FOREBYG HPV-relaterede kræftformer RCT
4. juni 2026 opdateret af: University of Utah
FOREBYG: Praksisbaserede tilgange til at fremme HPV-vaccination i sikkerhedsnettet - Randomiseret kontrolleret forsøg (RCT)
Denne undersøgelse vil tjene som en af de første til at udvikle og teste effektiviteten af strategier til at fremme HPV-vaccination blandt forskellige landlige forældre og omsorgspersoner til børn i alderen 9-17 år i Mountain West. Når først implementeret i praksis, kan vores intervention betydeligt reducere forskellene i byrden af HPV-associerede kræftformer blandt landbefolkninger i USA.
Den foreslåede undersøgelse vil vurdere effektiviteten af klinikbaseret outreach for at øge vaccinationsraten for HPV på fire samfundsklinikker i landdistrikter i Washington. Denne undersøgelse er en bootcamp-oversættelse til skræddersyet meddelelser baseret på input fra patient og udbyder. Den foreslåede undersøgelse omfatter følgende: (1) Bootcamp-oversættelse til skræddersyede meddelelser baseret på input fra patient og udbyder; (2) FOREBYG randomiseret kontrolleret forsøg (RCT), der vil tildele voksne forældre/plejer deltagere til en tidslinje for modtagelse af intervention; og (3) kvalitative interviews med forældre/plejere, udbydere og andre sundhedsfaglige teammedlemmer og udvikling af bedste praksis, implementeringsvejledninger og formidling af resultater for andre klinikker til at implementere programmet i en bredere skala. Ved afslutningen af forsøget vil der blive gennemført personlige interviews med forældre/plejere, klinisk personale og udbydere for at forstå reaktioner på programmet og vedvarende barrierer for at påbegynde og fuldføre HPV-vaccination.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Det kliniske forsøg i PREVENT-studiet er et patient-randomiseret kontrolforsøg (RCT) af to human papillomavirus (HPV) vaccinationspatientpåmindelsesinterventionsarme, som vil finde sted i landdistriktsklinikker, der drives af Sea Mar Community Health Centres. Resultater fra BootCamp Translation (BCT)-aktiviteterne vil blive udført på engelsk og spansk og vil informere PREVENT RCT-udviklings- og meddelelsesstrategierne; BCT-aktiviteter er ikke en del af RCT.
PREVENT RCT vil administrere et randomiseret kontrolleret forsøg med tre arme, som vil vurdere færdiggørelsen af den næste nødvendige dosis HPV-vaccination og rettidig afslutning af multidosis HPV-vaccineserien. Studiearmene for hvert forsøg vil bestå af automatiserede påmindelser, automatiske plus live-påmindelser og sædvanlig pleje. Forældre/omsorgspersoner til børn og unge, der er udvalgt til forsøget, vil blive valgt ud fra etablerede undersøgelseskriterier, der anvendes på de elektroniske sundhedsjournaler, der er knyttet til statslige immuniseringsregistre. Som en undersøgelse med minimal risiko, kun for interventionen, vil efterforskerne ansøge om et frafald af informeret samtykke. RCT vil blive leveret som en del af standardbehandling, og patienter vil være uvidende om, at de er i forsøget. Leverede vaccinationsmeddelelser vil omfatte fravalgsvalg som anvist af BCT-aktiviteter og lokale politikker.
Afhængigt af de specifikke interventioner, der er defineret under BCT, vil forældre/plejere (P/C) for børn og unge (C/A) få tilsendt et vilkårligt antal påmindelser for at opmuntre forældre til at få en HPV-vaccine til deres aldersberettigede C/A. Påmindelser kan omfatte tekstbeskeder, automatiske telefonopkald, postede breve, liveopkald eller patientnavigation. Påmindelser vil blive leveret af en leverandør (automatiserede påmindelser) eller klinikpersonale (live påmindelser). Påmindelser vil blive leveret på engelsk og spansk, og tolketjenester kan bruges til live-påmindelser til den lille del af patienter, der taler andre sprog end engelsk eller spansk. Efterforskerne vil bruge elektroniske patientjournaldata til at dokumentere HPV-vaccinationshændelser som vores primære resultat af interesse. Investigatorerne vil også vurdere rækkevidden for hver interventionskomponent, defineret som andelen af patienter, der modtager en given interventionskomponent. Efterforskerne vil også vurdere forpassede muligheder, defineret som andelen af patienter, der modtager andre anbefalede vacciner (f.eks. Tdap eller meningokok), men ikke HPV, for hver undersøgelsesarm, under undersøgelsen. Mål 3 vil indsamle kvalitative data på patient- og udbyderniveau for at vurdere reaktion på programmet, faktorer forbundet med implementering og langsigtet bæredygtighed og muligheder for yderligere klinikbaserede interventioner. Under aktiv rekruttering af undersøgelser vil efterforskerne indkalde til et møde i vores datasikkerhedsmonitor bestyrelse hvert halve år. Efterforskerne vil formidle undersøgelsesresultater og forskningsprodukter i overensstemmelse med vores formidlingsplan. Resultaterne af undersøgelsen vil tjene som grundlag for et større multi-level forsøg med HPV-vaccination i landdistrikter.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
335
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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Washington
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Seattle, Washington, Forenede Stater, 98108
- Sea Mar Community Health Centers
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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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Forældre/omsorgspersoner (P/C) til børn/unge (C/A) i alderen 9-17 år (dvs. aldersberettiget til HPV-vaccination);
- P/C med aktive klinikpatienter (dvs. er set i klinikken inden for de sidste 12 måneder); og
- P/C, der taler enten engelsk eller spansk.
