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Impact of Indoor Residual Spraying on Aedes-borne Diseases

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

Tracking Information
First Submitted Date  ICMJE April 9, 2020
First Posted Date  ICMJE April 13, 2020
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE November 3, 2020
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Impact of Indoor Residual Spraying on Aedes-borne Diseases
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Aedes-borne Diseases
  • Dengue
  • Chikungunya
  • Zika
Intervention  ICMJE 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 15, 2021)
4702
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2020)
4600
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04343521
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Emory University
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE
Principal Investigator: Gonzalo Vazquez Prokopec, MD Emory University
PRS Account Emory University
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP