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L'essai clinique NCT06667323 (HPV-VISION) pour Vaccins contre le papillomavirus, HPV Vaccines, HPV Vaccine Acceptability, HPV Vaccine Attitudes, HPV Vaccinations, HPV Vaccine Knowledge, Santé de l'adolescent, Adolescent Health Services, Integrated Community-based Intervention Package est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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HPV Vaccine Integrated Service Implementation Research in Ethiopia (HPV-VISION) 1 140 Vaccin Adolescent

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT06667323 (HPV-VISION) est une étude interventionnel pour Vaccins contre le papillomavirus, HPV Vaccines, HPV Vaccine Acceptability, HPV Vaccine Attitudes, HPV Vaccinations, HPV Vaccine Knowledge, Santé de l'adolescent, Adolescent Health Services, Integrated Community-based Intervention Package. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 31 octobre 2024, avec un objectif de 1 140 participants. Dirigée par Population Services International, l'étude devrait être terminée d'ici le 1 mars 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 31 octobre 2024.
Résumé succinct

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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Description détaillée
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 ...Afficher plus
Titre officiel

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

Pathologies
Vaccins contre le papillomavirusHPV VaccinesHPV Vaccine AcceptabilityHPV Vaccine AttitudesHPV VaccinationsHPV Vaccine KnowledgeSanté de l'adolescentAdolescent Health ServicesIntegrated Community-based Intervention Package
Autres identifiants de l'étude
  • HPV-VISION
  • 1861.2024
  • GAVI100001742 (Autre financement) (Gavi, The Vaccine Alliance)
Numéro NCT
NCT06667323
Date de début (réel)
2024-10-31
Dernière mise à jour publiée
2024-10-31
Date de fin (estimée)
2026-03
Inscription (estimée)
1 140
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
Implementation Science
Implementation Research
Objectif principal
Recherche sur les services de santé
Méthode d'allocation
Non randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalIntegrated 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 \[aged 9-14 years\]) ...Afficher plus
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.
Aucune interventionStandard 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/A
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
9 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
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
Contact central de l'étude
Contact: Claire W Rothschild, PhD, MS, 206-909-6982, [email protected]
Aucune donnée sur les lieux ou centres d'investigation disponible