Figure 1.

Flow of participants through the SHINE early child development (ECD) sub‐study. ¹In all, 212 clusters were randomized, 53 in each of the four trial arms. After randomization, 1 cluster was excluded as it was determined to be in an urban area, 1 cluster was excluded as the village health worker covering it mainly had clients outside the study area, and 1 more was merged into a neighbouring cluster based on subsequent data on village health worker coverage. Three new cluster designations were created due to anomalies in the original mapping: for 2 of these, the trial arm was clear; the third contained areas that were in 2 trial arms, and was assigned to the underrepresented arm, resulting in 53 clusters in each arm. All of this occurred before enrolment began. When enrolment was completed, however, there was 1 standard‐of‐care cluster in which no women were enrolled, leaving a total of 211 clusters available for analysis. ²Children were not eligible for the ECD sub‐study if they turned two years of age (allowable range 102 to 112 weeks) before 1 March 2016. ³Children were eligible for the ECD sub‐study if they turned two years of age (allowable range 102 to 112 weeks) between 1 March 2016, and April 30, 2017. ⁴Children were eligible for the ECD sub‐study because they turned two years of age (allowable range 102 to 112 weeks) between 1 March 2016, and 30 April 2017, but they were not contactable or were not approached for consent because the number of children becoming 102 to 112 weeks of age between 1 March 2016, and 30 April 2017, exceeded the capacity of the 11 ECD‐trained nurses. ⁵Children in the WASH plus IYCF combined arm were excluded from this analysis because of an interaction between HIV exposure and IYCF plus WASH for the total MDAT score (p = 0.008, Wald test). IYCF: infant and young child feeding; SOC: standard of care; WASH: water, sanitation and hygiene.