Vaccine HesitancyNCT03854734

Healthy, Immunized Communities Study

A study testing Community Event and Educational Material in people with Vaccine Hesitancy and Communicable Diseases in Children, run by Milton S. Hershey Medical Center at 1 site in United States.

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

This project aims to understand how improving vaccine education and awareness can impact the number of parents who vaccinate, or intend to vaccine, their middle school-aged children with age-appropriate vaccines, including human papillomavirus (HPV), meningitis (MCV) and tetanus, diphtheria, pertussis (TDap). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vaccine Hesitancy, Communicable Diseases in Children
What is being tested?: Community Event and Educational Material
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 148 participants
Where: 1 siteUnited States
Study dates: 14 Feb 2019to 9 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

18 years or older
Parents and guardians of children who attend a School District of Lancaster middle schools
Individuals who read and understand English
Individuals with an email address

Who cannot join

Individuals who are non-English speaking
Parents/Guardians <18 years or older who do not have children attending a middle school in the School District of Lancaster
Individuals who do not have an email address
Individuals who plan on moving out of the Lancaster City area in the next year

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State College of Medicine
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: A Randomized Study to Determine the Efficacy of a Multi-tiered Community- and School-based Approach to Enhance School-aged Children's Recommended Vaccinations.

Read the detailed description

Vaccines are considered one of the greatest public health successes. Unfortunately, an increasing rate of parental resistance in recent years has led to a reemergence of vaccine-preventable diseases. This project seeks to determine the effect of a multi-tiered school and community-based approach to improving rates of parental intent to vaccinate for middle school-aged vaccinations including Human Papillomavirus (HPV), meningitis (MCV) and Tetanus, Diphtheria, Pertussis (TDap).

By randomizing participating schools, parents receiving the intervention participated in (1) a community-based event to raise parental awareness of the importance of vaccination and (2) a social marketing campaign targeting parents' attitudes and knowledge around vaccinations.

The Investigators hypothesized that participation in this study would increase parental intention to vaccinate. In addition, this study intended to improve rates of recommended vaccination among middle school-aged children, as measured through vaccine uptake information required for annual entry into Pennsylvania public schools.

The Penn State team brings a breadth of experience in pediatrics, community-engaged research, adolescent health, and engagement with schools.

Conditions: Vaccine Hesitancy, Communicable Diseases in Children
Being tested: Community Event, Educational Material
Keywords: Vaccinations, Vaccine hesitancy, School-based research
Medical subject headings: Vaccination Hesitancy

What participants receive

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

Community EventBehavioural
Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.
Educational MaterialBehavioural
Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants

Study groups in NCT03854734
Study group	Role	What they receive
Usual Care	No intervention	Educational emails about broad health topics to keep control group engaged
Multi-Component Intervention	Active comparator	(1) a community event to raise parental awareness of the importance of vaccination; (2) social marketing to target parents' attitudes and knowledge around vaccinations in the form of educational material Receives: Behavioral: Community Event; Behavioral: Educational Material

What is being measured

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

Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)
Parental intent to vaccinate their adolescent child with Tdap, MCV, and HPV vaccines, was dichotomized for each vaccine in the survey. Tdap and MCV included the options 1) intention to vaccinate/vaccinated ("plan to get this shot before the first day of 7th grade" or "up-to-date with this shot") or 2) no intention to vaccinate ("no plans to get this shot" or "have or plan to submit an exemption for this shot"). The HPV variable excluded the option "have or plan to submit an exemption for this shot" as vaccine is not required for school entry. Variables (Tdap, MCV, HPV) were compared within and between treatment groups from baseline to 6 mo. follow up with a generalized estimating equations model using the framework of a log-binomial logistic regression model. Risk ratios resulting from these models were used to quantify the magnitude and direction of any significant differences.
Measured: Participants were assessed at baseline and follow-up at 6 months.

Timeline

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

14 Feb 20199 Feb 2023

First posted26 Feb 2019
Study start14 Feb 2019
Primary completion28 Feb 2020
Study completion9 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03854734
Sponsor's protocol ID: Study000011289
Status last verified: Jan 2024
First submitted: 20 Feb 2019
Last updated: 12 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The following steps will be taken to protect subjects' privacy interests: identification and recruitment of potential subjects follows procedures consistent with privacy standards; consent discussion and research interventions will take place in a private setting; the information being collected will be limited to only the minimum amount of data necessary to accomplish the research purposes; the people with access to the identifiable research data will be limited to the minimum necessary as specified in the application and consent process. To external researchers or sponsors, data will be sent sent/received in aggregate/metrics (just counts, no individual data).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of a Vaccine Chatbot on HPV Vaccine Confidence and Hesitancy
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Vaccine Hesitancy

