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Vaccine RefusalNCT05238428

Understanding and Overcoming the Racial/Ethnic Inequalities in COVID-19 Vaccination Acceptance

A study testing Trust boost in people with Vaccine Refusal, run by University of Essex at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

With the constant threat of new epidemic waves and the emergence of variants, COVID-19 resilience can only be attained when a sufficient level of immunity is achieved. Yet, in the US and the UK, COVID-19 vaccination campaigns have failed to secure consistent vaccination acceptance in racial/ethnic minority… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Vaccine Refusal
What is being tested?
Trust boost
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,039 participants
Where
1 siteUnited Kingdom
Study dates
3 Feb 2022to 5 Mar 2022
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • if participants complete the study in less than 5 minutes
  • if participants complete the study without paying attention (as indicated by their answers to two attention check questions)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Qualtrics. The data is gathered via an online platform.

    London

Other trials in United Kingdom

About this study

Official title: Mind the Vaccination Gap: Understanding and Overcoming the Racial/Ethnic Inequalities in COVID-19 Vaccination Acceptance

With the constant threat of new epidemic waves and the emergence of variants, COVID-19 resilience can only be attained when a sufficient level of immunity is achieved. Yet, in the US and the UK, COVID-19 vaccination campaigns have failed to secure consistent vaccination acceptance in racial/ethnic minority communities. Despite racial/ethnic minorities being more at risk from COVID-19, they are less vaccinated than the White majority. The investigators propose that current vaccination invitation messages are deemed less trustworthy by racial/ethnic minorities than the White majority and that this might partly explain reduced vaccination acceptance. To provide causal evidence of the role of trust and actionable insights, the investigators will experimentally assess the benefits of new invitation messages to receive the COVID-19 booster dose in large, racially/ethnically diverse samples in the US and the UK. Results will evidence how to increase message and source trustworthiness to foster trust and vaccination acceptance across racial/ethnic groups.

Conditions
Vaccine Refusal
Being tested
Trust boost
Keywords
COVID-19 vaccination acceptance, vaccine hesitancy, trust, health inequality, racial/ethnicity
Medical subject headings
Vaccination Refusal, Vaccination Hesitancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trust boostBehavioural

    The investigators adapt the wording of the vaccination invitation to foster trust and increase vaccination acceptance.

