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LLIN Evaluation in Uganda Project (LLINEUP3)

NCT ID: NCT05950191

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

215903 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Malaria

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PermaNet Dual

long lasting insecticidal nets with chlorfenapyr-pyrethroid

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Social Behavior Change Communication

Intervention Type 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

long lasting insecticidal nets with PBO-pyrethroid

Group Type ACTIVE_COMPARATOR

long lasting insecticidal nets with PBO-pyrethroid (PermaNet)

Intervention Type OTHER

Next-generation bed net combining an insecticide with a synergist

Social Behavior Change Communication

Intervention Type 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.

Interventions

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

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

Intervention Type OTHER

long lasting insecticidal nets with PBO-pyrethroid (PermaNet)

Next-generation bed net combining an insecticide with a synergist

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


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

Clinical Survey


1\. Resident not home on day of survey
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Infectious Diseases Research Collaboration, Uganda

OTHER

Sponsor Role collaborator

Ministry of Health, Uganda

OTHER_GOV

Sponsor Role collaborator

Against Malaria Foundation

UNKNOWN

Sponsor Role collaborator

Liverpool School of Tropical Medicine

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moses Kamya, MBChB, MMed, PhD

Role: PRINCIPAL_INVESTIGATOR

Makerere University; Infectious Diseases Research Collaboration

Grant Dorsey, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Infectious Diseases Research Collaboration

Kampala, , Uganda

Site Status RECRUITING

Countries

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Uganda

Central Contacts

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Grant Dorsey, MD, PhD

Role: CONTACT

Phone: 628-206-4680

Email: [email protected]

Tamara Clark, MHS

Role: CONTACT

Phone: 628-206-8790

Email: [email protected]

Facility Contacts

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Moses Kamaya, MBChB, MPH, PhD

Role: primary

Other Identifiers

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U19AI089674

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LLINEUP3

Identifier Type: -

Identifier Source: org_study_id