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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI148069-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number Positive Tests of Laboratory Confirmed Aedes-borne Viruses Infections By Season | Number of laboratory confirmed (IgG ELISA and neutralization testing) Aedes-borne Viruses (DENV, CHIKV and ZIKV) in annual surveillance samples. | Up to 36 months, during serosurvey seasons 2021-2022, 2022-2023, and 2023-2024 |
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Inclusion Criteria:
Household Level Inclusion Criteria:
Individual Level Inclusion Criteria:
Exclusion Criteria:
Household Level Exclusion Criteria:
Individual Level Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gonzalo Vazquez Prokopec, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Autonoma de Yucatan | Mérida | Yucatán | 97203 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33032661 | Background | 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. | |
| 34606519 |
| Label | URL |
|---|---|
| link to project website | View source |
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Deidentified individual participant data that underlie the results reported in publications of this study will be available for sharing with other researchers.
Data will be made available for sharing starting one year following conclusion of the trial, with no end date.
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.
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Participants are children from households in the study clusters in Merida, Yucatan, Mexico. Participant enrollment began November 3, 2020 and all follow-up assessments were completed by April 28, 2024.
| ID | Title | Description |
|---|---|---|
| FG000 | Targeted Indoor Residual Spraying (TIRS) | Children residing in households located in Targeted Indoor Residual Spraying (TIRS) clusters that were offered the intervention. During Targeted Indoor Residual Spraying (TIRS), spraying of the insecticide Actellic 300CS began in May or June extending for 1 to 2 months. Residents were 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 followed a strict protocol developed by the Centers for Disease Control and Prevention (CDC), Emory University, and the Universidad Autónoma de Yucatán. |
| FG001 | Routine Aedes-borne Virus (ABV) Prevention and Control | Children residing in households located in routine Aedes-borne virus (ABV) prevention and control clusters, without Targeted Indoor Residual Spraying (TIRS). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Targeted Indoor Residual Spraying (TIRS) | Children residing in households located in Targeted Indoor Residual Spraying (TIRS) clusters that were offered the intervention. |
| BG001 | Routine Aedes-borne Virus (ABV) Prevention and Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This analysis includes symptomatic children who were tested for Andes-borne viruses during high transmission seasons. | Posted | Count of Participants | Participants | 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) |
|
Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 41 months and 26 days).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Targeted Indoor Residual Spraying (TIRS) | Children residing in households located in Targeted Indoor Residual Spraying (TIRS) clusters that were offered the intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Admission to emergency room due to dengue with warning signs | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gonzalo Vazquez-Prokopec, PhD | Emory University | 404-727-4217 | gmvazqu@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2019 | Apr 14, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 3, 2021 | Apr 27, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D003715 | Dengue |
| D065632 | Chikungunya Fever |
| D000071243 | Zika Virus Infection |
| ID | Term |
|---|---|
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
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|
|
| Ae. Aegypti Mosquito Infection Rate With Aedes-borne Viruses (DENV, CHIKV and ZIKV) |
Ae. aegypti mosquito infection rate with Aedes-borne Viruses (DENV, CHIKV and ZIKV) assessed by the number of positive RT-PCR tests. Infection is mosquitoes is analyzed by collecting binary data (a mosquito pool is either infected or not) and transforming that into minimum infection rates (MIR) with the calculation: (1/number of mosquitoes in the pool) times 1000. Households were randomly selected for testing; houses were eligible for testing if they were located within the central blocks and had at least one child enrolled in the study. |
| 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 | The Ae. aegypti indoor entomological index of adult mosquito presence/abundance is calculated as the number of adult mosquitoes per house. Higher values mean that more mosquitoes are found within houses. | Up to 36 months starting at the first TIRS application |
| Ae. Aegypti Indoor Entomological Index of Female Mosquito Abundance | The Ae. aegypti indoor entomological index of female mosquito presence/abundance is calculated as the number of female mosquitoes per house. Higher values mean that more mosquitoes are found within houses. | Up to 36 months starting at first TIRS application |
| Ae. Aegypti Indoor Entomological Index of Bloodfed Female Mosquito Abundance | The Ae. aegypti indoor entomological index of bloodfed female mosquito presence/abundance is calculated as the number of bloodfed female mosquitoes per house. Higher values mean that more mosquitoes are found within houses. | Up to 36 months starting at first TIRS application |
| Number of Households Where the Head of Household Would Recommend the Intervention | Acceptability of the intervention is determined through household surveys, for households that received the intervention. Acceptability is assessed as the number of households where the head of that household would recommend the intervention to others. | Post-intervention (up to 41 months and 26 days after the start of the intervention) |