Study groups in NCT05238428
Study groupRoleWhat they receive
Control sender + control contentNo interventionParticipants will read the following text in an online survey: You are invited to book your COVID-19 booster vaccination. Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Control sender + Low trust boost contentExperimentalParticipants will read the following text in an online survey: You are invited to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Receives: Behavioral: Trust boost
Control sender + Medium trust boost contentExperimentalParticipants will read the following text in an online survey: You are invited to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. Vaccines may cause side effects, but the benefits outweigh the risks. The most common side effects are very mild (e.g., sore arm, fever) and severe side effects are very rare (e.g., allergic reaction). Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Receives: Behavioral: Trust boost
Control sender+ high trust boost contentExperimentalParticipants will read the following text in an online survey: You are invited to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. This vaccination is especially important for people who are at higher risk from COVID such as older individuals or those from ethnic minorities. Vaccines may cause side effects, but the benefits outweigh the risks. The most common side effects are very mild (e.g., sore arm, a fever) and severe side effects are very rare (e.g., allergic reaction). Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Receives: Behavioral: Trust boost
Low trust boost Sender + control contentExperimentalParticipants will read the following text in an online survey: As your local GP, I would like to invite you to book your COVID-19 booster vaccination. Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Receives: Behavioral: Trust boost
Low trust boost Sender + low trust boost contentExperimentalParticipants will read the following text in an online survey: As your local GP, I would like to invite you to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Receives: Behavioral: Trust boost
Low trust boost Sender + medium trust boost contentExperimentalParticipants will read the following text in an online survey: As your local GP, I would like to invite you to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. Vaccines may cause side effects, but the benefits outweigh the risks. The most common side effects are very mild (e.g., sore arm, fever) and severe side effects are very rare (e.g., allergic reaction). Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Receives: Behavioral: Trust boost
Low trust boost sender + high trust boost contentExperimentalParticipants will read the following text in an online survey: As your local GP, I would like to invite you to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. This vaccination is especially important for people who are at higher risk from COVID such as older individuals or those from ethnic minorities. Vaccines may cause side effects, but the benefits outweigh the risks. The most common side effects are very mild (e.g., sore arm, a fever) and severe side effects are very rare (e.g., allergic reaction). Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Receives: Behavioral: Trust boost
Medium trust boost Sender + control contentExperimentalParticipants will read the following text in an online survey: As your local GP and a health expert who cares for the local community, I would like to invite you to book your COVID-19 booster vaccination. Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Receives: Behavioral: Trust boost
Medium trust boost sender + low trust boost contentExperimentalParticipants will read the following text in an online survey: As your local GP and a health expert who cares for the local community, I would like to invite you to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Receives: Behavioral: Trust boost
Medium trust boost sender + Medium trust boost contentExperimentalParticipants will read the following text in an online survey: As your local GP and a health expert who cares for the local community, I would like to invite you to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. Vaccines may cause side effects, but the benefits outweigh the risks. The most common side effects are very mild (e.g., sore arm, fever) and severe side effects are very rare (e.g., allergic reaction). Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Receives: Behavioral: Trust boost
Medium trust boost Sender+ high trust boost contentExperimentalParticipants will read the following text in an online survey: As your local GP and a health expert who cares for the local community, I would like to invite you to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. This vaccination is especially important for people who are at higher risk from COVID such as older individuals or those from ethnic minorities. Vaccines may cause side effects, but the benefits outweigh the risks. The most common side effects are very mild (e.g., sore arm, a fever) and severe side effects are very rare (e.g., allergic reaction). Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5
Receives: Behavioral: Trust boost
High trust boost sender + control contentExperimentalParticipants will read the following text in an online survey: As your local GP and a health expert who cares for the local community, I would like to invite you to book your COVID-19 booster vaccination. Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5 Dr Sanjay Kumar
Receives: Behavioral: Trust boost
High trust boost sender + low trust boost contentExperimentalParticipants will read the following text in an online survey: As your local GP and a health expert who cares for the local community, I would like to invite you to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5 Dr Sanjay Kumar
Receives: Behavioral: Trust boost
High trust boost Sender + medium trust boost contentExperimentalParticipants will read the following text in an online survey: As your local GP and a health expert who cares for the local community, I would like to invite you to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. Vaccines may cause side effects, but the benefits outweigh the risks. The most common side effects are very mild (e.g., sore arm, fever) and severe side effects are very rare (e.g., allergic reaction). Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5 Dr Sanjay Kumar
Receives: Behavioral: Trust boost
High trust boost sender + high trust boost contentExperimentalParticipants will read the following text in an online survey: As your local GP and a health expert who cares for the local community, I would like to invite you to book your COVID-19 booster vaccination. The vaccine reduces your chance of becoming infected and protects you against severe forms of the illness. It also protects your loved ones by reducing the risk that you infect others. COVID can be severe, don't risk it. This vaccination is especially important for people who are at higher risk from COVID such as older individuals or those from ethnic minorities. Vaccines may cause side effects, but the benefits outweigh the risks. The most common side effects are very mild (e.g., sore arm, a fever) and severe side effects are very rare (e.g., allergic reaction). Click here to book an appointment: accurx.thirdparty.nhs.uk/r/aafwaczmd5 Dr Sanjay Kumar
Receives: Behavioral: Trust boost

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trust perception

    Perceived trustworthiness of the vaccine invitation. Participants will rate how trustworthy is the invitation message on a 5 point Likert scale (1: Untrustworthy 3: Not sure, 5: Trustworthy)

    Measured: immediately after intervention

  2. Vaccination appointment booking

    Likelihood to book a vaccination appointment via the message. Participants will report if they would use the link in the message to book their vaccination appointment on a 5 point Likert scale (1: No, I would not, 3: Not sure/maybe later, 5: Yes, I would)

    Measured: immediately after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start3 Feb 2022
  3. Primary completion28 Feb 2022
  4. Study completion5 Mar 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
In a 4 x 4 experimental design, the investigators will manipulate the content of the vaccination invitation message in within-subject and the message source in between-subjects. Each participant will hence read four versions of the COVID-19 booster vaccination invitation message sent by one of the four possible sources.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,039 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05238428
Sponsor's protocol ID
ETH2122-0265
Status last verified
May 2022
First submitted
1 Feb 2022
Last updated
24 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data of the study will be shared on the Open Science Framework after publication.

Questions about this trial

What is this clinical trial studying?

A study testing Trust boost in people with Vaccine Refusal, run by University of Essex at 1 site in United Kingdom.

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 0 inclusion and 2 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: finished, as of the sponsor's last update on 24 May 2022. 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 Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trust perception (time frame: immediately after intervention). 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 24 May 2022.

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