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Assessment of Communication Interventions on Vaccination Knowledge and Acceptance (Y4F WP5/3)
Effectiveness Assessment of Communication Interventions to Improve Vaccination Knowledge and Acceptance
An online randomized controlled trial (RCT) examining the effectiveness of communication measures regarding TBE vaccination in the European context and yellow fever vaccination in the South American context on an informed vaccination decision. Building on an exploratory qualitative focus group study conducted in 2024 with vaccine-hesitant individuals (Ethics Committee Approval Number EA1/119/24) and an exploratory quantitative study conducted in 2025 among the general population in Germany and Colombia (Ethics Committee Approval Number EA2/112/25), the communication measures were designed to improve education about vaccinations and to increase individual willingness to be vaccinated.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
The study design consists of an online survey. The questionnaire and the communication measures were developed in collaboration with the following partners: the Amsterdam Institute for Global Health and Development (AIGHD) in Amsterdam, the Netherlands, and CIDEIM (Centro Internacional de Entrenamiento e Investigaciones Médicas) in Cali, Colombia, based on the findings of the previous focus group studies and the subsequent quantitative study on the prevalence of knowledge about and acceptance of novel (flavivirus) vaccines and perceived barriers to vaccination among the general population in Germany and Colombia.
Potential participants will be invited to participate in the study by the panel provider Toluna via a link in an email. Individuals who express their willingness to participate will first be asked questions about their sociodemographic background, their vaccination status against TBE (Germany) or yellow fever (Colombia), as well as their perception of risk regarding TBE or yellow fever and the associated vaccinations.
Participants will then be randomly assigned in a 1:1:1 ratio to one of three study arms:
- Control group (in Germany, a vaccination check based on the COVID-19 vaccination check on infektionsschutz.de; in Colombia, an educational video about the yellow fever vaccination from the Colombian Ministry of Health)
- Intervention group 1: Information format A (website)
- Intervention group 2: Information format B (slideshow/carousel)
In both countries, the intervention formats are implemented in the same way; only the vaccination being addressed differs (TBE in Germany, yellow fever in Colombia).
Within the two intervention groups, A and B, there is also a second randomized assignment to a presentation of an established (inactivated vaccine or live vaccine) versus a novel vaccine technology ("NovaCarrier"). This second randomization ensures that the assignment to vaccine technologies within the respective formats is not systematically linked to other participant characteristics. It serves exclusively to explore possible effects of the vaccine technologies on attitudes and intentions and does not form the basis of the primary case number planning.
Participants who view the materials featuring the hypothetical novel vaccine technology are transparently informed at the end of the study that this is a hypothetical technology.
Following the intervention, all participants will complete an adapted Informed Choice questionnaire (Marteau et al., 2001), which assesses risk understanding, knowledge, attitudes, and intention to be vaccinated against TBE or yellow fever. Subsequently, risk perception is assessed again after viewing an informational piece, and finally, participantsare asked two open-ended questions about safety and information needs regarding vaccinations.
The drafted communication measures will first be tested in a pilot study (n = 150; 75 participants per country) in order to adjust the materials to be developed before the main study (n = 1,374; 687 participants per country) if necessary. For this pilot study, the same questionnaire as for the main study will be used, with the addition of three open-ended questions regarding the information formats. The pilot study is not intended for final hypothesis testing, but solely to optimize the informational materials to be tested and, if necessary, the survey questions.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Odette Wegwarth, Prof. Dr.
- Telefoonnummer: +49 30 450 531 074
- E-mail: odette.wegwarth@charite.de
Studie Contact Back-up
- Naam: Miriam K Rumpel, M.Sc.
- Telefoonnummer: +49 30 450 531 058
- E-mail: miriam.rumpel@charite.de
Studie Locaties
-
-
State of Berlin
-
Berlin, State of Berlin, Duitsland, 10117
- Werving
- Charité - Universitätsmedizin Berlin, Berlin-Mitte
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- German citizens
- Colombian citizens
Exclusion Criteria:
- Citizens of all other countries
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Intervention group 1 (website)
Participants are shown informational material A (website) before completing an adapted informed choice questionnaire that assesses participant risk understanding, knowledge, attitudes, and intention to get vaccinated against TBE/yellow fever. |
Participants are shown informational material A (website) |
|
Actieve vergelijker: Intervention group 2 (slideshow/carousel)
Participants are shown informational material B (slideshow/carousel) before completing an adapted informed choice questionnaire that assesses participant risk understanding, knowledge, attitudes, and intention to get vaccinated against TBE/yellow fever. |
Participants are shown informational material B (slideshow/carousel) |
|
Placebo-vergelijker: Control group (vaccine check)
Participants are shown the control informational material (vaccine check) before completing an adapted informed choice questionnaire that assesses participant risk understanding, knowledge, attitudes, and intention to get vaccinated against TBE/yellow fever. |
Participants are shown the control informational material (vaccine check) |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Relative frequency of informed decisions based on respective informational material
Tijdsspanne: Immediately post intervention
|
The relative frequency of informed decisions based on the respective materials developed. Participants are classified into "informed" and "uninformed" based on their responses and the instrument developed my Marteau et al. (2001) |
Immediately post intervention
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 2026_Y4F_WP5.3
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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