Educational Intervention to Minimize Disparities in Humanpapillomavirus Vaccination (HPV)

Educational Intervention to Minimize Disparities in HPV Vaccination

The purpose of this study is to evaluate an innovative approach to improving HPV vaccination among the Hispanic population. The clinical objectives/aims of this HPV educational intervention project are to determine:

1. The number of young adults and adolescents in each arm who received any dose of the HPV vaccine during the study period,
2. The number of young adults and adolescents in each arm who initiated the HPV vaccine series during the study period,
3. The number of young adults and adolescents in each arm who initiated but did not complete the HPV vaccine series during the study period,
4. The number of young adults and adolescents in each arm, among all eligible, who completed the HPV vaccine series during the study period,
5. The number of young adults and adolescents in each arm who completed the HPV vaccine series during the study period, among those who initiated the series at study start, and
6. The number of young adults and adolescents in each arm who completed the HPV vaccine series among those who initiated the series during the study period.

The implementation of this educational intervention in clinic waiting rooms is intended to assist primary care providers in communicating HPV vaccine awareness and education to parents and patients in a culturally tailored format.

Study Overview

• Status: Completed
• Conditions: HPV Vaccination Status
• Intervention / Treatment: Behavioral: Tailored educational materials; Behavioral: Untailored educational materials; Behavioral: Survey-only

Detailed Description

While HPV infection is nearly ubiquitous among the sexually active population, the morbidity and mortality from HPV-related diseases disproportionately affects minorities and the poor. Hispanic women are at particularly high risk as they have the highest rates of invasive cervical cancer when compared to all other racial or ethnic groups in the U.S. Initiating the 3-dose HPV vaccination series is more common among Hispanic adolescents than whites, but series completion has been lowest among Hispanic populations.

To understand barriers to HPV vaccination and to provide insight into ways in which an existing educational intervention should be modified for a Hispanic population, the investigators conducted focus groups among Hispanic parents and Latina young adults. All groups reported vaccine cost, access to insurance, and a general lack of awareness and/or understanding of either HPV or the vaccine as barriers. All groups also wanted substantially more "general" information about both HPV and the vaccine in order to make informed vaccination decisions. The educational intervention was generally well received but there were universal suggestions from all the groups to provide additional basic information about HPV infection, to add information about the vaccine for boys/young men, and to modify the color scheme and logo to make it more eye-catching and pleasing.

This current phase of the project will be comprised of real world testing of an iPad-based educational intervention about HPV, "Combatting HPV Infection and Cancer" (CHICOS) that has been revised and developed per focus group feedback to target the Hispanic population.

By providing information that patients and parents have clearly indicated they want in a way that is culturally sensitive and meaningful and also individually personalized, the investigators hope to improve HPV vaccination rates.

• Study Type: Interventional
• Enrollment (Actual): 1294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Parents of an adolescent between the ages of 9-17; OR a young adult patient between the ages of 18-26;
2. Adolescent/young adult has not yet received all three doses of the HPV vaccine.
3. Parent/young adult can read and converse in either English or Spanish

Exclusion Criteria:

1. Age <18,
2. Prisoners
3. Decisionally challenged subjects
4. Those who cannot read and converse in either English or Spanish
5. Those who have received all 3 doses of the HPV vaccine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Untailored Intervention; Intervention: untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.	Behavioral: Untailored educational materials; The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.
Experimental: Tailored intervention; Intervention: tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.	Behavioral: Tailored educational materials; The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.
Other: Usual Care; Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.	Behavioral: Survey-only; Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period	This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.	16 months
Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period	This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.	16 months
Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period	This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.	16 months
Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period	This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.	16 months
Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start	This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.	16 months
Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period	This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.	16 months
Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period	This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.	16 months
Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period	This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.	16 months
Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period	This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.	16 months
Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period	This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.	16 months
Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start	This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.	16 months
Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period	This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.	16 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: University of Michigan
• Investigators: Principal Investigator: Amanda F Dempsey, MD, PhD, MPH, University of Colorado, Denver

Publications and helpful links

General Publications

• Dempsey AF, Maertens J, Sevick C, Jimenez-Zambrano A, Juarez-Colunga E. A randomized, controlled, pragmatic trial of an iPad-based, tailored messaging intervention to increase human papillomavirus vaccination among Latinos. Hum Vaccin Immunother. 2019;15(7-8):1577-1584. doi: 10.1080/21645515.2018.1559685. Epub 2019 Feb 20.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: May 30, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: HPV vaccination; Tailored health messaging
• Other Study ID Numbers: 14-0402; PCORI 1455 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)