Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06900829

#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

On this page

Sponsors

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

Eligible

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
Not Eligible

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

AI-Screening

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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

Ivano-Frankivsk, Ukraine

Actively Recruiting

26

Lviv National Medical University

Lviv, Ukraine, 79010

Actively Recruiting

27

Buckinghamshire Healthcare NHS Trust

Aylesbury, United Kingdom, HP21 8AL

Actively Recruiting

28

Royal Free London

London, United Kingdom, NW3 2QG

Actively Recruiting

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Research Team

K

Klaske J Vliegenthart-Jongbloed, Internist-Infectiologist, DTMH

M

Marianne van Wingerden, Research nurse

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Implementing HIV teams sustainably improves HIV indicator condition testing rates in hospitals in the Netherlands: the #aware.hiv clinical trial.

Carlijn C E Jordans, Klaske Vliegenthart-Jongbloed, Kara K Osbak...

https://pubmed.ncbi.nlm.nih.gov/40053486

Unmasking Individual and Institutional HIV Stigma in Hospitals: Perspectives of Dutch Healthcare Providers.

C C E Jordans, K J Vliegenthart-Jongbloed, A W van Bruggen...

https://pubmed.ncbi.nlm.nih.gov/38869755

Systematic Review: Strategies for Improving HIV Testing and Detection Rates in European Hospitals.

Klaske J Vliegenthart-Jongbloed, Marta Vasylyev, Carlijn C E Jordans...

https://pubmed.ncbi.nlm.nih.gov/38399659