Vaccine HesitancyKidivaxNCT06155877
Testing The Effectiveness Of Two Interventions To Reduce Vaccine Hesitancy Among Adolescents
A study testing Activité Vaccins et Vaccination - LAMAP and Kidivax Chatbot in people with Vaccine Hesitancy and Vaccine Refusal, run by Centre National de la Recherche Scientifique, France at 1 site in France.
Trial summary
Vaccines currently prevent several million deaths every year and more lives could be saved if vaccination take up increased. The World Health Organization identifies vaccine hesitancy as one of the ten most important threats to global health and emphasizes the importance of devising interventions to reduce vaccine… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy, Vaccine Refusal, Health Knowledge, Attitudes, Practice
- What is being tested?
- Activité Vaccins et Vaccination - LAMAP and Kidivax Chatbot
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,590 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2022to 23 Jun 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- French 9th grade students (equivalent to "troisième")'
- One class per school
Who cannot join
- Do not understand French
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Jean Nicod, Département d'études cognitives, École Normale Supérieure, Université PSL, EHESS, CNRS
Paris, 75005
About this study
Official title: Interventions to Reduce Vaccine Hesitancy Among Adolescents: A Randomized Controlled Trial.
Vaccines currently prevent several million deaths every year and more lives could be saved if vaccination take up increased. The World Health Organization identifies vaccine hesitancy as one of the ten most important threats to global health and emphasizes the importance of devising interventions to reduce vaccine hesitancy. The two most promising interventions rely on consensus messaging, which has robust but small effects, and interactive discussion, which has larger effects, but is difficult to scale up. School-based interventions aimed at adolescents have the potential to make the best of both types of interventions. Interventions that take place in schools can be conducted over longer periods of time (up to several hours) and are rolled out by a figure that is typically trusted and respected (the teacher). Moreover, intervening during adolescence is particularly timely since important vaccines are delivered at that age (most notably the human papillomavirus vaccine), and because attitudes towards vaccination during adolescence might have a long-lasting impact, as is the case for other health related attitudes.
This study tests the effectiveness of two interventions, a pedagogical intervention based on consensus messaging, and a chatbot intervention designed to mimic interactive discussion, on 9th grade French pupils.
- Being tested
- Activité Vaccins et Vaccination - LAMAP, Kidivax Chatbot
- Medical subject headings
- Vaccination Hesitancy, Vaccination Refusal, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activité Vaccins et Vaccination - LAMAPBehavioural
Two activities created by the La Main a la Pate foundation
Kidivax ChatbotBehavioural
A chatbot created by our team to answer the most common questions about vaccination, based on a literature review and on focus groups.
| Study group | Role | What they receive |
|---|---|---|
| LAMAP intervention | Experimental | Teachers receive two sets of activities, accompanied by a tutorial. Both sets of activities also include evaluation tools that teachers can use to clarify the objectives of the lesson and to assess the pupils' learning progress. The estimated length of each set is 5 hours.The activities and the tutorials were created by pedagogical experts of the Fondation La Main à la pâte, an NGO whose goal is to foster science education. Activities and tutorials are now freely available on the La Main a la pâte website. Teachers were free to choose whether to present the first or the second set of activities, and to choose how many of the activities to conduct. The actual length of the intervention thus varied from one classroom to another, which mimics ecological conditions. Teachers were asked to devote at least one hour to the activities.
