LLIN Evaluation in Uganda Project (LLINEUP3) - Trial NCT05950191
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Study Focus
long lasting insecticidal nets with chlorfenapyr-pyrethroid (PermaNet Dual)
Interventional
other
Sponsor & Location
University of California, San Francisco
Timeline & Enrollment
N/A
Sep 01, 2023
Dec 31, 2025
Primary Outcome
Number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area
Summary
In Uganda, the National Malaria Control Division (NMCD) and implementing partners are
 planning to deliver long-lasting insecticidal nets (LLINs) nationwide, through a mass
 distribution campaign in 2023. LLINs will be distributed free-of-charge to all Ugandan
 households, aiming to achieve universal coverage. LLINs treated with a pyrethroid insecticide
 plus chlorfenapyr (PermaNet Dual, Vestergaard) and LLINs treated with a pyrethroid
 insecticide plus PBO (PermaNet 3.0, Vestergaard) will be distributed as part of this
 distribution campaign, presenting an opportunity to rigorously evaluate and compare these two
 LLINs at scale across Uganda. In collaboration with the MOH, this cluster-randomised trial
 will compare the impact of LLINs combining chlorfenapyr with a pyrethroid to LLINs combining
 PBO with a pyrethroid into Uganda's 2023 LLIN distribution campaign, as was done successfully
 at the time of the last LLIN distribution campaign conducted in 2020-21. A major strength of
 this trial is the use of malaria incidence as the primary outcome measure. Incidence of
 malaria, defined as the number of symptomatic cases of malaria occurring in a population at
 risk over time, is the gold standard for assessing malaria burden. However,
 cluster-randomised trials using malaria incidence as the primary outcome typically involve
 study cohorts and are very expensive and logistically challenging. The novel approach for
 measuring malaria incidence is to utilize data collected routinely at health facilities. By
 defining target areas around health facilities and collecting data on the location of
 residence of patients diagnosed with malaria, this study will be able to generate
 longitudinal measures of malaria incidence at an unprecedented scale across Uganda as done in
 the LLINEUP2 trial (NCT04566510). These results will inform policies and programmes for
 malaria and potentially provide evidence to support widescale deployment of dual AI
 chlorfenapyr-pyrethroid LLINs. This study, the first evaluating PermaNet Dual LLINs, will
 also provide evidence for a second in class chlorfenapyr net, a potential tool to be added to
 the malaria control tool kit.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05950191
Non-Device Trial