[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Casper Rokx\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":55},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100585320","awarehiv-europe-supporting-healthcare-professionals-to-find-undiagnosed-hiv-in-european-hospitals-an-effectiveness-implementation-trial-100585320",false,"NCT06900829","#AWARE.HIV Europe: Supporting Healthcare Professionals to Find Undiagnosed HIV in European Hospitals: An Effectiveness-implementation Trial.","#aware hiv","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.\n\nInclusion Criteria:\n\n1. 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.\n2. 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.\n3. Resources: Assembling an HIV team led by a local HIV expert should be viable considering the available human resources.\n4. 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.\n5. Quality assurance: Continuous linkage for care and access to antiretroviral therapy must be assured.\n6. Ethics and Regulatory Compliance: Provision for ethical and regulatory compliance is necessary.\n\nExclusion Criteria:\n\nAny 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.",true,"ALL","18 Years",{"count":20,"type":21},5200,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nStudy Design:\n\nThe 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.\n\nIntervention:\n\nThe 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:\n\nIdentification and Surveillance: Screening routine electronic health records for HIV indicator conditions using predefined ICD-10 codes and verifying cases that warrant HIV testing.\n\nAudit \\& Feedback: Providing targeted recommendations to treating physicians when an HIV test is indicated but has not been performed, thereby prompting action.\n\nEducation \\& Training: Delivering training sessions to healthcare professionals to improve their knowledge and attitudes towards HIV testing, prevention, and care.\n\nEnabling Environment: Implementing digital solutions and other support mechanisms to streamline testing processes, reduce stigma, and enhance overall guideline adherence.\n\nLinkage to prevention: Improving linkage to the locally available preventive services.\n\nThe intervention is intended to integrate seamlessly into routine hospital care, thereby reinforcing existing guidelines while addressing the current diagnostic testing gap.\n\nEndpoints and Outcome Measures:\n\nPrimary Endpoint:\n\nThe change in HIV testing rate among patients diagnosed with HIV indicator conditions before and after the implementation of HIV teams.\n\nKey Secondary Endpoints:\n\nThe change in the incidence of new HIV diagnoses among patients with HIV indicator conditions.\n\nVariations in HIV testing rates across different countries, medical specialties, and types of indicator conditions, as well as over time.\n\nAssessment 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.\n\nEvaluation of the cascade of HIV care and prevention, including linkage to HIV care, achievement of viral suppression, and referral and uptake of preventive services.\n\nChanges in healthcare professionals' knowledge, attitudes, and levels of stigma towards HIV.\n\nImplementation outcomes such as fidelity of HIV team activities, resource utilization, cost-effectiveness, and sustainability of the intervention.\n\nAnalysis of contextual factors, barriers, and facilitators impacting the implementation process, using established frameworks like CFIR and RE-AIM.\n\nImpact:\n\nBy 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.\n\nThis 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.",[27,28,29,30,31,32],"HIV Infection","HIV","Stigma","Education","Prevention of Infection With HIV-1","Electronic Health Records",[34,35,36,37,38,39,40,41],"hiv","stigma","linkage to care","linkage to prevention","electronic prompts","behavioural intervention","ICD-10 code based","audit and feedback","RECRUITING","2026-03-11",{"date":45,"type":46},"2026-03-12","ACTUAL",{"date":48,"type":46},"2025-10-01",{"date":50,"type":21},"2030-02-01",{"name":52,"class":53},"Casper Rokx","OTHER",28,""]