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

2 november 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

1524

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

    • State of Berlin
      • Berlin, State of Berlin, Tyskland, 10117
        • Rekrytering
        • Charité - Universitätsmedizin Berlin, Berlin-Mitte

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • German citizens
  • Colombian citizens

Exclusion Criteria:

  • Citizens of all other countries

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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)

Aktiv komparator: 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-jämförare: 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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Relative frequency of informed decisions based on respective informational material
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

23 oktober 2026

Primärt slutförande (Beräknad)

1 november 2026

Avslutad studie (Beräknad)

1 november 2026

Studieregistreringsdatum

Först inskickad

2 november 2026

Först inskickad som uppfyllde QC-kriterierna

2 november 2026

Första postat (Faktisk)

6 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

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Nej

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Nej

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