Star Homes - Better Health Through Better Housing: Phase 2 House Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,183
- 试验地点
- 2
- 主要终点
- Incidence of respiratory tract disease in children under 13 years of age.
研究概览
简要总结
Malaria, pneumonia and diarrhoea causes a lot of illness in children in Tanzania and the study want to find better ways of protecting people against these diseases and want to find out if the type of house design can affect the general health of children living in the house.
详细描述
The study hypothesis is that healthy houses will reduce the incidence of malaria, respiratory diseases and diarrhoeal diseases in children compared with traditional houses. And healthy houses are also likely to reduce the incidence of all-cause morbidity incidence, disease severity, improve growth and well-being. The primary endpoints will be assessed in children under 13 years of age through weekly household visits for three years. All homes will have access to basic vector control, such as insecticide treated nets (ITNs). Access to early diagnosis and appropriate malaria treatment will be assured. Approximately 2,750 Tanzanians living in 550 houses in Mtwara region, of which 110 are new design houses (Star Homes) and the remaining 440 traditional African houses will be participating in this study. 330 children living in the novel design houses and 1320 children in traditional homes will be followed for three years for the assessment of malaria, respiratory tract infections and diarrhoea. Mosquito density will be assessed from all 550 houses where tent/light trap will be used for mosquito catch at night in all study houses. Acceptance of the novel designed houses will be assessed using mixed methods. Acceptability surveys will be conducted with 550 household heads concurrently with in-depth interviews with 30 purposively selected heads of the households in the intervention arm. Ten focus group discussions will be conducted each comprising 10 heads of households making it to be 100 heads of households.
Funder: Hanako Foundation, Singapore
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
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children, aged under 13 years old, male or female
- •Residing in a study village for at least 3 years
- •Parents/guardian is willing and able to give written informed consent for the child to participate in the baseline and end-of study evaluation and the surveillance for malaria, respiratory tract infection and diarrhoeal disease.
- •Additionally, children 10, 11, and 12 years of age provide assent to participate.
- •Ancillary studies
- •Head of a household or other family member of a household that is taking part in the main study
- •18 years and above
- •Consent to take part in the main study
- •Residing and live in the village for 3 years or more
- •Live in the intervention or comparison houses or a trusted community member (community leaders, medical officer and community health worker)
排除标准
- •Any participant who refuses, or in the case of children whose parents/guardian refuses, to participate in the study.
- •Any child who is between 10 and 12 years who refuses to provide assent
- •If the family plans for moving to other village during the study period
- •Parents/guardians have mental health problems
- •Ancillary studies
- •Under 18 years
- •Not provide consent
- •Not living in the study village for 3 years or more
研究组 & 干预措施
Arm 1
Households living in novel-design houses.
干预措施: Star Homes (Other)
Arm 2
Households living in traditional African houses.
干预措施: Traditional African houses (Other)
结局指标
主要结局
Incidence of respiratory tract disease in children under 13 years of age.
时间窗: Approximately 3 years
The incidence per year of respiratory tract disease in children under 13 years old.
Incidence of malaria in children under 13 years of age.
时间窗: Approximately 3 years
The incidence per year of malaria in children under 13 years old.
Incidence of diarrhoeal disease in children under 13 years of age.
时间窗: Approximately 3 years
The incidence per year of diarrhoeal disease in children under 13 years old.
次要结局
- Major respiratory pathogens(Approximately 3 years)
- Prevalence of malaria parasitaemia among children living in novel design houses and traditional homes.(Approximately 3 years)
- Mean number of female An. gambiae s.l.(Approximately 3 years)
- Entomological inoculation rate of malaria vectors.(Approximately 3 years)
- Major enteric pathogens(Approximately 3 years)
- Mean changes in height(Approximately 3 years)
- Mean changes in body mass index (BMI)(Approximately 3 years)
- Mean number of flies(Approximately 3 years)
- Children requiring hospital admission(Approximately 3 years)
- Particulate matter 2.5 (PM2.5) particle pollution(Approximately 2 years)
- Durability(End of year 1, 2 and 3.)
- Humidity(Approximately 2 years)
- Mean changes in weight(Approximately 3 years)
- Indoor temperature(Approximately 2 years)
- Carbon dioxide (CO2)(Approximately 2 years)
- Bednet use(Annually (for three years))
- Mean changes in mid-upper arm circumference(Approximately 3 years)
- Disease severity(Approximately 3 years)
- Acceptability of the novel design houses.(Interviews at 6 months after moving in, 1 year and at the end of the study)
- Life-cycle analysis(Over 36 months period starting from moving in date.)