RecruitingNAINTERVENTIONAL

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

This European study, called #AWARE.HIV, is exploring if having special HIV teams in hospitals can help more people get tested for HIV, especially when they have certain health conditions that might suggest HIV infection. The teams will look at patient records, remind doctors about testing, educate staff, and make it easier to get tested. By doing this, researchers hope to find HIV earlier, reduce stigma, and improve patient care and prevention. This project involves hospitals in ten European countries, comparing testing rates before and after these teams are introduced to see how effective they are in real hospital settings.

At a glance

Status

Recruiting

Phase

Sponsor

Casper Rokx

Enrolment target

5,200

Start

01 Oct 2025

Estimated completion

01 Feb 2030

HIV Infection HIV Stigma Education Prevention of Infection With HIV-1 Electronic Health Records

What is this study about?

The #AWARE.HIV Europe study is looking into a really important question: can dedicated teams in hospitals help more people get diagnosed with HIV earlier? Sometimes, people come to the hospital with health problems that can be warning signs of HIV, but they might not get tested. This study involves hospitals across ten different European countries to see if having a special team focused on HIV can change that.

These HIV teams, made up of specialists like doctors and nurses, will work within the hospital. Their job is to regularly check patient records for those warning signs (called 'HIV indicator conditions'). If a patient has one of these conditions but hasn't been tested for HIV, the team will gently remind the treating doctor that a test might be a good idea. They will also provide training to other healthcare staff to improve their understanding of HIV, reduce any stigma, and make the whole testing process smoother. The goal is to make sure that if you have a health condition that could be related to HIV, testing becomes a routine part of your care, leading to faster diagnosis and better health outcomes.

Ultimately, by introducing these teams and seeing how well they work, the study hopes to improve how HIV is found and managed in hospitals. Earlier diagnosis means people can start treatment sooner, which is good for their health and also helps prevent the spread of HIV. The findings from this study could help shape future healthcare guidelines, ensuring that more people get access to timely HIV testing and care.

Key takeaways

A study to improve HIV testing rates in European hospitals.
Special hospital teams will help identify and prompt HIV testing.
Aims for earlier HIV diagnosis and better patient care.
No direct patient participation; focuses on hospital-level changes.
Could lead to new guidelines for HIV testing in hospitals.
Ultimately aims to reduce HIV-related illness and deaths.

Who may be eligible?

This study isn't about inviting individual patients to take part directly. Instead, it's about how hospitals change their approach to HIV testing. So, the 'eligibility' refers to the hospitals themselves.

For a hospital to be included in the study, it needs to already follow healthcare guidelines that suggest HIV testing for certain conditions. The hospital management must also agree to set up an HIV team and provide the necessary resources, like staff and computer systems. They need to be able to safely store patient information and have ethical approval in place for the project.

Any hospital that can't meet these requirements won't be part of the study. Also, if a patient has clearly said they don't want their health information used for research, their data will not be included in the study.

Quick self-check

Are you a patient in a participating hospital in Europe?
Do you have a health condition that your doctor might link to HIV?
Is your hospital set up to ethically review patient data?
Does your hospital have an HIV specialist who could lead a team?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

As an individual patient, you wouldn't directly 'participate' in this study in the usual sense, meaning you won't be asked to visit a clinic or take new medication specifically for the study. Instead, the study is about how your local hospital practices HIV testing if it's one of the hospitals involved. The HIV team in your hospital would review routine electronic health records. If you have what's called an 'HIV indicator condition' (a health problem that might suggest HIV) and haven't been tested, the team might prompt your doctor to offer you an HIV test. Any testing offered would be part of your usual medical care, guided by your doctor, not a research procedure. You would always have the right to accept or decline any medical test offered to you. The project spans four years in the participating hospitals.

Potential risks and benefits

There are no direct risks to individual patients from participating in this study, as it primarily involves changes to hospital procedures and data review, not experimental treatments. The potential benefit is that if you have an HIV indicator condition, your doctor might be more likely to offer you an HIV test, potentially leading to an earlier HIV diagnosis if you have it. Earlier diagnosis means you can start treatment sooner, which is very good for your long-term health and helps prevent further transmission. You always have the right to accept or decline any medical test, including an HIV test, offered as part of your care.

Locations (28)

University Hospital Ghent
Ghent, Belgium· Not yet recruiting
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
L'Istituto Nazionale per le Malattie Infettive "L. Spallanzani" IRCCS
Roma, Italy· Recruiting
Rijnstate ziekenhuis
Arnhem, Netherlands· Recruiting
Stichting Catharina Ziekenhuis
Eindhoven, Netherlands· Recruiting
University Medical Center Groningen
Groningen, Netherlands· Recruiting
Stichting Maasstad Ziekenhuis
Rotterdam, Netherlands· Recruiting

+16 more sites — see the official record for the full list.

Common questions

What is an 'HIV indicator condition'?

These are certain health problems or symptoms that can sometimes be early signs of HIV infection, making an HIV test a sensible step.

Will I be directly involved in this study?

No, this study looks at how hospitals change their practices, not individual patients. You won't be asked to do anything extra for the study.

Does this mean I have HIV if my doctor offers a test?

Not at all. Your doctor might offer an HIV test as a routine check if you have a condition that makes it a good idea, just to be thorough and ensure you get the best care.

What happens if a hospital finds HIV through this project?

If someone is diagnosed with HIV, they will be linked to care and treatment services quickly, following standard medical guidelines.

Which hospitals are taking part?

Hospitals from ten European countries, including the UK, are involved. Specific hospitals aren't named to protect privacy.

How to find out more

Klaske J Vliegenthart-Jongbloed, Internist-Infectiologist, DTMH

k.vliegenthart-jongbloed@erasmusmc.nl 0031648382045 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.