Clinical trial NCT06900829: #AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.
Official title: #AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
name: Gilead Sciences
First posted: 2025-03-28
Enrollment: 5200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge design
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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 \&amp;amp; Feedback, Education \&amp;amp; 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.

Primary outcomes:
measure: HIV testing rate in patients with HIV indicator conditions
timeFrame: 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:
measure: HIV incidence in patients with HIV indicator conditions
timeFrame: 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.
measure: Subgroup analysis 1: HIV testing rate by country and region
timeFrame: 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.
measure: Subgroup analysis 2: HIV testing rate by HIV indicator condition
timeFrame: 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.
measure: Subgroup analysis 3: HIV testing rate by medical specialty
timeFrame: 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.
measure: Subgroup analysis 4: HIV testing rate over time
timeFrame: 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.
measure: Cascade 1: The cascade of HIV diagnosis
timeFrame: 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.
measure: Cascade 1b: The cascade of HIV diagnosis - reasons for not testing for HIV
timeFrame: 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.
measure: Cascade 1c: The cascade of HIV diagnosis - descriptions of existing consent procedures in different hospital sites
timeFrame: Description of consent procedures as documented during the 1-year implementation phase across different hospital sites.
measure: Cascade 2: The cascade of HIV care
timeFrame: 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.
measure: Cascade 3: The cascade of HIV prevention
timeFrame: 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.
measure: HIV stigma indicators among health care professionals
timeFrame: Assessed at baseline (before implementation) and at 12 months (after 1 year of implementation).
measure: Implementation science 1: Assessment of key barriers and facilitators over time (CFIR)
timeFrame: Every 3 months during the implementation phase (first year). Every 6 months during the continuation phase (up to 3 years post-implementation).
measure: Implementation science 2: Reach: Proportion of patients benefiting from HIV team-supported testing
timeFrame: Measured during the implementation phase (1st year) and continuation phase (2nd year), compared to the control phase (6-18 months before implementation).
measure: Implementation science 3a: Effectiveness: Impact on HIV diagnosis rate
timeFrame: Measured during the implementation phase (1st year) and continuation phase (2nd year), compared to the control phase (6-18 months before implementation).
measure: Implementation science 3b: Effectiveness: Impact on disease stage at presentation
timeFrame: Measured during the implementation phase (1st year) and continuation phase (2nd year), compared to the control phase (6-18 months before implementation).
measure: Implementation science 4a: Adoption of HIV Indicator Condition-based testing
timeFrame: Measured during the implementation phase (1st year) and continuation phase (2nd year), compared to the control phase (6-18 months before implementation).
measure: Implementation science 5a: Implementation - Fidelity to the implementation strategies
timeFrame: Measured during the implementation phase (1st year) and continuation phase (2nd year)
measure: Implementation science 5b: Implementation - Adaptation of the implementation strategies
timeFrame: This will be assessed every three months during the implementation phase, and every 6 months in the first year of the continuation phase..
measure: Implementation science 5c: Implementation - Acceptability and appropriateness of the implementation strategies
timeFrame: As part of the stigma questionnaire before and after the implementation phase.
measure: Cost-effectiveness
timeFrame: 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.
measure: Epidemiological impact
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Erasmus Medical Center
name: Casper Rokx, Infectiologist, associate prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.