Akinyotu 2019.
Study characteristics | ||
Methods | Single‐blind RCT | |
Participants | 123 HIV‐positive pregnant women in Nigeria Inclusion criteria
Exclusion criteria
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Interventions | Single‐dose azithromycin vs 3‐dose SP for IPTp | |
Outcomes | The primary study outcome was malaria parasitaemia at delivery. The secondary outcomes included maternal peripheral parasitaemia during pregnancy, placental malaria, clinical malaria episodes during pregnancy, maternal anaemia, birth weight, prematurity, and drug‐related adverse events. | |
Notes | All participants received an LLIN. All participants received routine care for HIV‐infected women to prevent mother‐to‐child transmission of HIV. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were enrolled and allocated into study arms using block randomization (block size of 4). |
Allocation concealment (selection bias) | Low risk | Allocation numbers and drugs were kept in opaque envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | There was no masking of the intervention drugs. Both drugs were self‐administered and the dosing regimens for the drugs differed. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The outcome assessor was blinded to the allocation group and drug administered. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | A total of 123 participants (87.9%) completed the study and 17 participants (12.1%) were lost to follow‐up. It is unclear whether loss‐to‐follow‐up was balanced between the study arms. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported. |
Other bias | Unclear risk | Possible selection bias due to significant differences in participant's parity, gestational age at enrolment, and occupation between treatment groups. It is not clear whether these differences were accounted for during data analysis. Adherence to treatment was not reported. |