A cluster randomized intervention trial to promote shoe use by children at high risk for podoconiosis.

The aim was to evaluate whether an intervention including education about the role of inherited susceptibility in development of a tropical lymphedema increased shoe-wearing among high risk children without increasing community stigma. A cluster randomized intervention trial was conducted with caregivers in affected and unaffected households. Six communities in Ethiopia were randomly assigned to: (1) usual care health education (UC), (2) household-based skills training and community awareness campaign (HB), or (3) HB plus a genetics education module (GE). Recruitment for the six month intervention began in February 2012 and study activities were completed May 2013. Primary outcomes 3 and 12 months were direct observation of shoe use by an index child (age 3-6), experienced stigma among affected participants (n=585), and unaffected participants’ (n=1,124) reports of enacted stigma. Among affected households, neither intervention arm increased shoe wearing or reduced stigma relative to the usual care condition at 3 or 12 months (shoe wearing 3-month difference (95% CI): HB-UC 0.15 (-0.09, 0.40); GE-UC 0.07 (-0.18, 0.32); 12- month: HB-UC -0.24 (-0.34, -0.14); GE-UC -0.18 (-0.28, -0.08); stigma 3-month: HB-UC 0.42 ( -0.63, 1.47); GE-UC 0.62 (-0.43, 1.66); 12-month: HB-UC 0.49 (-0.02, 0.99) ; GE-UC 0.12 ( -0.38, 0.62)). Among unaffected households, differences by intervention arms were marginally significant (p<0.09) with the GE and HB arms showing the largest baseline to 12 month decreases in enacted stigma: HB-UC -0.25 (-0.64, 0.15) ; GE-UC -0.45 (-0.84, -0.05). Improved understanding of disease heritability showed greatest benefit for unaffected households.