Statistical and Agent-based Modeling of Complex Microbial Systems: a Means for Understanding Enteric Disease Transmission Among Children in Urban Neighborhoods of Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- 14-day enteric pathogen incidence
研究概览
简要总结
The objective of the PATHOME study is to (1) develop statistical and computational methods for examining a complex disease system of interactions between and amongst children, animals, the environment, and enteric pathogens and (2) build a virtual laboratory for predicting which social and environmental developmental improvements best prevents multi-pathogen transmission to infants in urbanizing areas of high disease burden countries. Investigators will characterize how social and environmental development of urban neighborhoods in disease endemic settings modifies the "enteric pathome", i.e. the microbial communities of viral, bacterial, and protozoan pathogens transmitted by human and animal feces in the environment to infants. They will measure the impact of societal development on pathogen transmission to infants by applying a One Health ecosystem-based approach to characterizing interactions between enteric pathome agents in the environment and their transmission via interactions between infants, caregivers (CGs), animals, and environmental materials across domestic and public spaces and climate conditions. Data-validated statistical and computational models can quantify pathogen-specific attributable risk of infection through multiple pathways, and the extent that these risks are due to pathogen interactions with each other and the environment. The overall study hypothesis is that joint modeling of enteric pathome agents across urban households and neighborhoods representing transitional improvements in societal development will show that development leads to lower pathogen-specific detection frequencies, and thus evolution of the pathome from complex to simple microbial community structures. By studying spatial scale, developed and underdeveloped neighborhoods, specific transmission pathways, and seasonality in this process, the conditions that lead to the greatest declines in enteric disease incidence can be identified. This virtual laboratory will be built upon extensive data collection in two different Kenyan cities, including household and neighborhood economic indicators, clinical, zoonotic, and environmental microbiology, behavioral observation, geotracking of humans and domestic animals, climate conditions, population density, and infant anthropometry. This initial virtual lab will provide an evidence-based tool for predicting effective urban interventions to control fecally-transmitted disease in cities globally undergoing epidemiological transitions in infectious disease.
详细描述
STUDY OBJECTIVES
The overall hypothesis of the PATHOME Study is that joint modeling of enteric pathome agents across households and neighborhoods that represent contrasts in urban societal development will show that development leads to pathome evolution from complex to simple community structures, and thus lower detection frequencies for individual pathogen taxa. The study aims to (1) develop spatiotemporal and trajectory statistical models to understand the complex exposure risks for infants from the enteric pathome; (2) collect environmental, behavioral, spatial, economic, and microbial data to characterize the enteric pathome along pathways for disease diffusion and the intersection of humans and animals with these pathways; and (3) develop and validate agent-based models (ABMs) for predicting which social and environmental urban developmental interventions (e.g. animal penning, building latrines or drains, concrete floors) best prevent multipathogen transmission to infants in high disease burden countries using established Kenyan study sites as a model.
To fulfill the modeling and computational aims, comprehensive, interlinked data is needed that does not currently exist. For example, there is little data on child health and exposure to enteric pathogens in middle class populations in cities undergoing epidemiological transitions from infectious to non-communicable disease burden for contrasting against the more abundant data from children in low-income urban areas. Spatial data on where children may be exposed and for how long is a complete gap. Therefore, investigators will implement an empirical data collection study in two different cities in Kenya that collects a broad variety of socioeconomic, behavioral, spatial, child health, zoonotic vector health, environmental contamination, behavioral, and climate data in neighborhoods representing high and low infectious disease transmission potential. This protocol specifically describes the study design that will be applied to collect, summarize, and report infant health and exposure data by study group prior to further model development. The objective of the epidemiological study is to evaluate by city (Nairobi, Kisumu) and neighborhood socioeconomic development level (low versus middle income):
- Differences in prevalence of enteric pathogen detection in infant feces, diarrhea and other health symptoms, stunting and wasting, mid-upper arm circumference, and preterm birth status
- Differences in exposure behaviors, environmental contamination, and enteric pathogen detection in feces of domestic animals that could expose infants to enteric pathogens
METHODS
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Week 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
14-day enteric pathogen incidence
时间窗: continuous over 14 days
the proportion of infants whose feces tests positive by qRT-PCR for a specific type of enteric virus or bacteria that was not detected in feces at enrollment
enteric pathogen diversity
时间窗: continuous over 14 days
cumulative count of unique enteric pathogen types detected in infant feces at enrollment
enteric pathogen prevalence
时间窗: continuous over 14 days
the proportion of infants who test positive by qRT-PCR for a specific type of enteric virus or bacteria at enrollment
次要结局
- stunting prevalence(Day 3 or 5)
- 14-day self-reported diarrheal symptom prevalence(continuous over 14 days)
- mid-upper arm circumference(Day 3 or 5)
- wasting prevalence(Day 3 or 5)
- preterm birth prevalence(enrollment Day 1)
- 7 day self-reported prevalence of prior symptoms(enrollment Day 1)
研究者
Kelly K Baker
Associate Professor
University of Iowa