Clinical trial NCT02797054: Educational Intervention to Improve HPV Vaccination Decision Quality
Official title: Culturally Tailored Educational Intervention to Improve Decision Quality Around Humanpapillomavirus (HPV) Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Vaccination Decision Quality
Keywords: HPV vaccination
Vaccination decision-making
Tailored health messaging
Barriers to vaccination
Attitudes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2016-06-13
Enrollment: 1205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention
timeFrame: 1 day
measure: Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention
timeFrame: 1 day
measure: Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Post-intervention
timeFrame: 1 day
measure: Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Post-intervention
timeFrame: 1 day
measure: Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up
timeFrame: 2 Months
measure: Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up
timeFrame: 2 Months
measure: Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Follow-up
timeFrame: 2 Months
measure: Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Follow-up
timeFrame: 2 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Amanda F Dempsey, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: