Quantifying the Epidemiological Impact of Targeted Indoor Residual Spraying on Aedes-borne Diseases

NCT04343521 | Completed Results

• 2 other identifiers: IRB001086661U01AI148069-01
• Study Type: interventional
• Target: 4,461
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is evaluate the efficacy of Targeted Indoor Residual Spraying (TIRS) in preventing symptomatic disease caused by Aedes-borne diseases (ABDs) in children 2 to 15 years of age in the city of Merida, Yucatan State, Mexico.

Conditions

Aedes-borne Diseases; Dengue; Chikungunya; Zika

Keywords

Targeted Indoor Residual Spraying; Children; Dengue virus (DENV); Chikungunya virus (CHIKV); Zika virus (ZIKV); Ae. aegypti mosquito

Outcome Measures

Primary Outcomes (1)

• Number of Symptomatic Participants Testing Positive for Aedes-borne Virus Infections That Are Laboratory Confirmed or Serologically

  The number of symptomatic children with laboratory confirmed, by reverse transcription-polymerase chain reaction (RT-PCR) or immunoglobulin M/ immunoglobulin G (IgM/IgG) enzyme-linked immunosorbent assay (ELISA), Aedes-borne Viruses infections. The number of any Aedes-borne virus infection during three seasons of high transmission is described, as well as the number of Dengue virus (DENV), Chikungunya virus (CHIKV), Zika virus (ZIKV) and coinfections.

  18 months of active surveillance during high transmission seasons (each 6 months in duration) during 3 years (July through December in 2021, 2022, and 2023)

Secondary Outcomes (7)

• Number Positive Tests of Laboratory Confirmed Aedes-borne Viruses Infections By Season

  Up to 36 months, during serosurvey seasons 2021-2022, 2022-2023, and 2023-2024

• Ae. Aegypti Mosquito Infection Rate With Aedes-borne Viruses (DENV, CHIKV and ZIKV)

  Up to 6 months (mosquito pools were collected during the 6 months post TIRS spraying samplings in 2021)

• Ae. Aegypti Indoor Entomological Index of Adult Mosquito Abundance

  Up to 36 months starting at the first TIRS application

• Ae. Aegypti Indoor Entomological Index of Female Mosquito Abundance

  Up to 36 months starting at first TIRS application

• Ae. Aegypti Indoor Entomological Index of Bloodfed Female Mosquito Abundance

  Up to 36 months starting at first TIRS application

Study Arms (2)

Targeted Indoor Residual Spraying (TIRS)

EXPERIMENTAL

All households in Targeted Indoor Residual Spraying (TIRS) clusters will be offered the intervention, and children in households that consent to TIRS will be recruited into this study arm.

Other: Targeted Indoor Residual Spraying (TIRS)

Routine Aedes-borne Virus (ABV) Prevention and Control

NO INTERVENTION

Households in the control clusters receive routine Aedes-borne virus (ABV) prevention and control, without Targeted Indoor Residual Spraying (TIRS). Children in the control households will be recruited into this study arm.

Interventions

Targeted Indoor Residual Spraying (TIRS) OTHER

Spraying of insecticide Actellic 300CS will start in May or June extending for 1 to 2 months. Residents will be asked to temporarily leave the house during treatment and wait half an hour to one hour for the product to dry before re-entering the house. Insecticide application will follow strict protocol developed by the Centers for Disease Control and Prevention (CDC), Emory University, and the Universidad Autónoma de Yucatán.

Also known as: Actellic 300CS

Targeted Indoor Residual Spraying (TIRS)

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Household is located within the bounds of a study cluster (5x5 city-block clusters)
• City block has at least 60% premises that are residential
• or more and up to 15 years of age at the time of initial enrollment
• Living in a house that consented to TIRS (for children in TIRS cluster)

You may not qualify if:

• Households where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile)
• Sites where no residents spend time during the day (i.e. work 7days a week outside the home)
• Inability for a resident to provide informed consent
• Non-residential places (e.g., businesses, schools, markets, etc.)
• Less than 2 years of age or more than 15 years of age at the time of enrollment
• Not living in a house that consented to TIRS (for children in TIRS cluster)
• Having a medical condition that prevents implementation of study procedures
• Temporary visitor to household
• Plans to leave study area within next 12 months

Sponsors & Collaborators

• Emory University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Universidad Autonoma de Yucatan

Mérida, Yucatán, 97203, Mexico

Location

Related Publications (6)

• Manrique-Saide P, Dean NE, Halloran ME, Longini IM, Collins MH, Waller LA, Gomez-Dantes H, Lenhart A, Hladish TJ, Che-Mendoza A, Kirstein OD, Romer Y, Correa-Morales F, Palacio-Vargas J, Mendez-Vales R, Perez PG, Pavia-Ruz N, Ayora-Talavera G, Vazquez-Prokopec GM. 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. 2020 Oct 8;21(1):839. doi: 10.1186/s13063-020-04780-7.

