Vaccine HesitancyNCT05120817
Emphasizing the Personal Versus the Social in Educational Interventions For Decreasing Vaccine Hesitancy
A study testing "Personal" intervention, "Social" intervention and "Personal" + "Social" intervention in people with Vaccine Hesitancy and Communication, run by National Research University Higher School of Economics at 1 site in Russia.
Trial summary
This experimental study aims to investigate the effect of different types of educational interventions on overcoming Coronavirus disease 2019 (COVID-19) vaccine hesitancy among the Higher School of Economics (HSE) bachelor students in Russia. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy, Communication
- What is being tested?
- "Personal" intervention, "Social" intervention and "Personal" + "Social" intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteRussia
- Study dates
- Nov 2021to Jan 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- HSE bachelor students from 18 to 25 years old, who agreed to participate in the study.
Who cannot join
- Students who have got vaccinated already.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Higher School of Economics
Moscow
Anastasia Kapuza, + 7 (495) 772 9590 ext. 22094, akapuza@hse.ru
Aynur Kulieva, + 7 (495) 772 9590 ext. 22094, akulieva@hse.ru
About this study
Official title: Me or We? Emphasizing the Personal Versus the Social in Educational Interventions For Decreasing Vaccine Hesitancy
This experimental study aims to investigate the effect of different types of educational interventions on overcoming Coronavirus disease 2019 (COVID-19) vaccine hesitancy among the Higher School of Economics (HSE) bachelor students in Russia.
Read the detailed description
The researchers aim to investigate the effectiveness of three types of educational interventions on overcoming COVID-19 vaccine hesitancy among the HSE bachelor students. The study design implies the comparison of three types of educational interventions which differ in the message that they deliver to the participants: the personal, the social, and a combination of the two. The effects of these interventions will be compared to the control group with no intervention.
Participants in these three experimental groups will receive a link to an educational video about the benefits and costs of vaccination against COVID-19. The videos for the three groups will contain information about vaccination, but each of them will have a different focus.
The participants will be hired on a voluntary basis. All the participants will sign the informed consent form, and the measures will be taken to ensure that their personal data will be protected.
- Conditions
- Vaccine Hesitancy, Communication
- Being tested
- "Personal" intervention, "Social" intervention, "Personal" + "Social" intervention
- Keywords
- vaccine hesitancy, education, COVID-19 vaccine
- Medical subject headings
- Vaccination Hesitancy, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Personal" interventionBehavioural
Participants will receive a link with an invitation to watch a 10-minute educational video about the personal benefits and costs of vaccination against COVID-19. They will also go through pre-and post-test data collection.
"Social" interventionBehavioural
Participants will receive a link with an invitation to watch a 10-minute educational video about the social benefits and costs of vaccination against COVID-19. They will also go through pre-and post-test data collection.
"Personal" + "Social" interventionBehavioural
Participants will receive a link with an invitation to watch a 10-minute educational video about both personal and social benefits and costs of vaccination against COVID-19. They will also go through pre-and post-test data collection.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants do not undergo any intervention. Pre-and post data collection only. |
| Personal | Experimental | Participants are exposed to the message about the personal benefits (and costs) of vaccination which refers to their own safety, their freedoms, their worries about the well-being of their significant others. Receives: Behavioral: "Personal" intervention |
| Social | Experimental | Participants are exposed to the message about the social benefits (and costs) of vaccination which refers to public safety, the well-being of others in their community, the vulnerable groups, etc. Receives: Behavioral: "Social" intervention |
| Personal + Social | Experimental | Participants are exposed to the message about both personal and social benefits (and costs) of vaccination. The message alludes to personal safety as well as public safety and the strain on the healthcare system associated with the uncontrollable spread of the virus. Receives: Behavioral: "Personal" + "Social" intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real vaccination status
Participants report whether they have got vaccinated against COVID-19.
