{ "abstract": "Introduction: Across Europe, many people with HIV are diagnosed late despite repeated contact with hospital services for HIV indicator conditions. These conditions flag a possible underlying HIV infection for which HIV testing is recommended. They provide an opportunity to identify people with HIV, yet implementation of indicator condition-based testing remains insufficient in hospital practice. The #aware.hiv Europe study was developed to address this gap by embedding HIV teams into routine care to normalise HIV testing.\n\nMethods and analysis: #aware.hiv Europe is a stepped-wedge cluster randomised trial in 30 hospitals across ten European countries. Five clusters of six hospitals each will sequentially transition from control to implementation periods when local HIV teams led by an infectious diseases specialist will be installed. Intervention activities include hospital-wide peer audit and feedback on missed testing opportunities, targeted education, stigma reduction activities and strengthening of linkage to HIV prevention and care. Patients with predefined HIV indicator conditions are identified using International Classification of Diseases, 10th Revision (ICD-10) diagnosis codes, confirmed through manual review.\n\nThe primary outcome is the change in HIV testing rate among patients with confirmed HIV indicator conditions. Secondary outcomes include HIV case detection, cascades of diagnosis, care and prevention, variation in testing practices, healthcare professional knowledge and stigma, and implementation outcomes. Analyses will use mixed effects regression models accounting for clustering and time within the stepped-wedge design.\n\nEthics and dissemination: The study has ethical approval in all hospitals to use routinely collected clinical data under exemption from informed consent for patient level data. Results will be disseminated through peer reviewed publications, conferences and collaboration with clinical and community partners with the goal to inform HIV testing policies.\n\nTrial registration number: NCT06900829 .", "abstract_shown": true, "affiliations": [ "Internal Medicine, Section Infectious Diseases, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands", "Department of Medical Microbiology and Infectious Diseases, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands", "Department of Infectious Diseases I, University of Medicine and Pharmacy Carol Davila Bucharest, Bucharest, Romania", "National Institute of Infectious Diseases Prof Dr Matei Bals, Bucharest, Romania", "Department of Adults’ Infectious Diseases, Hospital for Infectious Diseases, University Clinical Center of the Medical University of Warsaw, Warsaw, Poland", "Doctoral school, Medical University of Warsaw Faculty of Medicine, Warsaw, Poland", "Department of Internal Medicine, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands", "Department of HIV Medicine, Royal Free Hospital, London, UK", "Institute for Global Health, University College London, London, UK", "HIV and infectious diseases section, department of Internal Medicine, Hospital Universitario La Paz, Madrid, Spain", "Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, CIBERINFEC, Madrid, Spain", "Clinic of Infectious Diseases, San Raffaele Hospital, Milano, Italy", "IRCCS Ospedale San Raffaele, Milan, Italy", "European Hospital Marseille, Marseille, France", "Department of Internal Medicine, University Hospital Ghent, Gent, Belgium", "Astar Medical Center, Lviv, Ukraine", "TUM School of Medicine and Health - Clinical Department of Internal Medicine II, TUM, Munich, Germany", "Bow and Arrows Studios, Rotterdam, The Netherlands", "Department of Infectious Diseases I, Faculty of Medicine, University of Medicine and Pharmacy Carol Davila Bucharest, Bucharest, Romania", "Epidemiology and