  PMID: 33032661 BACKGROUND

• Che-Mendoza A, Gonzalez-Olvera G, Medina-Barreiro A, Arisqueta-Chable C, Bibiano-Marin W, Correa-Morales F, Kirstein OD, Manrique-Saide P, Vazquez-Prokopec GM. Efficacy of targeted indoor residual spraying with the pyrrole insecticide chlorfenapyr against pyrethroid-resistant Aedes aegypti. PLoS Negl Trop Dis. 2021 Oct 4;15(10):e0009822. doi: 10.1371/journal.pntd.0009822. eCollection 2021 Oct.

  PMID: 34606519 BACKGROUND

• Dzul-Manzanilla F, Correa-Morales F, Che-Mendoza A, Palacio-Vargas J, Sanchez-Tejeda G, Gonzalez-Roldan JF, Lopez-Gatell H, Flores-Suarez AE, Gomez-Dantes H, Coelho GE, da Silva Bezerra HS, Pavia-Ruz N, Lenhart A, Manrique-Saide P, Vazquez-Prokopec GM. Identifying urban hotspots of dengue, chikungunya, and Zika transmission in Mexico to support risk stratification efforts: a spatial analysis. Lancet Planet Health. 2021 May;5(5):e277-e285. doi: 10.1016/S2542-5196(21)00030-9.

  PMID: 33964237 BACKGROUND

• Kirstein OD, Ayora-Talavera G, Koyoc-Cardena E, Chan Espinoza D, Che-Mendoza A, Cohuo-Rodriguez A, Granja-Perez P, Puerta-Guardo H, Pavia-Ruz N, Dunbar MW, Manrique-Saide P, Vazquez-Prokopec GM. Natural arbovirus infection rate and detectability of indoor female Aedes aegypti from Merida, Yucatan, Mexico. PLoS Negl Trop Dis. 2021 Jan 4;15(1):e0008972. doi: 10.1371/journal.pntd.0008972. eCollection 2021 Jan.

  PMID: 33395435 BACKGROUND

• Dzib-Florez S, Ponce-Garcia G, Medina-Barreiro A, Gonzalez-Olvera G, Contreras-Perera Y, Del Castillo-Centeno F, Ahmed AMM, Che-Mendoza A, McCall PJ, Vazquez-Prokopec G, Manrique-Saide P. Evaluating Over-the-Counter Household Insecticide Aerosols for Rapid Vector Control of Pyrethroid-Resistant Aedes aegypti. Am J Trop Med Hyg. 2020 Nov;103(5):2108-2112. doi: 10.4269/ajtmh.20-0515.

  PMID: 32748782 BACKGROUND

• Dean NE, Crisp AM, Che-Mendoza A, Kirstein OD, Barrera-Fuentes GA, Earnest JT, Puerta-Guardo HN, Collins MH, Pavia-Ruz N, Ayora-Talavera G, Gonzalez-Olvera G, Medina-Barreiro A, Bibiano-Marin W, Jabbarzadeh S, Halloran ME, Longini IM Jr, Lenhart A, Waller LA, Correa-Morales F, Palacio-Vargas J, Gomez-Dantes H, Manrique-Saide P, Vazquez-Prokopec GM. Randomized Trial of Targeted Indoor Spraying to Prevent Aedes-Borne Diseases. N Engl J Med. 2025 Oct 9;393(14):1387-1398. doi: 10.1056/NEJMoa2501069.

  PMID: 41061233 DERIVED

Related Links

• link to project website

MeSH Terms

Conditions

Mosquito-Borne Diseases; Dengue; Chikungunya Fever; Zika Virus Infection

Condition Hierarchy (Ancestors)

Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral; Alphavirus Infections; Togaviridae Infections

Results Point of Contact

• Title: Gonzalo Vazquez-Prokopec, PhD
• Organization: Emory University

gmvazqu@emory.edu

404-727-4217

Study Officials

• Gonzalo Vazquez Prokopec, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 13, 2020
• Study Start: November 3, 2020
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be made available for sharing starting one year following conclusion of the trial, with no end date.
• Access Criteria: Investigators wanting to share data from this study should provide a methodologically sound proposal. Data will be shared with other researchers in order for them to achieve aims in the approved proposal. Proposals should be directed to lwaller@emory.edu. To gain access, data requesters will need to sign a data access agreement.

Locations

ME (1)