An interventional study of E-screening checklist application and Distribution of BCC materials in Vaccine Preventable Diseases, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 0 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Not applicable, Interventional, and Health services research
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:
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.
53 studies on the registry are indexed under Vaccine-Preventable Diseases; 12 are open to participants now.
This study's enrollment of 25,730 is above the median of 190 across 42 interventional studies indexed under Vaccine-Preventable Diseases.
Browse Vaccine-Preventable Diseases studies →International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 206 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
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
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.
Locally tailored communications materials were developed for this project and used during interpersonal communication (IPC) by EPI field staff.
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 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
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
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 were conducted with caregivers by EPI staff to enhance awareness on child immunization.
Change in prevalence of "Zero-dose and under-immunized" children from baseline to endline
Time frame: 11 months
Plan to share: No — The data will be as per icddr,b data access policy: https://www.icddrb.org/storage/file/Document/66d3e78270ffe.pdf
Ran from Sep 2023 to primary completion in Sep 2023, 0 months.
Of 17 interventional studies with no phase under Vaccine-Preventable Diseases, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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