CSK Research Solutions
Dar Es Salaam, Mtwara, Tanzania
NCT Number: NCT04529434
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.
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Notify MeUp to 12 year
All sexes
Interventional
Not applicable
Dar Es Salaam, Mtwara, Tanzania
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Main study
Ancillary studies
Exclusion criteria
Main study
Ancillary studies
110 identical novel-designed houses, known as Star Homes, include the critical structural components e.g. building orientated to provide optimal shading throughout the day, light-weight & durable roof, facade and openings screened from insects to reduce insect entry while assuring airflow, an outdoor fly-proof latrine, and solar power providing electric light at night etc.
A traditional mud house: with wattle and daub walls, a thatched roof, and no electricity or piped water supply.
Time frame: Approximately 3 years
The incidence per year of malaria in children under 13 years old.
Time frame: Approximately 3 years
The incidence per year of respiratory tract disease in children under 13 years old.
Time frame: Approximately 3 years
The incidence per year of diarrhoeal disease in children under 13 years old.
Time frame: Approximately 3 years
Mean number of female An. gambiae s.l./light trap/night
Time frame: Approximately 3 years
Mean number of flies/sticky trap/week in kitchens of the houses
Time frame: Approximately 3 years
Compare entomological inoculation rate of mosquito inside novel and traditional rural houses.
Time frame: Approximately 3 years
Compare hospitalization rate of children under 13 years living inside novel and traditional rural houses.
Time frame: Approximately 3 years
From children requiring hospital admission, the most frequently detected respiratory tract pathogens will be assessed through blood culture.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 3 years
Weight in kilograms of children under 13 years of age recorded at baseline, annually and at end of the study.
Time frame: Approximately 3 years
Height in meters of children under 13 years of age recorded at baseline, annually and at end of the study.
Time frame: 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.
Time frame: 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.
Time frame: Approximately 3 years
A subgroup analysis of children requiring hospital consultation and children requiring hospitalization.
Time frame: Approximately 2 years
Temperature will be measured using data loggers.
Time frame: Approximately 2 years
Humidity will be measured using data loggers.
Time frame: Approximately 2 years
Carbon dioxide (CO2) will be measured using data loggers.
Time frame: Approximately 2 years
PM2.5 particle pollution will be measured using data loggers.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of year 1, 2 and 3.
Yearly inspections of houses (control and intervention). Maintenance of structural problems on demand.
University of Oxford
Other
Star Homes - Better Health Through Better Housing: Phase 2 House Evaluation
Acronym: SHP2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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