Star Homes Project 2
- Conditions
- Respiratory Tract Infection AcuteDiarrhoea;AcuteMalaria
- Interventions
- Other: Star HomesOther: Traditional African houses
- Registration Number
- NCT04529434
- Lead Sponsor
- University of Oxford
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2750
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Star Homes Households living in novel-design houses. Arm 2 Traditional African houses Households living in traditional African houses.
- Primary Outcome Measures
Name Time Method Incidence of respiratory tract disease in children under 13 years of age. 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. 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. Approximately 3 years The incidence per year of diarrhoeal disease in children under 13 years old.
- Secondary Outcome Measures
Name Time Method Major respiratory pathogens Approximately 3 years From children requiring hospital admission, the most frequently detected respiratory tract pathogens will be assessed through blood culture.
Prevalence of malaria parasitaemia among children living in novel design houses and traditional homes. Approximately 3 years Prevalence will be assessed from a cross-sectional surveys of children, based on dried blood smears will be collected for quantitative polymerase chain reaction once per quarter.
Indoor temperature Approximately 2 years Temperature will be measured using data loggers.
Mean number of female An. gambiae s.l. Approximately 3 years Mean number of female An. gambiae s.l./light trap/night
Entomological inoculation rate of malaria vectors. Approximately 3 years Compare entomological inoculation rate of mosquito inside novel and traditional rural houses.
Major enteric pathogens Approximately 3 years From children requiring hospital admission, the most frequently detected enteric pathogens will be assessed through rotavirus ELISA testing and bacterial culture of stool specimens.
Mean changes in height Approximately 3 years Height in meters of children under 13 years of age recorded at baseline, annually and at end of the study.
Mean changes in body mass index (BMI) Approximately 3 years BMI in Kg/m2 in meters of children under 13 years of age recorded at baseline, annually and at end of the study.
Mean number of flies Approximately 3 years Mean number of flies/sticky trap/week in kitchens of the houses
Children requiring hospital admission Approximately 3 years Compare hospitalization rate of children under 13 years living inside novel and traditional rural houses.
Particulate matter 2.5 (PM2.5) particle pollution Approximately 2 years PM2.5 particle pollution will be measured using data loggers.
Durability End of year 1, 2 and 3. Yearly inspections of houses (control and intervention). Maintenance of structural problems on demand.
Carbon dioxide (CO2) Approximately 2 years Carbon dioxide (CO2) will be measured using data loggers.
Humidity Approximately 2 years Humidity will be measured using data loggers.
Mean changes in weight Approximately 3 years Weight in kilograms of children under 13 years of age recorded at baseline, annually and at end of the study.
Bednet use Annually (for three years) Assessed by asking residents and in children with less than 5 years old in traditional and novel design homes regarding the use of insecticide treated bednets.
Mean changes in mid-upper arm circumference Approximately 3 years Mid-upper arm circumference in millimeters of children under 13 years of age recorded at baseline, annually and at end of the study.
Disease severity Approximately 3 years A subgroup analysis of children requiring hospital consultation and children requiring hospitalization.
Acceptability of the novel design houses. Interviews at 6 months after moving in, 1 year and at the end of the study The acceptability will be measured through a mixed method: 1) quantitative method i.e. closed ended questions with a pre-determined set of choices 2) qualitative method i.e. open ended questions through focused group discussions and in-depth interviews.
Life-cycle analysis Over 36 months period starting from moving in date. This is the cost of illness averted by living in a novel-designed home against a background of complete coverage with insecticide-treated nets. The analysis will include cost comparison (construction and maintenance of novel and control houses) and market analysis.
Trial Locations
- Locations (1)
CSK Research Solutions
🇹🇿Dar Es Salaam, Mtwara, Tanzania