- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02797054
Educational Intervention to Improve HPV Vaccination Decision Quality
Culturally Tailored Educational Intervention to Improve Decision Quality Around Humanpapillomavirus (HPV) Vaccination
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:
- To measure the quality of the HPV vaccine decision among participants in different arms of the intervention
- 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- University of Colorado Denver
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Parents of an adolescent between the ages of 9-17
- A young adult patient between the ages of 18-26
- Adolescent/young adult who has not yet received all three doses of the HPV vaccine.
- Parent/young adult who 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
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Altro: 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.
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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.
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Altro: Usual Care
Intervention: usual care as experienced during appointment with primary care provider.
Participants in the usual care arm will not view any educational materials or complete the baseline survey.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention
Lasso di tempo: 1 day
|
1 day
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Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention
Lasso di tempo: 1 day
|
1 day
|
Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Post-intervention
Lasso di tempo: 1 day
|
1 day
|
Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Post-intervention
Lasso di tempo: 1 day
|
1 day
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Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up
Lasso di tempo: 2 Months
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2 Months
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Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up
Lasso di tempo: 2 Months
|
2 Months
|
Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Follow-up
Lasso di tempo: 2 Months
|
2 Months
|
Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Follow-up
Lasso di tempo: 2 Months
|
2 Months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Amanda F Dempsey, MD, PhD, MPH, University of Colorado, Denver
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 14-0402-1
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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