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ClinicalTrials.gov ID

NCT06900829

Lead Sponsor

Casper RokxOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

5,200Estimated

Last Update Posted

Mar 12, 2026Actual

Start Date

Oct 1, 2025Actual

Primary Completion Date

Apr 1, 2029Estimated

Completion Date

Feb 1, 2030Estimated

Official Title

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

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.

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

• HIV team implementation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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 & 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.

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

Casper RokxOTHER

Collaborators

ViiV HealthcareINDUSTRY

Gilead SciencesINDUSTRY

pabloryan@gmail.com+34 911 91 80 00

luciojesus.garcia@salud.madrid.org+34915202200