MalariaNCT05950191
LLIN Evaluation in Uganda Project (LLINEUP3)
A study testing long lasting insecticidal nets with chlorfenapyr-pyrethroid (PermaNet Dual), long lasting insecticidal nets with PBO-pyrethroid (PermaNet) and Social Behavior Change Communication in people with Malaria, run by University of California, San Francisco at 1 site in Uganda.
Trial 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. 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 chlorfenapyr-pyrethroid (PermaNet Dual), long lasting insecticidal nets with PBO-pyrethroid (PermaNet) and Social Behavior Change Communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215,903 participants
- Where
- 1 siteUganda
- Study dates
- 27 Nov 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 and entomology survey
- Usual resident who was present in the sampled household on the night before the survey
- Agreement of adult or parent/guardian (of children) to provide informed consent
- Agreement of child aged 8 years or older to provide assent
Who cannot join
- Dwelling destroyed or not found
- Household vacant
- No adult resident home on more than 3 occasions
- Clinical Survey
- 1. Resident not home on day of survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LLIN Evaluation in Uganda Project (LLINEUP3): Impact of Long-lasting Insecticidal Nets (LLINs) Treated With Chlorfenapyr Plus Pyrethroid vs LLINs Treated With Piperonyl Butoxide Plus Pyrethroid on Malaria Incidence in Uganda: a Cluster-randomised Trial
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.
Read the detailed description
This is a cluster-randomised trial to evaluate the impact of long-lasting insecticidal nets (LLINs) distributed in Uganda through the 2023 national universal coverage campaign. A cluster has been defined as the target area surrounding an MRC. A total of 24 clusters will be included in the study, covering 20 moderate-high malaria burden districts in Uganda. Clusters have been randomised in a 1:1 ratio to receive one of two types of LLINs: (1) chlorfenapyr-pyrethroid LLINs (PermaNet Dual, n=12) or (2) PBO-pyrethroid LLINs (PermaNet 3.0, n=12). The intervention, including delivery of the LLINs and social and behaviour change communication (SBCC), will be led by the Ugandan NMCD and other stakeholders. Currently, LLINs are scheduled to be distributed in the study areas during waves 5 and 6 from September to October 2023 as part of the national LLIN distribution campaign. The evaluation of the intervention will include: 1) health facility surveillance at the participating MRCs to generate continuous estimates of malaria incidence for each MRC target area; 2) cross-sectional community surveys at 12- and 24-months post-LLIN distribution to gather information on parasite prevalence, anaemia prevalence, net ownership, coverage, and use, 3) entomology surveys at 12 and 24 months to gather information on vector density. The primary outcome of the trial will be malaria incidence as estimated using the health facility surveillance.
- Conditions
- Malaria
- Being tested
- long lasting insecticidal nets with chlorfenapyr-pyrethroid (PermaNet Dual), long lasting insecticidal nets with PBO-pyrethroid (PermaNet), Social Behavior Change Communication
- Keywords
- long lasting insecticidal nets with chlorfenapyr-pyrethroid, long lasting insecticidal nets with with PBO-pyrethroid
- 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 chlorfenapyr-pyrethroid (PermaNet Dual)Other
Next-generation bed net combining insecticides with different modes of action
long lasting insecticidal nets with PBO-pyrethroid (PermaNet)Other
Next-generation bed net combining an insecticide with a synergist
Social Behavior Change CommunicationBehavioural
The NMCD and other stakeholders will take the lead on Social Behaviour Change Communication (SBCC). SBCC activities will use digital and other platforms, including the following: (1) LLIN launch at the World Malaria Day celebrations; (2) regional in-person advocacy meetings; (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 malaria, and use, care, repair and repurposing of bed nets.
| Study group | Role | What they receive |
|---|---|---|
| PermaNet Dual | Experimental | long lasting insecticidal nets with chlorfenapyr-pyrethroid Receives: Other: long lasting insecticidal nets with chlorfenapyr-pyrethroid (PermaNet Dual); Behavioral: Social Behavior Change Communication |
| PermaNet 3.0 | Active comparator | long lasting insecticidal nets with PBO-pyrethroid Receives: Other: long lasting insecticidal nets with PBO-pyrethroid (PermaNet); Behavioral: Social Behavior Change Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area
malaria incidence: number of cases divided by the total population of the target area
Measured: 24-months follow up
Secondary outcomes (6)
Prevalence of parasitaemia
Proportion of blood smears positive for parasites by microscopy in individuals of all ages at the time of cross-sectional surveys
Measured: 24-months following LLIN distribution
Prevalence of anemia
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
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
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
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
Number of female anopheles mosquitoes collected per household at the time of cross-sectional surveys
Vector density
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.
- First posted18 Jul 2023
- Study start27 Nov 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 to evaluate the impact of LLINs distributed in Uganda through the 2023 national universal coverage campaign. A cluster has been defined as the target area surrounding an MRC. A total of 24 clusters will be included in the study, covering 20 moderate-high malaria burden districts in Uganda. Clusters have been randomised in a 1:1 ratio to receive one of two types of LLINs: (1) chlorfenapyr-pyrethroid LLINs (PermaNet Dual, n=12) or (2) PBO-pyrethroid LLINs (PermaNet 3.0, n=12).
