Quantifying the Epidemiological Impact of Targeted Indoor Residual Spraying on Aedes-borne Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,461
- 试验地点
- 2
- 主要终点
- Number of Symptomatic Participants Testing Positive for Aedes-borne Virus Infections That Are Laboratory Confirmed or Serologically
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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 (for children in TIRS cluster)
排除标准
- •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 7days a week outside the home)
- •Inability for a resident to provide informed consent
- •Non-residential places (e.g., businesses, schools, markets, etc.)
- •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 (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
结局指标
主要结局
Number of Symptomatic Participants Testing Positive for Aedes-borne Virus Infections That Are Laboratory Confirmed or Serologically
时间窗: 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)
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.
次要结局
- 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)
- Number of Households Where the Head of Household Would Recommend the Intervention(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(Post-intervention (up to 41 months and 26 days after the start of the intervention))
研究者
Gonzalo Vazquez-Prokopec
Professor
Emory University