NCT06900829: #aware hiv

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

Recruiting now NA Last updated 12 March 2026

What this trial tests

NA trial testing HIV team implementation in HIV Infection in 5,200 participants. Currently enrolling.

Timeline

1 October 2025

Primary endpoint
1 April 2029

1 February 2030

Quick facts

Lead sponsor	Casper Rokx
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	5,200
Start date	1 October 2025
Primary completion	1 April 2029
Estimated completion	1 February 2030
Sites	28 locations across France, Italy, Netherlands, Ukraine, Belgium, United Kingdom, Germany, Poland

Drugs / interventions tested

• HIV team implementation

Conditions studied

• HIV Infection — all drugs for HIV Infection →
• HIV — all drugs for HIV →
• Stigma — all drugs for Stigma →
• Education — all drugs for Education →

Sponsor

Casper Rokx

Who can join

18 and older, any sex, with HIV Infection or HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.