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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Uganda
Infectious Diseases Research Collaboration
RECRUITING
Kampala
Contact Information
Primary
Grant Dorsey, MD, PhD
grant.dorsey@ucsf.edu
628-206-4680
Backup
Tamara Clark, MHS
tamara.clark@ucsf.edu
628-206-8790
Time Frame
Start Date: 2023-11-27
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 215903
Treatments
Experimental: PermaNet Dual
long lasting insecticidal nets with chlorfenapyr-pyrethroid
Active_comparator: PermaNet 3.0
long lasting insecticidal nets with PBO-pyrethroid
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Ministry of Health, Uganda, Infectious Diseases Research Collaboration, Uganda, Against Malaria Foundation, Liverpool School of Tropical Medicine
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov