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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17516395
Enrollment
10000
Registered
2017-02-14
Start date
2017-03-16
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Infections and Infestations Malaria

Interventions

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 w

Sponsors

Liverpool School of Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 10 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Household exclusion criteria: 1. Dwelling destroyed or not found 2. Household vacant 3. No adult resident home on more than 3 occasions Children exclusion criteria: Child not home on day of survey

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Uganda

Contacts

Public ContactMartin Donnelly
martin.donnelly@lstmed.ac.uk+44 151 705 3296

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026