Improving HPV Vaccination Rates Among Rural and Native American Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03801603
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
HPV Vaccinations Behavioral: HPV vaccination training and education Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Accelerating Uptake of the HPV Vaccine Among Rural and Native American Adolescents
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03801603

United States, California
University of California, Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Julie Dang, PhD, MPH    916-734-5222   
Principal Investigator: Moon S. Chen Jr., PhD, MPH         
Sponsors and Collaborators
University of California, Davis

Responsible Party: University of California, Davis Identifier: NCT03801603     History of Changes
Other Study ID Numbers: 1330087
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs