Impact of long-lasting insecticide treated bednets with and without piperonyl butoxide (PBO) on malaria indicators in Uganda

INTERVENTION: A total of 104 clusters (defined as a health sub‐district) have been included in the study, covering 48 districts in Eastern and Western Uganda. Clusters are randomised by a member of the study team who is not based in Uganda, and who will not be directly involved in the field work to one of four groups, who receive different types of LLINs. Variation in the production capacity and the number of nets available for each manufacturer, is considered in the randomisation process, resulting in unequal numbers of clusters being allocated to each of the 4 study arms. Group 1: PermaNet 2.0 Group 2: PermaNet 3.0 Group 3: Olyset Net Group 4: Olyset Plus The Ugandan National Malaria Control Programme and other stakeholders will take the lead on delivering the LLINs to health sub districts in Uganda. Here, the plans for the net distribution campaign are described to provide background information on the intervention. The research team will only be responsible for carrying out the evaluation. Households in all intervention arms will receive 1 LLIN per 2 household members, rounded up in the case of an uneven number of household members. The bednets are deployed over the sleeping spaces in each household and are used to reduce the number of potentially malaria infectious bites received by household members whilst asleep. Social behaviour change communication (SBCC)/information, education, communication (IEC) will accompany net distribution to increase compliance. At each LLIN distribution point, a demonstration area will be set up to show how to correctly hang LLINs and to disseminate key messages about malaria, use of LLINs, and the importance of caring for the nets correctly. SBCC and health education sessions will focus on correct care and maintenance of LLINs, including washing, repair of holes and tears, and avoidance of sun when washing and drying nets. The evaluation will include repeated cross‐sectional community surveys to gather information on net survivorship and us CONDITION: Malaria ; Infections and Infestations ; Malaria PRIMARY OUTCOME: Parasite prevalence (defined as the proportion of thick blood smears that are positive for asexual parasites) in children aged 2‐10 years is assessed using cross‐sectional surveys at baseline (prior to distribution of the nets) and up to 3 times after nets are distributed, 6, 12 and 18‐24 months after distribution. INCLUSION CRITERIA: Household INCLUSION CRITERIA: 1. At least one household resident between 2‐10 years of age present (with an adult caregiver willing to provide informed consent for the clinical survey) 2. At least one adult aged 18 years or older present 3. Adult is a usual resident who slept in the sampled household on the night before the survey 4. Agreement of the adult resident to provide informed consent for the household survey Children INCLUSION CRITERIA: 1. Child aged 5 years and over 2. Usual resident who was present in the sampled household on the night before the survey 3. Agreement of parent/guardian to provide informed consent 4. Agreement of child aged 8 years or older to provide assent SECONDARY OUTCOME: 1. Prevalence of anaemia and mean haemoglobin in children aged 2‐10 years. Anaemia will be defined as a haemoglobin concentration (g/dl) less than 11 in children 24‐59 months and less than 11.5 in child 5‐10 years. Haemoglobin concentration will be measured on site using a drop of blood collected from a finger‐prick. The test will be conducted during the cross‐sectional surveys using a battery‐operated portable HemoCue analyzer (HemoCue, Anglom, Sweden) at baseline (prior to distribution of the nets) and up to 3 times after nets are distributed, 6, 12 and 18‐24 months after distribution; 2. Frequency of molecular markers associated with insecticide resistance in the primary malaria vector will be conducted on DNA extracted from mosquitoes collected in each of the study clusters during the cross‐sectional surveys and will utilise PCR and rtPCR approaches at baseline (prior to distribution of the nets) and up to 3 times after nets are distributed, 6, 12 and 18‐24 months after distribution; 3. Prevalence of phenotypic insecticide resistance in 12 study clusters will be assessed using standard World Health Organization (WHO) tests of insecticide resistance performed during the cross‐sectional surveys at baseline (prior to distribution of the nets) and up to 3 times after nets are distributed, 6, 12 and 18‐24 months after distribution; 4. LLIN survivorship, durability and bio‐efficacy will be assessed during a cross‐sectional survey conducted 12 months after distribution. The tests will follow WHO guidelines: survivorship defined as the presence or absence of a LLIN in a survey household; durability is defined based on the number and area of holes in the LLIN; bio‐efficacy is defined based the proportion of known susceptible mosquitoes surviving exposure to the LLIN netting.