LLIN Evaluation in Uganda Project (LLINEUP3)

NCT05950191 | Completed

• 2 other identifiers: LLINEUP3U19AI089674
• Study Type: interventional
• Target: 215,903
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malaria

Keywords

long lasting insecticidal nets with chlorfenapyr-pyrethroid; long lasting insecticidal nets with with PBO-pyrethroid

Outcome Measures

Primary Outcomes (1)

• 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

  24-months follow up

Secondary Outcomes (6)

• Prevalence of parasitaemia

  24-months following LLIN distribution

• Prevalence of anemia

  24-months following LLIN distribution

• Proportion of households that owned at least one LLIN

  24-months following LLIN distribution

• Proportion of households that owned at least one LLIN for every two occupants

  24-months following LLIN distribution

• Proportion of household residents who slept under an LLIN the previous night

  24-months following LLIN distribution

Study Arms (2)

PermaNet Dual

EXPERIMENTAL

long lasting insecticidal nets with chlorfenapyr-pyrethroid

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

Other: long lasting insecticidal nets with PBO-pyrethroid (PermaNet); Behavioral: Social Behavior Change Communication

Interventions

long lasting insecticidal nets with chlorfenapyr-pyrethroid (PermaNet Dual) OTHER

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

PermaNet Dual

long lasting insecticidal nets with PBO-pyrethroid (PermaNet) OTHER

Next-generation bed net combining an insecticide with a synergist

PermaNet 3.0

Social Behavior Change Communication BEHAVIORAL

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.

PermaNet 3.0; PermaNet Dual

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Dwelling destroyed or not found
• Household vacant
• No adult resident home on more than 3 occasions
• Clinical 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
• \. Resident not home on day of survey

Sponsors & Collaborators

• University of California, San Francisco: lead
• Infectious Diseases Research Collaboration, Uganda: collaborator
• Ministry of Health, Uganda: collaborator
• Against Malaria Foundation: collaborator
• Liverpool School of Tropical Medicine: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Infectious Diseases Research Collaboration

Kampala, Uganda

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Moses Kamya, MBChB, MMed, PhD

  Makerere University; Infectious Diseases Research Collaboration

  PRINCIPAL INVESTIGATOR

• Grant Dorsey, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: November 27, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)