Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Drug: Bismuth Subcitrate
- Registration Number
- NCT06216639
- Lead Sponsor
- National Institute of Public Health, Slovenia
- Brief Summary
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.
- Detailed Description
Gastric cancer remains an important public health issue due to its high incidence rate and relatively low five-year survival rate. H. pylori infection has been found to be the main cause of gastric cancer and is responsible for 89% of non-cardia gastric cancers. There is also evidence that H. pylori eradication significantly reduces the incidence and mortality due to gastric cancer. According to the proposal based on available data, the population-based test-and-treat screening program may be the best available evidence-based intervention to prevent the occurrence of gastric cancer. In its recommendations from September 9th 2023, the European Council also supported the implementation of a screening program particularly in European regions with an increased prevalence of H. pylori and incidence of gastric cancer. The aim of this study is to scientifically evaluate the feasibility, acceptability and effectiveness of the proposed population-based test-and-treat strategy for the eradication of H. pylori infection.
The proposed test-and-treat strategy is targeted at the population around the age of 30 years who are infected with H. pylori and predominantly asymptomatic. The main questions it aims to answer are:
* Is the proposed population-based H. pylori test-and-treat strategy feasible and acceptable in a community health service setting?
* Is the proposed population-based H. pylori test-and-treat strategy effective in a community health service setting?
* What is the profile of adverse events in the treated participants?
Participants will be randomly selected from the population pool of individuals aged 30-34 years who have a chosen personal physician at Community Healthcare Center dr. Adolf Drolc Maribor (HCM). Enrolled participants who will give their informed consent will be interviewed by a registered nurse regarding risk factors for developing H. pylori infection and selected lifestyle habits. In addition, serology testing for the presence of H. pylori antibodies will be performed on all participants. Participants with a positive serology result will be given a confirmatory urea breath test (UBT). Those participants with a confirmed active H. pylori infection will be treated with bismuth-based quadruple therapy, and the success of eradication will then be verified by UBT one month after the treatment. Participants with a positive result of the second UBT will be treated again with a second-line modified bismuth-based quadruple therapy, and the success of eradication will be verified by UBT. Compliance with testing and treatment, treatment outcomes, adverse events and reasons for withdrawing participation will be monitored for each of the participants. The feasibility and sustainability of the proposed test-and-treat strategy will be evaluated using several key performance indicators that follow the structure of five principal areas of feasibility. Data will be entered into the REDCap online survey application and analyzed using IBM SPSS Statistics software.
The results of this study will enable to potentially scale up the project to the national level and present a potential model for the implementation of this strategy in Europe. Second, the results will contribute to the implementation of the Europe's Beating Cancer Plan goal of preventing gastric cancers caused by H. pylori infections. Finally, this study will provide additional real-world data for the preparation of Expert Working Group Report of the International Agency for Research on Cancer of the World Health Organization (IARC/WHO), which will include a minimum set of standards for the implementation of a population-based screening program at the international level.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 2000
- Individuals aged 30-34 years,
- Individuals who have a chosen personal physician at HCM,
- Individuals who sign an informed consent to participate, and
- Individuals who do not have a congenital or acquired intellectual disability.
- Individuals younger than 30 years or older than 34 years,
- Individuals who do not have a chosen personal physician at HCM,
- Individuals who do not sign informed consent for participation,
- Individuals with intellectual or developmental limitations who are unable to provide a fully-informed consent to participate (based on the assessment of the patient's primary care team)
- Individuals who were previously treated for H. pylori infection, and
- Individuals with a history of partial of total gastric resection due to benign or malign lesions.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Individuals between 30 and 34 years of age registered at HCM Bismuth Subcitrate Random sample of participants representing the eligible cohort is drawn. Individuals between 30 and 34 years of age registered at HCM Esomeprazole Random sample of participants representing the eligible cohort is drawn. Individuals between 30 and 34 years of age registered at HCM Metronidazole Random sample of participants representing the eligible cohort is drawn. Individuals between 30 and 34 years of age registered at HCM Amoxicillin Random sample of participants representing the eligible cohort is drawn. Individuals between 30 and 34 years of age registered at HCM Clarithromycin Random sample of participants representing the eligible cohort is drawn. Individuals between 30 and 34 years of age registered at HCM Levofloxacin Random sample of participants representing the eligible cohort is drawn.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Participation rate of subjects selected for the program 3 months after: a) completion of the enrollment process (points a)-d)); b) completion of the prospective study (points e)-h)). Subtraction of 1) study participants who:
1. did not respond to an invitation,
2. signed the informed consent form but were not included in the study due to exclusion criteria,
3. declined to take a serology test,
4. declined to take any of the UBTs as specified in the study protocol,
5. had their therapy postponed due to maternity reasons,
6. declined to be re-treated after the treatment failure of primary therapy,
7. voluntarily withdrew at any time during their participation in the study,
8. withdrew from the study within points a)-g) combined,
from 2) all participants invited in the study.
The participation rate is measured in frequencies and percentage points (%).Eradication rate of infection with H. pylori 3 months after enrollment of the last participant who took a control UBT after the completion of primary bismuth-based quadruple therapy regimen. Subtraction of 1) participants who were subjected to treatment failure of the primary therapy regimen from 2) all participants with an active H. pylori infection who underwent the primary bismuth-based quadruple therapy regimen.
The eradication rate is measured in frequencies and percentage points (%).Description of the adverse events profile 6 months after enrollment of the last participant who took a second control UBT after the completion of secondary bismuth-based quadruple therapy regimen. Qualitative records of all self-reported (or physician-reported) adverse events during and after primary (or secondary) bismuth-based quadruple therapy regimen. All non-serious or serious adverse event will be reported.
Trial Locations
- Locations (1)
Community Healthcare Center dr. Adolf Drolc Maribor (HCM)
🇸🇮Maribor, Slovenia