Clinical trial NCT04529434: Star Homes Project 2
Official title: Star Homes - Better Health Through Better Housing: Phase 2 House Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malaria
Respiratory Tract Infection Acute
Diarrhoea;Acute
Keywords: Healthy houses
Tanzania
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Mahidol Oxford Tropical Medicine Research Unit
name: CSK Research Solutions
First posted: 2020-08-27
Enrollment: 2750
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open-label household randomised controlled trial that will compare the 110 novel-design houses with 440 traditional African homes.
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of malaria in children under 13 years of age.
timeFrame: Approximately 3 years
measure: Incidence of respiratory tract disease in children under 13 years of age.
timeFrame: Approximately 3 years
measure: Incidence of diarrhoeal disease in children under 13 years of age.
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Mean number of female An. gambiae s.l.
timeFrame: Approximately 3 years
measure: Mean number of flies
timeFrame: Approximately 3 years
measure: Entomological inoculation rate of malaria vectors.
timeFrame: Approximately 3 years
measure: Children requiring hospital admission
timeFrame: Approximately 3 years
measure: Major respiratory pathogens
timeFrame: Approximately 3 years
measure: Major enteric pathogens
timeFrame: Approximately 3 years
measure: Prevalence of malaria parasitaemia among children living in novel design houses and traditional homes.
timeFrame: Approximately 3 years
measure: Mean changes in weight
timeFrame: Approximately 3 years
measure: Mean changes in height
timeFrame: Approximately 3 years
measure: Mean changes in body mass index (BMI)
timeFrame: Approximately 3 years
measure: Mean changes in mid-upper arm circumference
timeFrame: Approximately 3 years
measure: Disease severity
timeFrame: Approximately 3 years
measure: Indoor temperature
timeFrame: Approximately 2 years
measure: Humidity
timeFrame: Approximately 2 years
measure: Carbon dioxide (CO2)
timeFrame: Approximately 2 years
measure: Particulate matter 2.5 (PM2.5) particle pollution
timeFrame: Approximately 2 years
measure: Acceptability of the novel design houses.
timeFrame: Interviews at 6 months after moving in, 1 year and at the end of the study
measure: Bednet use
timeFrame: Annually (for three years)
measure: Life-cycle analysis
timeFrame: Over 36 months period starting from moving in date.
measure: Durability
timeFrame: End of year 1, 2 and 3.
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: CSK Research Solutions
state: Mtwara
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Lorenz von Seidlein, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mshamu S, Mmbando A, Meta J, Bradley J, Bojstrup TC, Day NPJ, Mukaka M, Okumu F, Olotu A, Pell C, Deen J, Knudsen J, Lindsay SW, von Seidlein L. Assessing the impact of a novel house design on the incidence of malaria in children in rural Africa: study protocol for a household-cluster randomized controlled superiority trial. Trials. 2022 Jun 20;23(1):519. doi: 10.1186/s13063-022-06461-z.