Testing a Personalized Normative Feedback Intervention for Vaccine Hesitancy

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT05787015
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
600
1
2
25.9
23.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Vaccine Norms Feedback
  • Behavioral: Alcohol Norms Feedback
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Testing a Personalized Normative Feedback Intervention for Vaccine Hesitancy
Actual Study Start Date :
Oct 6, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. COVID-19 vaccine uptake [Through study completion, an average of 6 months]

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

  2. COVID-19 vaccine attitudes [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 24 Years
Sexes Eligible for Study:
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:
  • Not meeting inclusion criteria.

  • Not fluent in English.

  • Not providing consent.

  • Unwilling to participate.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Seattle Washington United States 98195

Sponsors and Collaborators

  • University of Washington
  • Centers for Disease Control and Prevention

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Scott Graupensperger, Assistant Professor, Department of Psychiatry and Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier:
NCT05787015
Other Study ID Numbers:
  • STUDY00015728
  • 6NU87PS004366-03-02
First Posted:
Mar 28, 2023
Last Update Posted:
Mar 28, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 28, 2023