Testing a Personalized Normative Feedback Intervention for Vaccine Hesitancy

NCT05787015 | Unknown

• 2 other identifiers: STUDY000157286NU87PS004366-03-02
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Vaccine Hesitancy

Outcome Measures

Primary Outcomes (2)

• COVID-19 vaccine uptake

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

  Through study completion, an average of 6 months

• COVID-19 vaccine attitudes

  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

Study Arms (2)

Vaccine Norms Feedback

EXPERIMENTAL

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

Alcohol Norms Feedback

ACTIVE COMPARATOR

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

Vaccine Norms Feedback BEHAVIORAL

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

Vaccine Norms Feedback

Alcohol Norms Feedback BEHAVIORAL

Personalized normative feedback pertaining to normative misperceptions about alcohol use.

Alcohol Norms Feedback

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Not fluent in English.
• Not providing consent.
• Unwilling to participate.

Sponsors & Collaborators

• University of Washington: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

COVID-19; Vaccination Hesitancy

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Scott Graupensperger, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Graupensperger, PhD

CONTACT

206-543-0080; graups@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 28, 2023
• Study Start: October 6, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

US (1)