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. 2021 May 5;17(2):e1156. doi: 10.1002/cl2.1156
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk

Quote: “The study statistician (JL) based in Pretoria, who had no knowledge of the study area, randomly generated the allocation sequence for each stratum. Then enrolled participants.”

Comment: random sequence generation was adequately done

Allocation concealment (selection bias) Low risk

Quote: “The study statistician (JL) based in Pretoria, who had no knowledge of the study area, randomly generated the allocation sequence”

Comment: allocation was adequately concealed

Similar baseline characteristics Unclear risk
Similar baseline outcome measurement Unclear risk
Blinding of participants and personnel (performance bias) Low risk Comment: personnel (field workers and interviewers) could not be blinded and were used for quality control of the measures. There was active recruiting the villages for participants in the study, again given the nature of the intervention blinding was not possible.
Blinding of outcome assessment (detection bias) Low risk

Quote: “All blood tests were conducted blind to the treatment arm”

Comment: outcome assessment was blind

Incomplete outcome data (attrition bias) Low risk

Quote: “No clusters were lost to follow‐up.”

“Loss to follow‐up was mainly because participants had moved and could not be located.”

Comment: missing outcome data is balanced across groups

Prevention of knowledge of allocated intervention Unclear risk
Protection against contamination Unclear risk
Selective reporting (reporting bias) Unclear risk Comment: insufficient information to permit judgement and no protocol was found.
Other bias Low risk Comment: no evidence to suggest this