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      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)

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          Abstract

          Background

          Spatial 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.

          Methods

          This 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 registration

          Sri Lanka Clinical Trial Registry SLCTR/2022/018. Registered on July 1, 2022.

          ClinicalTrials.govNCT05452447. Registered on July 11, 2022.

          The Universal Trial Number is U1111-1275-3055.

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          Most cited references55

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          Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing

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            The global distribution and burden of dengue

            Dengue is a systemic viral infection transmitted between humans by Aedes mosquitoes 1 . For some patients dengue is a life-threatening illness 2 . There are currently no licensed vaccines or specific therapeutics, and substantial vector control efforts have not stopped its rapid emergence and global spread 3 . The contemporary worldwide distribution of the risk of dengue virus infection 4 and its public health burden are poorly known 2,5 . Here we undertake an exhaustive assembly of known records of dengue occurrence worldwide, and use a formal modelling framework to map the global distribution of dengue risk. We then pair the resulting risk map with detailed longitudinal information from dengue cohort studies and population surfaces to infer the public health burden of dengue in 2010. We predict dengue to be ubiquitous throughout the tropics, with local spatial variations in risk influenced strongly by rainfall, temperature and the degree of urbanisation. Using cartographic approaches, we estimate there to be 390 million (95 percent credible interval 284-528) dengue infections per year, of which 96 million (67-136) manifest apparently (any level of clinical or sub-clinical severity). This infection total is more than three times the dengue burden estimate of the World Health Organization 2 . Stratification of our estimates by country allows comparison with national dengue reporting, after taking into account the probability of an apparent infection being formally reported. The most notable differences are discussed. These new risk maps and infection estimates provide novel insights into the global, regional and national public health burden imposed by dengue. We anticipate that they will provide a starting point for a wider discussion about the global impact of this disease and will help guide improvements in disease control strategies using vaccine, drug and vector control methods and in their economic evaluation. [285]
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              Defining Challenges and Proposing Solutions for Control of the Virus Vector Aedes aegypti

              If done properly, say the authors,Aedes aegypti suppression is a practical method to control urban dengue, yellow fever, and chikungunya viruses.
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                Author and article information

                Contributors
                jgrieco@nd.edu
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                4 January 2023
                4 January 2023
                2023
                : 24
                : 9
                Affiliations
                [1 ]GRID grid.466905.8, Epidemiology Unit, Ministry of Health, ; Colombo, Sri Lanka
                [2 ]GRID grid.466905.8, National Dengue Control Unit (NDCU), Ministry of Health, ; Colombo, Sri Lanka
                [3 ]GRID grid.267198.3, ISNI 0000 0001 1091 4496, Department of Immunology and Molecular Medicine, Faculty of Medical Sciences, , University of Sri Jayewardenepura, ; Nugegoda, Sri Lanka
                [4 ]GRID grid.45202.31, ISNI 0000 0000 8631 5388, Clinical Trials Unit, Faculty of Medicine, , University of Kelaniya, ; Kelaniya, Sri Lanka
                [5 ]GRID grid.27860.3b, ISNI 0000 0004 1936 9684, University of California Davis, ; Davis, CA USA
                [6 ]GRID grid.34477.33, ISNI 0000000122986657, University of Washington, ; Seattle, WA USA
                [7 ]GRID grid.131063.6, ISNI 0000 0001 2168 0066, Department of Biological Sciences, , Eck Institute for Global Health, University of Notre Dame, 243 Galvin Life Science Center, ; Notre Dame, IN 46556 USA
                Author information
                http://orcid.org/0000-0002-2080-8598
                Article
                6998
                10.1186/s13063-022-06998-z
                9811041
                36600308
                cdaf944e-342a-426b-8721-11792516fb92
                © The Author(s) 2023

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 8 November 2022
                : 8 December 2022
                Funding
                Funded by: Unitaid
                Award ID: 2018-29-UND
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2023

                Medicine
                spatial repellent,dengue,aedes-borne viruses,transfluthrin,incidence,cluster-randomized controlled trial,sri lanka

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