An innovative Community Mobilisation and Community Incentivisation for child health in rural Pakistan (CoMIC) a cluster-randomised, controlled trial

Background Infectious diseases remain the leading cause of death among children younger than 5 years due to disparities in access and acceptance of essential interventions. The Community Mobilisation and Community Incentivisation (CoMIC) trial was designed to evaluate a customised community mobilisation and incentivisation strategy for improving coverage of evidence-based interventions for child health in Pakistan. Methods CoMIC was a three-arm cluster-randomised, controlled trial in rural areas of Pakistan. Clusters were formed by grouping villages based on geographical proximity, ethnic consistency, and ensuring a population between 1500 to 3000 per cluster. Clusters were randomly assigned (1:1:1) to either community mobilisation, community mobilisation and incentivisation, or the control arm. Community mobilisation included formation of village committees which conducted awareness activities, while clusters in the community mobilisation and incentivisation group were provided with a novel conditional, collective, community-based incentive (C3I) in addition to community mobilisation. C3I was conditioned on serial incremental targets for collective improvement in coverage at cluster level of three key indicators (primary outcomes): proportion of fully immunised children, use of oral rehydration solution, and sanitation index, assessed at 6 months, 15 months, and 24 months, and village committees decided on non-cash incentives for people in the villages. Data were analysed as intention-to-treat by an independent team masked to study groups. The trial is registered at ClinicalTrials.gov, NCT03594279, and is completed. Findings Between Oct 1, 2018 and Oct 31, 2020, 21 638 children younger than 5 years from 24 846 households, with a total population of 139 005 in 48 clusters, were included in the study. 16 clusters comprising of 152 villages and 7361 children younger than 5 years were randomly assigned to the community mobilisation and incentivisation group; 16 clusters comprising of 166 villages and 7546 children younger than 5 years were randomly assigned to the community mobilisation group; and 16 clusters comprising of 139 villages and 6731 children younger than 5 years were randomly assigned to the control group. Endline analyses were conducted on 3812 children (1284 in the community mobilisation and incentivisation group, 1276 in the community mobilisation group, and 1252 in the control group). Multivariable analysis indicates improvements in all primary outcomes including a higher proportion of fully immunised children (risk ratio [RR] 1<middle dot>3 [95% CI 1<middle dot>0-1<middle dot>5]), higher total sanitation index (mean difference 1<middle dot>3 [95% CI 0<middle dot>6-1<middle dot>9]), and increased oral rehydration solution use (RR 1<middle dot>5 [1<middle dot>0-2<middle dot>2]) in the community mobilisation and incentivisation group compared with the control group at 24 months. There was no evidence of difference between community mobilisation and control for any of the primary outcomes. Interpretation Community mobilisation and incentivisation led to enhanced acceptance evidenced by improved community behaviours and increased coverage of essential interventions for child health. These findings have the potential to inform policy and future implementation of programmes targeting behaviour change but would need evaluation for varying outcomes and different contexts.