Viewing Study NCT02145156


Ignite Creation Date: 2025-12-24 @ 11:33 PM
Ignite Modification Date: 2025-12-29 @ 8:02 PM
Study NCT ID: NCT02145156
Status: COMPLETED
Last Update Posted: 2017-06-26
First Post: 2014-05-20
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Educational Intervention to Minimize Disparities in Humanpapillomavirus Vaccination
Sponsor: University of Colorado, Denver
Organization:

Study Overview

Official Title: Educational Intervention to Minimize Disparities in HPV Vaccination
Status: COMPLETED
Status Verified Date: 2017-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HPV
Brief Summary: 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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
PCORI 1455 OTHER_GRANT Patient Centered Outcomes Research Institute View