#AWARE.HIV Europe: Evaluating Hospital HIV Teams to Improve Testing
and Early Diagnosis in Patients with HIV Indicator Conditions Across Europe
Led by Casper Rokx · Updated on 2026-03-12
5200
Participants Needed
28
Research Sites
226 weeks
Total Duration
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C
Casper Rokx
Lead Sponsor
V
ViiV Healthcare
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether the introduction of dedicated hospital-based HIV teams can improve HIV testing rates among patients with HIV indicator conditions across ten European countries. This real-world, multicenter, stepped-wedge cluster randomized effectiveness-implementation trial spans four years and involves hospitals in the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. The study aims to address the current gap in HIV testing and improve early diagnosis by comparing testing rates before and after the implementation of HIV teams.
The intervention involves creating local HIV teams led by HIV specialists, supported by nurses and data collectors. These teams focus on auditing and providing feedback to healthcare professionals to encourage HIV testing when indicated, reducing stigma, educating staff on HIV prevention and care, and improving linkage to local prevention services. The HIV teams use electronic health records to identify patients with HIV indicator conditions and integrate their activities into routine hospital care.
Participants' data are collected retrospectively from routine care and prospectively at the healthcare professional level. Researchers measure changes in HIV testing rates, new HIV diagnoses, and variations across countries and specialties. They also assess the HIV diagnosis and care cascade, healthcare professionals' knowledge and stigma levels, and implementation outcomes such as resource use and cost-effectiveness. Monitoring includes feedback loops and evaluation of barriers and facilitators to implementation, aiming to improve HIV testing and care sustainability in hospitals.
CONDITIONS
Official Title
#AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
HIV testing for HIV indicator conditions should be part of routine care in the country
Hospital management must approve and allocate resources for HIV team activities
A local HIV expert must be available to lead the HIV team
IT specialist and infrastructure must be available to flag HIV indicator conditions and monitor implementation
Continuous linkage for care and access to antiretroviral therapy must be assured
Ethical and regulatory compliance must be ensured
You will not qualify if you...
Hospitals not meeting the inclusion criteria will be excluded
Data from patients who object to the use of their data for research will not be used
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Trial Site Locations
Total: 28 locations
1
University Hospital Ghent
Ghent, Belgium
Not Yet Recruiting
2
European hospital of Marseille
Marseille, France, 13003
Actively Recruiting
3
St. Joseph Krankenhaus Berlin Tempelhof
Berlin, Germany, 12101
Actively Recruiting
4
Charité Universitätsmedizin Berlin
Berlin, Germany, 13353
Actively Recruiting
5
Cologne University Hospital
Cologne, Germany, 50937
Actively Recruiting
6
Klinikum der Technischen Universität München (TUM)
München, Germany, 81675
Actively Recruiting
7
Ospedale San Raffaele S.r.l
Milan, Italy
Actively Recruiting
8
L'Istituto Nazionale per le Malattie Infettive "L. Spallanzani" IRCCS
Roma, Italy, 00149
Actively Recruiting
9
Rijnstate ziekenhuis
Arnhem, Netherlands
Actively Recruiting
10
Stichting Catharina Ziekenhuis
Eindhoven, Netherlands, 5623EJ
Actively Recruiting
11
University Medical Center Groningen
Groningen, Netherlands, 9713GZ
Actively Recruiting
12
Stichting Maasstad Ziekenhuis
Rotterdam, Netherlands, 3079DZ
Actively Recruiting
13
Haga Ziekenhuis
The Hague, Netherlands
Actively Recruiting
14
SPZZOZ Janów Lubelski
Janów Lubelski, Poland, 23-300
Actively Recruiting
15
Wojewodzki Szpital Zespolony
Kielce, Poland, 25-736
Actively Recruiting
16
Państwowy Instytut Medyczny MSWiA w Warszawie
Warsaw, Poland, 02-507
Actively Recruiting
17
Central Military Emergency University Hospital "Dr. Carol Davila"
Bucharest, Romania, 010825
Actively Recruiting
18
Clinical Emergency Hospital "Prof. Dr. Agrippa Ionescu"
Bucharest, Romania, 011356
Actively Recruiting
19
National Institute for Infectious Diseases "Prof. Dr. Matei Bals"
Bucharest, Romania, 021105
Actively Recruiting
20
Fundeni Clinical institute
Bucharest, Romania, 022328
Actively Recruiting
21
Spitalul Universitar de Urgență București
Bucharest, Romania, 050098
Actively Recruiting
22
Hospital Universitario La Paz-Carlos III
Madrid, Spain, 28029
Actively Recruiting
23
Infanta Leonor
Madrid, Spain
Actively Recruiting
24
La Princesa
Madrid, Spain
Actively Recruiting
25
Central city clinical hospital of Ivano-Frankivsk city council