Randomization and blinding
EVENTS, PILE
Randomization events with all health facilities and the District Health Management Team were conducted in each district between October 25 and 30, 2019. At these events, health facility representatives drew opaque, sealed, equally sized envelopes containing the group allocation (control or intervention) from a Mokorotlo (traditional Lesotho hat), and disclosure took place only once all facilities had drawn their envelope. Additionally, to minimize potential selection bias, the sequence of drawing was randomly selected in advance by an independent person drawing from a second pile of opaque, sealed envelopes containing the names of the facility. Randomization was stratified by district (Butha-Buthe versus Leribe versus Mokhotlong), using 1 block per strata. Participating clinics were assigned (1:1) to either offer standard of care or the PEBRA model. This was an open-label trial; however, laboratory staff who assessed the primary endpoint were blinded. We used non-site-specific study ID numbers on all laboratory and data collection forms to maintain masking.