| Number of Households With a Resident That Had a Reaction to the Insecticide | Safety of the intervention is assessed as the number of households receiving the TIRS intervention that had evidence of a household resident having a reaction possibly related to the insecticide, which was assessed and confirmed by study doctors. | Post-intervention (up to 41 months and 26 days after the start of the intervention) |
| 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. |
| 33964237 | 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. |
| 33395435 | 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. |
| 32748782 | 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. |
| 41061233 | Derived | 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. |
| Lost to follow-up due to moving from the cluster |
|
| Withdrawal by Subject |
|
| Withdrawal by study team |
|
Children residing in households located in routine Aedes-borne virus (ABV) prevention and control clusters, without Targeted Indoor Residual Spraying (TIRS). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Children residing in households located in Targeted Indoor Residual Spraying (TIRS) clusters that were offered the intervention. |
| OG001 | Routine Aedes-borne Virus (ABV) Prevention and Control | Children residing in households located in routine Aedes-borne virus (ABV) prevention and control clusters, without Targeted Indoor Residual Spraying (TIRS). |
|
|
| Secondary | Number Positive Tests of Laboratory Confirmed Aedes-borne Viruses Infections By Season | Number of laboratory confirmed (IgG ELISA and neutralization testing) Aedes-borne Viruses (DENV, CHIKV and ZIKV) in annual surveillance samples. | The population analyzed includes children living in study households where annual surveillance sampling for Aedes-borne viruses occurred. | Posted | Count of Units | Number of Tests | Up to 36 months, during serosurvey seasons 2021-2022, 2022-2023, and 2023-2024 | Number of Tests | Number of Tests |
|
|
|
| Secondary | Ae. Aegypti Mosquito Infection Rate With Aedes-borne Viruses (DENV, CHIKV and ZIKV) | Ae. aegypti mosquito infection rate with Aedes-borne Viruses (DENV, CHIKV and ZIKV) assessed by the number of positive RT-PCR tests. Infection is mosquitoes is analyzed by collecting binary data (a mosquito pool is either infected or not) and transforming that into minimum infection rates (MIR) with the calculation: (1/number of mosquitoes in the pool) times 1000. Households were randomly selected for testing; houses were eligible for testing if they were located within the central blocks and had at least one child enrolled in the study. | This analysis includes households where mosquito sampling occurred. Individual participants were not analyzed. Only households contributed data. | Posted | Count of Units | Households samples | Up to 6 months (mosquito pools were collected during the 6 months post TIRS spraying samplings in 2021) | Households samples | Households samples |
|
|
|
| Secondary | Ae. Aegypti Indoor Entomological Index of Adult Mosquito Abundance | The Ae. aegypti indoor entomological index of adult mosquito presence/abundance is calculated as the number of adult mosquitoes per house. Higher values mean that more mosquitoes are found within houses. | Posted | Mean | Standard Deviation | mosquitoes/house | Up to 36 months starting at the first TIRS application | Households | Households |
|
|
|
| Secondary | Ae. Aegypti Indoor Entomological Index of Female Mosquito Abundance | The Ae. aegypti indoor entomological index of female mosquito presence/abundance is calculated as the number of female mosquitoes per house. Higher values mean that more mosquitoes are found within houses. | Posted | Mean | Standard Deviation | mosquitoes/house | Up to 36 months starting at first TIRS application | Households | Households |
|
|
|
| Secondary | Ae. Aegypti Indoor Entomological Index of Bloodfed Female Mosquito Abundance | The Ae. aegypti indoor entomological index of bloodfed female mosquito presence/abundance is calculated as the number of bloodfed female mosquitoes per house. Higher values mean that more mosquitoes are found within houses. | Posted | Mean | Standard Deviation | mosquitoes/house | Up to 36 months starting at first TIRS application | Households | Households |
|
|
|
| Secondary | Number of Households Where the Head of Household Would Recommend the Intervention | Acceptability of the intervention is determined through household surveys, for households that received the intervention. Acceptability is assessed as the number of households where the head of that household would recommend the intervention to others. | This analysis includes households in TIRS clusters where the head of the household completed the household survey. | Posted | Count of Units | Households | Post-intervention (up to 41 months and 26 days after the start of the intervention) | Households | Households |
|
|
|
| Secondary | Number of Households With a Resident That Had a Reaction to the Insecticide | Safety of the intervention is assessed as the number of households receiving the TIRS intervention that had evidence of a household resident having a reaction possibly related to the insecticide, which was assessed and confirmed by study doctors. | This analysis includes households in TIRS clusters where the head of the household completed the household survey. | Posted | Count of Units | Households | Post-intervention (up to 41 months and 26 days after the start of the intervention) | Households | Households |
|
|
|
| 1 |
| 2,239 |
| 0 |
| 2,239 |
| 6 |
| 2,239 |
| EG001 | Routine Aedes-borne Virus (ABV) Prevention and Control | Children residing in households located in routine Aedes-borne virus (ABV) prevention and control clusters, without Targeted Indoor Residual Spraying (TIRS). | 2 | 2,222 | 2 | 2,222 | 4 | 2,222 |
| Aplastic anemia secondary to parvovirus and rickettsiosis infection | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Admission to emergency room due to suspected dengue with warning signs | Infections and infestations | Non-systematic Assessment |
|
| Mild allergic reaction | General disorders | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D018177 |
| Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D018354 | Alphavirus Infections |
| D014036 | Togaviridae Infections |
|
| Number of Positive Tests for all Aedes-borne Viruses During 2022-2023 Season |
|
|
| Number of Positive Tests for all Aedes-borne Viruses During 2023-2024 Season |
|
|