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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Infection; HIV; Education; Electronic Health Records; Stigma; Prevention of Infection With HIV-1
• Intervention / Treatment: Behavioral: HIV team implementation

• Study Type: Interventional
• Enrollment (Estimated): 5200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klaske J Vliegenthart-Jongbloed, Internist-Infectiologist, DTMH; Phone Number: 0031648382045; Email: k.vliegenthart-jongbloed@erasmusmc.nl
• Study Contact Backup: Name: Marianne van Wingerden, Research nurse; Phone Number: 0031107040704; Email: aware.hiv@erasmusmc.nl

Study Locations

• Belgium
  • Ghent, Belgium
    • Not yet recruiting
    • University Hospital Ghent
    • Contact: Marie-Angélique De Scheerder, Prof. dr.; Phone Number: +32 9 332 21 11; Email: Marie-Angelique.DeScheerder@uzgent.be
• France
  • Marseille, France, 13003
    • Recruiting
    • European hospital of Marseille
    • Contact: Christina Psomas, Dr.; Phone Number: +33 4 13 42 70 00; Email: kcpsomas@gmail.com
    • Principal Investigator: Christina Psomas, Dr.
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité Universitätsmedizin Berlin
    • Contact: Christian Gaebler, Prof. Dr. Med.; Phone Number: +49 30 45050; Email: christian.gaebler@charite.de
    • Principal Investigator: Christian Gaebler, Prof. Dr. med.
  • Berlin, Germany, 12101
    • Recruiting
    • St. Joseph Krankenhaus Berlin Tempelhof
    • Contact: Pascal Migaud, Dr. Med.; Phone Number: +493078825500; Email: Pascal.Migaud@sjk.de
    • Principal Investigator: Pascal Migaud, Dr. Med.
  • Cologne, Germany, 50937
    • Recruiting
    • Cologne University Hospital
    • Contact: Jakob J. Malin, Priv.-Doz. Dr.; Phone Number: +492214780; Email: Jakob.Malin@uk-koeln.de
    • Principal Investigator: Jakob J. Malin, Priv.-Doz. Dr.
  • München, Germany, 81675
    • Recruiting
    • Klinikum der Technischen Universität München (TUM)
    • Contact: Florian Voit, Dr. med.sci.; Phone Number: +498941408274; Email: florian.voit@mri.tum.de
    • Principal Investigator: Florian Voit, Dr. med. sci.
• Italy
  • Milan, Italy
    • Recruiting
    • Ospedale San Raffaele S.r.l
    • Contact: Silvia Nozza, Dr.; Phone Number: +39 02 26431; Email: nozza.silvia@hsr.it
    • Principal Investigator: Silvia Nozza, Dr.
  • Roma, Italy, 00149
    • Recruiting
    • L'Istituto Nazionale per le Malattie Infettive "L. Spallanzani" IRCCS
    • Contact: Valentina Mazzotta, Dr.; Phone Number: +390655170923; Email: valentina.mazzotta@inmi.it
    • Principal Investigator: Valentina Mazzotta, Dr.
• Netherlands
  • Arnhem, Netherlands
    • Recruiting
    • Rijnstate Ziekenhuis
    • Contact: Jet Gisolf, Dr.; Phone Number: 0880056735; Email: jgisolf@rijnstate.nl
    • Principal Investigator: Jet Gisolf, Dr.
  • Eindhoven, Netherlands, 5623EJ
    • Recruiting
    • Stichting Catharina Ziekenhuis
    • Contact: Heidi Ammerlaan, Dr.; Phone Number: 040 239 9111; Email: heidi.ammerlaan@catharinaziekenhuis.nl
    • Principal Investigator: Heidi Ammerlaan, Dr.
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: Wouter F.W. Bierman, Dr.; Phone Number: 050 361 6161; Email: w.f.w.bierman@umcg.nl
    • Principal Investigator: Wouter F.W. Bierman, Dr.
  • Rotterdam, Netherlands, 3079DZ
    • Recruiting
    • Stichting Maasstad Ziekenhuis
    • Contact: Lennert van den Dries, Dr.; Email: DriesL@maasstadziekenhuis.nl
    • Principal Investigator: Lennert van den Dries, Dr.
  • The Hague, Netherlands
    • Recruiting
    • Haga Ziekenhuis
    • Contact: Charlotte de Bree, M.D. PhD; Phone Number: 003170 210 0000; Email: l.debree@hagaziekenhuis.nl
• Poland
  • Janów Lubelski, Poland, 23-300
    • Recruiting
    • SPZZOZ Janów Lubelski
