Randomization

Faculty based at Heidelberg University in Germany performed the stratified randomization of the 84 mentor mothers, eligible for participation, using a computer-generated random allocation sequence. Randomization was stratified by settlement type. Email was used to transfer the allocations to Philani, where they were implemented by senior Philani staff overseeing the mentor mothers. We chose cluster randomization over individual randomization in this trial due to the organically occurring clusters formed by each mentor mother counseling the pregnant women within her neighborhood. This organization of mentor mothers’ work made individual participant randomization logistically challenging, while cluster randomization was both easier and aligned with community practice. Mentor mothers enrolled individual participants on a rolling basis, including checking eligibility criteria and eliciting informed consent.