MalariaSHP2NCT04529434
Star Homes Project 2
A study testing Star Homes and Traditional African houses in people with Malaria and Respiratory Tract Infection Acute, run by University of Oxford at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Respiratory Tract Infection Acute, Diarrhoea;Acute
- What is being tested?
- Star Homes and Traditional African houses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,183 participants
- Where
- 1 siteTanzania
- Study dates
- 4 Jan 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Under 18 years
- Not provide consent
- Not living in the study village for 3 years or more
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Star Homes - Better Health Through Better Housing: Phase 2 House Evaluation
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.
Read the 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
- Conditions
- Malaria, Respiratory Tract Infection Acute, Diarrhoea;Acute
- Being tested
- Star Homes, Traditional African houses
- Keywords
- Healthy houses, Tanzania
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Star HomesOther
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 housesOther
A traditional mud house: with wattle and daub walls, a thatched roof, and no electricity or piped water supply.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Households living in novel-design houses. Receives: Other: Star Homes |
| Arm 2 | Other | Households living in traditional African houses. Receives: Other: Traditional African houses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of malaria in children under 13 years of age.
The incidence per year of malaria in children under 13 years old.
Measured: Approximately 3 years
Incidence of respiratory tract disease in children under 13 years of age.
The incidence per year of respiratory tract disease in children under 13 years old.
Measured: Approximately 3 years
Incidence of diarrhoeal disease in children under 13 years of age.
The incidence per year of diarrhoeal disease in children under 13 years old.
Measured: Approximately 3 years
Secondary outcomes (20)
Mean number of female An. gambiae s.l.
Mean number of female An. gambiae s.l./light trap/night
Measured: Approximately 3 years
Mean number of flies
Mean number of flies/sticky trap/week in kitchens of the houses
Measured: Approximately 3 years
Entomological inoculation rate of malaria vectors.
Compare entomological inoculation rate of mosquito inside novel and traditional rural houses.
Measured: Approximately 3 years
Children requiring hospital admission
Compare hospitalization rate of children under 13 years living inside novel and traditional rural houses.
Measured: Approximately 3 years
Major respiratory pathogens
From children requiring hospital admission, the most frequently detected respiratory tract pathogens will be assessed through blood culture.
Measured: Approximately 3 years
Major enteric pathogens
From children requiring hospital admission, the most frequently detected enteric pathogens will be assessed through rotavirus ELISA testing and bacterial culture of stool specimens.
Measured: Approximately 3 years
Prevalence of malaria parasitaemia among children living in novel design houses and traditional homes.
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.
Measured: Approximately 3 years
Mean changes in weight
Weight in kilograms of children under 13 years of age recorded at baseline, annually and at end of the study.
Measured: Approximately 3 years
Mean changes in height
Height in meters of children under 13 years of age recorded at baseline, annually and at end of the study.
Measured: Approximately 3 years
Mean changes in body mass index (BMI)
BMI in Kg/m2 in meters of children under 13 years of age recorded at baseline, annually and at end of the study.
Measured: Approximately 3 years
Mean changes in mid-upper arm circumference
Mid-upper arm circumference in millimeters of children under 13 years of age recorded at baseline, annually and at end of the study.
Measured: Approximately 3 years
Disease severity
A subgroup analysis of children requiring hospital consultation and children requiring hospitalization.
Measured: Approximately 3 years
Indoor temperature
Temperature will be measured using data loggers.
Measured: Approximately 2 years
Humidity
Humidity will be measured using data loggers.
Measured: Approximately 2 years
Carbon dioxide (CO2)
Carbon dioxide (CO2) will be measured using data loggers.
Measured: Approximately 2 years
Particulate matter 2.5 (PM2.5) particle pollution
PM2.5 particle pollution will be measured using data loggers.
Measured: Approximately 2 years
Acceptability of the novel design houses.
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.
Measured: Interviews at 6 months after moving in, 1 year and at the end of the study
Bednet use
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.
Measured: Annually (for three years)
Life-cycle analysis
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.
Measured: Over 36 months period starting from moving in date.
Durability
Yearly inspections of houses (control and intervention). Maintenance of structural problems on demand.
Measured: End of year 1, 2 and 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start4 Jan 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open-label household randomised controlled trial that will compare the 110 novel-design houses with 440 traditional African homes.
- Masking
- None (open label)
- Enrolment
- 1,183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, CSK Research Solutions
- Responsible party
- Sponsor
- Investigators
- Lorenz von Seidlein, Ass.Prof., Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529434
- Sponsor's protocol ID
- MAL19012
- Acronym
- SHP2
- Status last verified
- Apr 2026
- First submitted
- 6 Aug 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected for this study will be under the custodianship of MORU. With participant's consent, data from this study may be shared in a de-identified form with other groups or researchers in accordance with the MORU Data Sharing Policy.
