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School-located Influenza Vaccination Clinics for Adolescents (SKIPP RCT2)

Primary Purpose

Childhood Influenza Vaccination, School-located Influenza Vaccination

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
School-located Influenza Vaccination
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Childhood Influenza Vaccination focused on measuring Influenza Vaccination Rates

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Currently enrolled students of a participating school

Exclusion Criteria:

  • Not a currently enrolled student of a participating school

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    School-located Influenza Vaccination

    Arm Description

    No school-located influenza vaccination clinic

    Children in intervention schools were offered a chance to receive influenza vaccination at a school-located influenza vaccination clinic, if their parent or legal guardian provided permission

    Outcomes

    Primary Outcome Measures

    Influenza vaccination status as recorded in the NY state registry (NYSIIS)
    Vaccination status for the 2014/2015 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2017
    Last Updated
    May 2, 2017
    Sponsor
    University of California, Los Angeles
    Collaborators
    University of Rochester, Agency for Healthcare Research and Quality (AHRQ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03137667
    Brief Title
    School-located Influenza Vaccination Clinics for Adolescents
    Acronym
    SKIPP RCT2
    Official Title
    Efficacy Study of School-located Influenza Vaccination Clinics to Increase Influenza Vaccination Rates in Monroe County, New York
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 30, 2015 (Actual)
    Primary Completion Date
    January 15, 2016 (Actual)
    Study Completion Date
    July 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    University of Rochester, Agency for Healthcare Research and Quality (AHRQ)

    4. Oversight

    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A cluster-randomized trial (clustering by school) was conducted in Monroe County, NY. Twenty middle and high schools were paired based on several characteristics and randomized within pairs to receiving a school-based influenza vaccination clinic or not (control).
    Detailed Description
    The overarching goal of the study was to evaluate the effectiveness and cost-effectiveness of offering school-based influenza vaccination clinics during school hours on influenza vaccination rates. A cluster-randomized trial (clustering by school) was conducted in Monroe County, NY. Twenty middle and high schools were paired based on several characteristics including urban/suburban,school grade-span (6-8th, 9-12th), school size, percent of students eligible for free or reduced school lunch, and influenza vaccination rates in the previous season among students in the school. School were randomized within pairs, with one school offering a school-based influenza vaccination clinic or and one school not offering the clinic (control).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Influenza Vaccination, School-located Influenza Vaccination
    Keywords
    Influenza Vaccination Rates

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Masking Description
    The investigator is not aware of the allocation at the level of the patient. In addition, the investigator is not involved in vaccine verification (data collection involving patient-level vaccination status)
    Allocation
    Randomized
    Enrollment
    17650 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No school-located influenza vaccination clinic
    Arm Title
    School-located Influenza Vaccination
    Arm Type
    Experimental
    Arm Description
    Children in intervention schools were offered a chance to receive influenza vaccination at a school-located influenza vaccination clinic, if their parent or legal guardian provided permission
    Intervention Type
    Other
    Intervention Name(s)
    School-located Influenza Vaccination
    Intervention Description
    Children in the intervention arm are enrolled in schools in Monroe County, New York that are offering school-located influenza vaccination clinics during school hours
    Primary Outcome Measure Information:
    Title
    Influenza vaccination status as recorded in the NY state registry (NYSIIS)
    Description
    Vaccination status for the 2014/2015 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic
    Time Frame
    Within one year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Currently enrolled students of a participating school Exclusion Criteria: Not a currently enrolled student of a participating school

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    31234842
    Citation
    Yoo BK, Schaffer SJ, Humiston SG, Rand CM, Goldstein NPN, Albertin CS, Concannon C, Szilagyi PG. Cost effectiveness of school-located influenza vaccination programs for elementary and secondary school children. BMC Health Serv Res. 2019 Jun 24;19(1):407. doi: 10.1186/s12913-019-4228-5.
    Results Reference
    derived
    PubMed Identifier
    30878250
    Citation
    Schaffer SJ, Rand CM, Humiston SG, Concannon C, Hightower AD, Albertin C, Szilagyi PG. Practical considerations in developing a successful school-located influenza vaccination (SLIV) program. Vaccine. 2019 Apr 10;37(16):2171-2173. doi: 10.1016/j.vaccine.2019.01.088. Epub 2019 Mar 13. No abstract available.
    Results Reference
    derived
    PubMed Identifier
    30600690
    Citation
    Szilagyi PG, Schaffer S, Rand CM, Goldstein NPN, Younge M, Mendoza M, Albertin CS, Concannon C, Graupman E, Hightower AD, Yoo BK, Humiston SG. Text Message Reminders for Child Influenza Vaccination in the Setting of School-Located Influenza Vaccination: A Randomized Clinical Trial. Clin Pediatr (Phila). 2019 Apr;58(4):428-436. doi: 10.1177/0009922818821878. Epub 2019 Jan 2.
    Results Reference
    derived

    Learn more about this trial

    School-located Influenza Vaccination Clinics for Adolescents

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