Denoeud‐Ndam 2014b.

Study characteristics
Methods	One of 2 parallel open‐label, non‐inferiority RCTs investigating cotrimoxazole prophylaxis vs mefloquine: “cotrimoxazole not mandatory” trial
Participants	140 HIV‐positive pregnant women in 5 hospitals in Benin Inclusion criteria HIV‐positive Aged ≥ 18 years Living permanently in the study area Gestational age between 16 and 28 weeks Giving a written informed consent Exclusion criteria Age < 18 years History of a neuropsychiatric disorder Severe kidney or liver disease Serious adverse reactions to mefloquine, sulfa drugs, or quinine
Interventions	Daily cotrimoxazole vs 3 doses of mefloquine as IPTp
Outcomes	The primary outcome was proportion of placental malaria. Secondary outcomes were maternal peripheral parasitaemia during pregnancy and at delivery, maternal anaemia, cord blood malaria infection at delivery, low birth weight, preterm deliveries, spontaneous abortions, stillbirths, congenital anomalies, neonatal and infant mortality, adverse drug effects, and mother‐to‐child HIV transmission rate.
Notes	All participants received insecticide‐treated bed nets. All women received ART to prevent mother‐to‐child transmission of HIV according to national guidelines. Women who were already under treatment before pregnancy continued with the same ART. In other cases, ART was prescribed immediately if HIV pregnant women needed treatment for themselves, or at different times during pregnancy according to the ongoing PMTCT guidelines: before June 2010, ART was recommended from 28 weeks of pregnancy; after June 2010, it was recommended from 14 weeks of pregnancy (Denoeud‐Ndam 2013).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Rrandomization was stratified according to the study site and the number of previous pregnancies (primigravid vs multigravida). The randomization procedure used was not described.
Allocation concealment (selection bias)	High risk	It is an open‐label, noninferiority controlled trial based on the participants’ immunodeficiency levels. Randomization was stratified according to the study site and the number of previous pregnancies (primigravid vs multigravid). The study co‐ordination centre retained the master list and assigned treatments by phone.
Blinding of participants and personnel (performance bias) All outcomes	High risk	This open‐label trial was blinded only to the microscopists who evaluated blood smears.
Blinding of outcome assessment (detection bias) All outcomes	High risk	This trial was blinded only to the microscopists who evaluated blood smears. Those assessing other outcomes, including adverse events, were not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	The reasons for exclusion are well explained and balanced.
Selective reporting (reporting bias)	Low risk	Not observed
Other bias	Low risk	Not observed