MenB Vaccine: Implementation Via Information, Empowerment and Accessibility

Meningococcal Vaccine Clinical Trial

— MenBVaccine  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975596
• Other study ID #: IRB201601894
• Secondary ID: 27449113IRB20170
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: October 8, 2019

Study information

• Verified date: February 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1326
• Est. completion date: October 8, 2019
• Est. primary completion date: October 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 99 Years

Eligibility

Inclusion Criteria:

• Must be able to provide informed consent or assent

Exclusion Criteria:

• Inability to provide informed consent or assent

Related Conditions & MeSH terms

• Meningococcal Vaccine

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
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	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (16)

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Centers for Disease Control and Prevention. Adolescent and adult vaccine quiz. http://www2.cdc.gov/nip/adultimmsched/. Accessed 24 June 2016.

Corbin J, Strauss A. Basics of qualitative research: Techniques and procedures for developing grounded theory. Sage publications; 2014.

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Edwards PJ, Roberts I, Clarke MJ, Diguiseppi C, Wentz R, Kwan I, Cooper R, Felix LM, Pratap S. Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev. 2009 Jul 8;(3):MR000008. doi: 10.1002/14651858.MR000008.pub4. Review. — View Citation

Faes C, Molenberghs G, Aerts M, Verbeke G, Kenward MG. The effective sample size and an alternative small-sample degrees-of-freedom method. Am Stat. 2009 Nov 1;63(4):389-99.

Hamborsky J, Kroger A, Wolfe CS. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. 13th ed. Washington D.C. Public Health Foundation; 2015.

Livingston MD, Komro KA, Wagenaar AC. The effects of survey modality on adolescents' responses to alcohol use items. Alcohol Clin Exp Res. 2015 Apr;39(4):710-5. doi: 10.1111/acer.12659. Epub 2015 Mar 9. — View Citation

MacNeil JR, Rubin L, Folaranmi T, Ortega-Sanchez IR, Patel M, Martin SW. Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR Morb Mortal Wkly Rep. 2015 Oct 23;64(41):1171-6. doi: 10.15585/mmwr.mm6441a3. — View Citation

McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988 Winter;15(4):351-77. Review. — View Citation

Reagan-Steiner S, Yankey D, Jeyarajah J, Elam-Evans LD, Singleton JA, Curtis CR, MacNeil J, Markowitz LE, Stokley S. National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13-17 Years--United States, 2014. MMWR Morb Mortal Wkly Rep. 2015 Jul 31;64(29):784-92. — View Citation

Soeters HM, McNamara LA, Whaley M, Wang X, Alexander-Scott N, Kanadanian KV, Kelleher CM, MacNeil J, Martin SW, Raines N, Sears S, Vanner C, Vuong J, Bandy U, Sicard K, Patel M; Centers for Disease Control (CDC). Serogroup B Meningococcal Disease Outbreak and Carriage Evaluation at a College - Rhode Island, 2015. MMWR Morb Mortal Wkly Rep. 2015 Jun 12;64(22):606-7. — View Citation

Tran CH, Sugimoto JD, Pulliam JR, Ryan KA, Myers PD, Castleman JB, Doty R, Johnson J, Stringfellow J, Kovacevich N, Brew J, Cheung LL, Caron B, Lipori G, Harle CA, Alexander C, Yang Y, Longini IM Jr, Halloran ME, Morris JG Jr, Small PA Jr. School-located influenza vaccination reduces community risk for influenza and influenza-like illness emergency care visits. PLoS One. 2014 Dec 9;9(12):e114479. doi: 10.1371/journal.pone.0114479. eCollection 2014. — View Citation

Tsai Y, Zhou F, Wortley P, Shefer A, Stokley S. Trends and characteristics of preventive care visits among commercially insured adolescents, 2003-2010. J Pediatr. 2014 Mar;164(3):625-30. doi: 10.1016/j.jpeds.2013.10.042. Epub 2013 Nov 25. — View Citation

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* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine uptake in adolescents and young adults	Percentage receiving MenB vaccine	12 months
Primary	Knowledge about MenB vaccine efficacy, potential benefits, possible side effects	Percent of parents and young adults with Men B knowledge	12 months
Secondary	Attitudes re: Meningococcal B vaccine	Pre- and Post- intervention surveys to assess attitudes, perceptions and decision-making re vaccine acceptance	12 months