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CompletadoNCT07928115Registro de ClinicalTrials.gov

Implementation Research Zero-dose and Under-immunized Children

Vaccine Preventable Diseases

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
0 meses - 23 meses
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
25730 Real

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

Background:

This protocol describes both a broader development initiative to address the needs of "zero-dose" (ZD) and under-vaccinated children, and embedded research. The embedded research includes primary data collection through interview and group discussions, and formal implementation research activities. All are funded by Gavi, the vaccine Alliance to generate timely information products for use in tailoring immunization strategies, and in tracking progress in reducing the numbers of ZD and under-vaccinated children.

Every year, nearly 10 million of the 72.5 million children that Gavi aims to reach in low-income countries do not receive a single dose of vaccine. Thus, these children are left susceptible to some of the world's deadliest diseases. The zero-dose (missing first dose of pentavalent vaccine) children account for nearly half of all vaccine-preventable deaths in Bangladesh. Approximately, 45% of the 9.7 million zero-dose (ZD) children reside in urban/peri-urban, remote rural or conflict settings of the country. Notably, about 16-20% of Bangladeshi population remain continuously unvaccinated or under-vaccinated which leaves critical gaps in protection and renders vulnerability to outbreaks.

Gavi and the Global Immunization Agenda 2030 have greatly intensified their emphasis on equity, intending to reach ZD, under-immunized (missing third dose of pentavalent vaccine) children and their communities. Gavi's new five-year strategy 5.0 to improve equity in vaccination coverage hinges on five key intervention areas within the Identify, Reach, Monitor, Measure, and Advocate (IRMMA) framework. To support this, Gavi is setting up "Gavi zero-dose country learning hubs" in order to identify and select a consortium of partners for implementing the learning hubs in Bangladesh, Mali, Nigeria and Uganda. The functioning of a country learning hub in each study country will ensure increased and timely availability of evidence to meet needs prioritized by country level stakeholders and that are aligned with Gavi learning priorities. Therefore, the ZD country learning hub in Bangladesh will conduct implementation research aligning Gavi's IRMMA framework for generating evidence-based interventions for reducing ZD and UI children. This will be accomplished by working in conjunction with the Government, local academic institutions and civil society organizations (CSOs) of the country.

Objectives:

The objectives of the research are to:

1. Understand the effective methods for identifying ZD children and missed communities
2. Identify the key barriers and enabling factors at different levels (policy down to community, and including supply, demand, and gender-related barriers) to identify ZD children
3. Develop and test appropriate approaches to reach ZD children and missed communities and to bring them into the health system in order to achieve full immunization
4. Identify the key barriers and enabling factors at each level (down to community) to reach ZD children and to bring them into the health system through full immunization

Methods:

This quasi-experimental pre-post design study will be conducted in six areas selected via rapid assessment that was conducted by Bangladesh country learning hub team. Each of the selected area will have a comparison area. The duration of the IR will be 18 months starting from September 2023. We will conduct the implementation research to test a set of interventions targeted to six types of areas already known to have higher levels of ZD. Mixed methods approach including baseline and endline household surveys and qualitative methods will be used for evaluation of effectiveness of the interventions. The baseline and endline survey data in the intervention and comparison areas will be analysed for comparison and estimation of difference-in-difference in ZD level. Multivariate analyses will be carried out to estimate the net effect of the intervention on zero-dose level, controlling for all confounders.

Outcome measures/variables:

The primary outcomes are the change(s) in prevalence of "ZD and under-immunized" children from baseline to endline periods.

¿Quién podría participar?

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Inclusion Criteria:

  • Children aged 0-23 months
  • Living in the selected areas for at least 3 months

Exclusion Criteria:

  • Children aged more than 23 months
  • Living in the selected areas for less than 3 months
Entiende la evaluación inicial

Tratamiento, grupos y participación

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Asignación
Asignación al azar
Enmascaramiento
Sin enmascaramiento
Intervention

The intervention arms received multiple interventions

Device: E-screening checklist application · Behavioral: Distribution of BCC materials · Other: Evening sessions · Other: Advocacy with community leaders · Other: Health education through Community Health Care Providers (CHCP) · Device: E-supervision checklist · Other: Courtyard meetings

Comparison

No informado en este registro.

E-screening checklist application DEVICE

Service providers who were not directly involved in vaccination programme but engaged in health service delivery, helped to identify and vaccinate ZD/UI children using the e-screening checklist.

Distribution of BCC materials BEHAVIORAL

Locally tailored communications materials were developed for this project and used during interpersonal communication (IPC) by EPI field staff.

Evening sessions OTHER

Alternative session schedule was introduced to make EPI sessions more efficient, accessible, and convenient. Modified EPI schedule was implemented as per the requirement of IR areas

Advocacy with community leaders OTHER

Advocacy meetings were held at the study areas with community leaders. The EPI staff of selected areas provided them with information on benefits of vaccination of children, consequences of ZD, UI and motivated them to support the EPI programme

Health education through Community Health Care Providers (CHCP) OTHER

We trained the CHCPs (working at community clinics) of study sites to hold education sessions at community clinics with pregnant and recently delivered women to inform them about benefits of vaccines and motivate them to vaccinate their children

E-supervision checklist DEVICE

We developed an online base e-supervision checklist for EPI supervisors to ensure field visit. The supervisors of HAs used this app when they visit to EPI center for supervision.

Courtyard meetings OTHER

Courtyard meetings were conducted with caregivers by EPI staff to enhance awareness on child immunization.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Change in prevalence of "Zero-dose and under-immunized" children from baseline to endline

Plazo: 11 months

No informado en este registro.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

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1 centros

Icddr,BDhaka, Mohakhali, BangladeshEstado desconocido

Equipo y fechas

Patrocinador principal
International Centre for Diarrhoeal Disease Research, Bangladesh
Inicio del estudio
1 sept 2023 Real
Finalización primaria
30 sept 2023 Real
Finalización del estudio
31 ago 2024 Real
Primera publicación
10 nov 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

Implementation Research to Reduce Zero-dose and Under-immunized Children in Selected Areas of Bangladesh

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026