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De klinische studie NCT06667323 (HPV-VISION) voor Papillomavirus vaccins, HPV Vaccines, HPV Vaccine Acceptability, HPV Vaccine Attitudes, HPV Vaccinations, HPV Vaccine Knowledge, Gezondheid van adolescenten, Adolescent Health Services, Integrated Community-based Intervention Package is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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HPV Vaccine Integrated Service Implementation Research in Ethiopia (HPV-VISION) 1.140 Vaccin Adolescenten

Nog niet rekruterend
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De klinische studie NCT06667323 (HPV-VISION) is een interventioneel studie bij Papillomavirus vaccins, HPV Vaccines, HPV Vaccine Acceptability, HPV Vaccine Attitudes, HPV Vaccinations, HPV Vaccine Knowledge, Gezondheid van adolescenten, Adolescent Health Services, Integrated Community-based Intervention Package met de status nog niet rekruterend. De inclusie van 1.140 deelnemers start op 31 oktober 2024. De studie wordt geleid door Population Services International en de voltooiing is gepland op 1 maart 2026. Laatste update op ClinicalTrials.gov: 31 oktober 2024.
Beknopte samenvatting

The goal of this implementation research study is to understand whether a package of community-based interventions can increase access to and uptake of the human papillomavirus (HPV) vaccine among very young adolescent girls in rural Ethiopia. The main questions this study aims to answer are:

  • Can a package of community-based interventions increase delivery of routine HPV vaccination to girls aged 9-14 in rural Eth...
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Uitgebreide beschrijving
Background Cervical cancer is the second most common cancer in Ethiopia. Vaccinating very young adolescent girls is the most effective long-term strategy to reduce its risk. Ethiopia introduced the human papillomavirus (HPV) vaccine in 2018, initially targeting 14-year-old girls through school-based campaigns and updated its guidelines in 2021 to target girls aged 9-14 years. Despite vaccinating around eight million ...Toon meer
Officiële titel

Human Papillomavirus Vaccine Integrated Service Implementation Study in Ethiopia (HPV-VISION)

Aandoeningen
Papillomavirus vaccinsHPV VaccinesHPV Vaccine AcceptabilityHPV Vaccine AttitudesHPV VaccinationsHPV Vaccine KnowledgeGezondheid van adolescentenAdolescent Health ServicesIntegrated Community-based Intervention Package
Andere studie-ID's
  • HPV-VISION
  • 1861.2024
  • GAVI100001742 (Ander subsidie-/financieringsnummer) (Gavi, The Vaccine Alliance)
NCT-ID
NCT06667323
Startdatum (Werkelijk)
2024-10-31
Laatste update geplaatst
2024-10-31
Verwachte einddatum
2026-03
Inschrijving (Geschat)
1.140
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Trefwoorden
Implementation Science
Implementation Research
Primaire doel
Onderzoek naar gezondheidsdiensten
Toewijzing
Niet-gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelIntegrated health service delivery for very young adolescent girls
The intervention will be implemented in four non-randomly selected districts (woreda) in the Oromia, Sidama, and Somali regions of Ethiopia: Gomma, Sokoru, Hawella, and Owbare. In intervention areas, the intervention (a complex, supply- and demand-side implementation model with the primary objective of increasing access to HPV vaccination and other health services for very young adolescent girls \[aged 9-14 years\]) ...Toon meer
Integrated health service delivery for very young adolescent girls
The proposed HPV-VISION intervention will aim to increase girl-centered access to HPV vaccination and other VYA services through an integrated, routine, community-based delivery model that incorporates household mobilization efforts with enhanced service delivery at the health post level.
Geen interventieStandard of care
Four non-randomly selected districts (woreda) in the Oromia, Sidama, and Somali regions of Ethiopia have been selected as concurrent comparison areas: Dedo, Gera, Teticha, and Dembel. These areas will conduct HPV vaccination (and any other adolescent health service delivery) through the standard-of-care procedures.
N.v.t.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
HPV vaccine delivery
Number of HPV vaccinations provided to girls aged 9-14 years old per facility per month
The primary outcome measure is an aggregated, facility-level outcome which will be assessed at the facility-month level using aggregated routine service statistics data over a period of up to 36 months
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Kind, Volwassene, Oudere volwassene
Minimumleeftijd
9 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
EXCLUSION CRITERIA:

- Does not provide informed consent

- Does not provide informed consent

INCLUSION CRITERIA:

  • Girl: aged 9-14 years, female
  • Caregiver: Parent/legal guardian of eligible 9-14-year-old girl (above); 18 years of age or older

Exclusion Criteria:

  • Girl: Does not provide informed assent, including to audio-recording, Parent/legal guardian does not provide consent
  • Caregiver: Does not provide informed consent, including to audio-recording

Inclusion Criteria for exit interviews:

  • Girl accompanied by adult (18+) parent/legal guardian: Aged 9-14 years old; Female; Received a VYA health services supported by the program*, including HPV vaccination, on the date of recruitment
  • Girl accompanied by an/other adult(s) (18+): Aged 9-14 years old; Female; Received a VYA health services supported by the program*, including HPV vaccination, on the date of recruitment
  • Girl accompanied by an/other minor(s) only: Aged 9-14 years old; Female; Received a VYA health services supported by the program*, including HPV vaccination, on the date of recruitment
  • Girl completely unaccompanied: Aged 9-14 years old; Female; Received a VYA health services supported by the program*, including HPV vaccination, on the date of recruitment
  • Caregiver: Parent/legal guardian or caregiver of eligible 9-14-year-old girl (above); Accompanying eligible 9-14-year-old girl (above) during care/service visit; 18 years of age or older

Exclusion Criteria:

  • Girl accompanied by adult (18+) parent/legal guardian: Does not provide informed assent; Parent/legal guardian does not provide consent; Requires urgent medical treatment or referral
  • Girl accompanied by an/other adult(s) (18+): • Does not provide informed assent; Caregiver does not provide permission; Requires urgent medical treatment or referral
  • Girl accompanied by an/other minor(s) only or completely unaccompanied: Does not provide informed assent; Requires urgent medical treatment or referral
  • Caregiver: Does not provide informed consent
Population Services International logoPopulation Services International
  • Addis Ababa University logoAddis Ababa University
  • Federal Democratic Republic of Ethiopia Ministry of Health logoFederal Democratic Republic of Ethiopia Ministry of Health
Centraal Contactpersoon
Contact: Claire W Rothschild, PhD, MS, 206-909-6982, [email protected]
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