Star Homes Project 2

NCT04529434 | Completed

• 1 other identifier: MAL19012
• Study Type: interventional
• Target: 1,183
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria; Respiratory Tract Infection Acute; Diarrhoea;Acute

Keywords

Healthy houses; Tanzania

Outcome Measures

Primary Outcomes (3)

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

  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.

  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.

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

  Approximately 3 years

Secondary Outcomes (20)

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

  Approximately 3 years

• Mean number of flies

  Approximately 3 years

• Entomological inoculation rate of malaria vectors.

  Approximately 3 years

• Children requiring hospital admission

  Approximately 3 years

• Major respiratory pathogens

  Approximately 3 years

Study Arms (2)

Arm 1

EXPERIMENTAL

Households living in novel-design houses.

Other: Star Homes

Arm 2

OTHER

Households living in traditional African houses.

Other: Traditional African houses

Interventions

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.

Arm 1

Traditional African houses OTHER

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

Arm 2

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• CSK Research Solutions: collaborator

Study Sites (1)

CSK Research Solutions

Dar Es Salaam, Mtwara, Tanzania

Location

Related Publications (3)

• 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 Apr 21. doi: 10.1038/s41591-026-04367-w. Online ahead of print.

  PMID: 42014505 RESULT

• Mmbando 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.

  PMID: 40252672 DERIVED

• 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.

  PMID: 35725486 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Lorenz von Seidlein, Ass.Prof.

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label household randomised controlled trial that will compare the 110 novel-design houses with 440 traditional African homes.

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 27, 2020
• Study Start: January 4, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of trial activities and reporting
• Access Criteria: MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)

Locations

TA (1)