LAMAP activities are available on the experiment's OSF repository Receives: Behavioral: Activité Vaccins et Vaccination - LAMAP |
| Chatbot intervention | Experimental | Teachers, and then pupils, receive a link to a chatbot. This chatbot is a basic conversational agent that can answer the most common questions about vaccination. The chatbot is entirely scripted, providing users with a limited choice of questions at each stage. These questions are the most commonly raised questions about vaccination in adolescents, based on existing literature, and on focus groups conducted by our team. In this intervention, teachers will be asked to supervise the use of the chatbot in class. Pupils will use the chatbot either individually or in groups depending on the number of computers available. Teachers will be encouraged to conclude the intervention by a class discussion. Teachers will be asked to devote about one hour to this intervention (use of the chatbot and class discussion). The full chatbot text is available on the experiment's OSF repository Receives: Behavioral: Kidivax Chatbot |
| Control | No intervention | In the control group, teachers were not sent any extra materials, and pupils were exposed to the standard curriculum. Teachers in the control group received the material after the end of the intervention. French teachers most commonly offer the course on vaccination during the last year of middle school (the equivalent of 9th grade). Time spent on this course varies and can be quite small. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitude towards vaccination
Participants' attitude towards vaccination were measured as the average agreement with 4 questions measured on a 7-points Likert Scale created for this study, ranging from 1 - "Completely disagree" to 7 - "Totally agree", where a higher score corresponds to more positive attitudes towards vaccination.
"The vaccines used in France are effective" "The vaccines used in France are safe" "Vaccines are useful because they protect us from dangerous diseases". "It is important to get vaccinated to protect others". For the full questionnaire, see the experiment's OSF repository.
All outcomes were assessed three times: before teachers received our interventions (November 15th - December 12th), in the middle of the school year (March 6th -June 8th), and after all teachers used our interventions (May 11th - June 23rd).
Measured: Up to 8 months
Secondary outcomes (2)
Knowledge about vaccination
Knowledge is measured as the average number of correct answers to 11 True or False questions:
"Vaccines are not necessary, since diseases can be treated by drugs (such as antibiotics)" "Without vaccines, smallpox would still exist" "The effectiveness of vaccines has been scientifically proven" "Children would be more resistant if they did not receive so many vaccines" "Vaccination can cause certain disorders, such as autism, multiple sclerosis or diabetes" "If a child receives too many vaccines at once, it can overload their immune system" "The chemicals included in vaccines are not dangerous" "Vaccination increases the risk of developing allergies" "Vaccines are injected too early, which prevents children from building their immune systems" "Vaccines cannot cause the disease they protect against" "Thanks to scientific advances, scientists can create vaccines with fewer side effects"
Like all other outcomes, knowledge was assessed three times during the year.
Measured: Up to 8 months
Intention to be vaccinated
Intention to be vaccinated is measured as the average agreement with 5 questions, measured on a 7-points Likert Scale created for this study, ranging from 1 - "Completely disagree" to 7 - "Totally agree", where a higher score corresponds to a stronger intention to be vaccinated.
"If a vaccine for a new disease becomes available, I would get vaccinated" "If an AIDS vaccine became available, I would get vaccinated" "If a common cold vaccine became available, I would get vaccinated" "If a gastroenteritis vaccine became available, I would get vaccinated" "If a vaccine for certain cancers became available, I would get vaccinated" For the full questionnaire, see the experiment's OSF repository
All outcomes were assessed three times: before teachers received our interventions (November 15th - December 12th), in the middle of the school year (March 6th -June 8th), and after all teachers used our interventions (May 11th - June 23rd).
