MenB Vaccine: Implementation Via Information, Empowerment and Accessibility

Not Applicable

Completed

• Conditions: Meningococcal Vaccine
• Interventions: Other: Awareness; Other: Education; Other: Empowerment; Other: Accessibility

• Registration Number: NCT02975596
• Lead Sponsor: University of Florida

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Study Start: 2016-12
• Primary Completion: 2019-10-08
• Study Completion: 2019-10-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1326

Inclusion Criteria

• Must be able to provide informed consent or assent

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Exclusion Criteria

• Inability to provide informed consent or assent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Youth	Awareness	Youth between the ages beteen ages 13-18 will be offered awareness, education, empowerment and accessibility intervention components.
Youth	Accessibility	Youth between the ages beteen ages 13-18 will be offered awareness, education, empowerment and accessibility intervention components.
College	Education	Age between 18-23 will be offered awareness, education, empowerment and accessibility intervention components.
Adult	Education	parents of adolescents and young adults will be offered awareness, education, and accessibility intervention components.
Youth	Education	Youth between the ages beteen ages 13-18 will be offered awareness, education, empowerment and accessibility intervention components.
Youth	Empowerment	Youth between the ages beteen ages 13-18 will be offered awareness, education, empowerment and accessibility intervention components.
College	Empowerment	Age between 18-23 will be offered awareness, education, empowerment and accessibility intervention components.
Adult	Accessibility	parents of adolescents and young adults will be offered awareness, education, and accessibility intervention components.
College	Awareness	Age between 18-23 will be offered awareness, education, empowerment and accessibility intervention components.
College	Accessibility	Age between 18-23 will be offered awareness, education, empowerment and accessibility intervention components.
Adult	Awareness	parents of adolescents and young adults will be offered awareness, education, and accessibility intervention components.

Primary Outcome Measures

Name	Time	Method
Vaccine uptake in adolescents and young adults	12 months	Percentage receiving MenB vaccine
Knowledge about MenB vaccine efficacy, potential benefits, possible side effects	12 months	Percent of parents and young adults with Men B knowledge

Secondary Outcome Measures

Name	Time	Method
Attitudes re: Meningococcal B vaccine	12 months	Pre- and Post- intervention surveys to assess attitudes, perceptions and decision-making re vaccine acceptance

Trial Locations

Locations (6)

UF Health Pediatrics - Gerold L. Schiebler CMS Center; 🇺🇸 Gainesville, Florida, United States

UF Health Pediatrics - Tower Square; 🇺🇸 Gainesville, Florida, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

UF Family Medicine - Eastside; 🇺🇸 Gainesville, Florida, United States

UF Health Family Medicine and Pediatrics - Magnolia Parke; 🇺🇸 Gainesville, Florida, United States

UF Health Pediatric After Hours; 🇺🇸 Gainesville, Florida, United States