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Table 1 Noted differences between the Mali, Kenya, and Zambia protocols

From: Attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia

 

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