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

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

Interventions

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)

Sponsors & Collaborators

• ViiV Healthcare

  collaborator INDUSTRY

• Gilead Sciences

  collaborator INDUSTRY

• Casper Rokx

  lead OTHER

Principal Investigators

• Casper Rokx, Infectiologist, associate prof · Erasmus Medical Center

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2029-04-01

Completion

2030-02-01

Countries

• Belgium
• France
• Germany
• Italy
• Netherlands
• Poland
• Romania
• Spain
• Ukraine
• United Kingdom

Study Locations