MenB Vaccine: Implementation Via Information, Empowerment and Accessibility

NCT02975596 | Completed

• 3 other identifiers: IRB20160189427449113IRB201703013
• Study Type: interventional
• Target: 1,326
• Locations: 1 country
• Sites: 6

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.

Conditions

Meningococcal Vaccine

Keywords

educational intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Attitudes re: Meningococcal B vaccine

  12 months

Study Arms (5)

Youth

OTHER

Youth between the ages beteen ages 13-18 will be offered awareness, education, empowerment and accessibility intervention components.

Other: Awareness; Other: Education; Other: Empowerment; Other: Accessibility

College

OTHER

Age between 18-23 will be offered awareness, education, empowerment and accessibility intervention components.

Other: Awareness; Other: Education; Other: Empowerment; Other: Accessibility

Adult

OTHER

parents of adolescents and young adults will be offered awareness, education, and accessibility intervention components.

Other: Awareness; Other: Education; Other: Accessibility

Parent focus group

NO INTERVENTION

Parents discussed barriers and reviewed MenB education materials.

Provider focus groups

NO INTERVENTION

Providers discussed barriers and reviewed MenB education materials.

Interventions

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.

Adult; College; Youth

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.

Adult; College; Youth

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.

College; Youth

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.

Adult; College; Youth

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to provide informed consent or assent

You may not qualify if:

• Inability to provide informed consent or assent

Sponsors & Collaborators

• University of Florida: lead

Study Sites (6)

UF Health Family Medicine and Pediatrics - Magnolia Parke

Gainesville, Florida, 32606, United States

Location

UF Health Pediatric After Hours

Gainesville, Florida, 32608, United States

Location

UF Health Pediatrics - Gerold L. Schiebler CMS Center

Gainesville, Florida, 32608, United States

Location

UF Health Pediatrics - Tower Square

Gainesville, Florida, 32608, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

UF Family Medicine - Eastside

Gainesville, Florida, 32641, United States

Location

Related Publications (17)

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• Richardson E, Ryan KA, Lawrence RM, Harle CA, Desai SM, Livingston MD, Rawal A, Staras SAS. Increasing awareness and uptake of the MenB vaccine on a large university campus. Hum Vaccin Immunother. 2021 Sep 2;17(9):3239-3246. doi: 10.1080/21645515.2021.1923347. Epub 2021 Jun 2.

  PMID: 34076556 DERIVED

MeSH Terms

Interventions

Immunization Programs; Educational Status

Intervention Hierarchy (Ancestors)

Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Kathleen Ryan, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 29, 2016
• Study Start: December 1, 2016
• Primary Completion: October 8, 2019
• Study Completion: October 8, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)