All Vaccine Hesitancy trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Study to Determine the Efficacy of a Multi-tiered Community- and School-based Approach to Enhance School-aged Children's Recommended Vaccinations.
ClinicalTrials.gov ID: NCT03854734
Acronym / sponsor ID: Study000011289
Conditions: Vaccine Hesitancy, Communicable Diseases in Children
Keywords: Vaccinations, Vaccine hesitancy, School-based research
Study type: Interventional
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 14 Feb 2019 (actual)
Primary completion: 28 Feb 2020 (actual)
Study completion: 9 Feb 2023 (actual)
First posted: 26 Feb 2019 (actual)
Results: Posted 12 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The Penn State team brings a breadth of experience in pediatrics, community-engaged research, adolescent health, and engagement with schools.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Usual Care	No intervention	–Educational emails about broad health topics to keep control group engaged
Multi-Component Intervention	Active comparator	Behavioral: Community Event, Behavioral: Educational Material(1) a community event to raise parental awareness of the importance of vaccination; (2) social marketing to target parents' attitudes and knowledge around vaccinations in the form of educational material

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18 years or older
Parents and guardians of children who attend a School District of Lancaster middle schools
Individuals who read and understand English
Individuals with an email address

Key exclusion criteria (4 listed)

Individuals who are non-English speaking
Parents/Guardians <18 years or older who do not have children attending a middle school in the School District of Lancaster
Individuals who do not have an email address
Individuals who plan on moving out of the Lancaster City area in the next year

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
Community EventFormative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.	Behavioural	Multi-Component Intervention
Educational MaterialFormative focus group data was used to design educational messaging to be electronically distributed to intervention participants	Behavioural	Multi-Component Intervention

Primary outcome

Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)
Time frame: Participants were assessed at baseline and follow-up at 6 months.
Parental intent to vaccinate their adolescent child with Tdap, MCV, and HPV vaccines, was dichotomized for each vaccine in the survey. Tdap and MCV included the options 1) intention to vaccinate/vaccinated ("plan to get this shot before the first day of 7th grade" or "up-to-date with this shot") or 2) no intention to vaccinate ("no plans to get this shot" or "have or plan to submit an exemption for this shot"). The HPV variable excluded the option "have or plan to submit an exemption for this shot" as vaccine is not required for school entry. Variables (Tdap, MCV, HPV) were compared within and between treatment groups from baseline to 6 mo. follow up with a generalized estimating equations model using the framework of a log-binomial logistic regression model. Risk ratios resulting from these models were used to quantify the magnitude and direction of any significant differences.

Results and safety

Results posted to the registry on 12 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	70	70
Multi-Component Intervention	78	78

Primary outcome: Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV)

Time frame: Participants were assessed at baseline and follow-up at 6 months.. Number. Unit: percentage of participants

Measure	Usual Care n = 70	Multi-Component Intervention n = 78
Tetanus, diphtheria, acellular pertussis (Tdap) : Vaccine intention at baseline	74.3	83.3
Tetanus, diphtheria, acellular pertussis (Tdap) : Vaccine intention at follow-up	97.9	93.0
Meningococcal conjugate vaccine (MCV) : Vaccine intention at baseline	72.9	80.5
Meningococcal conjugate vaccine (MCV) : Vaccine intention at follow-up	91.5	91.6
Human papillomavirus (HPV) : Vaccine intention at baseline	84.1	84.4
Human papillomavirus (HPV) : Vaccine intention at follow-up	85.7	87.3

Multi-Component Intervention: Risk Ratio (RR): 1.12 (95% CI 1.00 to 1.25), Regression, Logistic
Multi-Component Intervention: Risk Ratio (RR): 1.14 (95% CI 1.00 to 1.29), Regression, Logistic
Multi-Component Intervention: Risk Ratio (RR): 1.05 (95% CI 0.96 to 1.14), Regression, Logistic

Population analysed: 4 middle schools were randomized to either a usual care or multi-component intervention arm. Participants (parents) were assigned to a study arm based on their associated middle school. 30 participants either did not complete the follow up survey (n=27) or did not answer all questions (n=3), as questions were not required. Discrepancies in percentage reporting in the outcomes table below results from inconsistent rates of missingess (range 0-4) across variables (Tdap, MCV, HPV).

Adverse events

Time frame: Due to the nature of the intervention, adverse events were not monitored/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 0	0 of 0	0
Multi-Component Intervention	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): We experienced low parent participation in the intervention activities, potentially limiting the effectiveness of the intervention and resulting outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Peer-reviewed manuscript describing primary study outcomesLink provided by the sponsor.
Individual participant dataSharing planned: No. The following steps will be taken to protect subjects' privacy interests: identification and recruitment of potential subjects follows procedures consistent with privacy standards; consent discussion and research interventions will take place in a private setting; the information being collected will be limited to only the minimum amount of data necessary to accomplish the research purposes; the people with access to the identifiable research data will be limited to the minimum necessary as specified in the application and consent process. To external researchers or sponsors, data will be sent sent/received in aggregate/metrics (just counts, no individual data).

Related trials for Vaccine Hesitancy

Recruiting
Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)
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Development and Evaluation of a Digital Educational Intervention to Improve Vaccine Confidence and Communication Among Registered Nurses: Protocol for a Randomized Controlled Trial (VaxNurse-RCT).
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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.

Jennifer Kraschnewski principal investigator

Penn State College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Community Event and Educational Material in people with Vaccine Hesitancy and Communicable Diseases in Children, run by Milton S. Hershey Medical Center 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: finished, as of the sponsor's last update on 12 Jul 2024. 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?

Yes. Results are posted in the registry (first posted 12 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) (time frame: Participants were assessed at baseline and follow-up at 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03854734.

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 12 Jul 2024.