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start15 Nov 2022
- Primary completion23 Jun 2023
- Study completion23 Jun 2023
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized at the school level, to minimize contamination between experimental conditions. Using administrative data, schools were stratified by their Priority Education status and by geographical categories (urban with high density, urban with medium density, rural). Then, within each stratum, schools were matched by triplets using the closest-neighbors approach, minimizing the quadratic distance between schools' success rate at the national end-of-middle school exam and Covid vaccination rate at the EPCI3 level. This resulted in 149 triplets. Within each triplet, schools were randomly assigned to one of the three experimental groups. Randomization code is available at the experiment's OSF repository: https://osf.io/rf5w9/?view\_only=de759e4e36914c909adeac5fd541babf
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8,590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre National de la Recherche Scientifique, France
- Sponsor type
- University, hospital or other
- Collaborators
- Université Paris-Dauphine, Fondation La main à la pâte, Direction de l Évaluation, de la Prospective et de la Performance
- Responsible party
- Principal investigator, Hugo Mercier, Centre National de la Recherche Scientifique, France
- Investigators
- Hugo Mercier, PhD, Principal investigator, Institut Jean Nicod, Département d'études cognitives, École normale supérieure, Université PSL, EHESS, CNRSCoralie Chevallier, PhD, Principal investigator, Institut Jean Nicod, Département d'études cognitives, École normale supérieure, Université PSL, EHESS, CNRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155877
- Sponsor's protocol ID
- ANR-21-SSMS-0006
- Acronym
- Kidivax
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The chatbot discussion tree, as well as LAMAP activities, consent forms, questionnaires, randomization and analysis codes will be made available online on the OSF repository. All consenting participants' responses to the three questionnaires will be anonymized and made available online. Individual covariates obtained from the French ministry of education cannot be made available online, which includes parents' sociodemographics, participants' gender, age, and their results on the French national 6th grade entrance exam.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Reduce Vaccine Hesitancy Among Adolescents: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06155877
- Acronym / sponsor ID
- Kidivax / ANR-21-SSMS-0006
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,590 participants (actual)
- Lead sponsor
- Centre National de la Recherche Scientifique, FranceUniversity, hospital or other
- Collaborators
- Université Paris-Dauphine, Fondation La main à la pâte, Direction de l Évaluation, de la Prospective et de la Performance
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 5 Dec 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.
Vaccines currently prevent several million deaths every year and more lives could be saved if vaccination take up increased. The World Health Organization identifies vaccine hesitancy as one of the ten most important threats to global health and emphasizes the importance of devising interventions to reduce vaccine hesitancy. The two most promising interventions rely on consensus messaging, which has robust but small effects, and interactive discussion, which has larger effects, but is difficult to scale up. School-based interventions aimed at adolescents have the potential to make the best of both types of interventions. Interventions that take place in schools can be conducted over longer periods of time (up to several hours) and are rolled out by a figure that is typically trusted and respected (the teacher). Moreover, intervening during adolescence is particularly timely since important vaccines are delivered at that age (most notably the human papillomavirus vaccine), and because attitudes towards vaccination during adolescence might have a long-lasting impact, as is the case for other health related attitudes.
This study tests the effectiveness of two interventions, a pedagogical intervention based on consensus messaging, and a chatbot intervention designed to mimic interactive discussion, on 9th grade French pupils.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomized at the school level, to minimize contamination between experimental conditions. Using administrative data, schools were stratified by their Priority Education status and by geographical categories (urban with high density, urban with medium density, rural). Then, within each stratum, schools were matched by triplets using the closest-neighbors approach, minimizing the quadratic distance between schools' success rate at the national end-of-middle school exam and Covid vaccination rate at the EPCI3 level. This resulted in 149 triplets. Within each triplet, schools were randomly assigned to one of the three experimental groups. Randomization code is available at the experiment's OSF repository: https://osf.io/rf5w9/?view_only=de759e4e36914c909adeac5fd541babf
| Arm | Type | Receives |
|---|---|---|
