The TIRS trial: protocol for a cluster randomized controlled trial assessing the efficacy of preventive targeted indoor residual spraying to reduce Aedes-borne viral illnesses in Merida, Mexico

Trials

M. Elizabeth Halloran¹  Audrey Lenhart²  Fabian Correa-Morales³  Norma Pavia-Ruz⁴  Guadalupe Ayora-Talavera⁴  Lance A. Waller⁵  Natalie E. Dean⁶  Ira M. Longini⁷  Gonzalo M. Vazquez-Prokopec⁸  Yamila Romer⁸  Oscar D. Kirstein⁸  Thomas J. Hladish⁹  Hector Gomez-Dantes^1,10  Matthew H. Collins^1,11  Jorge Palacio-Vargas^1,12  Rosa Mendez-Vales^1,12  Pilar Granja Pérez^1,12  Pablo Manrique-Saide^1,13  Azael Che-Mendoza^1,13 

[1] Center for Inference and Dynamics of Infectious Diseases, 98109, Seattle, WA, USA;Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 98109, Seattle, WA, USA;Department of Biostatistics, University of Washington, 98109, Seattle, WA, USA;Centers for Disease Control and Prevention, Atlanta, GA, USA;Centro Nacional de Programas Preventivos y Control de Enfermedades (CENAPRECE) Secretaría de Salud Mexico, Mexico City, Mexico;Centro de Investigaciones Regionales Hideyo Noguchi, Universidad Autonoma de Yucatan, Merida, Mexico;Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, 30322, Atlanta, GA, USA;Department of Biostatistics, University of Florida, 32611, Gainesville, FL, USA;Department of Biostatistics, University of Florida, 32611, Gainesville, FL, USA;Emerging Pathogens Institute, University of Florida, 32611, Gainesville, FL, USA;Department of Environmental Sciences, Math and Science Center, Emory University, 400 Dowman Drive, 5th floor, Suite E530, 30322, Atlanta, GA, USA;Emerging Pathogens Institute, University of Florida, 32611, Gainesville, FL, USA;Department of Biology, University of Florida, 32611, Gainesville, FL, USA;Health Systems Research Center, National Institute of Public Health, Cuernavaca, Mexico;Hope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, School of Medicine, Emory University, 30030, Decatur, GA, USA;Secretaria de Salud de Yucatan, Merida, Yucatan, Mexico;Unidad Colaborativa de Bioensayos Entomológicos, Campus de Ciencias Biológicas y Agropecuarias, Universidad Autónoma de Yucatán, Merida, Mexico;

关键词: Cluster randomized;    Insecticide;    Aedes aegypti;    Dengue;    Chikungunya;    Zika;    Indoor;    Urban;   

DOI  :  10.1186/s13063-020-04780-7

来源: Springer

【 摘 要 】

BackgroundCurrent urban vector control strategies have failed to contain dengue epidemics and to prevent the global expansion of Aedes-borne viruses (ABVs: dengue, chikungunya, Zika). Part of the challenge in sustaining effective ABV control emerges from the paucity of evidence regarding the epidemiological impact of any Aedes control method. A strategy for which there is limited epidemiological evidence is targeted indoor residual spraying (TIRS). TIRS is a modification of classic malaria indoor residual spraying that accounts for Aedes aegypti resting behavior by applying residual insecticides on exposed lower sections of walls (< 1.5 m), under furniture, and on dark surfaces.Methods/designWe are pursuing a two-arm, parallel, unblinded, cluster randomized controlled trial to quantify the overall efficacy of TIRS in reducing the burden of laboratory-confirmed ABV clinical disease (primary endpoint). The trial will be conducted in the city of Merida, Yucatan State, Mexico (population ~ 1million), where we will prospectively follow 4600 children aged 2–15 years at enrollment, distributed in 50 clusters of 5 × 5 city blocks each. Clusters will be randomly allocated (n = 25 per arm) using covariate-constrained randomization. A “fried egg” design will be followed, in which all blocks of the 5 × 5 cluster receive the intervention, but all sampling to evaluate the epidemiological and entomological endpoints will occur in the “yolk,” the center 3 × 3 city blocks of each cluster. TIRS will be implemented as a preventive application (~ 1–2 months prior to the beginning of the ABV season). Active monitoring for symptomatic ABV illness will occur through weekly household visits and enhanced surveillance. Annual sero-surveys will be performed after each transmission season and entomological evaluations of Ae. aegypti indoor abundance and ABV infection rates monthly during the period of active surveillance. Epidemiological and entomological evaluation will continue for up to three transmission seasons.DiscussionThe findings from this study will provide robust epidemiological evidence of the efficacy of TIRS in reducing ABV illness and infection. If efficacious, TIRS could drive a paradigm shift in Aedes control by considering Ae. aegypti behavior to guide residual insecticide applications and changing deployment to preemptive control (rather than in response to symptomatic cases), two major enhancements to existing practice.Trial registrationClinicalTrials.gov NCT04343521. Registered on 13 April 2020. The protocol also complies with the WHO International Clinical Trials Registry Platform (ICTRP) (Additional file 1).Primary sponsorNational Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID).

【 授权许可】

CC BY