AWARE.HIV Europe: supporting hospital teams to find undiagnosed HIV across Europe

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This stepped-wedge cluster randomized trial introduces dedicated hospital HIV teams sequentially across ten European countries, allowing each hospital to act as its own control as it moves from routine care to the intervention. Patient-level testing and outcome data are collected retrospectively from routine records, while healthcare professional-level data are gathered prospectively. The intervention package includes surveillance, audit and feedback, education and training, linkage to prevention services, stigma-reduction activities, and IT support to flag HIV indicator conditions. Comparison of HIV testing rates and linkage outcomes before and after implementation across diverse hospital settings will measure both effectiveness and implementation outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• European hospital of Marseille
  Marseille, France Recruiting
• St. Joseph Krankenhaus Berlin Tempelhof
  Berlin, Germany Recruiting
• Charité Universitätsmedizin Berlin
  Berlin, Germany Recruiting
• Cologne University Hospital
  Cologne, Germany Recruiting
• Klinikum der Technischen Universität München (TUM)
  München, Germany Recruiting
• Ospedale San Raffaele S.r.l
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Casper Rokx, Infectiologist, associate prof — Erasmus Medical Center
• Study coordinator: Klaske J Vliegenthart-Jongbloed, Internist-Infectiologist, DTMH
• Email: k.vliegenthart-jongbloed@erasmusmc.nl
• Phone: 0031648382045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.