Publications
Mshamu S, Mukaka M, Sanga C, Kambanga S, Rutaihwa AD, Bojstrup TC, Meta J, Mmbando A, Pell C, Adhikari B, Olotu AI, Kapologwe N, White NJ, Dondorp AM, Day NPJ, Imwong M, Deen J, Lindsay SW, Knudsen JB, von Seidlein L. A sustainable house design to improve child health in rural Africa: a cluster-randomized controlled trial. Nat Med. 2026 Jun;32(6):2294-2301. doi: 10.1038/s41591-026-04367-w. Epub 2026 Apr 21.
PubMed 42014505Mmbando AS, Ngonzi AJ, Mshamu S, Bradley J, Bojstrup TC, Ngowo HS, Knudsen J, von Seidlein L, Okumu FO, Lindsay SW. Effect of a novel house design (star home) on indoor malaria mosquito abundance in rural Tanzania: secondary outcomes of an open-label, household, randomised controlled trial. Lancet Planet Health. 2025 Apr;9(4):e253-e263. doi: 10.1016/S2542-5196(25)00046-4.
PubMed 40252672Mshamu 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.
PubMed 35725486
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Star Homes - Better Health Through Better Housing: Phase 2 House Evaluation
- ClinicalTrials.gov ID
- NCT04529434
- Acronym / sponsor ID
- SHP2 / MAL19012
- Conditions
- Malaria, Respiratory Tract Infection Acute, Diarrhoea;Acute
- Keywords
- Healthy houses, Tanzania
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,183 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, CSK Research Solutions
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label household randomised controlled trial that will compare the 110 novel-design houses with 440 traditional African homes.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Star HomesHouseholds living in novel-design houses. |
| Arm 2 | Other | Other: Traditional African housesHouseholds living in traditional African houses. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Star Homes110 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 1 |
| Traditional African housesA traditional mud house: with wattle and daub walls, a thatched roof, and no electricity or piped water supply. | Other | Arm 2 |
Primary outcome
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.
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.
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.
20 secondary outcomes
Mean number of female An. gambiae s.l.
Time frame: Approximately 3 years
Mean number of flies
Time frame: Approximately 3 years
Entomological inoculation rate of malaria vectors.
Time frame: Approximately 3 years
Children requiring hospital admission
Time frame: Approximately 3 years
Major respiratory pathogens
Time frame: Approximately 3 years
Major enteric pathogens
Time frame: Approximately 3 years
Prevalence of malaria parasitaemia among children living in novel design houses and traditional homes.
Time frame: Approximately 3 years
Mean changes in weight
Time frame: Approximately 3 years
Mean changes in height
Time frame: Approximately 3 years
Mean changes in body mass index (BMI)
Time frame: Approximately 3 years
Mean changes in mid-upper arm circumference
Time frame: Approximately 3 years
Disease severity
Time frame: Approximately 3 years
Indoor temperature
Time frame: Approximately 2 years
Humidity
Time frame: Approximately 2 years
Carbon dioxide (CO2)
Time frame: Approximately 2 years
Particulate matter 2.5 (PM2.5) particle pollution
Time frame: 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
Bednet use
Time frame: Annually (for three years)
Life-cycle analysis
Time frame: Over 36 months period starting from moving in date.
Durability
Time frame: End of year 1, 2 and 3.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 42014505Mshamu S, Mukaka M, Sanga C, Kambanga S, Rutaihwa AD, Bojstrup TC, Meta J, Mmbando A, Pell C, Adhikari B, Olotu AI, Kapologwe N, White NJ, Dondorp AM, Day NPJ, Imwong M, Deen J, Lindsay SW, Knudsen JB, von Seidlein L. A sustainable house design to improve child health in rural Africa: a cluster-randomized controlled trial. Nat Med. 2026 Jun;32(6):2294-2301. doi: 10.1038/s41591-026-04367-w. Epub 2026 Apr 21.
- Derived from this study: PubMed 40252672Mmbando AS, Ngonzi AJ, Mshamu S, Bradley J, Bojstrup TC, Ngowo HS, Knudsen J, von Seidlein L, Okumu FO, Lindsay SW. Effect of a novel house design (star home) on indoor malaria mosquito abundance in rural Tanzania: secondary outcomes of an open-label, household, randomised controlled trial. Lancet Planet Health. 2025 Apr;9(4):e253-e263. doi: 10.1016/S2542-5196(25)00046-4.
- Derived from this study: PubMed 35725486Mshamu 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.
- Individual participant dataSharing planned: Yes. Data collected for this study will be under the custodianship of MORU. With participant's consent, data from this study may be shared in a de-identified form with other groups or researchers in accordance with the MORU Data Sharing Policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenz von Seidlein, Ass.Prof. principal investigator
Mahidol Oxford Tropical Medicine Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Star Homes and Traditional African houses in people with Malaria and Respiratory Tract Infection Acute, run by University of Oxford at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of malaria in children under 13 years of age. (time frame: Approximately 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04529434, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.