Ekskluderingskriterier:
- P/C for C/A med tidligere eksklusiv HPV-vaccinationshistorie (f.eks. afsluttet vaccination eller ikke forfalden);
- P/C for C/A med kliniske tilstande, der påvirker CDC HPV-vaccinationsanbefalingerne (f.eks. graviditet);
- P/C af C/A med andre faktorer, der ville påvirke CDC HPV-anbefalinger; og
- P/C, der ikke taler spansk eller engelsk.
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: Sekventiel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Sædvanlig pleje (UC)
UC-gruppen vil ikke modtage skræddersyede påmindelser, men vil kun modtage opportunistiske vaccinepåmindelser, der leveres under klinikbesøg eller MyChart EPJ-baserede patientportalpåmindelser.
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Eksperimentel: Automatiseret intervention (Auto)
Deltagere i autointervention er berettigede til opsøgende leveret ved hjælp af automatiserede telefonopkald, tekst eller e -mail -beskeder med tilstanden, frekvens, tidspunkt for påmindelser og meddelelsesindhold.
Automatiseret opsøgende kan også omfatte innovative kommunikationsstrategier, såsom tekstbundne videoer, P/C eller patientfortællinger.
Auto Outreach til P/C vil invitere P/CS til at deltage i gratis HPV-vaccinationsbesøg og understrege familievenlige timer.
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Den foreslåede undersøgelse vil vurdere muligheden for en RCT for klinikbaseret opsøgning for at øge vaccinationsraterne for HPV på samfundsklinikker i landdistrikterne.
Undersøgelsen er en pilotforsøg, der tildeler voksne forældre/plejepersonale til en tidslinje til modtagelse af vaccinationsmeddelelsesintervention.
Auto- og auto-plus-interventionsarme kan bruge nogle af de samme komponenter (automatiserede opkald, liveopkald, tekstbeskeder, e-mails og mailinger).
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Eksperimentel: Automated Intervention Plus (Auto-Plus)
Deltagere i auto-plus-intervention er berettigede til automatiserede påmindelser plus yderligere P/C-anvisninger til patienter, der ikke gennemgår vaccination inden for tre uger.
Disse anmodninger kan leveres via live telefonopkaldsopsøgning eller patientnavigation.
Aktiviteter valgt fra en liste over mulige muligheder fra National HPV Vaccination Roundtable og vores placering af effektiviteten af sprog- og kulturelt skræddersyede interventionsmateriale.
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Den foreslåede undersøgelse vil vurdere muligheden for en RCT for klinikbaseret opsøgning for at øge vaccinationsraterne for HPV på samfundsklinikker i landdistrikterne.
Undersøgelsen er en pilotforsøg, der tildeler voksne forældre/plejepersonale til en tidslinje til modtagelse af vaccinationsmeddelelsesintervention.
Auto- og auto-plus-interventionsarme kan bruge nogle af de samme komponenter (automatiserede opkald, liveopkald, tekstbeskeder, e-mails og mailinger).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Antal deltagere randomiserede korrekt
Tidsramme: Op til 1 dag efter randomisering
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At vurdere gennemførligheden af undersøgelsesinterventionen.
Dette resultatmål rapporterer antallet af deltagere, der blev korrekt randomiseret i henhold til undersøgelsesprotokollen.
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Op til 1 dag efter randomisering
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Antal deltagere, der svarede på tekstinterventionen
Tidsramme: Op til 1 måned efter randomisering
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At vurdere gennemførligheden af undersøgelsesinterventionen.
Dette resultatmål rapporterer antallet af deltagere, der svarede på den tekstbaserede intervention, som defineret af undersøgelsesprotokollen.
