The #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.

IntroductionAcross 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 6 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 disseminationThe 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 registrationClinicalTrials.gov NCT06900829. https://clinicaltrials.gov/study/NCT06900829 Strengths and limitations of this study+ Large, multinational, real-world, stepped-wedge, cluster randomized trial design. + Primary outcome derived from routinely collected clinical data, using a GDPR- and GCP-compliant approach with exemption from informed consent. + Hospital-wide intervention targeting care professionals, delivered through proactive expert HIV teams across departments powered to conclude on hard HIV care cascade clinical endpoints and stigma reducing interventions. + Implementation science design informed by established frameworks (CFIR and RE-AIM) to strengthen cross-continental generalisability. - Variation in healthcare systems and baseline testing practices across countries may contribute to heterogeneity in implementation and outcomes. - Despite standardised SOPs, local clinical judgement influences the assessment of HIV indicator conditions.