County Level Correlates of HPV Vaccine Series Completion Among Children Ages 11-14 Years in Indiana

NCT04576962 | Completed

• 1 other identifier: MISP# 60560
• Study Type: observational
• Target: 122,152
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Human Papillomavirus Vaccination

Keywords

HPV Vaccines; Health Status; Access to Care

Outcome Measures

Primary Outcomes (1)

• Percentage of children who complete the 2-dose HPV vaccine series

  For those children aged 14 years and younger who received the first dose of HPV vaccine in 2017 or 2018 we will measure what percentage complete the second dose of vaccine during 18 months of follow-up.

  2017-2020

Secondary Outcomes (1)

• Percentage of children who receive other adolescent vaccines

  2017-2018

Study Arms (1)

Children aged 14 years or younger

All children in Indiana aged 14 years and younger who received the first dose of HPV vaccine during the 2017 and 2018 calendar years. This is a non-interventional study, with data to be analyzed at the county level only.

Other: Immunization Information System Review

Interventions

Immunization Information System Review OTHER

Extraction of county- and state-level data on HPV vaccine completion from Indiana's Immunization Information System

Children aged 14 years or younger

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children with Indiana Immunization Information System (IIS) records who are 9 through 14 years of age and received their first dose of HPV vaccine during the 2017 or 2018 calendar years. All information on vaccination will be examined only at the county and state levels. No individual information will be used.

You may qualify if:

• Children aged 9 through 14 years of age in Indiana who received the first dose of HPV vaccine during the 2017 or 2018 calendar year.

You may not qualify if:

• Children younger than 9, as HPV vaccine is not licensed for children under 9 years of age
• Children older than 14 when they receive the first dose of vaccine

Sponsors & Collaborators

• Indiana University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Study Officials

• Gregory D Zimet, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 6, 2020
• Study Start: February 9, 2021
• Primary Completion: January 24, 2022
• Study Completion: January 24, 2022
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)