Skip to main content
OpenTrials
Completed

NCT Number: NCT04529434

Star Homes Project 2

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CSK Research Solutions

Dar Es Salaam, Mtwara, Tanzania

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Main study

  • 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)

Exclusion criteria

Main study

  • 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

Treatment and study plan

Star Homes

Other

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.

Traditional African houses

Other

A traditional mud house: with wattle and daub walls, a thatched roof, and no electricity or piped water supply.

Primary outcomes

  1. Incidence of malaria in children under 13 years of age.

    Time frame: Approximately 3 years

    The incidence per year of malaria in children under 13 years old.

  2. Incidence of respiratory tract disease in children under 13 years of age.

    Time frame: Approximately 3 years

    The incidence per year of respiratory tract disease in children under 13 years old.

  3. Incidence of diarrhoeal disease in children under 13 years of age.

    Time frame: Approximately 3 years

    The incidence per year of diarrhoeal disease in children under 13 years old.

Secondary outcomes

  1. Mean number of female An. gambiae s.l.

    Time frame: Approximately 3 years

    Mean number of female An. gambiae s.l./light trap/night

  2. Mean number of flies

    Time frame: Approximately 3 years

    Mean number of flies/sticky trap/week in kitchens of the houses

  3. Entomological inoculation rate of malaria vectors.

    Time frame: Approximately 3 years

    Compare entomological inoculation rate of mosquito inside novel and traditional rural houses.

  4. Children requiring hospital admission

    Time frame: Approximately 3 years

    Compare hospitalization rate of children under 13 years living inside novel and traditional rural houses.

  5. Major respiratory pathogens

    Time frame: Approximately 3 years

    From children requiring hospital admission, the most frequently detected respiratory tract pathogens will be assessed through blood culture.

  6. Major enteric pathogens

    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.

  7. Prevalence of malaria parasitaemia among children living in novel design houses and traditional homes.

    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.

  8. Mean changes in weight

    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.

  9. Mean changes in height

    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.

  10. Mean changes in body mass index (BMI)

    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.

  11. Mean changes in mid-upper arm circumference

    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.

  12. Disease severity

    Time frame: Approximately 3 years

    A subgroup analysis of children requiring hospital consultation and children requiring hospitalization.

  13. Indoor temperature

    Time frame: Approximately 2 years

    Temperature will be measured using data loggers.

  14. Humidity

    Time frame: Approximately 2 years

    Humidity will be measured using data loggers.

  15. Carbon dioxide (CO2)

    Time frame: Approximately 2 years

    Carbon dioxide (CO2) will be measured using data loggers.

  16. Particulate matter 2.5 (PM2.5) particle pollution

    Time frame: Approximately 2 years

    PM2.5 particle pollution will be measured using data loggers.

  17. Acceptability of the novel design houses.

    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.

  18. Bednet use

    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.

  19. Life-cycle analysis

    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.

  20. Durability

    Time frame: End of year 1, 2 and 3.

    Yearly inspections of houses (control and intervention). Maintenance of structural problems on demand.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • CSK Research Solutions
  • Mahidol Oxford Tropical Medicine Research Unit

Registry information

Official study title

Star Homes - Better Health Through Better Housing: Phase 2 House Evaluation

Acronym: SHP2

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.