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

NCT06900829 | Recruiting

• 1 other identifier: MEC-2024-0236
• Study Type: interventional
• Target: 5,200
• Locations: 10 countries
• Sites: 28

Brief Summary

The #aware.hiv Europe study is a real-world, multicenter, stepped-wedge cluster randomized, effectiveness-implementation trial designed to evaluate whether the introduction of dedicated HIV teams in hospitals can improve HIV testing rates among patients presenting with HIV indicator conditions across ten European countries. Study Design: The study employs a stepped-wedge design, whereby clusters of hospitals transition sequentially from a control phase (routine care) to an intervention phase. All patient data are collected retrospectively from routine care, while prospective data are gathered at the healthcare professional level. The project spans four years and involves hospitals from the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. This design allows for comparison of HIV testing rates and related outcomes before and after the implementation across different settings and time points. Intervention: The core intervention involves the establishment of hospital-based HIV teams. Each team is led by an HIV specialist and supported by nurses and data collectors. Their responsibilities include: Identification and Surveillance: Screening routine electronic health records for HIV indicator conditions using predefined ICD-10 codes and verifying cases that warrant HIV testing. Audit \& Feedback: Providing targeted recommendations to treating physicians when an HIV test is indicated but has not been performed, thereby prompting action. Education \& Training: Delivering training sessions to healthcare professionals to improve their knowledge and attitudes towards HIV testing, prevention, and care. Enabling Environment: Implementing digital solutions and other support mechanisms to streamline testing processes, reduce stigma, and enhance overall guideline adherence. Linkage to prevention: Improving linkage to the locally available preventive services. The intervention is intended to integrate seamlessly into routine hospital care, thereby reinforcing existing guidelines while addressing the current diagnostic testing gap. Endpoints and Outcome Measures: Primary Endpoint: The change in HIV testing rate among patients diagnosed with HIV indicator conditions before and after the implementation of HIV teams. Key Secondary Endpoints: The change in the incidence of new HIV diagnoses among patients with HIV indicator conditions. Variations in HIV testing rates across different countries, medical specialties, and types of indicator conditions, as well as over time. Assessment of the cascade of HIV diagnosis, including the proportion of patients identified with an indicator condition, the offer and acceptance of HIV testing, and documented reasons for non-testing. Evaluation of the cascade of HIV care and prevention, including linkage to HIV care, achievement of viral suppression, and referral and uptake of preventive services. Changes in healthcare professionals' knowledge, attitudes, and levels of stigma towards HIV. Implementation outcomes such as fidelity of HIV team activities, resource utilization, cost-effectiveness, and sustainability of the intervention. Analysis of contextual factors, barriers, and facilitators impacting the implementation process, using established frameworks like CFIR and RE-AIM. Impact: By introducing HIV teams and systematically monitoring their effect on HIV testing practices, the study aims to enhance early HIV diagnosis and improve patient outcomes. The findings will contribute to evidence-based guidelines and may promote the adoption of similar interventions across European healthcare settings, ultimately reducing HIV-associated morbidity, mortality, and transmission rates. This project not only addresses a critical diagnostic gap in HIV care but also provides valuable insights into the effective implementation of complex interventions in routine clinical practice.

Conditions

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

Keywords

hiv; stigma; linkage to care; linkage to prevention; electronic prompts; behavioural intervention; ICD-10 code based; audit and feedback

Outcome Measures

Primary Outcomes (1)

• HIV testing rate in patients with HIV indicator conditions

  Proportion of patients diagnosed with an HIV indicator condition who receive an HIV test, compared between the control and implementation phases.

  Comparison between 1 year of implementation and a control phase lasting between 6 to 18 months, depending on the site's randomization in the stepped-wedge trial design.

Secondary Outcomes (21)

• HIV incidence in patients with HIV indicator conditions

  Comparison between 1 year of implementation and a control phase lasting between 6 to 18 months, depending on the site's randomization in the stepped-wedge trial design.

• Subgroup analysis 1: HIV testing rate by country and region

  Comparison between 1 year of implementation and a control phase lasting between 6 to 18 months, depending on the site's randomization in the stepped-wedge trial design.

• Subgroup analysis 2: HIV testing rate by HIV indicator condition

  Comparison between 1 year of implementation and a control phase lasting between 6 to 18 months, depending on the site's randomization in the stepped-wedge trial design.

• Subgroup analysis 3: HIV testing rate by medical specialty

  Comparison between 1 year of implementation and a control phase lasting between 6 to 18 months, depending on the site's randomization in the stepped-wedge trial design.

• Subgroup analysis 4: HIV testing rate over time

  Comparison between 1 year of implementation and a control phase lasting between 6 to 18 months, depending on the site's randomization in the stepped-wedge trial design.

Study Arms (1)

hiv team implemented

EXPERIMENTAL

A local hiv team will be implemented in a certain hospital. This will result in different activities, with a focus on: * audit and feedback (reminding health care professionals to test for hiv) * stigma reduction (raising awareness on existing hiv stigma towards hiv) * education (increasing knowledge on hiv among health care professionals) * linkage to prevention and care (improving pathways for hiv care and prevention)

Behavioral: HIV team implementation

Interventions

HIV team implementation BEHAVIORAL

A local hiv team will be implemented in a certain hospital. This will result in different activities, with a focus on: * audit and feedback (reminding health care professionals to test for hiv) * stigma reduction (raising awareness on existing hiv stigma towards hiv) * education (increasing knowledge on hiv among health care professionals) * linkage to prevention and care (improving pathways for hiv care and prevention)

hiv team implemented

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.
• Resources: Assembling an HIV team led by a local HIV expert should be viable considering the available human resources.
• 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.
• Quality assurance: Continuous linkage for care and access to antiretroviral therapy must be assured.
• Ethics and Regulatory Compliance: Provision for ethical and regulatory compliance is necessary.

