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Educational Intervention to Minimize Disparities in Humanpapillomavirus Vaccination (HPV)

2017. május 30. frissítette: University of Colorado, Denver

Educational Intervention to Minimize Disparities in HPV 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.

A tanulmány áttekintése

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

1294

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

    • Colorado
      • Aurora, Colorado, Egyesült Államok, 80045
        • University of Colorado Denver

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Igen

Tanulmányozható nemek

Összes

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Egészségügyi szolgáltatások kutatása
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Egyéb: 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.
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.
Kísérleti: 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.
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.
Egyéb: Usual Care
Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period
Időkeret: 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.
16 months
Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period
Időkeret: 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.
16 months
Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period
Időkeret: 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.
16 months
Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period
Időkeret: 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.
16 months
Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start
Időkeret: 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.
16 months
Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period
Időkeret: 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.
16 months
Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period
Időkeret: 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.
16 months
Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period
Időkeret: 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.
16 months
Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period
Időkeret: 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.
16 months
Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period
Időkeret: 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.
16 months
Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start
Időkeret: 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.
16 months
Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period
Időkeret: 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.
16 months

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Együttműködők

Nyomozók

  • Kutatásvezető: Amanda F Dempsey, MD, PhD, MPH, University of Colorado, Denver

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2014. június 1.

Elsődleges befejezés (Tényleges)

2015. december 1.

A tanulmány befejezése (Tényleges)

2016. június 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2014. május 20.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2014. május 21.

Első közzététel (Becslés)

2014. május 22.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2017. június 26.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2017. május 30.

Utolsó ellenőrzés

2017. május 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Egyéb vizsgálati azonosító számok

  • 14-0402
  • PCORI 1455 (Egyéb támogatási/finanszírozási szám: Patient Centered Outcomes Research Institute)

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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