    • Contact: Tomasz Szumski, Dr.; Phone Number: +48 15 843 63 61; Email: tommyszumski10@wp.pl
    • Principal Investigator: Tomasz Szumski, Dr.
  • Kielce, Poland, 25-736
    • Recruiting
    • Wojewodzki Szpital Zespolony
    • Contact: Dorota Zarębska-Michaluk, Dr.; Phone Number: +48 41 367 13 01; Email: dorota1010@tlen.pl
    • Principal Investigator: Dorota Zarębska-Michaluk, Dr.
  • Warsaw, Poland, 02-507
    • Recruiting
    • Panstwowy Instytut Medyczny MSWiA w Warszawie
    • Contact: Jakub Klapaczyński, Dr.; Phone Number: +48 47 722 15 52; Email: jakub.klapaczynski@cskmswia.gov.pl
    • Principal Investigator: Jakub Klapaczyński, Dr.
• Romania
  • Bucharest, Romania, 022328
    • Recruiting
    • Fundeni Clinical Institute
    • Contact: Cristina Negulescu, Dr.; Phone Number: +4 021.317.21.94; Email: secretariat@icfundeni.ro
    • Principal Investigator: Cristina Negulescu, Dr.
  • Bucharest, Romania, 050098
    • Recruiting
    • Spitalul Universitar de Urgenta Bucuresti
    • Contact: Diana G. Iacob, Dr.; Phone Number: (+40) 733 650 240; Email: secretariat@suub.ro
    • Principal Investigator: Diana G. Iacob, Dr.
  • Bucharest, Romania, 010825
    • Recruiting
    • Central Military Emergency University Hospital "Dr. Carol Davila"
    • Contact: Stefan Ion, Dr.; Phone Number: +40 744 309 559; Email: dr.stefanion@gmail.com
    • Principal Investigator: Ștefan Ion, Dr.
  • Bucharest, Romania, 011356
    • Recruiting
    • Clinical Emergency Hospital "Prof. Dr. Agrippa Ionescu"
    • Contact: Valeriu Gheorghiță, MD. PhD; Phone Number: +40377726145; Email: secretariat.agrippa@dcti.ro
    • Principal Investigator: Valeriu Gheorghiță, MD. PhD
  • Bucharest, Romania, 021105
    • Recruiting
    • National Institute for Infectious Diseases "Prof. Dr. Matei Bals"
    • Contact: Oana Săndulescu, MD. PhD; Phone Number: +40723768779; Email: oana.sandulescu@umfcd.ro
    • Principal Investigator: Oana Săndulescu, MD. PhD
• Spain
  • Madrid, Spain, 28029
    • Recruiting
    • Hospital Universitario La Paz-Carlos III
    • Contact: José Bernardino, Dr.; Phone Number: +34 914 53 25 00; Email: jose.bernardino@salud.madrid.org
    • Principal Investigator: José Bernardino, Dr.
  • Madrid, Spain
    • Recruiting
    • Infanta Leonor
    • Contact: Pablo Ryan Murua, M.D. PhD; Phone Number: +34 911 91 80 00; Email: pabloryan@gmail.com
  • Madrid, Spain
    • Recruiting
    • La Princesa
    • Contact: Lucio Garcia, M.D.; Phone Number: +34915202200; Email: luciojesus.garcia@salud.madrid.org
• Ukraine
  • Ivano-Frankivsk, Ukraine
    • Recruiting
    • Central City Clinical Hospital of Ivano-Frankivsk City Council
    • Contact: Roman Fishchuk, Dr.; Phone Number: +380 95 103 1030; Email: fishchukroman@gmail.com
    • Principal Investigator: Roman Fishchuk, Dr.
  • Lviv, Ukraine, 79010
    • Recruiting
    • Lviv National Medical University
    • Contact: Maryana Sluzhynska, Dr.; Phone Number: +380 322 757 632; Email: msluzhynska@gmail.com
    • Principal Investigator: Maryana Sluzhynska, Dr.
• United Kingdom
  • Aylesbury, United Kingdom, HP21 8AL
    • Recruiting
    • Buckinghamshire Healthcare NHS Trust
    • Contact: Angela Bailey, Dr.; Phone Number: 01296 315000; Email: angela.bailey16@nhs.net
    • Principal Investigator: Angela Bailey, Dr.
  • London, United Kingdom, NW3 2QG
    • Recruiting
    • Royal Free London
    • Contact: Tristan Barber, MD.; Phone Number: +44 20 7794 0500; Email: t.barber@nhs.net
    • Principal Investigator: Tristan Barber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Since this study involves screening individuals presenting to a specific hospital through a hospital-wide intervention, the inclusion and exclusion criteria are established at the hospital level.

