjects with HBV infection and HBV HDV co-infection according to international guidelines.
In the Retrospective phase of the project about 2000 stored samples of migrant enrolled in a previous study will be re-tested for HBsAG, HCV Ab and HIV ab. In the same blood sample testing positive for HBsAg, anti-HDV will be tested; in cases of anti-HDV positivity the same serum sample will be collected to test HDV RNA.
anti-HDV positive with the reflex testing methodology
Rate 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
anti-HDV positive with the reflex testing methodology
Rate 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gilead Sciences
INDUSTRY
University of Campania Luigi Vanvitelli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nicola Coppola
Chief of Infectoius Diseases Unit
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicola Coppola, MD
Role: PRINCIPAL_INVESTIGATOR
Università della Campania Luigi Vanvitelli
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Beguelin C, Moradpour D, Sahli R, Suter-Riniker F, Luthi A, Cavassini M, Gunthard HF, Battegay M, Bernasconi E, Schmid P, Calmy A, Braun DL, Furrer H, Rauch A, Wandeler G; Swiss HIV Cohort Study. Hepatitis delta-associated mortality in HIV/HBV-coinfected patients. J Hepatol. 2017 Feb;66(2):297-303. doi: 10.1016/j.jhep.2016.10.007. Epub 2016 Oct 14.
Roulot D, Brichler S, Layese R, BenAbdesselam Z, Zoulim F, Thibault V, Scholtes C, Roche B, Castelnau C, Poynard T, Chazouilleres O, Ganne N, Fontaine H, Gournay J, Guyader D, Le Gal F, Nahon P, Roudot-Thoraval F, Gordien E; Deltavir study group. Origin, HDV genotype and persistent viremia determine outcome and treatment response in patients with chronic hepatitis delta. J Hepatol. 2020 Nov;73(5):1046-1062. doi: 10.1016/j.jhep.2020.06.038. Epub 2020 Jul 4.
Fattovich G, Giustina G, Christensen E, Pantalena M, Zagni I, Realdi G, Schalm SW. Influence of hepatitis delta virus infection on morbidity and mortality in compensated cirrhosis type B. The European Concerted Action on Viral Hepatitis (Eurohep). Gut. 2000 Mar;46(3):420-6. doi: 10.1136/gut.46.3.420.
Romeo R, Del Ninno E, Rumi M, Russo A, Sangiovanni A, de Franchis R, Ronchi G, Colombo M. A 28-year study of the course of hepatitis Delta infection: a risk factor for cirrhosis and hepatocellular carcinoma. Gastroenterology. 2009 May;136(5):1629-38. doi: 10.1053/j.gastro.2009.01.052. Epub 2009 Jan 29.
Stockdale AJ, Kreuels B, Henrion MYR, Giorgi E, Kyomuhangi I, de Martel C, Hutin Y, Geretti AM. The global prevalence of hepatitis D virus infection: Systematic review and meta-analysis. J Hepatol. 2020 Sep;73(3):523-532. doi: 10.1016/j.jhep.2020.04.008. Epub 2020 Apr 23.
Miao Z, Zhang S, Ou X, Li S, Ma Z, Wang W, Peppelenbosch MP, Liu J, Pan Q. Estimating the Global Prevalence, Disease Progression, and Clinical Outcome of Hepatitis Delta Virus Infection. J Infect Dis. 2020 Apr 27;221(10):1677-1687. doi: 10.1093/infdis/jiz633.
Rizzetto M, Ponzetto A, Forzani I. Hepatitis delta virus as a global health problem. Vaccine. 1990 Mar;8 Suppl:S10-4; discussion S21-3. doi: 10.1016/0264-410x(90)90207-3.
Stockdale AJ, Chaponda M, Beloukas A, Phillips RO, Matthews PC, Papadimitropoulos A, King S, Bonnett L, Geretti AM. Prevalence of hepatitis D virus infection in sub-Saharan Africa: a systematic review and meta-analysis. Lancet Glob Health. 2017 Oct;5(10):e992-e1003. doi: 10.1016/S2214-109X(17)30298-X.
Sagnelli E, Stroffolini T, Mele A, Imparato M, Sagnelli C, Coppola N, Almasio PL. Impact of comorbidities on the severity of chronic hepatitis B at presentation. World J Gastroenterol. 2012 Apr 14;18(14):1616-21. doi: 10.3748/wjg.v18.i14.1616.
Sagnelli E, Sagnelli C, Pisaturo M, Macera M, Coppola N. Epidemiology of acute and chronic hepatitis B and delta over the last 5 decades in Italy. World J Gastroenterol. 2014 Jun 28;20(24):7635-43. doi: 10.3748/wjg.v20.i24.7635.
Stroffolini T, Sagnelli E, Sagnelli C, Russello M, De Luca M, Rosina F, Cacopardo B, Brancaccio G, Furlan C, Gaeta GB, Licata A, Almasio PL; behalf of EPACRON study group. Hepatitis delta infection in Italian patients: towards the end of the story? Infection. 2017 Jun;45(3):277-281. doi: 10.1007/s15010-016-0956-1. Epub 2016 Nov 5.
Gaeta GB, Stroffolini T, Smedile A, Niro G, Mele A. Hepatitis delta in Europe: vanishing or refreshing? Hepatology. 2007 Oct;46(4):1312-3. doi: 10.1002/hep.21816. No abstract available.
Sagnelli E, Stroffolini T, Mele A, Imparato M, Almasio PL; Italian Hospitals' Collaborating Group. Chronic hepatitis B in Italy: new features of an old disease--approaching the universal prevalence of hepatitis B e antigen-negative cases and the eradication of hepatitis D infection. Clin Infect Dis. 2008 Jan 1;46(1):110-3. doi: 10.1086/524074.
Sagnelli C, Sagnelli E, Russo A, Pisaturo M, Occhiello L, Coppola N. HBV/HDV Co-Infection: Epidemiological and Clinical Changes, Recent Knowledge and Future Challenges. Life (Basel). 2021 Feb 22;11(2):169. doi: 10.3390/life11020169.
Coppola N, Alessio L, Onorato L, Sagnelli C, Sagnelli E, Pisaturo M. HDV infection in immigrant populations. J Med Virol. 2019 Dec;91(12):2049-2058. doi: 10.1002/jmv.25570. Epub 2019 Aug 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MIGRED
Identifier Type: -
Identifier Source: org_study_id