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MalariaLLINEUP2NCT04566510

LLIN Evaluation in Uganda Project

A study testing long lasting insecticidal nets with alpha-cypermethrin + pyriproxyfen (PPF LLIN, Royal Guard)), long lasting insecticidal nets with deltamethrin + piperonyl butoxide (PBO LLIN, PermaNet 3.0)) and Social behaviour change communication in people with Malaria, run by University of California, San Francisco at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
long lasting insecticidal nets with alpha-cypermethrin + pyriproxyfen (PPF LLIN, Royal Guard)), long lasting insecticidal nets with deltamethrin + piperonyl butoxide (PBO LLIN, PermaNet 3.0)) and Social behaviour change communication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32,895 participants
Where
1 siteUganda
Study dates
17 Oct 2020to 31 Mar 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Dwelling destroyed or not found
  • Household vacant
  • No adult resident home on more than 3 occasions

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • Infectious Diseases Research Collaboration

    Kampala

Other trials in Uganda

About this study

Official title: Impact of Long-lasting Insecticidal Nets (LLINs) Treated With Pyrethroid Plus Pyriproxyfen vs LLINs Treated With Pyrethroid Plus Piperonyl Butoxide on Malaria Incidence in Uganda: a Cluster-randomised Trial

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).

Read the detailed description

This rigorous, cluster-randomised trial will evaluate the impact of long-lasting insecticidal nets (LLINs) distributed in Uganda through the 2020-21 national universal coverage campaign. A cluster has been defined as the catchment area of a Malaria Reference Centre (MRC). A total of 64 clusters have been included in the study, covering 32 high malaria burden districts in Uganda where IRS is not being implemented. Clusters have been randomised in a 1:1 ratio in blocks of two by district to receive one of two types of LLINs: (1) pyriproxyfen (PPF) LLINs (Royal Guard) [n=32] and (2) piperonyl butoxide (PBO) LLINs (PermaNet 3.0) [n=32].

The intervention, including delivery of the LLINs and social and behaviour change communication (SBCC), will be led by the Ugandan National Malaria Control Division (NMCD) and other stakeholders. Currently, LLINs are scheduled to be delivered in the study areas from October 2020 to January 2021. The evaluation will include health facility surveillance at the MRCs to generate continuous estimates of malaria incidence for each MRC catchment area, cross-sectional community surveys at baseline (if additional resources are available), and at 12- and 24-months after LLIN distribution to gather information on net survivorship and use, and parasite prevalence in children 2-10 years of age, entomology surveys, and assessment of net durability and efficacy. The primary outcome of the trial will be malaria incidence as estimated using the health facility surveillance.

For each cluster the study will use a 'fried egg' approach for delivering the intervention ('egg white') and measuring our outcomes ('egg yolk'). The 'white' of the egg will include one sub-county per cluster, where the MRC is located. PPF LLINs and PBO LLINs will be distributed to the designated sub-county, as allocated in the randomisation. The 'yolk' of the egg will be the catchment area directly surrounding each MRC, where care-seeking at the MRC is expected to be high (i.e. if someone within the catchment area develops malaria, they are likely to seek care at the MRC). To determine the population of the MRC catchment areas, and to generate a sampling frame for the community surveys, the investigators will do the following: (1) define the catchment area of each MRC before the onset of the trial using data on village of residence from patients attending the MRCs, (2) map and enumerate all households within the MRC catchment areas before the 12-month community survey, and (3) conduct a census survey within each MRC catchment area to generate an accurate estimate of the study population in which study outcomes will be measured concurrently with the 12-month community survey.

Conditions
Malaria
Being tested
long lasting insecticidal nets with alpha-cypermethrin + pyriproxyfen (PPF LLIN, Royal Guard)), long lasting insecticidal nets with deltamethrin + piperonyl butoxide (PBO LLIN, PermaNet 3.0)), Social behaviour change communication
Keywords
long-lasting insecticidal net, pyriproxyfen, piperonyl butoxide, alpha-cypermethrin, deltamethrin
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • long lasting insecticidal nets with alpha-cypermethrin + pyriproxyfen (PPF LLIN, Royal Guard))Other

    Next-generation bed net combining insecticides with different modes of action

  • long lasting insecticidal nets with deltamethrin + piperonyl butoxide (PBO LLIN, PermaNet 3.0))Other

    Next-generation bed net combining an insecticide with a synergist

  • Social behaviour change communicationBehavioural

    SBCC activities will use digital and other platforms, similar to those used for the COVID-19 response, including the following: (1) LLIN launch on television and radio; (2) regional advocacy meetings on Zoom; (3) mass media platforms (for advertisements, mini skits, DJ mentions, radio spots, interactive talks); (4) social media platforms; (5) VHTs; (6) operation hotlines and toll-free call centres; (7) community mobilisation (megaphones); and (8) use of appropriate information, education, and communication materials. Communication will include messages about COVID-19, malaria, and use, care, repair and repurposing of LLINs.

