- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04566510
LLIN Evaluation in Uganda Project (LLINEUP2)
Impact of Long-lasting Insecticidal Nets (LLINs) Treated With Pyrethroid Plus Pyriproxyfen vs LLINs Treated With Pyrethroid Plus Piperonyl Butoxide on Malaria Incidence in Uganda: a Cluster-randomised Trial
Study Overview
Status
Conditions
Detailed Description
This rigorous, cluster-randomised trial will evaluate the impact of long-lasting insecticidal nets (LLINs) distributed in Uganda through the 2020-21 national universal coverage campaign. A cluster has been defined as the catchment area of a Malaria Reference Centre (MRC). A total of 64 clusters have been included in the study, covering 32 high malaria burden districts in Uganda where IRS is not being implemented. Clusters have been randomised in a 1:1 ratio in blocks of two by district to receive one of two types of LLINs: (1) pyriproxyfen (PPF) LLINs (Royal Guard) [n=32] and (2) piperonyl butoxide (PBO) LLINs (PermaNet 3.0) [n=32].
The intervention, including delivery of the LLINs and social and behaviour change communication (SBCC), will be led by the Ugandan National Malaria Control Division (NMCD) and other stakeholders. Currently, LLINs are scheduled to be delivered in the study areas from October 2020 to January 2021. The evaluation will include health facility surveillance at the MRCs to generate continuous estimates of malaria incidence for each MRC catchment area, cross-sectional community surveys at baseline (if additional resources are available), and at 12- and 24-months after LLIN distribution to gather information on net survivorship and use, and parasite prevalence in children 2-10 years of age, entomology surveys, and assessment of net durability and efficacy. The primary outcome of the trial will be malaria incidence as estimated using the health facility surveillance.
For each cluster the study will use a 'fried egg' approach for delivering the intervention ('egg white') and measuring our outcomes ('egg yolk'). The 'white' of the egg will include one sub-county per cluster, where the MRC is located. PPF LLINs and PBO LLINs will be distributed to the designated sub-county, as allocated in the randomisation. The 'yolk' of the egg will be the catchment area directly surrounding each MRC, where care-seeking at the MRC is expected to be high (i.e. if someone within the catchment area develops malaria, they are likely to seek care at the MRC). To determine the population of the MRC catchment areas, and to generate a sampling frame for the community surveys, the investigators will do the following: (1) define the catchment area of each MRC before the onset of the trial using data on village of residence from patients attending the MRCs, (2) map and enumerate all households within the MRC catchment areas before the 12-month community survey, and (3) conduct a census survey within each MRC catchment area to generate an accurate estimate of the study population in which study outcomes will be measured concurrently with the 12-month community survey.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Grant Dorsey, MD, PhD
- Phone Number: 628-206-4680
- Email: grant.dorsey@ucsf.edu
Study Contact Backup
- Name: Sarah Staedke, MD, PhD
- Email: Sarah.Staedke@lshtm.ac.uk
Study Locations
-
-
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Kampala, Uganda
- Infectious Diseases Research Collaboration
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
A) Primary outcome: All patients who present to the outpatient departments of the MRCs
B) Community surveys for secondary outcomes:
Inclusion Criteria:
- 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 survey
Exclusion Criteria:
- Dwelling destroyed or not found
- Household vacant
- No adult resident home on more than 3 occasions
Study Plan
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 |
Intervention / Treatment |
---|---|
Experimental: Royal Guard
alpha-cypermethrin + pyriproxyfen (PPF)
|
Next-generation bed net combining insecticides with different modes of action
SBCC activities will use digital and other platforms, similar to those used for the COVID-19 response, including the following: (1) LLIN launch on television and radio; (2) regional advocacy meetings on Zoom; (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 COVID-19, malaria, and use, care, repair and repurposing of LLINs.
|
Active Comparator: PermaNet 3.0
deltamethrin + piperonyl butoxide (PBO)
|
SBCC activities will use digital and other platforms, similar to those used for the COVID-19 response, including the following: (1) LLIN launch on television and radio; (2) regional advocacy meetings on Zoom; (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 COVID-19, malaria, and use, care, repair and repurposing of LLINs.
Next-generation bed net combining an insecticide with a synergist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Malaria incidence
Time Frame: 24 months following LLIN distribution
|
Number of cases of laboratory-confirmed malaria diagnosed at the MRC among patients residing in the catchment areas per unit time/the population of the catchment areas
|
24 months following LLIN distribution
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of parasitaemia
Time Frame: 12 months following LLIN distribution
|
Proportion of blood smears positive for parasites by microscopy in children aged 2-10 years at the time of cross-sectional surveys
|
12 months following LLIN distribution
|
Prevalence of parasitaemia
Time Frame: 24 months following LLIN distribution
|
Proportion of blood smears positive for parasites by microscopy in children aged 2-10 years at the time of cross-sectional surveys
|
24 months following LLIN distribution
|
Prevalence of anaemia
Time Frame: 12 months following LLIN distribution
|
Proportion of children aged 2-4 years with haemoglobin < 11 g/dL at the time of cross-sectional surveys
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12 months following LLIN distribution
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Prevalence of anaemia
Time Frame: 24 months following LLIN distribution
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Proportion of children aged 2-4 years with haemoglobin < 11 g/dL at the time of cross-sectional surveys
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24 months following LLIN distribution
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Proportion of households that owned at least one LLIN
Time Frame: 12 months following LLIN distribution
|
Proportion of households with at least one LLIN at the time of cross-sectional surveys
|
12 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
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Proportion of households that owned at least one LLIN for every two occupants
Time Frame: 12 months following LLIN distribution
|
Proportion of households with at least one LLIN per every two occupants at the time of cross-sectional surveys
|
12 months following LLIN distribution
|
Proportion of households that owned at least one LLIN for every two occupants
Time Frame: 24 months following LLIN distribution
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Proportion of households with at least one LLIN per every two occupants at the time of cross-sectional surveys
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24 months following LLIN distribution
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Proportion of household residents who slept under an LLIN the previous night
Time Frame: 12 months following LLIN distribution
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Proportion of households residents who report sleeping under LLIN the previous night at the time of cross-sectional surveys
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12 months following LLIN distribution
|
Proportion of household residents who slept under an LLIN the previous night
Time Frame: 24 months following LLIN distribution
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Proportion of households residents who report sleeping under LLIN the previous night at the time of cross-sectional surveys
|
24 months following LLIN distribution
|
Incremental cost-effectiveness ratios
Time Frame: 24 months following LLIN distribution
|
USD per disability-adjusted life year adverted and per malaria case adverted
|
24 months following LLIN distribution
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sarah Staedke, MD, PhD, London School of Hygiene and Tropical Medicine
- Principal Investigator: Moses Kamya, MBChB, MMed, PhD, Infectious Diseases Research Collaboration
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LLINEUP2
- U19AI089674 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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