protocolSection identificationModule nctId: NCT06361628, orgStudyIdInfo id: RIVER-EU WP4, briefTitle: Implementation and Evaluation of Tailored Interventions to Increase MMR and/or HPV Vaccine, acronym: RIVER-EU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: Prolepsis Institute for Preventive, Environmental and Occupational Medicine, collaborators name: University in Zielona Góra, collaborators name: Pavol Jozef Safarik University, descriptionModule briefSummary: The goal of the study is to monitor and evaluate the implementation of interventions that aim to increase HPV \& MMR vaccines among underserved communities across four European countries: Greece, Netherlands, Poland, and Slovakia. The interventions will target identified health systems barriers in an earlier phase of the project. The interventions that will be implemented employ trusted community members as health promotors whom will provide educational sessions on HPV and MMR vaccination to the target groups. In addition, the cost-effectiveness of vaccine uptake strategies for the target groups is being evaluated.The main research question is: to what extent is the multicomponent tailored intervention effective to increase MMR/HPV intention and vaccine uptake in the target population in Greece, Netherlands, Poland and Slovakia?, conditionsModule conditions: Vaccination, conditions: Health Systems, conditions: Knowledge, Attitudes, Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: multicomponent intervention on vaccination awareness, outcomesModule primaryOutcomes measure: Intention to vaccinate MMR and/or HPV by questionnaire, secondaryOutcomes measure: Uptake of MMR and/or HPV vaccinations by questionnaire, secondaryOutcomes measure: Knowledge concerning MMR and/or HPV vaccinations in the target group using a questionnaire, secondaryOutcomes measure: Communication skills of health care professionals using a questionnaire, secondaryOutcomes measure: Satisfaction of the stakeholders as measured by a questionnaire, otherOutcomes measure: Improved access to vaccinations by addressing identified health system barriers - number of barriers addressed, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prolepsis, city: Athens, state: Athene, zip: 151 25, country: Greece, contacts name: Pania Karnaki, role: CONTACT, phone: +30 210 6255700, email: p.karnaki@prolepsis.gr, contacts name: Nikole Papaevgeniou, PhD, role: CONTACT, email: n.papaevgeniou@prolepsis.gr, geoPoint lat: 37.97945, lon: 23.71622, locations facility: University Medical Center Groningen, city: Groningen, zip: 9713 GZ, country: Netherlands, contacts name: Janine de Zeeuw, PhD, role: CONTACT, phone: +31 6 45552994, email: j.de.zeeuw@umcg.nl, geoPoint lat: 53.21917, lon: 6.56667, locations facility: University of Zielona Gora, city: Zielona Góra, state: Lubusz, zip: 65 417, country: Poland, contacts name: Maria Ganczak, MD PhD, role: CONTACT, email: m.ganczak@inm.uz.zgora.pl, geoPoint lat: 51.93548, lon: 15.50643, locations facility: PJ Šafárik University, city: Košice, state: Košice Region, zip: 04180, country: Slovakia, contacts name: Daniela Fiľakovská, PhD, role: CONTACT, phone: +421 55 234 3390, email: daniela.filakovska@upjs.sk, geoPoint lat: 48.71395, lon: 21.25808, hasResults: False