Effects of engaging communities in decision making and action through traditional and religious leaders on fully vaccination rates; a cluster randomised control trial (TRL project)


Low vaccination rates continue to be a problem, especially for vulnerable and marginalised populations in the midst of weak routine vaccination services. There is need for interventions to increase uptake in a sustainable and cost-effective manner. Traditional and religious leaders are influential and are respected in their communities as opinion formers and guides in religious, social and family life. They have been used to support mass campaigns for vaccination activities and as agents of change to get communities to use health services. National immunisation programs have adopted this strategy as part of their mandate for Polio Eradication. However, most interventions are focused on the provision of information, which is useful, but fall short to really empowering communities to act.

This intervention aims at evaluating the use of the traditional and religious leaders (TRLs) as a means to engage communities in the planning, implementation, and monitoring of immunisation services in selected communities in Cross River State, Southern Nigeria.

Objectives and Aims

The primary objective of the trial is:

  • to evaluate the effects of a community- and health facility-based multicomponent intervention on vaccination coverage in children 0-23 months old.

The secondary objectives of the trial are to:

  • evaluate the impact on the proportion of children 0-23 months old starting but not completing the course of Pentavalent 1-3 vaccinations
  • evaluate the impact on the timing of Pentavalent and measles vaccinations
  • evaluate the impact on the morbidity and mortality to vaccine-preventable diseases
  • evaluate the changes in the processes and perceptions of actors
  • estimate the costs and cost-effectiveness of the intervention
  • evaluate the impact on utilization of other preventive clinic services

Methods / Approaches

This is a prospective cluster-randomised controlled trial. The intervention has multiple components targeting:

  • TRL: Continuous education programmes
  • Communities: meetings with WDC to exchange ideas, organization of utilisation of services
  • Health services: quality of care, feedback on vaccination status
  • Ward Development Committees (WDC): strengthening decision-making and monitoring

The study is sited in Cross River State, South South geopolitical zone of Nigeria. The State has 18 Local Government Areas and 193 political wards. There are 18 Local Government Areas (LGAs) in the study location. Eight LGAs are selected from the north, central and south of the State. The eight LGAs are selected, in four strata. The strata are: north urban, central rural, south rural, mixed urban. Two LGAs are randomly selected per strata and one of each pair is randomised to control or intervention. Three wards are selected within each LGA using simple random sampling using R. Each ward has between 2 and 16 villages, within the region of 500-2000 inhabitants. Wards adjacent to a ward in the opposite study arm are not eligible for selection. Within each ward, four villages are randomly selected. Where there are less than four villages in a ward all the villages are included in the study. Within each village, 25 children aged 0-23 months are selected.

The total sample size for the baseline survey is 1200 children per study arm. Details of the sample size calculation are available in the pre-analysis plan. The sample size was calculated on the basis that 53% of children would be fully vaccinated in the absence of the intervention: from the tables below this number is reasonable. The sample size is based on the desired 10% change from 53% assumed pre-intervention proportion of fully vaccinated children with at least 80% power and a 5% significance level.