Improving HPV Vaccination Rates Among Rural and Native American Adolescents

Accelerating Uptake of the HPV Vaccine Among Rural and Native American Adolescents

This study will develop and implement a multi-level intervention aimed at improving human papillomavirus (HPV) vaccination rates at an Indian rural health clinic.

Study Overview

• Status: Completed
• Conditions: HPV Vaccinations
• Intervention / Treatment: Behavioral: HPV vaccination training and education

Detailed Description

The focus of this study is to develop, implement, and evaluate a human papillomavirus (HPV) vaccination program aimed at accelerating vaccine uptake among rural and Native American adolescents ages 11-17. HPV vaccination coverage with at least one dose remains disproportionately lower among rural adolescent compared to adolescents residing in urban areas and the rate of series completion is lower among Native American adolescent girls compared to non-Hispanic White adolescent girls.

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinic patients between the ages of 11-17 who are eligible for the HPV vaccine

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPV Vaccination Training and Education; Participants will be educated on the importance of HPV vaccination.	Behavioral: HPV vaccination training and education; 1) Training of providers and clinic staff on the importance of providing a strong HPV vaccination program and 2) HPV vaccination education for parents and the community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinic HPV Vaccination Rates	HPV vaccine uptake rates (initiation and completion of the 2-dose series) among clinic patients aged 11-17 as measured by the HPV ICD code from baseline to post.	One year

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1330087

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