Human Papillomavirus VaccinationNCT04576962
County Level Correlates of HPV Vaccine Series Completion Among Children Ages 11-14 Years in Indiana
An observational study of Human Papillomavirus Vaccination, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Human Papillomavirus Vaccination
- What is being tested?
- Immunization Information System Review
- Type of treatment
- Vaccines
- How many people
- 122,152 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2021to 24 Jan 2022
- Phase
- Observational
- 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 9 to 14 years
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
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.
Read the 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 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.
- Conditions
- Human Papillomavirus Vaccination
- Being tested
- Immunization Information System Review
- Keywords
- HPV Vaccines, Health Status, Access to Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunization Information System ReviewOther
Extraction of county- and state-level data on HPV vaccine completion from Indiana's Immunization Information System
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Immunization Information System Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2017-2020
Secondary outcomes (1)
Percentage of children who receive other adolescent vaccines
Receipt of Tdap, MenACWY, and HepA vaccination
Measured: 2017-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start9 Feb 2021
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus VaccinationStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 122,152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Gregory Zimet, Indiana University
- Investigators
- Gregory D Zimet, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576962
- Sponsor's protocol ID
- MISP# 60560
- Status last verified
- Feb 2022
- First submitted
- 30 Sep 2020
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- County Level Correlates of HPV Vaccine Series Completion Among Children Ages 11-14 Years in Indiana
- ClinicalTrials.gov ID
- NCT04576962
- Acronym / sponsor ID
- MISP# 60560
- Conditions
- Human Papillomavirus Vaccination
- Keywords
- HPV Vaccines, Health Status, Access to Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122,152 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children aged 14 years or younger | – | Other: Immunization Information System ReviewAll 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. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunization Information System ReviewExtraction of county- and state-level data on HPV vaccine completion from Indiana's Immunization Information System | Other | Children aged 14 years or younger |
Primary outcome
Percentage of children who complete the 2-dose HPV vaccine series
Time frame: 2017-2020
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.
1 secondary outcome
Percentage of children who receive other adolescent vaccines
Time frame: 2017-2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory D Zimet, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Vaccination, run by Indiana University at 1 site 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 2 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 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percentage of children who complete the 2-dose HPV vaccine series (time frame: 2017-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2022.