Star Homes Project 2 (SHP2)

University of Oxford

Status: Enrolling

Conditions: Respiratory Tract Infection Acute; Diarrhoea;Acute; Malaria

Treatments: Other: Traditional African houses; Other: Star Homes

Study type: Interventional

Funder types: Other

Identifiers

NCT04529434

MAL19012

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,750 estimated patients

Sex: All

Ages: Under 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,750 participants in 2 patient groups

Arm 1

Experimental group

Description:

Households living in novel-design houses.

Treatment:

Other: Star Homes

Arm 2

Other group

Description:

Households living in traditional African houses.

Treatment:

Other: Traditional African houses