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NCT03709602 Clinical Trial

SDH of HPV Vaccine Completion

Human Papilloma Virus Clinical Trial

Official title:
Social Determinants of HPV Vaccine Completion Among Adolescents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03709602
Other study ID # Pro00100733
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 7, 2019
Est. completion date December 17, 2019

Study information
Verified date August 2020
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 3076
Est. completion date December 17, 2019
Est. primary completion date December 17, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Duke University Primary Care Pediatrics at Roxboro Road Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall HPV Vaccine Completion Rates 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 HPV Vaccine Completion 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
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