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Status unknownNCT05787015Updated Mar 28, 2023

Testing a Personalized Normative Feedback Intervention for Vaccine Hesitancy

An interventional study of Vaccine Norms Feedback and Alcohol Norms Feedback in COVID-19 and Vaccine Hesitancy, sponsored by University of Washington. Status unknown at 1 site in United States. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by University of Washington · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2022, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Study summary

Rationale: The highest rates of coronavirus disease (i.e., COVID-19) vaccine hesitancy in the US are among young adults (YAs) aged 18-25. Our preliminary studies show that social norms - perceptions of peers' vaccination attitudes/behaviors - are most strongly related to YAs' vaccine intentions/uptake. Most YAs underestimate the perceived importance of vaccination and their peers' intentions to be vaccinated. The proposed research will develop and test an intervention to correct misperceived norms for vaccination hesitancy and uptake.

Methodology: Rapid prototyping with 20 unvaccinated YAs will help refine the content and design of the online intervention. Then, a diverse national sample (N=600) of unvaccinated YAs will be randomized to treatment or an attention-matched control. The treatment condition will receive personalized normative feedback (PNF) designed to correct normative misperceptions for vaccine hesitancy and uptake.

Normative feedback will be derived from the US Census Bureau's Household Pulse Survey. Follow-up surveys will be administered at 1, 2, 3, and 6 months to assess key outcomes including vaccine uptake, intentions, and reasons for vaccine hesitancy.

Aims and Data Analysis:

  • Aim 1: Develop and refine a PNF intervention for vaccine hesitancy/uptake with user feedback from YAs. Rapid analysis of qualitative data will involve looking for themes in responses. Changes will be made iteratively to refine intervention content, design, and delivery.
  • Aim 2: Evaluate intervention efficacy for increasing vaccine uptake and reducing time to first vaccine dose, relative to control, over the following year.
  • Aim 3: Examine mediators (changes in perceived norms) and moderators (intellectual humility, identification with other people and young adults) of intervention efficacy. A longitudinal moderated mediation model will be examined.

Impact: Findings will clarify the causal role of psychological determinants of vaccine hesitancy (social norms, intellectual humility, group identification). If preliminary intervention efficacy is supported, this intervention could be a low-cost, and easily disseminated strategy to promote YAs' vaccine uptake and contribute to public health efforts to address the COVID-19 pandemic.

02

Conditions studied

  • COVID-19
  • Vaccine Hesitancy
03

In context

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18-24 years old (at screening)
  • Reside in the United States.
  • Have not received a COVID-19 vaccine (at screening)
  • Pass attention checks.

Exclusion criteria

Exclusion Criteria:

  • Not meeting inclusion criteria.
  • Not fluent in English.
  • Not providing consent.
  • Unwilling to participate.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Vaccine Norms Feedback

    The participants in the treatment condition will receive personalized normative feedback (PNF) that entails correcting normative misperceptions for US young adults' vaccine uptake rates and prevalence of vaccine hesitancies (e.g., fear of side effects). Participants will be shown discrepancies between their perceived estimate of young adults' vaccination rates and actual national estimates derived from the US Census Bureau's Household Pulse Survey to highlight, in most cases, that they underestimated the vaccination norms.

    Behavioral: Vaccine Norms Feedback

  • Active comparator
    Alcohol Norms Feedback

    Participants randomized to control will complete all measures at the same time as participants in the treatment condition, but will not receive any normative information regarding vaccines. Instead, to match for attention and provide potential benefit, those in the control condition will receive a standard dynamic norms feedback pertaining to alcohol use norms and behaviors.

    Behavioral: Alcohol Norms Feedback

Interventions

  • BehavioralVaccine Norms Feedback

    Personalized normative feedback pertaining to normative misperceptions about vaccination rates and hesitant attitudes.

  • BehavioralAlcohol Norms Feedback

    Personalized normative feedback pertaining to normative misperceptions about alcohol use.

06

What researchers measure

Primary outcomes

  1. COVID-19 vaccine uptake

    Proportion of participants that have received a COVID-19 vaccine, following intervention

    Time frame: Through study completion, an average of 6 months

  2. COVID-19 vaccine attitudes

    Attitudes towards receiving a COVID-19 vaccine measured using the Vaccination Attitudes Examination Scale (modified to COVID-19 vaccines).

    Time frame: Through study completion, an average of 6 months

07

Study locations

1 of 1 sites recruiting
  • University of Washington
    Seattle, Washington 98195, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05787015
Lead sponsor
University of Washington
Collaborators
Centers for Disease Control and Prevention
Responsible party
Scott Graupensperger (Assistant Professor, Department of Psychiatry and Behavioral Sciences, University of Washington) — Principal investigator
First posted
Mar 28, 2023
Start date
Oct 6, 2022
Primary completion
Oct 2023 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 28, 2023

Study contacts

Scott Graupensperger, PhD
Contact
graups@uw.edu
206-543-0080
Scott Graupensperger, PhD
principal investigator · University of Washington

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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