Background
Primary objective and hypothesis
Secondary objectives and hypotheses
Study design
Methods
Study setting
Sensitisation
Baseline community surveys
Sampling frame
Recruitment and enrolment
Household survey
Clinical survey
Management of ill participants
Baseline entomology surveys for insecticide resistance monitoring
Assignment of interventions
Initial randomisation and net allocation
Type of LLIN | Targeted total number of nets for distribution | Cumulative number of nets allocated | Number of clusters (health sub-districts) allocated | ||||||
---|---|---|---|---|---|---|---|---|---|
Original randomisation | Final randomisation | Original randomisation | Final randomisation | Waves 2 and 3 | Wave 4 | Western region | Eastern region | Total | |
PermaNet 2.0 | 3,217,360 | 3,743,320 | 3,220,280 | 3,830,280 | 16 | 21 | 24 | 13 | 37 |
PermaNet 3.0 (contains PBO) | 4,100,000 | 3,570,640 | 4,101,840 | 3,515,520 | 18 | 14 | 16 | 16 | 32 |
Olyset Net | 650,000 | 1,244,400 | 651,240 | 1,239,640 | 4 | 11 | 11 | 4 | 15 |
Olyset Plus (contains PBO) | 1,000,000 | 1,601,560 | 994,000 | 1,574,480 | 6 | 14 | 15 | 5 | 20 |
Total | 8,967,360 | 10,159,920 | 8,967,360 | 10,159,920 | 44 | 60 | 66 | 38 | 104 |
LLIN distribution
Revised randomisation and net allocation
Data collection
Follow-up cross-sectional surveys
Phenotypic monitoring
LLIN durability and bio-efficacy
Laboratory procedures
Microscopy
Haemoglobin measurement
Filter paper samples
Rapid diagnostic tests
Insecticide resistance monitoring
Data management
Sample size calculations
Community surveys
Entomology surveys
Analytical issues
Primary and secondary outcomes
Indicator definition | |
---|---|
Community survey | |
Prevalence of parasitaemia | Proportion of thick blood smears that are positive for asexual parasites |
Prevalence of anaemia | Proportion of haemoglobin measurements categorized as anaemia (< 10.0 g/dL) |
LLIN coverage | Proportion of households owning at least one net |
Proportion of households owning at least one LLIN | |
Average number of nets per household | |
Average number of LLINs per household | |
Proportion of households with one LLIN for every two residents | |
Proportion of children who slept under an LLIN the prior night | |
Proportion of pregnant women who slept under an LLIN the prior night | |
Insecticide resistance | |
Phenotyping | Prevalence of phenotypic insecticide resistance |
Genotyping | Prevalence of molecular markers associated with insecticide resistance |
LLINs | |
Survivorship | Proportion of households owning at least one 2016–2017 campaign net |
Proportion of households using at least one 2016–2017 campaign net the prior night | |
Durability | Proportionate Hole Index (PHI): |
1) good, 2) serviceable (repairable), or 3) in need of replacement | |
Bio-efficacy | Knock-down rate at 60 min of mosquitoes tested |
Mortality rate of mosquitoes tested |