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Assessment of Communication Interventions on Vaccination Knowledge and Acceptance (Y4F WP5/3)

2 november 2026 bijgewerkt door: Odette Wegwarth, Charite University, Berlin, Germany

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

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

Ingrijpend

Inschrijving (Geschat)

1524

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • State of Berlin
      • Berlin, State of Berlin, Duitsland, 10117
        • Werving
        • Charité - Universitätsmedizin Berlin, Berlin-Mitte

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • German citizens
  • Colombian citizens

Exclusion Criteria:

  • Citizens of all other countries

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

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

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

23 oktober 2026

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 november 2026

Studieregistratiedata

Eerst ingediend

2 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 november 2026

Eerst geplaatst (Werkelijk)

6 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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