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

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

Not applicable Interventional Erasmus Medical Center · NCT06900829

This project will test whether putting dedicated HIV teams into hospitals increases HIV testing for people who come in with conditions that could suggest HIV across ten European countries.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment5200 (estimated)
Ages18 Years and up
SexAll
SponsorErasmus Medical Center Academic / other
Locations28 sites (Ghent and 27 other locations)
Trial IDNCT06900829 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: People who present to participating hospitals with predefined HIV indicator conditions are the intended focus for offered HIV testing.

Not a fit: People who do not present with indicator conditions, those already diagnosed and linked to care, or attendees of nonparticipating hospitals are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could increase early HIV diagnoses and speed linkage to treatment or prevention services, reducing complications and onward transmission.

How similar studies have performed: Previous regional and single-country programs using indicator-condition testing, audit-and-feedback, and dedicated HIV staff have improved testing rates, but large multicountry stepped-wedge evidence is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Ghent and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIV InfectionHIVStigmaEducationPrevention of Infection With HIV-1Electronic Health Recordshivstigma
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.