- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04529434
Star Homes Project 2 (SHP2)
Star Homes - Better Health Through Better Housing: Phase 2 House Evaluation
Study Overview
Status
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lorenz von Seidlein, Ass.Prof.
- Phone Number: 66 9 2648-6322
- Email: Lorenz@tropmedres.ac
Study Contact Backup
- Name: Salum Mshamu, Dr.
- Email: salum.mshamu@gmail.com
Study Locations
-
-
Mtwara
-
Dar Es Salaam, Mtwara, Tanzania
- Recruiting
- CSK Research Solutions
-
Contact:
- Salum Mshamu, Dr.
- Email: salum.mshamu@gmail.com
-
Contact:
- Lorenz von Seidlein, Assoc. Prof
- Phone Number: 66 9 2648-6322
- Email: Lorenz@tropmedres.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Households living in novel-design houses.
|
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.
|
Other: Arm 2
Households living in traditional African houses.
|
A traditional mud house: with wattle and daub walls, a thatched roof, and no electricity or piped water supply.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Approximately 3 years
|
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.
|
Approximately 3 years
|
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.
|
Approximately 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean number of female An. gambiae s.l.
Time Frame: Approximately 3 years
|
Mean number of female An.
gambiae s.l./light trap/night
|
Approximately 3 years
|
Mean number of flies
Time Frame: Approximately 3 years
|
Mean number of flies/sticky trap/week in kitchens of the houses
|
Approximately 3 years
|
Entomological inoculation rate of malaria vectors.
Time Frame: Approximately 3 years
|
Compare entomological inoculation rate of mosquito inside novel and traditional rural houses.
|
Approximately 3 years
|
Children requiring hospital admission
Time Frame: Approximately 3 years
|
Compare hospitalization rate of children under 13 years living inside novel and traditional rural houses.
|
Approximately 3 years
|
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.
|
Approximately 3 years
|
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.
|
Approximately 3 years
|
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.
|
Approximately 3 years
|
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.
|
Approximately 3 years
|
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.
|
Approximately 3 years
|
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.
|
Approximately 3 years
|
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.
|
Approximately 3 years
|
Disease severity
Time Frame: Approximately 3 years
|
A subgroup analysis of children requiring hospital consultation and children requiring hospitalization.
|
Approximately 3 years
|
Indoor temperature
Time Frame: Approximately 2 years
|
Temperature will be measured using data loggers.
|
Approximately 2 years
|
Humidity
Time Frame: Approximately 2 years
|
Humidity will be measured using data loggers.
|
Approximately 2 years
|
Carbon dioxide (CO2)
Time Frame: Approximately 2 years
|
Carbon dioxide (CO2) will be measured using data loggers.
|
Approximately 2 years
|
Particulate matter 2.5 (PM2.5) particle pollution
Time Frame: Approximately 2 years
|
PM2.5 particle pollution will be measured using data loggers.
|
Approximately 2 years
|
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.
|
Interviews at 6 months after moving in, 1 year and at the end of the study
|
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.
|
Annually (for three years)
|
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.
|
Over 36 months period starting from moving in date.
|
Durability
Time Frame: End of year 1, 2 and 3.
|
Yearly inspections of houses (control and intervention).
Maintenance of structural problems on demand.
|
End of year 1, 2 and 3.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lorenz von Seidlein, Ass.Prof., Mahidol Oxford Tropical Medicine Research Unit
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAL19012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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