Status:
NOT_YET_RECRUITING
#AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.
Lead Sponsor:
Casper Rokx
Collaborating Sponsors:
ViiV Healthcare
Gilead Sciences
Conditions:
HIV Infection
HIV
Eligibility:
All Genders
18+ years
Phase:
NA
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 h...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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.
- Resources: Assembling an HIV team led by a local HIV expert should be viable considering the available human resources.
- 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.
- Quality assurance: Continuous linkage for care and access to antiretroviral therapy must be assured.
- Ethics and Regulatory Compliance: Provision for ethical and regulatory compliance is necessary.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
5200 Patients enrolled
Trial Details
Trial ID
NCT06900829
Start Date
July 1 2025
End Date
February 1 2030
Last Update
March 28 2025
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