Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04566510
Status:
COMPLETED
Last Update Posted:
2023-05-12
First Post:
2020-09-22
Brief Title:
LLIN Evaluation in Uganda Project
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LLINEUP2
Brief Summary:
In Uganda the National Malaria Control Division NMCD and implementing partners plan to deliver long-lasting insecticidal nets LLINs nationwide in 2020-21 through a mass distribution campaign supported by generous contributions from international donors LLINs will be distributed free-of-charge to all Ugandan households aiming to achieve universal coverage The Against Malaria Foundation has agreed to provide LLINs treated with a pyrethroid insecticide plus pyriproxyfen PPF Royal Guard Disease Control Technology and LLINs treated with a pyrethroid insecticide plus piperonyl butoxide PBO PermaNet 30 Vestergaard presenting an opportunity to rigorously evaluate and compare these two LLINs at scale across Uganda In collaboration with the MOH the investigators propose to embed a cluster-randomised trial to compare the impact of LLINs with PPF to LLINs with PBO into Ugandas 2020 LLIN distribution campaign The primary objective of the study is To evaluate the impact of LLINs treated with a pyrethroid insecticide plus pyriproxyfen PPF LLINs as compared to LLINs treated with a pyrethroid plus piperonyl butoxide PBO LLINs on malaria incidence in Uganda The study will test the hypothesis that malaria incidence will be lower in intervention clusters randomised to receive PPF LLINs than in control clusters randomised to receive PBO LLINs
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 11 ratio in blocks of two by district to receive one of two types of LLINs 1 pyriproxyfen PPF LLINs Royal Guard n32 and 2 piperonyl butoxide PBO LLINs PermaNet 30 n32
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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U19AI089674 | NIH | None | httpsreporternihgovquickSearchU19AI089674 |