SDH of HPV Vaccine Completion

NCT03709602 | Completed Results

• 1 other identifier: Pro00100733
• Study Type: observational
• Target: 3,076
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papilloma Virus

Keywords

HPV; adolescents; HPV Vaccine; social determinants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• HPV Vaccine Completion Within 14-Months

  within 14 months

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Primary Care Pediatrics at Roxboro Road

Durham, North Carolina, 27704, United States

Location

Results Point of Contact

• Title: Dr. Lisa Mansfield
• Organization: Duke University

lisa.mansfield@duke.edu

919-681-9198

Study Officials

• Rosa Gonzalez-Guarda, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 17, 2018
• Study Start: January 7, 2019
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: September 1, 2020
• Results First Posted: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)