Inclusion Criteria:

1. 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.
2. 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.
3. Resources: Assembling an HIV team led by a local HIV expert should be viable considering the available human resources.
4. 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.
5. Quality assurance: Continuous linkage for care and access to antiretroviral therapy must be assured.
6. Ethics and Regulatory Compliance: Provision for ethical and regulatory compliance is necessary.

Exclusion Criteria:

Any hospital that does not meet the inclusion criteria will be excluded from participation. We will not use data of patients who have objected against the use of their data for research.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: hiv team implemented; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV incidence in patients with HIV indicator conditions	Number of newly diagnosed HIV infections among patients with an HIV indicator condition, 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.
Subgroup analysis 1: HIV testing rate by country and region	Difference in HIV testing rate within and between countries, as well as between geographic regions (West: Netherlands, Belgium, UK, Germany; South: France, Italy, Spain; East: Poland, Romania, Ukraine), comparing 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.
Subgroup analysis 2: HIV testing rate by HIV indicator condition	Difference in HIV testing rate across different HIV indicator conditions, comparing 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.
Subgroup analysis 3: HIV testing rate by medical specialty	Difference in HIV testing rate across medical specialties, comparing 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.
Subgroup analysis 4: HIV testing rate over time	Change in HIV testing rate over time, comparing 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.
Cascade 1: The cascade of HIV diagnosis	Proportion of patients with a confirmed HIV indicator condition (focus population) who were offered an HIV test (reach) and who accepted testing (uptake), 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.
Cascade 1b: The cascade of HIV diagnosis - reasons for not testing for HIV	Qualitative analysis of documented reasons why patients with an HIV indicator condition did not receive an HIV test. Reasons will be classified according to predefined categories used in the study database: No reason registered (1) Patient was not seen again (2) Advice to the general practitioner or public health to test (3) No perceived indication or risk factors (4) Alternative diagnosis/explanation (5) No recommendation in local protocol (6) Patient refused (7) Shared decision-making not to test (8) Lack of time or opportunity (9) Planned but not performed (10) Already tested (confirmed) (11) Already tested (not confirmed or inadequate according to the SOP) (12) Palliative care or patient deceased during follow-up (13) Other (14)	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.
Cascade 1c: The cascade of HIV diagnosis - descriptions of existing consent procedures in different hospital sites	Qualitative description of the consent procedures in place for HIV testing across different hospital sites. This includes: The types of consent procedures in use, such as verbal or written consent. National or institutional guidelines or local standard procedures that shape consent practices. Data will be collected per site to document existing practices without assessing implementation or adherence.	Description of consent procedures as documented during the 1-year implementation phase across different hospital sites.
Cascade 2: The cascade of HIV care	Proportion of patients with a confirmed HIV indicator condition who were newly diagnosed with HIV (focus population) and subsequently linked or re-linked to routine HIV care (reach), with viral suppression as an indicator of successful engagement in care (uptake), 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.
Cascade 3: The cascade of HIV prevention	Proportion of patients with a confirmed HIV indicator condition who met the eligibility criteria for HIV prevention (focus population), were appropriately referred to prevention services (reach), and engaged in prevention interventions (uptake), 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.
