COVID-19NCT05787015
Testing a Personalized Normative Feedback Intervention for Vaccine Hesitancy
A study testing Vaccine Norms Feedback and Alcohol Norms Feedback in people with COVID-19 and Vaccine Hesitancy, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Vaccine Hesitancy
- What is being tested?
- Vaccine Norms Feedback and Alcohol Norms Feedback
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-24 years old (at screening)
- Reside in the United States.
- Have not received a COVID-19 vaccine (at screening)
- Pass attention checks.
Who cannot join
- Not meeting inclusion criteria.
- Not fluent in English.
- Not providing consent.
- Unwilling to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Scott Graupensperger, PhD, 206-543-0080, graups@uw.edu
Jack Hilovsky, 206-543-0080, jhilov@uw.edu
About this study
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.
Read more
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
- Being tested
- Vaccine Norms Feedback, Alcohol Norms Feedback
- Medical subject headings
- COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine Norms FeedbackBehavioural
Personalized normative feedback pertaining to normative misperceptions about vaccination rates and hesitant attitudes.
Alcohol Norms FeedbackBehavioural
Personalized normative feedback pertaining to normative misperceptions about alcohol use.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Alcohol Norms Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 vaccine uptake
Proportion of participants that have received a COVID-19 vaccine, following intervention
Measured: 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).
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start6 Oct 2022
- Primary completionOct 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Scott Graupensperger, University of Washington
- Investigators
- Scott Graupensperger, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787015
- Sponsor's protocol ID
- STUDY00015728
- Other IDs
- 6NU87PS004366-03-02
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Personalized Normative Feedback Intervention for Vaccine Hesitancy
- ClinicalTrials.gov ID
- NCT05787015
- Acronym / sponsor ID
- STUDY00015728
- Conditions
- COVID-19, Vaccine Hesitancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Norms Feedback | Experimental | Behavioral: Vaccine Norms FeedbackThe 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. |
| Alcohol Norms Feedback | Active comparator | Behavioral: Alcohol Norms FeedbackParticipants 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-24 years old (at screening)
- Reside in the United States.
- Have not received a COVID-19 vaccine (at screening)
- Pass attention checks.
Key exclusion criteria (4 listed)
- Not meeting inclusion criteria.
- Not fluent in English.
- Not providing consent.
- Unwilling to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccine Norms FeedbackPersonalized normative feedback pertaining to normative misperceptions about vaccination rates and hesitant attitudes. | Behavioural | Vaccine Norms Feedback |
| Alcohol Norms FeedbackPersonalized normative feedback pertaining to normative misperceptions about alcohol use. | Behavioural | Alcohol Norms Feedback |
Primary outcome
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
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Graupensperger, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccine Norms Feedback and Alcohol Norms Feedback in people with COVID-19 and Vaccine Hesitancy, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott Graupensperger, PhD (206-543-0080, graups@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 vaccine uptake (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.