| LAMAP intervention | Experimental | Behavioral: Activité Vaccins et Vaccination - LAMAPTeachers receive two sets of activities, accompanied by a tutorial. Both sets of activities also include evaluation tools that teachers can use to clarify the objectives of the lesson and to assess the pupils' learning progress. The estimated length of each set is 5 hours.The activities and the tutorials were created by pedagogical experts of the Fondation La Main à la pâte, an NGO whose goal is to foster science education. Activities and tutorials are now freely available on the La Main a la pâte website. Teachers were free to choose whether to present the first or the second set of activities, and to choose how many of the activities to conduct. The actual length of the intervention thus varied from one classroom to another, which mimics ecological conditions. Teachers were asked to devote at least one hour to the activities. LAMAP activities are available on the experiment's OSF repository |
| Chatbot intervention | Experimental | Behavioral: Kidivax ChatbotTeachers, and then pupils, receive a link to a chatbot. This chatbot is a basic conversational agent that can answer the most common questions about vaccination. The chatbot is entirely scripted, providing users with a limited choice of questions at each stage. These questions are the most commonly raised questions about vaccination in adolescents, based on existing literature, and on focus groups conducted by our team. In this intervention, teachers will be asked to supervise the use of the chatbot in class. Pupils will use the chatbot either individually or in groups depending on the number of computers available. Teachers will be encouraged to conclude the intervention by a class discussion. Teachers will be asked to devote about one hour to this intervention (use of the chatbot and class discussion). The full chatbot text is available on the experiment's OSF repository |
| Control | No intervention | –In the control group, teachers were not sent any extra materials, and pupils were exposed to the standard curriculum. Teachers in the control group received the material after the end of the intervention. French teachers most commonly offer the course on vaccination during the last year of middle school (the equivalent of 9th grade). Time spent on this course varies and can be quite small. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- French 9th grade students (equivalent to "troisième")'
- One class per school
Key exclusion criteria (1 listed)
- Do not understand French
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 |
|---|---|---|
| Activité Vaccins et Vaccination - LAMAPTwo activities created by the La Main a la Pate foundation | Behavioural | LAMAP intervention |
| Kidivax ChatbotA chatbot created by our team to answer the most common questions about vaccination, based on a literature review and on focus groups. | Behavioural | Chatbot intervention |
Primary outcome
Attitude towards vaccination
Time frame: Up to 8 months
Participants' attitude towards vaccination were measured as the average agreement with 4 questions measured on a 7-points Likert Scale created for this study, ranging from 1 - "Completely disagree" to 7 - "Totally agree", where a higher score corresponds to more positive attitudes towards vaccination. "The vaccines used in France are effective" "The vaccines used in France are safe" "Vaccines are useful because they protect us from dangerous diseases". "It is important to get vaccinated to protect others". For the full questionnaire, see the experiment's OSF repository. All outcomes were assessed three times: before teachers received our interventions (November 15th - December 12th), in the middle of the school year (March 6th -June 8th), and after all teachers used our interventions (May 11th - June 23rd).
2 secondary outcomes
Knowledge about vaccination
Time frame: Up to 8 months
Intention to be vaccinated
Time frame: Up to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- This experiment was pre-registered before data was collected on the OSF platform. This experiment is retroactively registered on an ICMJE-compatible database for publication needs. This is the final link for this repository, accessible after publicationLink provided by the sponsor.
- This experiment was pre-registered before data was collected on the OSF platform. This experiment is retroactively registered on an ICMJE-compatible database for publication needs. This is a temporary view-only link of this repositoryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The chatbot discussion tree, as well as LAMAP activities, consent forms, questionnaires, randomization and analysis codes will be made available online on the OSF repository. All consenting participants' responses to the three questionnaires will be anonymized and made available online. Individual covariates obtained from the French ministry of education cannot be made available online, which includes parents' sociodemographics, participants' gender, age, and their results on the French national 6th grade entrance exam.
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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.
Hugo Mercier, PhD principal investigator
Institut Jean Nicod, Département d'études cognitives, École normale supérieure, Université PSL, EHESS, CNRS
Coralie Chevallier, PhD principal investigator
Institut Jean Nicod, Département d'études cognitives, École normale supérieure, Université PSL, EHESS, CNRS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activité Vaccins et Vaccination - LAMAP and Kidivax Chatbot in people with Vaccine Hesitancy and Vaccine Refusal, run by Centre National de la Recherche Scientifique, France at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 5 Dec 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 France. 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?
Attitude towards vaccination (time frame: Up to 8 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 5 Dec 2023.