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#AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.

RecruitingNAAges 18 Years - anyAllCasper Rokx
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In plain words

What the trial is, and whether it could suit you

The #aware.hiv Europe study is a real-world, multicenter, stepped-wedge cluster randomized, effectiveness-implementation trial designed to evaluate whether the introduction of dedicated HIV teams in hospitals can improve HIV testing rates among patients presenting with HIV indicator conditions across ten European countries. Study Design: The study employs a stepped-wedge design, whereby clusters of hospitals transition sequentially from a control phase (routine care) to an intervention phase. All patient data are collected retrospectively from routine care, while prospective data are gathered at the healthcare professional level. The project spans four years and involves hospitals from the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. This design allows for comparison of HIV testing rates and related outcomes before and after the imp

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📋 Eligibility rules (as published)
Since this study involves screening individuals presenting to a specific hospital through a hospital-wide intervention, the inclusion and exclusion criteria are established at the hospital level. Inclusion Criteria: 1. Standard of care: HIV testing for HIV indicator conditions should be part of routine care in the country, and any prevailing guidelines on HIV testing and prevention policies can be integrated. 2. Management approval: Hospital management must be willing to allocate resources and provide authorization for the proposed activities, including Surveillance, Audit \& Feedback, Education \& Training, Linkage to Prevention, and fostering an Enabling Environment, including stigma reduction. 3. Resources: Assembling an HIV team led by a local HIV expert should be viable considering the available human resources. 4. Data collection: There should be an IT specialist and IT infrastructure capable of flagging a pre-defined set of HIV indicator conditions and monitoring the project's implementation effects with feedback loops to healthcare professionals. 5. Quality assurance: Continuous linkage for care and access to antiretroviral therapy must be assured. 6. Ethics and Regulatory Compliance: Provision for ethical and regulatory compliance is necessary. Exclusion Criteria: Any hospital that does not meet the inclusion criteria will be excluded from participation. We will not use data of patients who have objected against the use of their data for research.
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What it tests

  • HIV team implementation
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Where

28 sites
University Hospital Ghent
Ghent, Belgium
European hospital of Marseille
Marseille, France
St. Joseph Krankenhaus Berlin Tempelhof
Berlin, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
Cologne University Hospital
Cologne, Germany
Klinikum der Technischen Universität München (TUM)
München, Germany
Ospedale San Raffaele S.r.l
Milan, Italy
L'Istituto Nazionale per le Malattie Infettive "L. Spallanzani" IRCCS
Roma, Italy

…and 20 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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