Hamer 2007.

Study characteristics
Methods	A randomized, double‐blind, placebo‐controlled superiority trial
Participants	456 HIV‐seropositive pregnant women in 3 district health clinics in Zambia Inclusion criteria HIV‐1 infection All gravidities Gestation of 16 to 28 weeks Free of an acute illness requiring hospitalization Willing to deliver at a study maternity clinic Exclusion criteria Age < 18 years Prior enrolment in this study Residence outside of or intent to move out of the catchment areas of the clinics Severe anaemia (haemoglobin level < 6 g/dL) History of allergic reactions to sulfa drugs Prior major pregnancy complications (e.g. breech presentation, severe pre‐eclampsia, ≥ 2 caesarean sections) Major illness likely to influence pregnancy outcomes
Interventions	Monthly SP for IPTp vs 2‐dose SP for IPTp (standard of care)
Outcomes	The primary outcomes of this study were the prevalence of placental malaria infection and the prevalence of maternal peripheral parasitaemia at delivery. Secondary outcomes were clinical malaria during pregnancy, maternal anaemia, cord blood parasitaemia, birth weight, prematurity, spontaneous abortion, stillbirth, neonatal and infant death, and maternal death.
Notes	All participants were offered nevirapine for prevention of mother‐to‐child transmission of HIV.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization was performed in blocks of 20 in 1 of 2 dosing schedules (IPTp every month vs twice during pregnancy).
Allocation concealment (selection bias)	Low risk	Randomization codes were retained by the study biostatistician and stored in a locked cabinet. This code was broken upon completion of data collection and preliminary blinded analyses.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	This study is a double‐blind placebo‐controlled trial. Participants were given a sealed package of study drugs, containing the same number of tablets (SP or placebo, prepared by Roche Pharmaceuticals).
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No clear information provided in the methods section of the paper, but in their discussion the authors describe the clinical trial as "double‐blind" avoiding "theoretical biases associated with the open‐label designs".
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Of 456 women enrolled, 388 completed the study (35/224 women were lost to follow‐up in the monthly SP arm and 32/232 in the 2‐dose SP arm). Placental samples were collected from 361 participants (171/189 in the monthly SP arm and 189/200 in the 2‐dose SP arm).
Selective reporting (reporting bias)	Unclear risk	Rates of mild adverse events were not shown.
Other bias	Unclear risk	Possible selection bias due to a difference in baseline characteristics between the two groups: a higher proportion of primigravidae enrolled in the arm receiving monthly SP for IPTp. It is not clear whether this difference was accounted for during data analysis.