Filler 2006.

Study characteristics
Methods	Non‐blinded efficacy RCT
Participants	266 HIV‐positive pregnant women in Malawi Inclusion criteria Patients seeking antenatal care in Machinga District Hospital (Malawi) First or second pregnancy Gestational age between 16 and 28 weeks Exclusion criteria Women reporting a priori adverse drug reaction to sulfa‐containing medications or quinine > 28 weeks of gestation or < 16 weeks of gestation Not pregnant No foetal movement Moving from the study area Antimalarial or cotrimoxazole prophylaxis intake in last month Prior intake of IPTp with SP 2 or more prior pregnancies < 15 years of age
Interventions	Monthly SP for IPTp vs 2‐dose SP for IPTp (standard of care)
Outcomes	The primary outcome was placental malaria parasitaemia rates at delivery. Secondary outcomes were clinical malaria episodes during pregnancy, maternal peripheral parasitaemia at delivery, maternal anaemia, cord blood parasitaemia, low birth weight, prematurity, spontaneous abortions, stillbirths, and neonatal mortality.
Notes	Combination antiretroviral therapy was not routinely available in Malawi during the time of the trial. Single‐dose nevirapine was given to all HIV‐infected women at 32 weeks of gestation to self‐administer once they entered active labour.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Enrolled women were randomized, by permuted blocks of random length, to 1 of 2 IPTp regimens, by HIV status.
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Neither study participants nor clinicians were blinded to group assignment.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Trained laboratory workers who assessed the primary outcome of placental malaria were blinded to the women’s HIV status and treatment arm.
Incomplete outcome data (attrition bias) All outcomes	High risk	The study's main analysis excluded women who were reassigned from the 2‐dose arm to the monthly SP arm. Study authors performed an intention‐to‐treat analysis, which analyzed data according to original arm assignments. However, findings of this intention‐to‐treat analysis are only reported for the principal outcome (placental malaria) and not for other outcomes such as clinical malaria episodes or adverse events.
Selective reporting (reporting bias)	Low risk	Not observed
Other bias	Low risk	Not observed