Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04576962 |
| Other study ID # |
MISP# 60560 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 9, 2021 |
| Est. completion date |
January 24, 2022 |
Study information
| Verified date |
February 2022 |
| Source |
Indiana University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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 Indiana's 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 Indiana's 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.
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
CountyHealthRankings.Org.
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 CountyHealthRankings.Org. 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 CountyHealthRankings.Org.
