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Research Article: Study protocol for a cluster-randomised controlled trial of hybrid parents and health workers adaptive intervention for optimal routine childhood immunisation coverage in the communities of Ebonyi state, Nigeria: the AGINTOPIC trial protocol

Date Published: 2023-07-12

Abstract:
Introduction Vaccine-preventable infectious diseases (VPDs) are major causes of morbidity/mortality among children under 5?years of age worldwide and in Nigeria/Ebonyi state. Routine childhood immunisation is an invaluable prevention strategy for many VPDs. Due to suboptimal coverage and untimely receipt/delay in receipt of vaccinations, outbreaks of VPDs such as measles, yellow fever, diphtheria and others continue to reoccur around the world and in Nigeria/Ebonyi state. This study aims to evaluate the effectiveness of hybrid parents and health workers adaptive intervention in increasing the optimal/timely (cumulative age-appropriate) routine childhood immunisation coverage in the communities in Ebonyi state, Nigeria. Methods and analyses A two-arm, parallel, open label, covariate-constrained cluster-randomised controlled trial with 1:1 allocation of 16 geographical clusters (the nearest catchment areas for at least one public primary healthcare (PHC) facility with at least 500 households or a population size of 3000) will be used to evaluate the effects of hybrid/combined parents and PHC workers adaptive engagement compared with control. The primary outcomes are the optimal/timely (cumulative age-appropriate) receipt of the recommended vaccines in the routine childhood immunisation schedule by children aged 5–9 completed months and 10–11 completed months and the age-appropriate vaccines receipt score for the recommended vaccines. The outcomes will be measured through a population-based household survey of at least 15 children aged 5–9 and 10–11 months per cluster at baseline and at the end of the study using a structured interviewer-administered questionnaire in KoBoCollect installed in android devices. All analyses will be done using a cluster-level method on as-randomised basis. Ethics and dissemination Ethical approval for the trial was obtained from the Ebonyi State Health Research and Ethics Committee (EBSHREC/01/06/2022–31/05/2023) and verbal consent will be obtained from participants. Study findings will be reported at local/national and international levels as appropriate. Trial registration number ISRCTN59811905 .

Introduction:
Vaccine-preventable diseases, especially vaccine-preventable infectious diseases (VPDs), are major causes of morbidity and mortality worldwide and particularly in Nigeria and especially among children under 5?years of age. More than 90?million cases of VPDs occurred worldwide among children younger than 5?years in 2015 while more than 30?million (about 33%) of the global cases and more than half a million (about 58%) of the global deaths from VPDs among these children occurred in Africa due to poor access to…

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