Table 1.
Trial outcome measurements
| Outcome | Measurement | Collection | Frequency |
| Clinical outcomes | |||
| Malaria infection prevalence | Rapid diagnostic test | Cross-sectional survey | Baseline, 12, 18, 24, 30 and 36 months postintervention |
| Anaemia | Haematocrit | Cross-sectional survey | Baseline, 12, 18, 24, 30 and 36 months postintervention |
| Temperature | 1. Digital ear thermometer all children 2. Temperature and history of fever |
1. Cross-sectional survey 2. Cohort follow-up |
1. Baseline, 12, 18, 24, 30 and 36 months postintervention 2. Every month |
| Malaria case | Rapid diagnostic test taken when fever ≥37.5°C and or history of fever for the past 48 hours | Cohort follow-up | Every 2 weeks during high transmission season (October to July) and every month during dry season (August to September) |
| Measurement of entomological outcomes | |||
| Indoor Anopheles density | CDC light traps | Entomology surveillance | 8 houses per cluster every 3 months in all clusters for 3 years |
| Outdoor biting | Adapted Furvela tent trap55 | Sentinel site | Two times a year in 2–3 sentinel site per arm |
| Mosquito sporozoite rate | CSP-ELISA to estimate EIR46 | Entomology surveillance | Subsample (30%) of the mosquito collected in CDC light trap |
| Anopheles species identification |
1. A. funestus s.l. complex: conventional PCR or multiplex real time PCR49 2. A. gambiae s.l. complex: TaqMan real time PCR48 |
Entomology surveillance and Sentinel site and resistance test | Subsample of mosquitoes collected |
| Insecticide resistance frequency and intensity | WHO cylinder assay52 CDC bottle bioassays51 |
Collection of adult Anopheles resting indoors | Once a year in a subsample of clusters |
| Frequency of Vgsc mutation | TaqMan PCR50 | Entomology surveillance | Subsample of mosquitoes collected in light trap |
| Insecticide resistance mechanisms | Multiplex TaqMan reverse-transcription quantitative PCR (RT-qPCR) will be used to monitor expression of CYPs and other metabolic enzymes known to be over-expressed in resistant A. gambiae s.s. and A. funestus s.s. populations from previous studies in Tanzania54 | Collection of adult Anopheles resting indoors, previously phenotyped in resistance bioassays | At baseline and at each postintervention year in a subsample of clusters |
CDC, Centers for Disease Control and Prevention; CSP, circumsporozoite protein; EIR, entomological inoculation rate.