Effects of engaging communities in decision-making and action through traditional and religious leaders on vaccination coverage in Cross River State, Nigeria: A cluster-randomised control trial.

BACKGROUND: Vaccination coverage levels fall short of the Global Vaccine and Action Plan 90% target in low- and middle- income countries (LMICs). Having identified traditional and religious leaders (TRLs) as potential public health change agents, this study aimed at assessing the effect of training them to support routine immunisation for the purpose of improving uptake of childhood vaccines in Cross River State, Nigeria. METHODS: A cluster-randomised controlled study was conducted between 2016 and 2019. Of the 18 Local Government Areas (LGA) in Cross River State, eight (four urban and four rural LGAs) were randomized into the intervention and control study arms. A multi-component intervention involving the training of traditional and religious leaders was implemented in the four intervention LGAs. Baseline, midline and endline surveys collected information on children aged 0-23 months. The effect of the intervention on outcomes including the proportion fully up-to-date with vaccination, timely vaccination for pentavalent and measles vaccines, and pentavalent 1-3 dropout rates were estimated using logistic regression models using random effects to account for the clustered data. RESULTS: A total of 2598 children at baseline, 2570 at midline, and 2550 at endline were included. The intervention was effective in increasing the proportion with at least one vaccine (OR 12.13 95% CI 6.03-24.41p<0.001). However, there was no evidence of an impact on the proportion of children up-to-date with vaccination (p = 0.69). It was effective in improving timeliness of Pentavalent 3 (OR 1.55; 95% CI: 1.14, 2.12; p = 0.005) and Measles (OR 2.81; 96% CI: 1.93-4.1; p<0.001) vaccination. The odds of completing Pentavalent vaccination increased (OR = 1.66 95% CI: 1.08,2.55). CONCLUSION: Informal training to enhance the traditional and religious leaders' knowledge of vaccination and their leadership role can empower them to be good influencers for childhood vaccination. They constitute untapped resources in the community to boost routine immunisation. Pan African Clinical Trial Registry (PACTR) PACTR202008784222254.