MenB Vaccine: Implementation Via Information, Empowerment and Accessibility (MenBVaccine)

February 4, 2020 updated by: University of Florida

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1326

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Gainesville, Florida, United States, 32608
        • UF Health Pediatrics - Gerold L. Schiebler CMS Center
      • Gainesville, Florida, United States, 32606
        • UF Health Family Medicine and Pediatrics - Magnolia Parke
      • Gainesville, Florida, United States, 32608
        • UF Health Pediatric After Hours
      • Gainesville, Florida, United States, 32608
        • UF Health Pediatrics - Tower Square
      • Gainesville, Florida, United States, 32641
        • UF Family Medicine - Eastside

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be able to provide informed consent or assent

Exclusion Criteria:

  • Inability to provide informed consent or assent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Youth
Youth between the ages beteen ages 13-18 will be offered awareness, education, empowerment and accessibility intervention components.
Other: Awareness
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.
Other: Education
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.
Other: Empowerment
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.
Other: Accessibility
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.
Other: College
Age between 18-23 will be offered awareness, education, empowerment and accessibility intervention components.
Other: Awareness
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.
Other: Education
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.
Other: Empowerment
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.
Other: Accessibility
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.
Other: Adult
parents of adolescents and young adults will be offered awareness, education, and accessibility intervention components.
Other: Awareness
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.
Other: Education
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.
Other: Accessibility
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.
No Intervention: Parent focus group
Parents discussed barriers and reviewed MenB education materials.
No Intervention: Provider focus groups
Providers discussed barriers and reviewed MenB education materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine uptake in adolescents and young adults
Time Frame: 12 months
Percentage receiving MenB vaccine
12 months
Knowledge about MenB vaccine efficacy, potential benefits, possible side effects
Time Frame: 12 months
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
Time Frame: 12 months
Pre- and Post- intervention surveys to assess attitudes, perceptions and decision-making re vaccine acceptance
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Kathleen Ryan, MD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

October 8, 2019

Study Completion (Actual)

October 8, 2019

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB201601894
  • 27449113 (Other Grant/Funding Number: Pfizer, Inc.)
  • IRB201703013 (Other Identifier: UF IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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