SDH of HPV Vaccine Completion

August 18, 2020 updated by: Duke University

Social Determinants of HPV Vaccine Completion Among Adolescents

The purpose of this research study is to find out which factors influence parents' ability to complete the human papillomavirus (HPV) vaccine series for their child. The information learned from this study may help the investigators develop programs to improve HPV vaccine completion rates among adolescents and reduce barriers to receiving the second shot of the vaccine series.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3076

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Duke University Primary Care Pediatrics at Roxboro Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adolescents ages 11 to 14 years and their parent from Duke University Primary Care Pediatrics at Roxboro Road.

Description

Inclusion Criteria:

  • For adolescents, participants need to be between the ages 11 to 14 years.
  • Received 1 dose of the HPV vaccine series between January 2017 and December 2017.
  • For parents, there is no age limit required.
  • Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian.
  • Parents or legal guardians who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent.

Exclusion Criteria:

  • Parents with cognitive impairment.
  • Adolescents with cognitive impairment.
  • Adolescents emancipated from their parents or legal guardian
  • Pregnant adolescent girls.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Adolescents ages 11 to 14 years
Adolescents ages 11 to 14 years who have received 1 dose of the HPV vaccine series between January 2017 and December 2017
Parent of adolescents
Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian, and who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent.
Cohort of Adolescents From Electronic Health Record (EHR)
A cohort of adolescents ages 11 to 14 who received 1 dose of the HPV vaccine from January 2017 to December 2017 within the university's health system network. The cohort was followed from January 2018 to February 2019 to assess vaccine completion within a 14-month period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall HPV Vaccine Completion Rates
Time Frame: up to 14 months
Adolescents who completed the required HPV vaccine doses (e.g. two or three doses based on the CDC's vaccine administration guidelines for adolescents' ages 11 to 14 years) during the January 2017 to February 2019 observation period.
up to 14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV Vaccine Completion Within 14-Months
Time Frame: within 14 months
Adolescents who received the required number of doses for vaccine completion, defined as the receipt of two or three doses based on the CDC's guidelines for adolescents' ages 11 to 14 years, within 14-months from their first vaccine dose.
within 14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Rosa Gonzalez-Guarda, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 7, 2019

Primary Completion (ACTUAL)

December 17, 2019

Study Completion (ACTUAL)

December 17, 2019

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (ACTUAL)

October 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00100733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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