LLIN Evaluation in Uganda Project (LLINEUP3)

January 15, 2026 updated by: University of California, San Francisco

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
215903

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Uganda
      • Kampala, Uganda
        • Infectious Diseases Research Collaboration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Household Survey

Inclusion Criteria:

  1. At least one adult aged 18 years or older present
  2. Adult is a usual resident who slept in the sampled household on the night before the survey
  3. Agreement of the adult resident to provide informed consent for the household and entomology survey

Exclusion Criteria:

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

Clinical Survey

Inclusion Criteria:

  1. Usual resident who was present in the sampled household on the night before the survey
  2. Agreement of adult or parent/guardian (of children) to provide informed consent
  3. Agreement of child aged 8 years or older to provide assent

Exclusion Criteria:

1. Resident not home on day of survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PermaNet Dual
long lasting insecticidal nets with chlorfenapyr-pyrethroid
Other: long lasting insecticidal nets with chlorfenapyr-pyrethroid (PermaNet Dual)
Next-generation bed net combining insecticides with different modes of action
Behavioral: Social Behavior Change Communication
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.
Active Comparator: PermaNet 3.0
long lasting insecticidal nets with PBO-pyrethroid
Behavioral: Social Behavior Change Communication
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.
Other: long lasting insecticidal nets with PBO-pyrethroid (PermaNet)
Next-generation bed net combining an insecticide with a synergist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24-months follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevalence of parasitaemia
Time Frame: 24-months following LLIN distribution
Proportion of blood smears positive for parasites by microscopy in individuals of all ages at the time of cross-sectional surveys
24-months following LLIN distribution
Proportion of households that owned at least one LLIN
Time Frame: 24-months following LLIN distribution
Proportion of households with at least one LLIN at the time of cross-sectional surveys
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
Vector density
24-months following LLIN distribution
Prevalence of anemia
Time Frame: 24-months following LLIN distribution
Proportion of children aged 2-4 years with haemoglobin < 11 g/dL at the time of cross-sectional surveys
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 households with at least one LLIN per every two occupants at the time of cross-sectional surveys
24-months following LLIN distribution
Proportion of household residents who slept under an LLIN the previous night
Time Frame: 24-months following LLIN distribution
Proportion of households residents who report sleeping under LLIN the previous night at the time of cross-sectional surveys
24-months following LLIN distribution

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)
Liverpool School of Tropical Medicine
Ministry of Health, Uganda
Infectious Diseases Research Collaboration, Uganda
Against Malaria Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Grant Dorsey, MD, PhD, University of California, San Francisco
  • Principal Investigator: Moses Kamya, MBChB, MMed, PhD, Makerere University; Infectious Diseases Research Collaboration

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LLINEUP3
  • U19AI089674 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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