MenB Vaccine: Implementation Via Information, Empowerment and Accessibility

Study Overview
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Brief Summary
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As part of an effort to increase MenB vaccine uptake among adolescents and young adults, study teams will conduct qualitative research to maximize the effectiveness of nationally recommended MenB educational materials. In this study, Study Teams will assess local barriers to MenB vaccination by conducting focus groups with parents, students, and health care professionals.

Detailed Description
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Participants (parents of 16-23 year old teens and young adults, high school and college students 16-23 years old, and health care professionals for 16-23 year olds) will be asked to share their thoughts on the completeness of nationally recommended and publicly available MenB vaccine educational materials in addressing hesitations to receipt of the MenB vaccine. There is no risk in discussing reactions to educational materials. The biggest risk is disclosure of information provided in the study which will be reactions to health-promotion material.

Official Title
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Establishing and Evaluating a School and University Campus-Based Approach to Implementing Serogroup B Meningococcal (MenB) Disease Recommendations in Older Adolescents and Young Adults.

Conditions
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Meningococcal Vaccine

Intervention / Treatment
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* Other: Awareness
* Other: Education
* Other: Empowerment
* Other: Accessibility


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be able to provide informed consent or assent Exclusion Criteria: Inability to provide informed consent or assent

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Youth<br>Youth between the ages beteen ages 13-18 will be offered awareness, education, empowerment and accessibility intervention components. | Other: Awareness<br>* Awareness: Conduct an awareness campaign throughout Alachua County to alert the community in general to the significance of Serogroup B meningococcal disease in the United States. To inform the material included in the awareness campaign and the education materials, semi-structured interviews with members for each of the key stakeholder groups: students, parents, and medical practitioners will be conducted.<br>Other: Education<br>* Education: This component will be both web-based and in-person to meet the individual needs of the learners. There will be parent and a student (18-23 years old) version of the educational curriculum. National resources of patient -focused materials and guidelines will be adapted. There will be pre- and post-education surveys to assess knowledge and vaccine decision-making.<br>Other: Empowerment<br>* Empowerment: A guided program for adolescents and young adults on Decision-Making for your Health will be offered on the vaccination days to assist youth in assessing and utilizing health information to guide their personal decision-making for vaccines.<br>Other: Accessibility<br>* Accessibility: MenB vaccine will be offer on the high school and university campuses through a collaborative program between the local schools, university and department of health. We will offer students booster shots of Men ACWY and HPV at the same time. All vaccines will be offered free of charge. Each vaccine administered will be recorded in Florida SHOTS.<br>|
| Other: College<br>Age between 18-23 will be offered awareness, education, empowerment and accessibility intervention components. | Other: Awareness<br>* Awareness: Conduct an awareness campaign throughout Alachua County to alert the community in general to the significance of Serogroup B meningococcal disease in the United States. To inform the material included in the awareness campaign and the education materials, semi-structured interviews with members for each of the key stakeholder groups: students, parents, and medical practitioners will be conducted.<br>Other: Education<br>* Education: This component will be both web-based and in-person to meet the individual needs of the learners. There will be parent and a student (18-23 years old) version of the educational curriculum. National resources of patient -focused materials and guidelines will be adapted. There will be pre- and post-education surveys to assess knowledge and vaccine decision-making.<br>Other: Empowerment<br>* Empowerment: A guided program for adolescents and young adults on Decision-Making for your Health will be offered on the vaccination days to assist youth in assessing and utilizing health information to guide their personal decision-making for vaccines.<br>Other: Accessibility<br>* Accessibility: MenB vaccine will be offer on the high school and university campuses through a collaborative program between the local schools, university and department of health. We will offer students booster shots of Men ACWY and HPV at the same time. All vaccines will be offered free of charge. Each vaccine administered will be recorded in Florida SHOTS.<br>|
| Other: Adult<br>parents of adolescents and young adults will be offered awareness, education, and accessibility intervention components. | Other: Awareness<br>* Awareness: Conduct an awareness campaign throughout Alachua County to alert the community in general to the significance of Serogroup B meningococcal disease in the United States. To inform the material included in the awareness campaign and the education materials, semi-structured interviews with members for each of the key stakeholder groups: students, parents, and medical practitioners will be conducted.<br>Other: Education<br>* Education: This component will be both web-based and in-person to meet the individual needs of the learners. There will be parent and a student (18-23 years old) version of the educational curriculum. National resources of patient -focused materials and guidelines will be adapted. There will be pre- and post-education surveys to assess knowledge and vaccine decision-making.<br>Other: Accessibility<br>* Accessibility: MenB vaccine will be offer on the high school and university campuses through a collaborative program between the local schools, university and department of health. We will offer students booster shots of Men ACWY and HPV at the same time. All vaccines will be offered free of charge. Each vaccine administered will be recorded in Florida SHOTS.<br>|
| No Intervention: Parent focus group<br>Parents discussed barriers and reviewed MenB education materials. | |
| No Intervention: Provider focus groups<br>Providers discussed barriers and reviewed MenB education materials. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine uptake in adolescents and young adults | Percentage receiving MenB vaccine | 12 months | 
| Knowledge about MenB vaccine efficacy, potential benefits, possible side effects | Percent of parents and young adults with Men B knowledge | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitudes re: Meningococcal B vaccine | Pre- and Post- intervention surveys to assess attitudes, perceptions and decision-making re vaccine acceptance | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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educational intervention