HIV stigma indicators among health care professionals	Descriptive assessment of self-reported HIV stigma among licensed healthcare professionals, including physicians, nurse practitioners, and physician assistants, before and after implementation. Stigma will be measured using a validated questionnaire developed by the Health Policy Project and USAID, and adapted from the ECDC survey published in Annex 1 of the report: "HIV stigma in the healthcare setting. Monitoring implementation of the Dublin Declaration on partnership to fight HIV/AIDS in Europe and Central Asia 2024." The survey includes self-reported responses on multiple dimensions of HIV stigma, expressed as percentages of participants reporting: Fear of HIV infection; Institutional facilitators and barriers; Negative attitudes towards people with HIV; Observed stigma in clinical settings. This is a descriptive outcome measure, reporting the proportion of participants endorsing each stigma-related item before and after the intervention.	Assessed at baseline (before implementation) and at 12 months (after 1 year of implementation).
Implementation science 1: Assessment of key barriers and facilitators over time (CFIR)	Description: Descriptive assessment of perceived barriers and facilitators to implementing and sustaining the HIV team intervention in hospital settings. Barriers and facilitators will be assessed based on a structured survey, capturing key constructs from the Consolidated Framework for Implementation Research (CFIR): Intervention characteristics, Outer setting, Inner setting, Characteristics of individuals and the Implementation process. Survey items will be derived from a systematic review of barriers and facilitators to HIV indicator condition-based testing. The review will be published separately. Data will be collected via an online survey in Castor, administered to the HIV team lead at each participating site	Every 3 months during the implementation phase (first year). Every 6 months during the continuation phase (up to 3 years post-implementation).
Implementation science 2: Reach: Proportion of patients benefiting from HIV team-supported testing	Proportion of patients with HIV indicator conditions who received an HIV test with direct (= feedback) or indirect (= other implementation strategies) involvement of the HIV team, stratified by: Country, hospital, and specialty to assess variation in reach; Equity analysis: evaluating differences in testing uptake by age and sex	Measured during the implementation phase (1st year) and continuation phase (2nd year), compared to the control phase (6-18 months before implementation).
Implementation science 3a: Effectiveness: Impact on HIV diagnosis rate	Proportion of individuals who test HIV-positive among: All individuals tested for HIV (primary analysis). All individuals identified with an HIV indicator condition (secondary analysis).	Measured during the implementation phase (1st year) and continuation phase (2nd year), compared to the control phase (6-18 months before implementation).
Implementation science 3b: Effectiveness: Impact on disease stage at presentation	Assessment of the impact of the HIV indicator condition-based testing approach on CD4 count at HIV diagnosis, measured as a continuous variable to assess shifts in stage at presentation. Primary analysis: Mean CD4 count at HIV diagnosis in the intervention phase vs. control phase (continuous variable). Secondary analysis: Distribution of CD4 counts at diagnosis (percentiles and quartiles) to evaluate changes in the proportion of late-stage diagnoses. Proportion of patients diagnosed with advanced HIV (CD4 <200 cells/µL) in both phases. Proportion of patients diagnosed with late-stage HIV (CD4 <350 cells/µL) in both phases. Proportion of patients diagnosed at higher CD4 thresholds (e.g., >500 cells/µL) to assess shifts towards earlier diagnosis.	Measured during the implementation phase (1st year) and continuation phase (2nd year), compared to the control phase (6-18 months before implementation).
Implementation science 4a: Adoption of HIV Indicator Condition-based testing	Hospital adoption rate (%): Proportion of participating hospitals that have adopted all core components of HIV indicator condition-based testing. as well as: Degree of adoption across the hospital (%): Proportion of hospital departments (inpatients, outpatients, SEH, IC) that are included in the surveillance of HIV indicator condition-based testing.	Measured during the implementation phase (1st year) and continuation phase (2nd year), compared to the control phase (6-18 months before implementation).
