N/A
Completed N=16,189
LLIN Evaluation in Uganda Project
Source: ClinicalTrials.gov NCT04566510 ↗Enrolled (actual)
16,189
Serious AEs
—
Results posted
Nov 2024
Primary outcomePrimary: Malaria Incidence — 90466; 95898 episodes of malaria over 24 months
Summary
In Uganda, the National Malaria Control Division (NMCD) and implementing partners plan to deliver long-lasting insecticidal nets (LLINs) nationwide in 2020-21, through a mass distribution campaign supported by generous contributions from international donors. LLINs will be distributed free-of-charge to all Ugandan households, aiming to achieve universal coverage. The Against Malaria Foundation has agreed to provide LLINs treated with a pyrethroid insecticide plus pyriproxyfen (PPF) (Royal Guard, Disease Control Technology) and LLINs treated with a pyrethroid insecticide plus piperonyl butoxide (PBO) (PermaNet 3.0, Vestergaard), presenting an opportunity to rigorously evaluate and compare these two LLINs at scale across Uganda. In collaboration with the MOH, the investigators propose to embed a cluster-randomised trial to compare the impact of LLINs with PPF to LLINs with PBO into Uganda's 2020 LLIN distribution campaign. The primary objective of the study is: To evaluate the impact of LLINs treated with a pyrethroid insecticide plus pyriproxyfen (PPF LLINs), as compared to LLINs treated with a pyrethroid plus piperonyl butoxide (PBO LLINs), on malaria incidence in Uganda. The study will test the hypothesis that malaria incidence will be lower in intervention clusters (randomised to receive PPF LLINs) than in control clusters (randomised to receive PBO LLINs).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Malaria Incidence |
90466; 95898 | — |
| SECONDARY Prevalence of Parasitaemia |
651; 602 | — |
| SECONDARY Prevalence of Anaemia |
178; 191 | — |
| SECONDARY Proportion of Households That Owned at Least One LLIN |
1345; 1384 | — |
| SECONDARY Proportion of Households That Owned at Least One LLIN for Every Two Occupants |
650; 695 | — |
| SECONDARY Proportion of Household Residents Who Slept Under an LLIN the Previous Night |
5117; 5341 | — |
Eligibility Criteria
A) Primary outcome: All patients who present to the outpatient departments of the MRCs
B) Community surveys for secondary outcomes:
Inclusion Criteria
- At least one adult aged 18 years or older present
- Adult is a usual resident who slept in the sampled household on the night before the survey
- Agreement of the adult resident to provide informed consent for the household survey
Exclusion Criteria
- Dwelling destroyed or not found
- Household vacant
- No adult resident home on more than 3 occasions
Data sourced from ClinicalTrials.gov (NCT04566510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.