Terminé

Improving Routine Immunization Coverage Through Educational Messages Delivered During Polio NIDs in Pakistan: A Cluster Randomized Trial

0 critères remplis à partir de votre profilVoyez en un coup d'œil comment votre profil répond à chaque critère d'éligibilité.
Ce qui est testé

Vaccine promotion messages

+ Distribution of Plastic Pouches to retain vaccination card

+ Vaccination Verification.

ComportementalAutre
Qui peut participer

Maladies neuroinflammatoires+10

+ Maladies du système nerveux central

+ Infections du système nerveux central

De 3 à 14 mois
+6 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude sur les services de santé

Interventionnel
Date de début : avril 2012
Voir le détail du protocole

Résumé

Sponsor principalAga Khan University
Dernière mise à jour : 16 janvier 2014
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 avril 2012

Date à laquelle le premier participant a commencé l'étude.

The overall objective of this study is to assess whether supplementary immunization activities (SIAs) held for polio eradication can be used to improve routine immunization coverage in Pakistan. Primary research objectives: (i) To assess effectiveness of educational messages regarding routine immunization during SIAs held for polio on improving routine immunization coverage in Pakistan. Secondary research objectives: (i) To assess maternal knowledge about routine immunization in the intervention and control arms. (ii) To estimate vaccination card retention in the intervention and control arms. This study will be completed in 12 months, between March 2012 to February 2013. Overall, three major operational steps have been defined for the study as follow: Baseline vaccine coverage survey: This is a 02-months activity in which a baseline household vaccine coverage survey will be carried out to independently assess the immunization coverage and socio-demographic indicators in the study areas. Participation in this survey will be voluntary and written consent from participants will be obtained prior to administering the study questionnaire. Training of vaccinators/volunteers and distribution of plastic pouches: The project research staff (Research Associate/Senior Research Assistants) will be exclusively trained by Principal Investigator/Research Supervisor on educational material. Having completed the baseline coverage survey, a one-day training session will be organized by trained project staff to provide trainings to participating EPI vaccinators/volunteers on the vaccine promotion educational messages to be delivered during intervention. These trainings will be held at a common venue (EPI center/public hospital) in the selected towns for this study. The messages will be low-literacy, of very short duration, and will be delivered with the help of pictorial cards which were previously developed for and used in a similar department-run study in Karachi. These educational messages will include the following messages: Vaccines can save a child's life Children who are immunized on time are less likely to become ill Unimmunized children can become disabled for life Photograph of the nearest EPI center where vaccines are offered free of charge, as well as its address and timings Additionally, at the start of this project, all EPI centers in the study areas will be provided with plastic pouches to be given to parents of all children coming to EPI centers for vaccinations. These pouches will be used to store a child's immunization card. In order to assess the likely change in vaccination card retention, we will compare the proportion of vaccination cards available on pre-and-post coverage assessment in both intervention and control groups. Endline vaccine coverage survey/outcome assessment. Outcome assessment will be done through a representative endline survey assessing vaccine coverage for Penta-3 and Measles-1 in the study areas, 3 months after the NID was held. Participation in this survey will be voluntary and written consent from study participants will be obtained prior too administering the study questionnaire. NID = National Immunization Days SNID = Sub-national Immunization Days EPI: Expanded Programme on Immunization SIA - Supplementary Immunization Activity CHW = Community Health Worker AKU = Aga Khan University, Karachi, Pakistan

Sponsor principalAga Khan University
Dernière mise à jour : 16 janvier 2014
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

4560 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Recherche sur les services de santé

Cette étude s'intéresse à la manière dont les soins de santé sont organisés et délivrés, et évalue l'efficacité de différents systèmes ou modèles de prise en charge.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

De 3 à 14 mois

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies neuroinflammatoiresMaladies du système nerveux centralInfections du système nerveux centralInfections à entérovirusInfectionsMyéliteMaladies du système nerveuxMaladies neuromusculairesInfections à PicornaviridaeInfections à virus ARNMaladies de la moelle épinièreMaladies viralesPoliomyélite

Critères

3 critères d'inclusion nécessaires pour participer
Households with children aged 3-14 months

Resident of selected cluster

Willing to consent for participation in the study

3 critères d'exclusion empêchent la participation
Households with children aged below 3 months or above 14 months

Non-resident of selected cluster

Refusing to consent

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

4 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
EPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization

Groupe II

Expérimental
EPI vaccinators/volunteers will identify and record details of un/under-vaccinated children less than 12 months old in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity.

Groupe III

Expérimental
EPI vaccinators/volunteers will educate mothers/care-providers of infants less than 12 months old months about the benefits of routine immunization, identify and record details of un/under-vaccinated children in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity.

Groupe IV

Pas d'intervention
No interventional activity will take place in this group. Therefore, the status quo (routine services) will be maintained during Polio NID

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Thatta, Hyderabad

Thatta, Hyderabad, PakistanOuvrir Thatta, Hyderabad dans Google Maps
Terminé1 Centres d'Étude