#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

@article{vliegenthartjongbloed2026awarehiv,
  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}},
  author = {Klaske J Vliegenthart-Jongbloed and Oana Mihaela Inescu and Filip Fijołek and Isabella Pepe Razzolini and Tristan J Barber and José I Bernardino and Silvia Nozza and Christina K Psomas and Marie-Angélique De Scheerder and Marta Vasylyev and Florian Voit and Carlijn C E Jordans and Rens Willemsen and Marianne D van Wingerden and Carlo Bieńkowski and Victor D Miron and Anna-Karina Felder and Bettina E Hansen and Jan A C Hontelez and Yunlei Li and Sarah E Stutterheim and Agata Skrzat-Klapaczyńska and Oana Săndulescu and Casper Rokx},
  journal = {BMJ Open},
  year = {2026},
  month = oct,
  doi = {10.1136/bmjopen-2026-121377},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121377},
  note = {CC BY-NC 4.0},
}

TY  - JOUR
TI  - #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
AU  - Klaske J Vliegenthart-Jongbloed
AU  - Oana Mihaela Inescu
AU  - Filip Fijołek
AU  - Isabella Pepe Razzolini
AU  - Tristan J Barber
AU  - José I Bernardino
AU  - Silvia Nozza
AU  - Christina K Psomas
AU  - Marie-Angélique De Scheerder
AU  - Marta Vasylyev
AU  - Florian Voit
AU  - Carlijn C E Jordans
AU  - Rens Willemsen
AU  - Marianne D van Wingerden
AU  - Carlo Bieńkowski
AU  - Victor D Miron
AU  - Anna-Karina Felder
AU  - Bettina E Hansen
AU  - Jan A C Hontelez
AU  - Yunlei Li
AU  - Sarah E Stutterheim
AU  - Agata Skrzat-Klapaczyńska
AU  - Oana Săndulescu
AU  - Casper Rokx
PY  - 2026
DA  - 2026/10/06
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-121377
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-121377
AB  - 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.  Methods 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.  The 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.  Ethics 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.  Trial registration number: NCT06900829 .
SN  - 2044-6055
SN  - 2044-6055
ER  -