SDH of HPV Vaccine Completion

Completed

• Conditions: Human Papilloma Virus

• Registration Number: NCT03709602
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Study Start: 2019-01-07
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-17
• Results First Submitted: 2020-06-05
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Results First Posted: 2020-09-01
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3076

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall HPV Vaccine Completion Rates	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.

Secondary Outcome Measures

Name	Time	Method
HPV Vaccine Completion Within 14-Months	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.

Trial Locations

Locations (1)

Duke University Primary Care Pediatrics at Roxboro Road; 🇺🇸 Durham, North Carolina, United States