Viewing Study NCT04576962



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Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04576962
Status: COMPLETED
Last Update Posted: 2022-02-25
First Post: 2020-09-30

Brief Title: County Level Correlates of HPV Vaccine Series Completion Among Children Ages 11-14 Years in Indiana
Sponsor: Indiana University
Organization: Indiana University

Study Overview

Official Title: County Level Correlates of HPV Vaccine Series Completion Among Children Ages 11-14 Years in Indiana
Status: COMPLETED
Status Verified Date: 2022-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The overall objective is to document geographic variability in HPV vaccine series completion across the state of Indiana and to identify factors associated with low versus high rates of completion

Objective a To map HPV vaccine series completion rates across Indianas 92 counties for children aged 14 years and younger Hypothesis The investigators expect wide variability in completion rates from county to county Further the investigators expect significantly less variability in county-level administration of vaccines required for middle-school entry Tdap MenACWY and HepA vaccines

Objective b To identify county-level characteristics associated with HPV vaccine series completion rates across Indianas 92 counties Hypothesis The investigators expect factors reflective of pragmatic obstacles to be associated with lower completion rates such as lower population density fewer primary health care providers HCP per capita longer commute to work lower median household income and lower rates of insurance coverage of children
Detailed Description: The investigators will obtain HPV vaccine series completion data from the Indiana State Department of Health Immunization Information System IIS registry The data will include all children 9 through 14 years of age who received the 1st dose of HPV vaccine during the 2017 and 2018 calendar years A minimum of 18 months after 1st dose administration will be allowed for follow-up evidence of two-dose series completion For comparison purposes the investigators will also request Tdap MenACWY and HepA administration coverage Tdap MenACWY and HepA vaccines are all required for middle-school-entry in the state of Indiana The investigators already have data on missed opportunities for the 1st dose of HPV vaccine during the 2017 calendar year Again for comparison purposes the investigators will request similar data for 2018 Tdap MenACWY and HepA administration rates will focus on children 11-14 years of age County-level data will include measures of population density primary health care providers per capita mean household income child insurance coverage children living in poverty length of work commute participation in health screening behaviors and other sociodemographic health and quality of life factors covered in CountyHealthRankingsOrg

the primary variable of interest is 2-dose series completion for HPV vaccination measured via IIS data All children and adolescents ages 9-14 years who received their first dose of vaccine during the 2017 and 2018 calendar years will be followed for series completion For comparison purposes IIS data on Tdap MenACWY HepA and HPV vaccine missed opportunities for 1st dose also will be derived from the IIS Potential predictors of HPV vaccine series completion will be derived from CountyHealthRankingsOrg The County Health Rankings program is a collaborative effort of the Robert Wood Johnson Foundation and the University of Wisconsin Population Health Institute Multiple health and sociodemographic indices measured at the county level are compiled and made publicly available on the website As noted above county-level measures derived from this program include population density primary health care providers per capita mean household income child insurance coverage children living in poverty length of work commute participation in health screening behaviors and other sociodemographic health and quality of life factors covered in CountyHealthRankingsOrg

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None