Vaccine Hesitancy, Communicable Diseases in Children
Conditions
Keywords
Vaccinations, Vaccine hesitancy, School-based research
Brief 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).
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.
Interventions
BEHAVIORALCommunity Event
Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.
BEHAVIORALEducational Material
Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants
Sponsors
Merck Sharp & Dohme LLC
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Masking description
Following collection of baseline data, schools will be randomized. Study staff measuring the primary outcome will be blinded to school group assignment. Given the intervention, it is not possible to blind participants to group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between February and September 2019. Participants were recruited through the participating school partner, who distributed a recruitment flyer via email and through social media channels. Participants were also recruited through in-person events at the participating schools, such as chorus concerts and parent-teacher conferences.
Pre-assignment details
Four schools were randomized to two arms (intervention vs. control). 502 individuals were assessed for eligibility and 354 were excluded for not meeting inclusion criteria (n=265) or declining to participate (n=89).
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Educational emails about broad health topics to keep control group engaged | 70 |
| Multi-Component Intervention (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
Community Event: Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.
Educational Material: Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants | 78 |
| Total | 148 |
Baseline characteristics
| Characteristic | Usual Care | Multi-Component Intervention | Total |
|---|---|---|---|
| Age, Continuous | 38.00 years STANDARD_DEVIATION 9.79 | 40.46 years STANDARD_DEVIATION 8.59 | 39.32 years STANDARD_DEVIATION 9.21 |
| Annual household income ≤$40,000 | 31 Participants | 27 Participants | 58 Participants |
| Annual household income $40,001 - $80,000 | 26 Participants | 25 Participants | 51 Participants |
| Annual household income >$80,000 | 12 Participants | 23 Participants | 35 Participants |
| Annual household income No Response | 1 Participants | 3 Participants | 4 Participants |
| Education College Graduate | 20 Participants | 37 Participants | 57 Participants |
| Education High School or Less | 35 Participants | 29 Participants | 64 Participants |
| Education No response | 0 Participants | 0 Participants | 0 Participants |
| Education Some College | 15 Participants | 12 Participants | 27 Participants |
| Gender of child Female | 30 Participants | 34 Participants | 64 Participants |
| Gender of child Male | 40 Participants | 44 Participants | 84 Participants |
| Grade of child 6th | 37 Participants | 33 Participants | 70 Participants |
| Grade of child 7th | 22 Participants | 29 Participants | 51 Participants |
| Grade of child 8th | 11 Participants | 16 Participants | 27 Participants |
| Parent participation in school events per year ≤1 | 41 Participants | 37 Participants | 78 Participants |
| Parent participation in school events per year 2-5 | 25 Participants | 24 Participants | 49 Participants |
| Parent participation in school events per year ≥6 | 4 Participants | 16 Participants | 20 Participants |
| Parent participation in school events per year No response | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black/African American | 6 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 22 Participants | 20 Participants | 42 Participants |
| Race/Ethnicity, Customized Race/Ethnicity No response | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 10 Participants | 7 Participants | 17 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 32 Participants | 43 Participants | 75 Participants |
| Relationship Status Married OR living with partner | 43 Participants | 46 Participants | 89 Participants |
| Relationship Status No response | 1 Participants | 2 Participants | 3 Participants |
| Relationship Status Single OR separated OR divorced OR widowed | 26 Participants | 30 Participants | 56 Participants |
| Relationship to child Father | 9 Participants | 8 Participants | 17 Participants |
| Relationship to child Guardian/Grandparent | 5 Participants | 4 Participants | 9 Participants |
| Relationship to child Mother | 56 Participants | 66 Participants | 122 Participants |
| Sex/Gender, Customized Gender Female | 57 Participants | 68 Participants | 125 Participants |
| Sex/Gender, Customized Gender Male | 11 Participants | 7 Participants | 18 Participants |
| Sex/Gender, Customized Gender No response | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Participants were assessed at baseline and follow-up at 6 months.
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Tetanus, diphtheria, acellular pertussis (Tdap) : Vaccine intention at baseline | 74.3 percentage of participants |
| Usual Care | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Tetanus, diphtheria, acellular pertussis (Tdap) : Vaccine intention at follow-up | 97.9 percentage of participants |
| Usual Care | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Meningococcal conjugate vaccine (MCV) : Vaccine intention at baseline | 72.9 percentage of participants |
| Usual Care | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Meningococcal conjugate vaccine (MCV) : Vaccine intention at follow-up | 91.5 percentage of participants |
| Usual Care | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Human papillomavirus (HPV) : Vaccine intention at baseline | 84.1 percentage of participants |
| Usual Care | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Human papillomavirus (HPV) : Vaccine intention at follow-up | 85.7 percentage of participants |
| Multi-Component Intervention | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Human papillomavirus (HPV) : Vaccine intention at baseline | 84.4 percentage of participants |
| Multi-Component Intervention | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Tetanus, diphtheria, acellular pertussis (Tdap) : Vaccine intention at baseline | 83.3 percentage of participants |
| Multi-Component Intervention | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Meningococcal conjugate vaccine (MCV) : Vaccine intention at follow-up | 91.6 percentage of participants |
| Multi-Component Intervention | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Tetanus, diphtheria, acellular pertussis (Tdap) : Vaccine intention at follow-up | 93.0 percentage of participants |
| Multi-Component Intervention | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Human papillomavirus (HPV) : Vaccine intention at follow-up | 87.3 percentage of participants |
| Multi-Component Intervention | Percentage of Participants With Intent to Vaccinate Adolescent Child (Tdap, MCV, HPV) | Meningococcal conjugate vaccine (MCV) : Vaccine intention at baseline | 80.5 percentage of participants |
Comparison: Analysis for vaccine intention of Tdap95% CI: [1, 1.25]Regression, Logistic
Comparison: Analysis for vaccine intention of MCV95% CI: [1, 1.29]Regression, Logistic
Comparison: Analysis for vaccine intention of HPV95% CI: [0.96, 1.14]Regression, Logistic