Testing a Personalized Normative Feedback Intervention for Vaccine Hesitancy

NCT ID: NCT05787015

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-06
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vaccine Norms Feedback

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Alcohol Norms Feedback

Intervention Type: BEHAVIORAL

Personalized normative feedback pertaining to normative misperceptions about alcohol use.

Interventions

Vaccine Norms Feedback

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

Intervention Type: BEHAVIORAL

Alcohol Norms Feedback

Personalized normative feedback pertaining to normative misperceptions about alcohol use.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Scott Graupensperger

Assistant Professor, Department of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Graupensperger, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Scott Graupensperger, PhD

Role: CONTACT

graups@uw.edu

206-543-0080

Facility Contacts

Scott Graupensperger, PhD

Role: primary

graups@uw.edu

206-543-0080

Jack Hilovsky

Role: backup

jhilov@uw.edu

206-543-0080

Other Identifiers

6NU87PS004366-03-02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00015728

Identifier Type: -

Identifier Source: org_study_id