Evidence map›Paper›PMID 36600308›Full record

ArticleTrials2023

A cluster-randomized, placebo-controlled trial to evaluate the efficacy of a spatial repellent (Mosquito Shield™) against Aedes-borne virus infection among children ≥ 4-16 years of age in the Gampaha District, Sri Lanka: study protocol (the AEGIS program).

Hasitha Tissera, D S Anoja F Dheerasinghe, Neelika Malavige, H Asita de Silva, Amy C Morrison, Thomas W Scott, Robert C Reiner, John P Grieco, Nicole L Achee

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05452447 (A Cluster Randomized, Placebo Control Trial to Evaluate the Efficacy of a Spatial Repellent), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.9field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05452447 nacompletednot on this map

A Cluster Randomized, Placebo Control Trial to Evaluate the Efficacy of a Spatial Repellent (Mosquito ShieldTM) Against Aedes-borne Virus Infection Among Children ≥ 4-16 Years of Age in the Gampaha District, Sri Lanka

TypeinterventionalSponsorUniversity of Notre DameRan2023 to 2025Enrolled6,949ConditionsArbovirus InfectionsArmsTransfluthrin, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 2 countries.

Hasitha TisseraEpidemiology Unit, Ministry of Health, Colombo, Sri Lanka.
D S Anoja F DheerasingheNational Dengue Control Unit (NDCU), Ministry of Health, Colombo, Sri Lanka.
Neelika MalavigeDepartment of Immunology and Molecular Medicine, Faculty of Medical Sciences, University of Sri Jayewardenepura, Nugegoda, Sri Lanka.
H Asita de SilvaClinical Trials Unit, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.
Amy C MorrisonUniversity of California Davis, Davis, CA, USA.
Thomas W ScottUniversity of California Davis, Davis, CA, USA.
Robert C ReinerUniversity of Washington, Seattle, WA, USA.
John P GriecoDepartment of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, 243 Galvin Life Science Center, Notre Dame, IN, 46556, USA. jgrieco@nd.edu.ORCID http://orcid.org/0000-0002-2080-8598
Nicole L AcheeDepartment of Biological Sciences, Eck Institute for Global Health, University of Notre Dame, 243 Galvin Life Science Center, Notre Dame, IN, 46556, USA.
University of California, Davis · USUniversity of Notre Dame · USMinistry of Health, Nutrition and Indigenous Medicine · LKUniversity of Kelaniya · LKUniversity of Sri Jayewardenepura · LKUniversity of Washington · US

Funding

Unitaid 2018-29-UND
6 · The paper itself

Abstract

backgroundSpatial repellents (SRs) have been widely used for prevention of mosquito bites, but their efficacy in reducing Aedes-borne viruses (ABV) has not been tested rigorously at large scale in Asia. To address this knowledge gap, a trial to evaluate the efficacy of Mosquito Shield™, a transfluthrin SR, was developed in Gampaha District of Sri Lanka across three Medical Officer of Health areas; i.e., Negombo, Wattala, and Kelaniya.

methodsThis trial is a cluster-randomized, placebo-controlled, double-blinded clinical trial. A total of ~14,430 subjects aged ≥ 6 months in 30 clusters (15 intervention, 15 placebo) from ~3900 households (HH) will be randomly selected for enrolment into a "febrile surveillance cohort." A subset of the surveillance cohort, ~3570 subjects aged ≥4-16 years that test seronegative (naïve) or are serologically positive for a previous single dengue virus (DENV) infection (monotypic) at baseline sampling, will be enrolled into a "longitudinal cohort" for measuring DENV infection based on laboratory-confirmed seroconversion during the trial. Persons identified positive for antibodies against multiple DENV serotypes (multitypic) at baseline will be monitored for secondary analyses. Active ABV disease will be assessed using an enhanced passive surveillance system with case ascertainment performed in designated healthcare facilities. Serum samples will be taken from longitudinal cohort subjects within 1-2 weeks of when intervention is first deployed (T0) with additional samples taken ~12 (T1) and ~24 months (T2) from baseline sampling. DENV seroconversion and ABV active disease rates from baseline (pre-intervention) and follow-up (post-intervention) samples will be compared between intervention and placebo clusters. Participating houses will be monitored entomologically (indoor adult Aedes aegypti population densities and adult female blood fed status) within 3 months before intervention deployment and monthly during the intervention phase. Entomological surveys will monitor indoor adult Ae. aegypti population densities and blood fed status. Dengue incidence in each cohort will be estimated and compared to determine the public health benefit of using an SR. Entomological parameters will be measured to determine if there are entomological correlates of SR efficacy that may be useful for the evaluation of new SR products. DISCUSSION: The trial will serve as an efficacy assessment of SR products in South Asia. Results will be submitted to the World Health Organization Vector Control Advisory Group for assessment of public health value towards an endorsement to recommend inclusion of SRs in ABV control programs.

trial registrationSri Lanka Clinical Trial Registry SLCTR /2022/018. Registered on July 1, 2022. CLINICALTRIALS: gov NCT05452447 . Registered on July 11, 2022. The Universal Trial Number is U1111-1275-3055.

Indexed as

AedesDengueVirus DiseasesAdolescentAdultAnimalsChildChild, PreschoolFemaleHumansMosquito ControlMosquito VectorsRandomized Controlled Trials as TopicSri LankaAedes-borne VirusesCluster-randomized controlled trialDengueIncidenceSpatial repellentSri LankaTransfluthrin

Identifiers

PMID36600308
PMCPMC9811041
OpenAlexW4313545789

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.