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EU4Health Project Eurohelican: A Single-center Prospective Feasibility Study of the Proposed Test-and-treat Preventive Screening Program in Younger Slovenian Participants Aged 30-34 Years With or Without Helicobacter Pylori Infection
This prospective non-interventional study is being conducted as part of the EU4Health project Eurohelican. The main goal of this pilot study is to evaluate the feasibility and acceptability of implementing the proposed "test-and-treat" screening program on a population-based sample. Participants will be randomly selected from a younger population registered at the primary level of care and tested for the presence of active infection with Helicobacter pylori (H. pylori). Infected participants will undergo a bismuth-based quadruple treatment with antibiotics and a proton pump inhibitor, and will be controlled for eradication success by taking the urea breath test (UBT). A number of other participant outcomes will be also measured to provide additional pro et contra argumentation for the potential future implementation of a population-based test-and-treat screening program in Slovenia. Research reports will be disseminated and results will be presented to the public and scientific community to foster future developments in gastric cancer prevention.
Details
| Lead sponsor | National Institute of Public Health, Slovenia |
|---|---|
| Status | UNKNOWN |
| Enrolment | 2000 |
| Start date | 2024-02-01 |
| Completion | 2025-01 |
Conditions
- Helicobacter Pylori Infection
Interventions
- Bismuth Subcitrate
- Esomeprazole
- Metronidazole
- Amoxicillin
- Clarithromycin
- Levofloxacin
Primary outcomes
- Healthcare workers' assessment of feasibility and acceptability of the proposed practical implementation of a screening program — 1 year after the completion of prospective study.
Responses to qualitative questions and summary statistics from a post-enrollment questionnaire for healthcare workers involved into the implementation of the screening program. The questionnaires will be completed by up to 100 chosen personal physicians and registered nurses from HCM who participated in this prospective study. Questionnaire preparation follows the key performance indicators for assessing the five dimensions of the standardized TELOS framework of project feasibility.
Countries
Slovenia