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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Event | Behavioral | Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants were assessed at baseline and follow-up at 6 months. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Kraschnewski | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
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| Label | URL |
|---|---|
| Peer-reviewed manuscript describing primary study outcomes | View source |
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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).
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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).
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Educational emails about broad health topics to keep control group engaged |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Educational emails about broad health topics to keep control group engaged |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Number | percentage of participants | Participants were assessed at baseline and follow-up at 6 months. |
Due to the nature of the intervention, adverse events were not monitored/assessed.
Due to the nature of the intervention, adverse events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Educational emails about broad health topics to keep control group engaged |
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We experienced low parent participation in the intervention activities, potentially limiting the effectiveness of the intervention and resulting outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Kraschnewski, Professor of Medicine and Public Health Sciences | Penn State College of Medicine | 717-531-8161 | jkraschnewski@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2019 | Mar 1, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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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.
| Educational Material | Behavioral | Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Relationship Status | Count of Participants | Participants |
|
| Annual household income | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Relationship to child | Count of Participants | Participants |
|
| Grade of child | Count of Participants | Participants |
|
| Gender of child | Count of Participants | Participants |
|
| Parent participation in school events per year | Count of Participants | Participants |
|
| Middle Schools |
| Middle Schools |
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|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001519 | Behavior |