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OpenTrials
Completed

NCT Number: NCT02975596

MenB Vaccine: Implementation Via Information, Empowerment and Accessibility

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.

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Key information

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Family Medicine - Eastside, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be able to provide informed consent or assent

Exclusion criteria

  • Inability to provide informed consent or assent

Treatment and study plan

Awareness

Other

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.

Education

Other

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.

Empowerment

Other

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.

Accessibility

Other

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.

Primary outcomes

  1. Vaccine uptake in adolescents and young adults

    Time frame: 12 months

    Percentage receiving MenB vaccine

  2. Knowledge about MenB vaccine efficacy, potential benefits, possible side effects

    Time frame: 12 months

    Percent of parents and young adults with Men B knowledge

Secondary outcomes

  1. Attitudes re: Meningococcal B vaccine

    Time frame: 12 months

    Pre- and Post- intervention surveys to assess attitudes, perceptions and decision-making re vaccine acceptance

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Acronym: MenBVaccine

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2016
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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