protocolSection identificationModule nctId: NCT06264583, orgStudyIdInfo id: IN-DE-980-6998, briefTitle: HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bonn, class: OTHER, collaborators name: Swiss HIV Cohort Study, collaborators name: ICONA Cohort, collaborators name: Amsterdam UMC, collaborators name: Royal Free Hospital NHS Foundation Trust, collaborators name: King's College London, collaborators name: University Hospital of Cologne, collaborators name: Goethe University, collaborators name: Heinrich-Heine University, Duesseldorf, collaborators name: University Hospital, Essen, collaborators name: ICH Hamburg, collaborators name: Praxiszentrum Hohenstaufenring Köln, collaborators name: Sorbonne University, collaborators name: Henri Mondor University Hospital, collaborators name: Hospital Universitario Infanta Leonor, collaborators name: Hospital General Universitario Gregorio Marañon, collaborators name: GEPCOI (Portuguese Group of Coinfection), descriptionModule briefSummary: The aim of this project is to set up a cross-sectional cohort study (France, Germany, The Netherlands, Poland, Spain, Switzerland, Italy, United Kingdom and Portugal) to assess the implementation of EACS guidelines for HDV-testing among PLWH with positive HbsAg and thereby evaluate the prevalence of HDV infection among HIV/HBV-coinfected in 2023, as well as corresponding risk factors. In addition to the testing itself, this study will also set up a cohort and databasee for future HDV studies among PLWH, including clinical, virological und laboratory parameters.1. Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing.   1. Evaluation of former screening of HDV by assessing existing data at study sites.   2. Determination of the HDV prevalence in European PLWH and HBV coinfection.2. Setting up a database of all PLWH with HBV/HDV coinfection   1. Analysis of transmission risk factors for HDV coinfection   2. Asses the rate of HDV positive patients with ongoing HDV replication.   3. Define the liver disease state by APRI score, fibroscan, ultrasound and routine laboratory test results., conditionsModule conditions: Hepatitis D, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 8000, type: ESTIMATED, armsInterventionsModule interventions name: HDV screening, outcomesModule primaryOutcomes measure: HDV prevalence in HIV/HBV coinfection, secondaryOutcomes measure: Degree of liver disease in pateints with HIV/HBV/HDV triple infection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Bonn, city: Bonn, state: NRW, zip: 53127, country: Germany, contacts name: Jürgen Rockstroh, role: CONTACT, phone: +491716575969, email: juergen.rockstroh@ukbonn.de, geoPoint lat: 50.73438, lon: 7.09549, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-10-31, uploadDate: 2024-02-09T03:56, filename: Prot_000.pdf, size: 798649, hasResults: False