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Educational Intervention to Minimize Disparities in Humanpapillomavirus Vaccination (HPV)

30 maja 2017 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

1294

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Colorado
      • Aurora, Colorado, Stany Zjednoczone, 80045
        • University of Colorado Denver

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 75 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: 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.
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: Tailored educational materials
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.
Inny: Usual Care
Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Behawioralne: Survey-only
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Colorado, Denver

Współpracownicy

University of Michigan

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 czerwca 2014

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2015

Ukończenie studiów (Rzeczywisty)

1 czerwca 2016

Daty rejestracji na studia

Pierwszy przesłany

20 maja 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 maja 2014

Pierwszy wysłany (Oszacować)

22 maja 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 czerwca 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 maja 2017

Ostatnia weryfikacja

1 maja 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • 14-0402
  • PCORI 1455 (Inny numer grantu/finansowania: Patient Centered Outcomes Research Institute)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na HPV Vaccination Status

Badania kliniczne na Tailored educational materials

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