Biostatistics, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands", "Public Health, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands", "Department of Pathology & Clinical Bioinformatics, Erasmus MC University Medical Center Rotterdam, Rotterdam, The Netherlands", "Department of Health Promotion & Care and Public Health Research Institute, Maastricht University Care and Public Health Research Institute, Maastricht, The Netherlands", "University of Medicine and Pharmacy Carol Davila Bucharest, Bucharest, Romania" ], "article_type": null, "arxiv": null, "author_total": 24, "authors": [ { "affs": [ 0, 1 ], "name": "Klaske J Vliegenthart-Jongbloed", "orcid": "0009-0007-1603-5223" }, { "affs": [ 2, 3 ], "name": "Oana Mihaela Inescu", "orcid": "0009-0009-7057-9912" }, { "affs": [ 4, 5 ], "name": "Filip Fijołek" }, { "affs": [ 1, 6 ], "name": "Isabella Pepe Razzolini", "orcid": "0009-0006-5040-446X" }, { "affs": [ 7, 8 ], "name": "Tristan J Barber" }, { "affs": [ 9, 10 ], "name": "José I Bernardino", "orcid": "0000-0003-3501-8529" }, { "affs": [ 11, 12 ], "name": "Silvia Nozza", "orcid": "0000-0002-2673-2731" }, { "affs": [ 13 ], "name": "Christina K Psomas", "orcid": "0000-0002-9811-1213" }, { "affs": [ 14 ], "name": "Marie-Angélique De Scheerder" }, { "affs": [ 6, 15 ], "name": "Marta Vasylyev" }, { "affs": [ 16 ], "name": "Florian Voit", "orcid": "0000-0002-6957-6628" }, { "affs": [ 1 ], "name": "Carlijn C E Jordans" }, { "affs": [ 17 ], "name": "Rens Willemsen" }, { "affs": [ 6 ], "name": "Marianne D van Wingerden" }, { "affs": [ 4 ], "name": "Carlo Bieńkowski", "orcid": "0000-0002-6488-4576" }, { "affs": [ 3, 18 ], "name": "Victor D Miron" }, { "affs": [ 1, 6 ], "name": "Anna-Karina Felder", "orcid": "0000-0002-8895-9798" }, { "affs": [ 19 ], "name": "Bettina E Hansen" }, { "affs": [ 20 ], "name": "Jan A C Hontelez", "orcid": "0000-0002-9323-7861" }, { "affs": [ 21 ], "name": "Yunlei Li", "orcid": "0000-0002-5697-1602" }, { "affs": [ 22 ], "name": "Sarah E Stutterheim" }, { "affs": [ 4 ], "name": "Agata Skrzat-Klapaczyńska", "orcid": "0000-0002-6367-5633" }, { "affs": [ 3, 18 ], "name": "Oana Săndulescu", "orcid": "0000-0002-2586-4070" }, { "affs": [ 0, 1, 23 ], "name": "Casper Rokx", "orcid": "0000-0002-1904-6450" } ], "bibtex": "https://research.draconitic.com/paper/bxayakjxnmk12.bib", "cited_by": 0, "doi": "10.1136/bmjopen-2026-121377", "fulltext_url": null, "id": "bxayakjxnmk12", "issns": [ "2044-6055", "2044-6055" ], "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121377", "language": null, "licence": "CC-BY-NC-4.0", "licence_label": "CC BY-NC 4.0", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/", "metadata_licence": null, "native_subjects": [ [ "openalex", "2725|HIV/AIDS Research and Interventions" ] ], "openalex": "W7220742257", "pdf_url": null, "pmcid": null, "pmid": null, "published": "2026-10-06", "publisher": "BMJ", "ris": "https://research.draconitic.com/paper/bxayakjxnmk12.ris", "sources": [ { "first_seen": "2026-10-30T12:19:44Z", "native_id": "10.1136/bmjopen-2026-121377", "source": "crossref", "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121377" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2725|HIV/AIDS Research and Interventions", "subfield": "infectious-disease" } ], "title": "#aware.hiv Europe study: protocol for a stepped-wedge cluster randomised trial of a multimodal hospital-based implementation strategy targeting HIV indicator-condition-guided testing in European hospitals", "title_text": "#aware.hiv Europe study: protocol for a stepped-wedge cluster randomised trial of a multimodal hospital-based implementation strategy targeting HIV indicator-condition-guided testing in European hospitals", "type": "peer-reviewed", "updated_at": "2026-10-30T12:19:44Z", "url": "https://research.draconitic.com/paper/bxayakjxnmk12", "venue": "BMJ Open", "versions": [] }