Clinical trial NCT04343521: Quantifying the Epidemiological Impact of Targeted Indoor Residual Spraying on Aedes-borne Diseases
Official title: Quantifying the Epidemiological Impact of Targeted Indoor Residual Spraying on Aedes-borne Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aedes-borne Diseases
Dengue
Chikungunya
Zika
Keywords: Targeted Indoor Residual Spraying
Children
DENV
CHIKV
ZIKV
Ae. aegypti mosquito
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-04-13
Enrollment: 4702
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of laboratory confirmed or serologically symptomatic DENV, CHIKV and ZIKV infections
timeFrame: Up to 5 years
Secondary outcomes:
measure: Number of laboratory confirmed DENV, CHIKV and ZIKV infections
timeFrame: Up to 5 years
measure: Ae. aegypti mosquito infection rate with Aedes-borne Viruses (DENV, CHIKV and ZIKV)
timeFrame: Up to 5 years
measure: Ae. aegypti indoor entomological index of adult mosquito abundance
timeFrame: Up to 5 years
measure: Ae. aegypti indoor entomological index of female mosquito abundance
timeFrame: Up to 5 years
measure: Ae. aegypti indoor entomological index of bloodfed female mosquito abundance
timeFrame: Up to 5 years
measure: Number of heads of household that would recommend the intervention
timeFrame: Up to 5 years
measure: Number households with reaction to the insecticide
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Merida
country: Mexico
facility: Universidad Autonoma de Yucatan
state: Yucatan
Study officials:
affiliation: Emory University
name: Gonzalo Vazquez Prokopec, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.