Sponsors & Collaborators

• Gilead Sciences: collaborator
• Casper Rokx: lead
• ViiV Healthcare: collaborator

Study Sites (28)

University Hospital Ghent

Ghent, Belgium

NOT YET RECRUITING

European hospital of Marseille

Marseille, 13003, France

RECRUITING

St. Joseph Krankenhaus Berlin Tempelhof

Berlin, 12101, Germany

RECRUITING

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Cologne University Hospital

Cologne, 50937, Germany

RECRUITING

Klinikum der Technischen Universität München (TUM)

München, 81675, Germany

RECRUITING

Ospedale San Raffaele S.r.l

Milan, Italy

RECRUITING

L'Istituto Nazionale per le Malattie Infettive "L. Spallanzani" IRCCS

Roma, 00149, Italy

RECRUITING

Rijnstate ziekenhuis

Arnhem, Netherlands

RECRUITING

Stichting Catharina Ziekenhuis

Eindhoven, 5623EJ, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

RECRUITING

Stichting Maasstad Ziekenhuis

Rotterdam, 3079DZ, Netherlands

RECRUITING

Haga Ziekenhuis

The Hague, Netherlands

RECRUITING

SPZZOZ Janów Lubelski

Janów Lubelski, 23-300, Poland

RECRUITING

Wojewodzki Szpital Zespolony

Kielce, 25-736, Poland

RECRUITING

Państwowy Instytut Medyczny MSWiA w Warszawie

Warsaw, 02-507, Poland

RECRUITING

Central Military Emergency University Hospital "Dr. Carol Davila"

Bucharest, 010825, Romania

RECRUITING

Clinical Emergency Hospital "Prof. Dr. Agrippa Ionescu"

Bucharest, 011356, Romania

RECRUITING

National Institute for Infectious Diseases "Prof. Dr. Matei Bals"

Bucharest, 021105, Romania

RECRUITING

Fundeni Clinical institute

Bucharest, 022328, Romania

RECRUITING

Spitalul Universitar de Urgență București

Bucharest, 050098, Romania

RECRUITING

Hospital Universitario La Paz-Carlos III

Madrid, 28029, Spain

RECRUITING

Infanta Leonor

Madrid, Spain

RECRUITING

La Princesa

Madrid, Spain

RECRUITING

Central city clinical hospital of Ivano-Frankivsk city council

Ivano-Frankivsk, Ukraine

RECRUITING

Lviv National Medical University

Lviv, 79010, Ukraine

RECRUITING

Buckinghamshire Healthcare NHS Trust

Aylesbury, HP21 8AL, United Kingdom

RECRUITING

Royal Free London

London, NW3 2QG, United Kingdom

RECRUITING

Related Publications (3)

• Jordans CCE, Vliegenthart-Jongbloed K, Osbak KK, Hanssen JLJ, van Beek J, Vriesde M, van Holten N, Dorama W, van der Sluis D, de Steenwinkel J, van Kampen J, Verbon A, Roukens AHE, Rokx C. Implementing HIV teams sustainably improves HIV indicator condition testing rates in hospitals in the Netherlands: the #aware.hiv clinical trial. AIDS. 2025 Jul 1;39(8):995-1004. doi: 10.1097/QAD.0000000000004167. Epub 2025 Mar 18.

  PMID: 40053486 BACKGROUND

• Jordans CCE, Vliegenthart-Jongbloed KJ, van Bruggen AW, van Holten N, van Beek JEA, Vriesde M, van der Sluis D, Verbon A, Roukens AHE, Stutterheim SE, Rokx C. Unmasking Individual and Institutional HIV Stigma in Hospitals: Perspectives of Dutch Healthcare Providers. AIDS Behav. 2024 Sep;28(9):3184-3195. doi: 10.1007/s10461-024-04404-0. Epub 2024 Jun 13.

  PMID: 38869755 BACKGROUND

• Vliegenthart-Jongbloed KJ, Vasylyev M, Jordans CCE, Bernardino JI, Nozza S, Psomas CK, Voit F, Barber TJ, Skrzat-Klapaczynska A, Sandulescu O, Rokx C; #aware.hiv Europe Project. Systematic Review: Strategies for Improving HIV Testing and Detection Rates in European Hospitals. Microorganisms. 2024 Jan 25;12(2):254. doi: 10.3390/microorganisms12020254.

  PMID: 38399659 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

HIV Infections; Social Stigma; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior; Slow Virus Diseases

Study Officials

• Casper Rokx, Infectiologist, associate prof

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaske J Vliegenthart-Jongbloed, Internist-Infectiologist, DTMH

CONTACT

0031648382045; k.vliegenthart-jongbloed@erasmusmc.nl

Marianne van Wingerden, Research nurse

CONTACT

0031107040704; aware.hiv@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Internist-infectiologist, Associate professor

Model Details: Stepped wedge design

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: March 28, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3); BE (1); FR (1); ES (3); NL (5); GB (2); DE (4); RO (5); UA (2); IT (2)