Implementation science 5a: Implementation - Fidelity to the implementation strategies	This outcome assesses the degree to which the #aware.hiv Europe implementation strategies were delivered as intended across participating hospitals. Percentage of flagged potential HIV indicator conditions that were assessed by the HIV team (surveillance) Percentage of untested indicator conditions for which HIV testing advice was provided to physicians (feedback) Number of teaching sessions delivered compared to the intended frequency, with a minimum of one session every three months in the implementation phase (teaching). Number of stigma-reducing events organized, with a minimum requirement of one event in the implementation phase (stigma).	Measured during the implementation phase (1st year) and continuation phase (2nd year)
Implementation science 5b: Implementation - Adaptation of the implementation strategies	This outcome assesses the extent to which the #aware.hiv Europe implementation strategies were adapted to fit the local context while maintaining core components across participating hospitals. The number and type of modifications made to the implementation strategy at the hospital level will be assessed using qualitative data collected via a structured questionnaire. Responses will be categorized according to the key components of the implementation strategy: Audit and Feedback; Teaching and Education; Enabling Environment (including stigma reduction); Linkage to Prevention	This will be assessed every three months during the implementation phase, and every 6 months in the first year of the continuation phase..
Implementation science 5c: Implementation - Acceptability and appropriateness of the implementation strategies	This outcome assesses how acceptable and appropriate the #aware.hiv Europe implementation strategies are perceived by healthcare professionals authorised to request HIV tests, using questions embedded in the hospital-wide stigma questionnaire.	As part of the stigma questionnaire before and after the implementation phase.
Cost-effectiveness	Cost-effectiveness will be estimated by calculating the budget impact and Quality-Adjusted Life Years (QALYs) saved to define an Incremental Cost-Effectiveness Ratio (ICER).	The one-year implementation phase will be compared to the preceding control phase, and the continuation phase (second year) will be compared to both the implementation and control phases to assess cost-effectiveness.
Epidemiological impact	The epidemiological impact will be estimated by quantifying the number of earlier HIV diagnoses achieved through the intervention, and modelling the resulting reduction in the number of person-years spent living with undiagnosed HIV. In addition, the number of secondary HIV infections potentially averted due to earlier diagnosis and treatment initiation will be estimated. Estimate the reduction in average time from infection to diagnosis based on clinical data and literature. Calculate the total number of person-years with undiagnosed HIV prevented through earlier detection. Use published transmission rates for undiagnosed individuals to model the number of secondary infections averted. If available, incorporate local or national modelling tools (e.g., ECDC HIV Modelling Tool) to support these estimates.	The one-year implementation phase will be compared to the control phase, and the continuation phase (second year) will be compared to both preceding phases.

Collaborators and Investigators

• Sponsor: Casper Rokx
• Collaborators: Gilead Sciences; ViiV Healthcare
• Investigators: Principal Investigator: Casper Rokx, Infectiologist, associate prof, Erasmus Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 22, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: stigma; hiv; audit and feedback; linkage to care; behavioural intervention; linkage to prevention; electronic prompts; ICD-10 code based
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; Behavior; Social Behavior; HIV Infections; Acquired Immunodeficiency Syndrome; Social Stigma
• Other Study ID Numbers: MEC-2024-0236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: While aggregated results may be published, the protocol does not support the sharing of individual-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No