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. 2024 Sep 26;2024(9):CD006689. doi: 10.1002/14651858.CD006689.pub3

González 2014.

Study characteristics
Methods An individually‐randomized, double‐blind, placebo‐controlled, multicentre efficacy trial
Participants 1071 HIV‐positive pregnant women receiving cotrimoxazole prophylaxis in selected antenatal care clinics in Tanzania, Mozambique, and Kenya
Inclusion criteria
  • Pregnant women

  • Permanent residents in the study area

  • Gestational age equal or below 28 weeks

  • Positive HIV‐test at recruitment

  • Absence of history of allergy to sulfa drugs and mefloquine

  • Absence of history of severe renal, hepatic, psychiatric, or neurological disease

  • Had not received mefloquine or halofantrine treatment in the preceding 4 weeks


Exclusion criteria
  • Residence outside the study area or planning to move out in the following 10 months from enrollment

  • Gestational age at the first antenatal visit > 28 weeks of pregnancy

  • Known history of allergy to cotrimoxazole or mefloquine

  • Known history of severe renal, hepatic, psychiatric or neurological disease

  • Mefloquine or halofantrine treatment in the preceding 4 weeks

  • Participating in other intervention studies

Interventions Cotrimoxazole plus mefloquine‐IPTp vs cotrimoxazole plus placebo
Outcomes The primary outcome of this study was maternal peripheral parasitaemia at delivery. Secondary outcomes included prevalence of placental Plasmodium falciparum infection, maternal anaemia, maternal viral load at delivery, cord blood parasitaemia, prevalence of low birth weight, prematurity rate, SAEs during pregancy, drug‐related adverse events, and mother‐to‐child transmission of HIV.
Notes All participants received an LLIN.
All participants received antiretroviral drugs for prevention of mother‐to‐child HIV transmission according to national guidelines.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The allocation of the participants to the study arms was done centrally by block randomization (block size of 6) stratified by country.
Allocation concealment (selection bias) Low risk The Pharmacy Department of the Hospital Clinic in Barcelona produced and safeguarded the computer‐generated randomization list for each recruiting site until unblinding, and carried out the masking, labelling, and packaging of all study interventional drugs. Study number allocation for each participant was concealed in opaque sealed envelopes that were sequentially numbered and opened only after recruitment by study health personnel.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Study participants were assigned a unique study number linked to the allocated treatment group. Investigators, laboratory staff, care providers, and study participants were blinded to intervention throughout the study. The placebo tablets were identical to mefloquine tablets in shape and colour.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Study participants were assigned a unique study number linked to the allocated treatment group. Investigators, laboratory staff, care providers, and study participants were blinded to intervention throughout the study.
Incomplete outcome data (attrition bias)
All outcomes Low risk All excluded participants, at each stage of the trial, are counted in the flow chart (both ITT and ATP cohorts). All main outcomes for both endpoints are correctly reported in the article. Only infant data are missing (reported in another article with a different objective).
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported.
Other bias Low risk Not observed