Improving HPV Vaccination Rates Among Rural and Native American Adolescents

March 15, 2021 updated by: University of California, Davis

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: One year
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

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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