Testing a Personalized Normative Feedback Intervention for Vaccine Hesitancy

March 14, 2023 updated by: Scott Graupensperger, University of Washington

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Scott Graupensperger, PhD
  • Phone Number: 206-543-0080
  • Email: graups@uw.edu

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:
          • Scott Graupensperger, PhD
          • Phone Number: 206-543-0080
          • Email: graups@uw.edu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Personalized normative feedback pertaining to normative misperceptions about vaccination rates and hesitant attitudes.
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
Personalized normative feedback pertaining to normative misperceptions about alcohol use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 vaccine uptake
Time Frame: Through study completion, an average of 6 months
Proportion of participants that have received a COVID-19 vaccine, following intervention
Through study completion, an average of 6 months
COVID-19 vaccine attitudes
Time Frame: Through study completion, an average of 6 months
Attitudes towards receiving a COVID-19 vaccine measured using the Vaccination Attitudes Examination Scale (modified to COVID-19 vaccines).
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Scott Graupensperger, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00015728
  • 6NU87PS004366-03-02 (Other Grant/Funding Number: Center for Disease Control and Prevention)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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