Measured: 1-3 months
Secondary outcomes (1)
Knowledge, attitudes, and self-reported behaviors
Participants will be given a questionnaire to test their knowledge, attitudes towards vaccination, and self-reported behaviors surrounding vaccination and safety protocols. The questionnaire will be designed by the researchers.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine HesitancyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research University Higher School of Economics
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Prashant Loyalka, PhD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120817
- Sponsor's protocol ID
- hsestudy2021
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The deidentified individual participant data (IPD) collected in the course of the experiment will be made available. The Study Protocol, Statistical Analysis Plan, and Informed Consent Form will also be available. All data will be available on request after 6 months following article publication.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Me or We? Emphasizing the Personal Versus the Social in Educational Interventions For Decreasing Vaccine Hesitancy
- ClinicalTrials.gov ID
- NCT05120817
- Acronym / sponsor ID
- hsestudy2021
- Conditions
- Vaccine Hesitancy, Communication
- Keywords
- vaccine hesitancy, education, COVID-19 vaccine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- National Research University Higher School of EconomicsUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Nov 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 15 Nov 2021 (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.
This experimental study aims to investigate the effect of different types of educational interventions on overcoming Coronavirus disease 2019 (COVID-19) vaccine hesitancy among the Higher School of Economics (HSE) bachelor students in Russia.
Detailed description
The researchers aim to investigate the effectiveness of three types of educational interventions on overcoming COVID-19 vaccine hesitancy among the HSE bachelor students. The study design implies the comparison of three types of educational interventions which differ in the message that they deliver to the participants: the personal, the social, and a combination of the two. The effects of these interventions will be compared to the control group with no intervention.
Participants in these three experimental groups will receive a link to an educational video about the benefits and costs of vaccination against COVID-19. The videos for the three groups will contain information about vaccination, but each of them will have a different focus.
The participants will be hired on a voluntary basis. All the participants will sign the informed consent form, and the measures will be taken to ensure that their personal data will be protected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants do not undergo any intervention. Pre-and post data collection only. |
| Personal | Experimental | Behavioral: "Personal" interventionParticipants are exposed to the message about the personal benefits (and costs) of vaccination which refers to their own safety, their freedoms, their worries about the well-being of their significant others. |
| Social | Experimental | Behavioral: "Social" interventionParticipants are exposed to the message about the social benefits (and costs) of vaccination which refers to public safety, the well-being of others in their community, the vulnerable groups, etc. |
| Personal + Social | Experimental | Behavioral: "Personal" + "Social" interventionParticipants are exposed to the message about both personal and social benefits (and costs) of vaccination. The message alludes to personal safety as well as public safety and the strain on the healthcare system associated with the uncontrollable spread of the virus. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- HSE bachelor students from 18 to 25 years old, who agreed to participate in the study.
Key exclusion criteria (1 listed)
- Students who have got vaccinated already.
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 |
|---|---|---|
| "Personal" interventionParticipants will receive a link with an invitation to watch a 10-minute educational video about the personal benefits and costs of vaccination against COVID-19. They will also go through pre-and post-test data collection. | Behavioural | Personal |
| "Social" interventionParticipants will receive a link with an invitation to watch a 10-minute educational video about the social benefits and costs of vaccination against COVID-19. They will also go through pre-and post-test data collection. | Behavioural | Social |
| "Personal" + "Social" interventionParticipants will receive a link with an invitation to watch a 10-minute educational video about both personal and social benefits and costs of vaccination against COVID-19. They will also go through pre-and post-test data collection. | Behavioural | Personal + Social |
Primary outcome
Real vaccination status
Time frame: 1-3 months
Participants report whether they have got vaccinated against COVID-19.
1 secondary outcome
Knowledge, attitudes, and self-reported behaviors
Time frame: 1-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: Yes. The deidentified individual participant data (IPD) collected in the course of the experiment will be made available. The Study Protocol, Statistical Analysis Plan, and Informed Consent Form will also be available. All data will be available on request after 6 months following article publication.
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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.
Prashant Loyalka, PhD study chair
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Personal" intervention, "Social" intervention and "Personal" + "Social" intervention in people with Vaccine Hesitancy and Communication, run by National Research University Higher School of Economics at 1 site in Russia.
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 1 inclusion and 1 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 15 Nov 2021. 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 Russia. 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 Anastasia Kapuza (+ 7 (495) 772 9590 ext. 22094, akapuza@hse.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real vaccination status (time frame: 1-3 months). 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 15 Nov 2021.