University of Colorado Denver
Aurora, Colorado, 80045, United States
Completed
NCT Number: NCT02145156
Educational Intervention to Minimize Disparities in Humanpapillomavirus 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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Parents of an adolescent between the ages of 9-17; OR a young adult patient between the ages of 18-26;
- Adolescent/young adult has not yet received all three doses of the HPV vaccine.
- Parent/young adult can read and converse in either English or Spanish
Exclusion criteria
- Age <18,
- Prisoners
- Decisionally challenged subjects
- Those who cannot read and converse in either English or Spanish
- Those who have received all 3 doses of the HPV vaccine
Treatment and study plan
Tailored educational materials
BehavioralThe 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 educational materials
BehavioralThe 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.
Survey-only
BehavioralThose 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 outcomes
-
Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period
Time frame: 16 months
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.
-
Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period
Time frame: 16 months
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.
-
Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period
Time frame: 16 months
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.
-
Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period
Time frame: 16 months
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.
-
Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start
Time frame: 16 months
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.
-
Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period
Time frame: 16 months
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.
-
Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period
Time frame: 16 months
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.
-
Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period
Time frame: 16 months
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.
-
Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period
Time frame: 16 months
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.
-
Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period
Time frame: 16 months
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.
-
Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start
Time frame: 16 months
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.
-
Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period
Time frame: 16 months
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.
Sponsors and collaborators
Lead sponsor
University of Colorado, Denver
Other
Collaborators
- University of Michigan
Registry information
Official study title
Educational Intervention to Minimize Disparities in HPV Vaccination
Acronym: HPV
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2016
- First posted
- May 22, 2014
- Registry last updated
- Jun 26, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.