- Masking
- None (open label)
- Enrolment
- 215,903 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Infectious Diseases Research Collaboration, Uganda, Ministry of Health, Uganda, Against Malaria Foundation, Liverpool School of Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Moses Kamya, MBChB, MMed, PhD, Principal investigator, Makerere University; Infectious Diseases Research CollaborationGrant Dorsey, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950191
- Sponsor's protocol ID
- LLINEUP3
- Other IDs
- U19AI089674
- Status last verified
- Jan 2026
- First submitted
- 10 Jul 2023
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LLIN Evaluation in Uganda Project (LLINEUP3): Impact of Long-lasting Insecticidal Nets (LLINs) Treated With Chlorfenapyr Plus Pyrethroid vs LLINs Treated With Piperonyl Butoxide Plus Pyrethroid on Malaria Incidence in Uganda: a Cluster-randomised Trial
- ClinicalTrials.gov ID
- NCT05950191
- Acronym / sponsor ID
- LLINEUP3
- Conditions
- Malaria
- Keywords
- long lasting insecticidal nets with chlorfenapyr-pyrethroid, long lasting insecticidal nets with with PBO-pyrethroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215,903 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Infectious Diseases Research Collaboration, Uganda, Ministry of Health, Uganda, Against Malaria Foundation, Liverpool School of Tropical Medicine
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a cluster-randomised trial to evaluate the impact of long-lasting insecticidal nets (LLINs) distributed in Uganda through the 2023 national universal coverage campaign. A cluster has been defined as the target area surrounding an MRC. A total of 24 clusters will be included in the study, covering 20 moderate-high malaria burden districts in Uganda. Clusters have been randomised in a 1:1 ratio to receive one of two types of LLINs: (1) chlorfenapyr-pyrethroid LLINs (PermaNet Dual, n=12) or (2) PBO-pyrethroid LLINs (PermaNet 3.0, n=12). The intervention, including delivery of the LLINs and social and behaviour change communication (SBCC), will be led by the Ugandan NMCD and other stakeholders. Currently, LLINs are scheduled to be distributed in the study areas during waves 5 and 6 from September to October 2023 as part of the national LLIN distribution campaign. The evaluation of the intervention will include: 1) health facility surveillance at the participating MRCs to generate continuous estimates of malaria incidence for each MRC target area; 2) cross-sectional community surveys at 12- and 24-months post-LLIN distribution to gather information on parasite prevalence, anaemia prevalence, net ownership, coverage, and use, 3) entomology surveys at 12 and 24 months to gather information on vector density. The primary outcome of the trial will be malaria incidence as estimated using the health facility surveillance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomised trial to evaluate the impact of LLINs distributed in Uganda through the 2023 national universal coverage campaign. A cluster has been defined as the target area surrounding an MRC. A total of 24 clusters will be included in the study, covering 20 moderate-high malaria burden districts in Uganda. Clusters have been randomised in a 1:1 ratio to receive one of two types of LLINs: (1) chlorfenapyr-pyrethroid LLINs (PermaNet Dual, n=12) or (2) PBO-pyrethroid LLINs (PermaNet 3.0, n=12).
| Arm | Type | Receives |
|---|---|---|
| PermaNet Dual | Experimental | Other: long lasting insecticidal nets with chlorfenapyr-pyrethroid (PermaNet Dual), Behavioral: Social Behavior Change Communicationlong lasting insecticidal nets with chlorfenapyr-pyrethroid |
| PermaNet 3.0 | Active comparator | Other: long lasting insecticidal nets with PBO-pyrethroid (PermaNet), Behavioral: Social Behavior Change Communicationlong lasting insecticidal nets with PBO-pyrethroid |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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 and entomology survey
- Usual resident who was present in the sampled household on the night before the survey
- Agreement of adult or parent/guardian (of children) to provide informed consent
Key exclusion criteria (5 listed)
- Dwelling destroyed or not found
- Household vacant
- No adult resident home on more than 3 occasions
- Clinical Survey
- 1. Resident not home on day of survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| long lasting insecticidal nets with chlorfenapyr-pyrethroid (PermaNet Dual)Next-generation bed net combining insecticides with different modes of action | Other | PermaNet Dual |
| long lasting insecticidal nets with PBO-pyrethroid (PermaNet)Next-generation bed net combining an insecticide with a synergist | Other | PermaNet 3.0 |
| Social Behavior Change CommunicationThe NMCD and other stakeholders will take the lead on Social Behaviour Change Communication (SBCC). SBCC activities will use digital and other platforms, including the following: (1) LLIN launch at the World Malaria Day celebrations; (2) regional in-person advocacy meetings; (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 malaria, and use, care, repair and repurposing of bed nets. | Behavioural | PermaNet 3.0, PermaNet Dual |
Primary outcome
Number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area
Time frame: 24-months follow up
malaria incidence: number of cases divided by the total population of the target area
6 secondary outcomes
Prevalence of parasitaemia
Time frame: 24-months following LLIN distribution
Prevalence of anemia
Time frame: 24-months following LLIN distribution
Proportion of households that owned at least one LLIN
Time frame: 24-months following LLIN distribution
Proportion of households that owned at least one LLIN for every two occupants
Time frame: 24-months following LLIN distribution
Proportion of household residents who slept under an LLIN the previous night
Time frame: 24-months following LLIN distribution
Number of female anopheles mosquitoes collected per household at the time of cross-sectional surveys
Time frame: 24-months following LLIN distribution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moses Kamya, MBChB, MMed, PhD principal investigator
Makerere University; Infectious Diseases Research Collaboration
Grant Dorsey, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing long lasting insecticidal nets with chlorfenapyr-pyrethroid (PermaNet Dual), long lasting insecticidal nets with PBO-pyrethroid (PermaNet) and Social Behavior 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 6 inclusion and 5 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 20 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the target area (time frame: 24-months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.