Actively Recruiting

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

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

Led by Casper Rokx · Updated on 2026-03-12

5200

Participants Needed

28

Research Sites

43 weeks

Total Duration

On this page

Sponsors

C

Casper Rokx

Lead Sponsor

V

ViiV Healthcare

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate whether creating dedicated HIV teams in hospitals across ten European countries can increase HIV testing rates among patients showing signs of HIV-related conditions. The study uses a stepped-wedge design, where hospitals switch from routine care to the new intervention in sequence. This approach compares outcomes before and after the teams are in place, helping to understand the impact of the intervention across various locations and medical specialties. The intervention involves establishing local HIV teams led by specialists and supported by nurses and data experts. These teams identify patients needing HIV tests through electronic health records, provide feedback to doctors to encourage testing, offer education to healthcare staff about HIV, reduce stigma, and improve connections to prevention and care services. This program integrates smoothly into regular hospital routines and aims to close gaps in HIV diagnosis. Participants' HIV testing rates will be monitored by reviewing records before and after the intervention. Researchers will also assess new HIV diagnoses, changes in testing patterns by country and specialty, and healthcare professionals' knowledge and attitudes toward HIV. The study includes ongoing evaluation of how well the teams operate, resource use, and cost-effectiveness. Data collection extends up to several years to observe long-term effects, with continuous monitoring of care access and prevention services.

CONDITIONS

Brief 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 indicator conditions is part of routine care in the hospital's country
  • Hospital management agrees to allocate resources and authorize HIV team activities
  • Hospital can assemble an HIV team led by a local HIV expert
  • IT support and infrastructure exist to flag HIV indicator conditions and monitor implementation
  • Continuous linkage to HIV care and access to antiretroviral therapy is assured
  • Ethical and regulatory compliance provisions are in place
Not Eligible

You will not qualify if you...

  • Hospitals that do not meet the inclusion criteria are excluded
  • Data from patients who object to use of their data for research will not be used

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 year

Participants experience the implementation of a local HIV team in the hospital to support healthcare professionals with activities including audit and feedback, stigma reduction, education, and linkage to prevention and care.

Periodic assessments every 3 months during implementation

Continuation Phase

Duration - Up to 2 years

Follow-up assessments continue after the initial implementation to monitor ongoing impact and adaptations of the HIV team activities.

Assessments every 6 months during continuation

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