SDH of HPV Vaccine Completion

NCT ID: NCT03709602

Last Updated: 2020-09-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3076 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-07

Study Completion Date

2019-12-17

Brief Summary

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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.

Detailed Description

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Conditions

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Human Papilloma Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rosa Gonzalez-Guarda, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Primary Care Pediatrics at Roxboro Road

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00100733

Identifier Type: -

Identifier Source: org_study_id

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