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Op til 1 måned efter randomisering
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Andel af deltagerne kontaktet med succes
Tidsramme: Op til 1 dag
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At vurdere gennemførligheden af undersøgelsesinterventionen.
Dette resultatmål rapporterer andelen af deltagere, der med succes blev kontaktet ud af det samlede antal forsøg på kontakter.
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Op til 1 dag
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Deanna Kepka, PhD, MPH, Study Principal Investigator
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Bruno DM, Wilson TE, Gany F, Aragones A. Identifying human papillomavirus vaccination practices among primary care providers of minority, low-income and immigrant patient populations. Vaccine. 2014 Jul 16;32(33):4149-54. doi: 10.1016/j.vaccine.2014.05.058. Epub 2014 Jun 2.
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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)
17. maj 2025
Primær færdiggørelse (Faktiske)
12. august 2025
Studieafslutning (Faktiske)
12. august 2025
Datoer for studieregistrering
Først indsendt
12. december 2024
Først indsendt, der opfyldte QC-kriterier
12. december 2024
Først opslået (Faktiske)
17. december 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Teenager
- Mennesker
- Barn
- Motivering
- Vaccination
- Forekomst
- Kvinde
- Han
- Forældre
- Omsorgspersoner
- Meddelelse
- Randomiseret kontrolforsøg
- Papillomavirusvacciner
- Tekstbeskeder
- Papillomavirus infektioner
- Kvalitativ forskning
- Religion
- Patientaccept af sundhedsvæsen
- Sundhedspersonale
- Sundhedsviden, holdninger, praksis
- Undersøgelser og spørgeskemaer
- Participatorisk tilgang
- Forenede Stater
- Hispanic eller Latino
- Interessenters deltagelse
- Landbefolkning
- Sociale normer
- Religiøsitet
- Papillomavirus Vacciner / administration & dosering
- Humant papillomavirus vira
- Papillomavirus infektioner / forebyggelse og kontrol
- Kræft / forebyggelse & kontrol
- Påmindelsessystemer / instrumentering
- Vaccinationsafslag
- Sundhedsfremme/metoder
- Forældre/uddannelse
- Kvantitativ forskning
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Patologiske processer
- Sygdomsegenskaber
- Infektioner
- Virussygdomme
- Overførbare sygdomme
- Seksuelt overførte sygdomme, virale
- Seksuelt overførte sygdomme
- DNA-virusinfektioner
- Tumorvirusinfektioner
- Patologiske tilstande, tegn og symptomer
- Behandlingsoverholdelse og compliance
- Sundhedsadfærd
- Afslag på behandling
- Neoplasmer
- Papillomavirus infektioner
- Meddelelse
- Opførsel
- Patientaccept af sundhedspleje
- Vaccinationsafslag
Andre undersøgelses-id-numre
- 161649-PILOT
- 1R01CA279973-01 (U.S. NIH-bevilling/kontrakt)
- DSS_10065815 (Anden identifikator: University of Utah, Document Summary Sheet (DSS) Number)
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Kliniske forsøg med HPV-vaccination
-
Xiamen UniversityXiamen Innovax Biotech Co., Ltd; Xiamen Center for Disease Control and...Ikke rekrutterer endnuHPV-vaccinationsrater | HPV-vaccinebevidsthed | Intention om HPV-vaccination
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Michigan State UniversityRekrutteringHPV-vaccinationForenede Stater
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Anne E RayReal Prevention, LLC; Merck Institute for Therapeutic ResearchIkke rekrutterer endnu
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Memorial Sloan Kettering Cancer CenterHackensack Meridian Health; The City College of New YorkAktiv, ikke rekrutterendeForsøg med en social marketingkampagne for at øge HPV-vaccination blandt mexicanske amerikanske børnHPV-vaccinationForenede Stater
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Yale UniversityNational Cancer Institute (NCI)Afsluttet
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Yasemin ATEŞEYANAfsluttet
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Northwestern UniversityNational Cancer Institute (NCI)RekrutteringHPV-vaccination | HPV-related CancersForenede Stater
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Xiamen UniversityXiamen Center for Disease Control and PreventionIkke rekrutterer endnuHPV-vaccinationsrater | HPV-vaccinebevidsthed | Intention om HPV-vaccination
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University of Alabama at BirminghamAktiv, ikke rekrutterendeHPV-vaccinationForenede Stater
-
Michigan State UniversityRekruttering
Kliniske forsøg med FORHINDRE
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Weill Medical College of Cornell UniversityNational Institute of Mental Health (NIMH)RekrutteringDepression | Selvmordstanker | Selvmord, ForsøgForenede Stater
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Metabiomics CorpSuspenderetKolorektal cancer | Kolorektalt adenomForenede Stater