Impact of Indoor Residual Spraying on Aedes-borne Diseases

• ClinicalTrials.gov Identifier: NCT04343521
• Recruitment Status: Active, not recruiting
• First Posted: April 13, 2020
• Last Update Posted: April 19, 2021
• Sponsor: Emory University
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Gonzalo Vazquez-Prokopec, Emory University

Tracking Information

• First Submitted Date: April 9, 2020
• First Posted Date: April 13, 2020
• Last Update Posted Date: April 19, 2021
• Actual Study Start Date: November 3, 2020
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2020)

Number of laboratory confirmed (RT-PCR or IgM/IgG ELISA) symptomatic Aedes-borne Viruses in paired acute and convalescent samples [ Time Frame: Up to 5 years ]

Number of laboratory confirmed (RT-PCR or IgM/IgG ELISA) symptomatic Aedes-borne Viruses (DENV, CHIKV and ZIKV) in paired acute and convalescent samples

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 15, 2020)

• Number of laboratory confirmed (IgG ELISA and neutralization testing) Aedes-borne Viruses cases in annual surveillance samples [ Time Frame: Up to 5 years ]
  Number of laboratory confirmed (IgG ELISA and neutralization testing) Aedes-borne Viruses (DENV, CHIKV and ZIKV) in annual surveillance samples
• Ae. aegypti mosquito infection rate with Aedes-borne Viruses (DENV, CHIKV and ZIKV) [ Time Frame: Up to 5 years ]
  Ae. aegypti mosquito infection rate with Aedes-borne Viruses (DENV, CHIKV and ZIKV) assessed by RT-PCR
• Ae. aegypti indoor entomological index adult presence/abundance [ Time Frame: Up to 5 years ]
  Ae. aegypti indoor entomological index adult presence/abundance will be calculated. Presence of mosquitoes/house. The higher the value, the worst the outcome.
• Ae. aegypti indoor entomological index female presence/abundance [ Time Frame: Up to 5 years ]
  Ae. aegypti indoor entomological index female presence/abundance will be calculated. Number of mosquitoes/house. The higher the value, the worst the outcome.
• Ae. aegypti indoor entomological index bloodfed female presence/abundance. Number of bloodfed females per house. The higher the value, the works the outcome. [ Time Frame: Up to 5 years ]
  Ae. aegypti indoor entomological index bloodfed female presence/abundance will be calculated

Original Secondary Outcome Measures (submitted: April 9, 2020)

• Number of laboratory confirmed (IgG ELISA and neutralization testing) Aedes-borne Viruses cases in annual surveillance samples [ Time Frame: Up to 5 years ]
  Number of laboratory confirmed (IgG ELISA and neutralization testing) Aedes-borne Viruses (DENV, CHIKV and ZIKV) in annual surveillance samples
• Ae. aegypti mosquito infection rate with Aedes-borne Viruses (DENV, CHIKV and ZIKV) [ Time Frame: Up to 5 years ]
  Ae. aegypti mosquito infection rate with Aedes-borne Viruses (DENV, CHIKV and ZIKV) assessed by RT-PCR
• Ae. aegypti indoor entomological index adult presence/abundance [ Time Frame: Up to 5 years ]
  Ae. aegypti indoor entomological index adult presence/abundance will be calculated
• Ae. aegypti indoor entomological index female presence/abundance [ Time Frame: Up to 5 years ]
  Ae. aegypti indoor entomological index female presence/abundance will be calculated
• Ae. aegypti indoor entomological index bloodfed female presence/abundance [ Time Frame: Up to 5 years ]
  Ae. aegypti indoor entomological index bloodfed female presence/abundance will be calculated

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of Indoor Residual Spraying on Aedes-borne Diseases
• Official Title: Quantifying the Epidemiological Impact of Targeted Indoor Residual Spraying on Aedes-borne Diseases
• Brief Summary: The trial will be conducted in the city of Merida extending ongoing longitudinal cohort to follow a population of 4,600 children 2-15 years old randomly allocated to receive either TIRS treatment or not. If efficacious, TIRS will drive a paradigm shift in Aedes control by: considering Ae. aegypti behavior to rationally guide insecticide applications; the change to preventive control (pre- ABD transmission season rather than in response to symptomatic cases); the use of third generation insecticides to which Ae. Aegypti is susceptible.

Detailed Description

Contemporaneous urban vector control (truck-mounted ultra-low volume spraying, thermal fogging, larviciding) has failed to contain dengue epidemics and to prevent the global range expansion of Aedes-borne diseases (ABDs: dengue, chikungunya, zika). Part of the challenge in sustaining effective ABD control emerges from the remarkable paucity of evidence about the epidemiological impact of any vector control method. Furthermore, the classic deployment of interventions in response to clinical cases fails to account for the important contribution of out-of-home human mobility and asymptomatic infections.

The trial will be conducted in the city of Merida extending ongoing longitudinal cohort to follow a population of 4,600 children 2-15 years old randomly allocated to receive either TIRS treatment or not. If efficacious, TIRS will drive a paradigm shift in Aedes control by: considering Ae. aegypti behavior to rationally guide insecticide applications; the change to preventive control (pre- ABD transmission season rather than in response to symptomatic cases); the use of third generation insecticides to which Ae. Aegypti is susceptible.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Aedes-borne Diseases
• Dengue
• Chikungunya
• Zika

Intervention

Biological: Targeted Indoor Residual Spraying (TIRS)

Spraying of insecticide Actellic 300CS will start May-June and extend for 1-2 months. Residents will be asked to temporarily leave the house during treatment and wait 0.5-1 h for the product to dry before re-entering the house. Insecticide application will follow strict protocol developed in CDC-Emory-UADY collaboration.

Other Name: Actellic 300CS

Study Arms

• Experimental: Targeted Indoor Residual Spraying (TIRS)
  All households in Targeted Indoor Residual Spraying (TIRS) clusters will be offered the intervention, epidemiological and entomological evaluation will occur in the center of each cluster
  Intervention: Biological: Targeted Indoor Residual Spraying (TIRS)
• No Intervention: Control
  Routine Aedes-borne virus (ABV) prevention and control, no Targeted Indoor Residual Spraying (TIRS)

• Publications *: 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, Pérez 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 15, 2021): 4702
• Original Estimated Enrollment (submitted: April 9, 2020): 4600
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Household Level Inclusion Criteria:

   • Household is located within the bounds of a study cluster (5x5 city-block clusters).
   • City block has at least 60% premises that are residential.

2. Individual Level Inclusion Criteria:

   • 2 or more and up to 15 years of age at the time of initial enrollment
   • Living in a house that consented to TIRS.

Exclusion Criteria:

1. Household Level Exclusion Criteria:

   • 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 7d a week outside the home).Inability for a resident to provide informed consent.
   • Non-residential places (e.g., businesses, schools, markets, etc.).

2. Individual Level Exclusion Criteria:

   • 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.
   • Having a medical condition that prevents implementation of study procedures.
   • Temporary visitor to household
   • Plans to leave study area within next 12 months

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 15 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico

Administrative Information

• NCT Number: NCT04343521
• Other Study ID Numbers: IRB00108666; 1U01AI148069-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, and appendices), will be shared.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: Starting one year following conclusion of the trial. No end date.
• Access Criteria: Investigators who provide a methodologically sound proposal will get access 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.

• Responsible Party: Gonzalo Vazquez-Prokopec, Emory University
• Study Sponsor: Emory University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Gonzalo Vazquez Prokopec, MD; Emory University

• PRS Account: Emory University
• Verification Date: April 2021