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Educational Intervention to Improve HPV Vaccination Decision Quality

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ClinicalTrials.gov Identifier: NCT02797054
Recruitment Status : Completed
First Posted : June 13, 2016
Results First Posted : August 24, 2018
Last Update Posted : September 21, 2018
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

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

  1. To measure the quality of the HPV vaccine decision among participants in different arms of the intervention
  2. To determine patterns of intervention utilization among participants in different arms of the intervention, and

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.


Condition or disease Intervention/treatment Phase
HPV Vaccination Decision Quality Behavioral: Tailored educational materials Behavioral: Untailored educational materials Behavioral: Usual care Not Applicable

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 the HPV vaccination decision-making process.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Culturally Tailored Educational Intervention to Improve Decision Quality Around Humanpapillomavirus (HPV) Vaccination
Actual Study Start Date : June 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Arm Intervention/treatment
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.

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.

Usual Care
Intervention: usual care as experienced during appointment with primary care provider. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Behavioral: Usual care
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.




Primary Outcome Measures :
  1. Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention [ Time Frame: 1 day ]
  2. Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention [ Time Frame: 1 day ]
  3. Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Post-intervention [ Time Frame: 1 day ]
  4. Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Post-intervention [ Time Frame: 1 day ]
  5. Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up [ Time Frame: 2 Months ]
  6. Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up [ Time Frame: 2 Months ]
  7. Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Follow-up [ Time Frame: 2 Months ]
  8. Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Follow-up [ Time Frame: 2 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Parents of an adolescent between the ages of 9-17
  2. A young adult patient between the ages of 18-26
  3. Adolescent/young adult who has not yet received all three doses of the HPV vaccine.
  4. Parent/young adult who 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

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 ClinicalTrials.gov identifier (NCT number): NCT02797054


Locations
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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
University of Michigan
Investigators
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Principal Investigator: Amanda F Dempsey, MD, PhD, MPH University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02797054     History of Changes
Other Study ID Numbers: 14-0402-1
First Posted: June 13, 2016    Key Record Dates
Results First Posted: August 24, 2018
Last Update Posted: September 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
HPV vaccination
Vaccination decision-making
Tailored health messaging
Barriers to vaccination
Attitudes

Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs