- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04017143
Multi-Level Communication Strategies for HPV Vaccination in Hmong Adolescents
13. april 2022 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Minnesota
-
Minneapolis, Minnesota, Forente stater
- University of Minnesota, Twin Cities
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
11 år til 17 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: HPV App group
Participants will be assigned to receive an HPV app.
|
Participants assigned to this group will receive an HPV app that targets a dyad of parent and a teen boy or girl.
|
|
Ingen inngripen: Usual Care
This is a usual care group that receives a brochure that is usually distributed by a clinic.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of HPV vaccination (completion of recommended HPV vaccine)
Tidsramme: 9-months
|
Number of teen participants who receive the complete series of recommended HPV vaccine
|
9-months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. september 2016
Primær fullføring (Faktiske)
30. september 2019
Studiet fullført (Faktiske)
30. september 2019
Datoer for studieregistrering
Først innsendt
17. desember 2018
Først innsendt som oppfylte QC-kriteriene
10. juli 2019
Først lagt ut (Faktiske)
12. juli 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. april 2022
Sist bekreftet
1. april 2022
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- STUDY00002064
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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