- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04017143
Multi-Level Communication Strategies for HPV Vaccination in Hmong Adolescents
13. april 2022 opdateret af: University of Minnesota
The specific aims are: 1) to design a multilevel, theory-driven, highly interactive, culturally and cognitively tailored hAppy app intervention to facilitate HPV vaccination completion among Hmong adolescents and their parents using CBPAR; 2) establish a systematic health care provider protocol for identifying and engaging Hmong adolescents and their parents in the use of the hAppy app; and 3) examine participants' intent, knowledge and self-efficacy of HPV vaccinations, perceptions of the hAppy app and their patient-provider experiences.
This study will advance existing knowledge of mHealth's impact on populations at risk for cancer and contribute new, important information to cancer health disparities research.
If found to be effective, this intervention will have extensive implications for prevention of other types of cancer among different underserved populations, potentially reducing cancer-related disparities, morbidity, and mortality.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A quarter million Hmong Americans (Hmong) reside in the United States and 25% live in the Twin Cities metropolitan area.
With a median age of 20.4 years old, this young community has a poverty rate of 26% in Minnesota and 27.4% nationally.
Cervical cancer knowledge and prevention, such as awareness of HPV's effectiveness in reducing cancer risk, is low among Hmong women (19-50%) and men (38%), which may explain Hmong's high cervical cancer incidence rates (three times higher than other Asian Americans (AA) and four times higher than Non-Hispanic Whites).
This problem is further aggravated by the rise of cervical cancer incidence and mortality rates among Hmong women.
Clearly, multilevel strategies to increase HPV vaccination rates and reduce HPV-related cancers among Hmong are urgently needed.
Yet Hmong women face structural and cultural barriers that limit their access to preventive health care.
Language difficulties, poor health literacy, lack of time or transportation, visiting a doctor only when symptomatic or in pain and abstaining from gynecological visits due to embarrassment are some of these barriers.
These barriers and beliefs must be carefully integrated into the design of any effective multilevel strategy to promote HPV vaccination uptake and completion.
This study proposes to use a Community-Based Participatory Action Research (CBPAR) approach to develop and test the effectiveness of a theory-based culturally and cognitively appropriate mobile application (hAppy app) intervention that facilitate HPV vaccination completion among Hmong adolescents (11 to 17 years old) and their parents.
Mobile health (mHealth) technology is a promising tool allowing for effective person-centered customization.
The study's primary objective is to evaluate the effectiveness of hAppy app intervention in Hmong adolescents and their parents.
100 Hmong adolescents and their parents will be recruited and a single blind, two arm, randomized controlled trial will be conducted.
Participants will be randomized by a 1:1 ratio to receive the hAppy app intervention (N=50) or usual care (UC, N=50) for a 9-month period.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forenede Stater
- University of Minnesota, Twin Cities
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
11 år til 17 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Teen: (1) aged between 11-17, (2) not yet completed HPV vaccination, (3) living in Minnesota
- Parents: those who have teen child aged between 11-17
Exclusion Criteria:
- Teens who have completed HPV vaccination
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: HPV App group
Participants will be assigned to receive an HPV app.
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Participants assigned to this group will receive an HPV app that targets a dyad of parent and a teen boy or girl.
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Ingen indgriben: Usual Care
This is a usual care group that receives a brochure that is usually distributed by a clinic.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Rate of HPV vaccination (completion of recommended HPV vaccine)
Tidsramme: 9-months
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Number of teen participants who receive the complete series of recommended HPV vaccine
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9-months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. september 2016
Primær færdiggørelse (Faktiske)
30. september 2019
Studieafslutning (Faktiske)
30. september 2019
Datoer for studieregistrering
Først indsendt
17. december 2018
Først indsendt, der opfyldte QC-kriterier
10. juli 2019
Først opslået (Faktiske)
12. juli 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. april 2022
Sidst verificeret
1. april 2022
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- STUDY00002064
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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Fudan UniversityThe University of Hong KongIkke rekrutterer endnu
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The University of Hong KongAfsluttet
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Ksana HealthNovo Nordisk A/SAfsluttetFedme | Overvægtig | Psykisk lidelseForenede Stater
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University of California, Los AngelesNational Cancer Institute (NCI); Children's Hospital of Philadelphia; University... og andre samarbejdspartnereAfsluttetVaccination | ImmuniseringForenede Stater
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University of California, Los AngelesNational Cancer Institute (NCI); Children's Hospital of Philadelphia; University... og andre samarbejdspartnereAktiv, ikke rekrutterende