Study groups in NCT04566510
Study groupRoleWhat they receive
Royal GuardExperimentalalpha-cypermethrin + pyriproxyfen (PPF)
Receives: Other: long lasting insecticidal nets with alpha-cypermethrin + pyriproxyfen (PPF LLIN, Royal Guard)); Behavioral: Social behaviour change communication
PermaNet 3.0Active comparatordeltamethrin + piperonyl butoxide (PBO)
Receives: Other: long lasting insecticidal nets with deltamethrin + piperonyl butoxide (PBO LLIN, PermaNet 3.0)); Behavioral: Social behaviour change communication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Malaria Incidence

    Number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the catchment areas per unit time/the population of the catchment areas

    Measured: 24 months following LLIN distribution

Secondary outcomes (10)

  1. Prevalence of Parasitaemia

    Proportion of children aged 2-10 years at the time of cross-sectional surveys with blood smears positive for parasites by microscopy

    Measured: 12 months following LLIN distribution

  2. Prevalence of Parasitaemia

    Proportion children aged 2-10 years at the time of cross-sectional surveys with blood smears positive for parasites by microscopy

    Measured: 24 months following LLIN distribution

  3. Prevalence of Anaemia

    Proportion of children aged 2-4 years with haemoglobin < 11 g/dL at the time of cross-sectional surveys

    Measured: 12 months following LLIN distribution

  4. Prevalence of Anaemia

    Proportion of children aged 2-4 years with haemoglobin < 11 g/dL at the time of cross-sectional surveys

    Measured: 24 months following LLIN distribution

  5. Proportion of Households That Owned at Least One LLIN

    Proportion of households with at least one LLIN at the time of cross-sectional surveys

    Measured: 12 months following LLIN distribution

  6. Proportion of Households That Owned at Least One LLIN

    Proportion of households with at least one LLIN at the time of cross-sectional surveys

    Measured: 24 months following LLIN distribution

  7. Proportion of Households That Owned at Least One LLIN for Every Two Occupants

    Proportion of households with at least one LLIN per every two occupants at the time of cross-sectional surveys

    Measured: 12 months following LLIN distribution

  8. Proportion of Households That Owned at Least One LLIN for Every Two Occupants

    Proportion of households with at least one LLIN per every two occupants at the time of cross-sectional surveys

    Measured: 24 months following LLIN distribution

  9. Proportion of Household Residents Who Slept Under an LLIN the Previous Night

    Proportion of households residents who report sleeping under LLIN the previous night at the time of cross-sectional surveys

    Measured: 12 months following LLIN distribution

  10. Proportion of Household Residents Who Slept Under an LLIN the Previous Night

    Proportion of households residents who report sleeping under LLIN the previous night at the time of cross-sectional surveys

    Measured: 24 months following LLIN distribution

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2020
  2. Study start17 Oct 2020
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
cluster-randomised trial
Masking
None (open label)
Enrolment
32,895 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04566510
Sponsor's protocol ID
LLINEUP2
Other IDs
U19AI089674
Acronym
LLINEUP2
Status last verified
Nov 2024
First submitted
22 Sep 2020
Last updated
14 Nov 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gonahasa S, Namuganga JF, Nassali MJ, Maiteki-Sebuguzi C, Nabende I, Epstein A, Snyman K, Nankabirwa JI, Opigo J, Donnelly MJ, Dorsey G, Kamya MR, Staedke SG. LLIN Evaluation in Uganda Project (LLINEUP2) - Effect of long-lasting insecticidal nets (LLINs) treated with pyrethroid plus pyriproxyfen vs LLINs treated with pyrethroid plus piperonyl butoxide in Uganda: A cluster-randomised trial. PLOS Glob Public Health. 2025 Feb 26;5(2):e0003558. doi: 10.1371/journal.pgph.0003558. eCollection 2025.

    PubMed 40009611

Questions about this trial

What is this clinical trial studying?

A study testing long lasting insecticidal nets with alpha-cypermethrin + pyriproxyfen (PPF LLIN, Royal Guard)), long lasting insecticidal nets with deltamethrin + piperonyl butoxide (PBO LLIN, PermaNet 3.0)) and Social behaviour change communication in people with Malaria, run by University of California, San Francisco at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Malaria Incidence (time frame: 24 months following LLIN distribution). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04566510, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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