Overview

This trial is active, not recruiting.

Condition hpv vaccination status
Treatments tailored educational materials, untailored educational materials, survey-only
Sponsor University of Colorado, Denver
Collaborator University of Michigan
Start date June 2014
End date December 2015
Trial size 1205 participants
Trial identifier NCT02145156, 14-0402, PCORI 1455

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 determine patterns of intervention utilization among parents/patients in different arms of the intervention,

2. To measure the quality of the HPV vaccine decision among parents/patients in different arms of the intervention, and

3. To determine if different arms of the intervention affect the likelihood of HPV vaccination among patients.

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose health services research
Arm
(Experimental)
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. The iPad will use an automated "tailoring engine" programmed into the intervention to immediately retrieve participants' survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will be individually tailored to reflect the top concerns indicated by the participant about the HPV vaccine for themselves or their adolescent child. 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.
tailored educational materials
The tailored intervention will use an automated "tailoring engine" to retrieve participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. To do this, the survey engine retrieves from a "message library" the specific educational messages that are linked to each individual participant's survey. These educational messages will be individually tailored to reflect the top concerns indicated by the participant about the HPV vaccine for themselves or their adolescent child. 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)
Intervention: untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their 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 and is required to be given to patients prior to HPV vaccine administration.
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 and is required to be given to patients prior to HPV vaccine administration
(Other)
Intervention: survey-only. Participants in the standard of care arm will not view any educational materials or complete the baseline survey. A random ½ of the sample in this arm will be provided with a paper version of the Post Intervention Survey to be completed after the clinic visit in person or by mail.
survey-only
For those in the "Standard of Care" arm, a random ½ of the sample 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 Outcomes

Measure
Quality of the HPV vaccine decision among parents/patients
time frame: 18 months

Secondary Outcomes

Measure
Likelihood of HPV vaccination among patients
time frame: 18 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Educational Intervention to Minimize Disparities in HPV Vaccination
Principal investigator Amanda F Dempsey, MD, PhD, MPH
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 next 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 both the HPV vaccination decision-making process and HPV vaccination rates.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.