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Meningococcal VaccineMenBVaccineNCT02975596

MenB Vaccine: Implementation Via Information, Empowerment and Accessibility

A study testing Awareness, Education and Empowerment in people with Meningococcal Vaccine, run by University of Florida at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Meningococcal Vaccine
What is being tested?
Awareness, Education and Empowerment
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,326 participants
Where
6 sitesUnited States
Study dates
Dec 2016to 8 Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Must be able to provide informed consent or assent

Who cannot join

  • Inability to provide informed consent or assent

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • UF Health Family Medicine and Pediatrics - Magnolia Parke

    Gainesville, Florida, 32606

  • UF Health Pediatric After Hours

    Gainesville, Florida, 32608

  • UF Health Pediatrics - Gerold L. Schiebler CMS Center

    Gainesville, Florida, 32608

  • UF Health Pediatrics - Tower Square

    Gainesville, Florida, 32608

  • University of Florida

    Gainesville, Florida, 32610

  • UF Family Medicine - Eastside

    Gainesville, Florida, 32641

Other trials in United States

About this study

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.

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.

Read the 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.

Being tested
Awareness, Education, Empowerment, Accessibility
Keywords
educational intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AwarenessOther

    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.

  • EducationOther

    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.

  • EmpowermentOther

    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.

  • AccessibilityOther

    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.

Study groups in NCT02975596
Study groupRoleWhat they receive
YouthOtherYouth between the ages beteen ages 13-18 will be offered awareness, education, empowerment and accessibility intervention components.
Receives: Other: Awareness; Other: Education; Other: Empowerment; Other: Accessibility
CollegeOtherAge between 18-23 will be offered awareness, education, empowerment and accessibility intervention components.
Receives: Other: Awareness; Other: Education; Other: Empowerment; Other: Accessibility
AdultOtherparents of adolescents and young adults will be offered awareness, education, and accessibility intervention components.
Receives: Other: Awareness; Other: Education; Other: Accessibility
Parent focus groupNo interventionParents discussed barriers and reviewed MenB education materials.
Provider focus groupsNo interventionProviders discussed barriers and reviewed MenB education materials.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vaccine uptake in adolescents and young adults

    Percentage receiving MenB vaccine

    Measured: 12 months

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

    Percent of parents and young adults with Men B knowledge

    Measured: 12 months

Secondary outcomes (1)

  1. Attitudes re: Meningococcal B vaccine

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2016 (estimated)
  2. Study startDec 2016
  3. Primary completion8 Oct 2019
  4. Study completion8 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02975596
Sponsor's protocol ID
IRB201601894
Other IDs
27449113, IRB201703013
Acronym
MenBVaccine
Status last verified
Feb 2020
First submitted
23 Nov 2016
Last updated
6 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26068563

  • 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.

    PubMed 26492381

  • Reagan-Steiner S, Yankey D, Jeyarajah J, Elam-Evans LD, Singleton JA, Curtis CR, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 Years - United States, 2014. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6429a3.htm. Accessed 24 June 2016.

  • 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.

  • 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.

    PubMed 3068205

  • 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.

    PubMed 17726032

  • 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.

    PubMed 22341170

  • 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.

    PubMed 25544805

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

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

  • 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.

    PubMed 24286572

  • 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.

    PubMed 25489850

  • 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.

    PubMed 25752744

  • 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.

    PubMed 19588449

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Awareness, Education and Empowerment in people with Meningococcal Vaccine, run by University of Florida at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccine uptake in adolescents and young adults (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02975596, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020; AzTrials last refreshed its copy on 31 Oct 2026.

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