Table 1.
Noted differences between the Mali, Kenya, and Zambia protocols
| Mali | Kenya | Zambia | |
|---|---|---|---|
| Site location in each country | Health districts of Kangaba, Kati, and Ouelessebougou in the Kolikoro Region | Rarieda and Alego-Usonga sub-counties, of Siaya County | Kaoma and Nkeyema Districts, Western Province |
| Transmission and seasonality | Intense and highly seasonal (peak May–Nov) | Moderate–high year-around (peaks Jun–Jul and Nov–Dec) | Moderate–high (peak Jan–Jun) |
| Primary (and secondary) vectors [13, 15, 16] | An. gambiae s.s., An. coluzzii (An. arabiensis) | An. funestus, An. arabiensis (An. gambiae s.s.) | An. arabiensis, An. funestus (An. coustani, An. squamosus, An. rufipes, An. pretoriensis) |
| ATSB deployment and replacement | ATSBs deployed continuously throughout 2-year trial (replaced at least every 6 months) | ATSBs deployed continuously throughout 2-year trial (replaced at least every 6 months) | ATSBs deployed seasonally during each year of the 2-year trial (Nov–Jun), replaced as needed |
| Standard of care | AL first-line treatment, universal coverage with LLINs, and SMC in children <5 years old | AL first-line treatment, universal coverage with LLINs, and RTS,S being piloted in 2/3 of the study area | AL first-line treatment, universal coverage with either LLINs or IRS |
| Total clusters (per arm) | 76 (38) | 70 (35) | 70 (35) |
| Cluster formation | Single villages or groups of adjacent villages (100–400 households per cluster) | Single villages or groups of adjacent villages (100–400 households per cluster) | Clusters do not necessarily abide by village boundaries (250–350 households per cluster) |
| Buffer between area of cluster used in analyses | Not required | >1.2 km | >1.2 km |
| Age used for primary outcome of confirmed malaria incidence from cohort | 5–<15 years | 1–<15 years | 1–<15 years |
| Cohort follow-up time periods | 8-month seasonal cohort per year, totaling 16 months of follow-up during 2-year trial | 12-month cohort per year, totaling 24 months of follow-up during 2-year trial (cohorts replaced every 6 months) | 6-month seasonal cohort per year, totaling 12 months of follow-up during 2-year trial |
| Confirmation of two consecutive RDT positive tests during cohort follow-up visits to rule out HRP2 persistence | Microscopy | Microscopy | PCR |
| Statistical power for analysis of primary outcome of confirmed malaria incidence from cohort | 90% | 80% | 80% |
| Timing of household surveys | Cross-sectional (peak transmission Oct–Nov) | Continuous (period) | Cross-sectional (peak transmission Mar–Apr) |
| Prevalence survey measure of infection | Microscopy, with PCR on negatives only | RDT, with dried blood spots available for PCR if desired | RDT, with dried blood spots available for PCR if desired |