Clinical trial NCT02975596: MenB Vaccine: Implementation Via Information, Empowerment and Accessibility
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meningococcal Vaccine
Keywords: educational intervention
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 1326
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* Must be able to provide informed consent or assent

Exclusion Criteria:

* Inability to provide informed consent or assent

Primary outcomes:
measure: Vaccine uptake in adolescents and young adults
timeFrame: 12 months
measure: Knowledge about MenB vaccine efficacy, potential benefits, possible side effects
timeFrame: 12 months
Secondary outcomes:
measure: Attitudes re: Meningococcal B vaccine
timeFrame: 12 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Family Medicine and Pediatrics - Magnolia Parke
state: Florida
city: Gainesville
country: United States
facility: UF Health Pediatric After Hours
state: Florida
city: Gainesville
country: United States
facility: UF Health Pediatrics - Gerold L. Schiebler CMS Center
state: Florida
city: Gainesville
country: United States
facility: UF Health Pediatrics - Tower Square
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Gainesville
country: United States
facility: UF Family Medicine - Eastside
state: Florida
Study officials:
affiliation: University of Florida
name: Kathleen Ryan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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. doi: 10.15585/mmwr.mm6429a3.
citation: 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.
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. doi: 10.1177/109019818801500401.
citation: DiClemente RJ, Salazar LF, Crosby RA. A review of STD/HIV preventive interventions for adolescents: sustaining effects using an ecological approach. J Pediatr Psychol. 2007 Sep;32(8):888-906. doi: 10.1093/jpepsy/jsm056. Epub 2007 Aug 27.
citation: Burrus B, Leeks KD, Sipe TA, Dolina S, Soler R, Elder R, Barrios L, Greenspan A, Fishbein D, Lindegren ML, Achrekar A, Dittus P; Community Preventive Services Task Force. Person-to-person interventions targeted to parents and other caregivers to improve adolescent health: a community guide systematic review. Am J Prev Med. 2012 Mar;42(3):316-26. doi: 10.1016/j.amepre.2011.12.001.
citation: Albert D, Chein J, Steinberg L. Peer Influences on Adolescent Decision Making. Curr Dir Psychol Sci. 2013 Apr;22(2):114-120. doi: 10.1177/0963721412471347.
citation: Corbin J, Strauss A. Basics of qualitative research: Techniques and procedures for developing grounded theory. Sage publications; 2014.
citation: Centers for Disease Control and Prevention. Adolescent and adult vaccine quiz. http://www2.cdc.gov/nip/adultimmsched/. Accessed 24 June 2016.
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.
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.
citation: 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.
citation: 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;2009(3):MR000008. doi: 10.1002/14651858.MR000008.pub4.
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.
citation: Yuan CT, Nembhard IM, Stern AF, Brush JE Jr, Krumholz HM, Bradley EH. Blueprint for the dissemination of evidence-based practices in health care. Issue Brief (Commonw Fund). 2010 May;86:1-16.
citation: 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.