NCT04622241

Brief Summary

To explore housing modification as a malaria control intervention, and to assess the degree to which it may offer protection in moderate to high malaria endemicity settings, we propose a two-phase study evaluating epidemiological and entomological effectiveness, cost-effectiveness, feasibility, and acceptability of housing modification in Uganda. The first phase will be a pilot implementation assessing the feasibility of candidate housing modification interventions, followed by a cluster randomised control trial of the most effective, scalable, and cost-effective interventions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,422

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 29, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

November 4, 2020

Last Update Submit

August 2, 2022

Conditions

Keywords

Housing ModificationVector ControlUgandaMalaria Control

Outcome Measures

Primary Outcomes (1)

  • Incidence of malaria

    Number of incident episodes of clinical malaria per time of observation. Incident episodes of malaria defined as any treatment for malaria \> 14 days after any prior treatment for malaria

    12 months following housing modification

Secondary Outcomes (20)

  • Parasite prevalence

    12 months following housing modification

  • Prevalence of anaemia

    12 months following housing modification

  • Vector density

    12 months following housing modification

  • Sporozoite rate

    12 months following housing modification

  • Annual entomological inoculation rate

    12 months following housing modification

  • +15 more secondary outcomes

Study Arms (10)

Eave Tubes - Traditional House

EXPERIMENTAL

Installation of eave tubes in traditional homes.

Other: Eave Tubes

Eave Tubes - Modern House

EXPERIMENTAL

Installation of eave tubes in modern homes.

Other: Eave Tubes

Eave Ribbons - Traditional House

EXPERIMENTAL

Installation of eave ribbons in traditional homes.

Other: Eave Ribbons

Eave Ribbons - Modern House

EXPERIMENTAL

Installation of eave ribbons in modern homes.

Other: Eave Ribbons

Full House Screening - Traditional House

EXPERIMENTAL

Installation of full house screening, includes screening eaves and windows, in traditional homes.

Other: Full House Screening

Full House Screening - Modern House

EXPERIMENTAL

Installation of full house screening, includes screening eaves and windows, in modern homes.

Other: Full House Screening

Partial House Screening - Traditional House

EXPERIMENTAL

Installation of partial screening, includee either screening of the eaves or installing a screened ceiling, in traditional homes.

Other: Partial House Screening

Partial House Screening - Modern House

EXPERIMENTAL

Installation of partial screening, includee either screening of the eaves or installing a screened ceiling, in modern homes.

Other: Partial House Screening

Control - Traditional House

NO INTERVENTION

Control group with no intervention in traditional homes

Control - Modern House

NO INTERVENTION

Control group with no intervention in modern homes.

Interventions

The eave tubes are PVC tubes with a diameter of 15 cm installed in the outer wall of occupied rooms (e.g. bedrooms and living rooms but not storage rooms) at 1.5-2 m intervals, fitted with electrostatic mesh inserts coated with insecticides. No additional screening will be done. All households will be provided with piperonyl butoxide (PBO) long-lasting insecticidal nets (LLINs) - one for every two residents.

Eave Tubes - Modern HouseEave Tubes - Traditional House

Eave ribbons are 15 cm-wide triple-layered hessian fabrics (burlap-line fabric woven from sisal fibres, procured locally), in lengths starting 1 m that can be attached to houses using nails, adhesives or Velcro, without completely closing eave-spaces. The eave ribbons will be treated by study staff with a commonly used spatial repellent, transfluthrin. Eave ribbons will be retreated by study staff after 6 months (only in Phase II, if selected for inclusion in the cluster-randomised trial). All households will be provided with piperonyl butoxide (PBO) long-lasting insecticidal nets (LLINs) - one for every two residents.

Eave Ribbons - Modern HouseEave Ribbons - Traditional House

Full house screening includes screening eaves/ceilings, ventilation openings, and windows. Eaves/ceiling, air vents, and windows of eligible houses will be screened with wire mesh or other locally available screening materials. or ceilings, if eaves are closed" and ventilation openings. We are also filling in any gaps in the walls. All households will be provided with piperonyl butoxide (PBO) long-lasting insecticidal nets (LLINs) - one for every two residents.

Full House Screening - Modern HouseFull House Screening - Traditional House

Partial screening will include either screening of the eaves or installing a screened ceiling, where no ceiling is present. In traditional houses, a netting (either insecticide-impregnated or untreated) may be either fixed in multiple places in the rafters or by hanging from a single central point and attached to the walls. No other screening or filling of the gaps will be done in partially screened houses.All households will be provided with piperonyl butoxide (PBO) long-lasting insecticidal nets (LLINs) - one for every two residents.

Partial House Screening - Modern HousePartial House Screening - Traditional House

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • At least one adult aged 18 years or older present
  • Agreement of the adult resident to provide informed consent for the pilot study
  • Phase II
  • Cohort Study
  • Household considered their primary residence
  • Child aged less than 59 months
  • Agreement to come to the study clinic for any febrile illness
  • Agreement to avoid antimalarial medications outside the study
  • Provision of written informed consent (for parent or guardian in case of children)
  • Cross-sectional Community Survey - Household Survey
  • At least one household resident between 6 months and 14 years of age present (with an adult caregiver willing to provide informed consent for the clinical survey)
  • At least one adult aged 18 years or older present
  • Adult is a usual resident who slept in the sampled household on the night before the survey
  • Agreement of the adult resident to provide informed consent for the household survey

You may not qualify if:

  • Dwelling destroyed or not found
  • Household vacant
  • No adult resident home on more than 3 occasions
  • Cross-sectional Community Survey - Clinical Survey
  • Child aged 6 months to 14 years
  • Usual resident who was present in the sampled household on the night before the survey
  • Agreement of parent/guardian to provide informed consent
  • Agreement of child aged 8 years or older to provide assent
  • Child not home on day of survey
  • Recruitment of Field Workers for entomology activities (human landing catches).
  • Willingness to take chemoprophylaxis for malaria
  • Willingness to abstain from alcohol during working hours
  • No significant past medical history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Infectious Diseases Research Collaboration

Kampala, Central Region, Uganda

Location

Related Publications (2)

  • Snyman K, Ochieng W, Gonahasa S, Aber J, Katureebe A, Staedke SG, Kamya MR, Westercamp N, Pitt C. Housing modification to prevent malaria in Uganda: an analysis of costs, willingness to pay, and equity. Malar J. 2025 Dec 24. doi: 10.1186/s12936-025-05757-0. Online ahead of print.

  • Kayendeke M, Nabirye C, Nayiga S, Westercamp N, Gonahasa S, Katureebe A, Kamya MR, Staedke SG, Hutchinson E. House modifications as a malaria control tool: how does local context shape participants' experience and interpretation in Uganda? Malar J. 2023 Aug 25;22(1):244. doi: 10.1186/s12936-023-04669-1.

MeSH Terms

Conditions

MalariaAnemia

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Nelli Westercamp, PhD MBA

    Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR
  • Moses Kamya, MBChB PhD

    Infectious Diseases Research Collaboration

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking is not possible due to the nature of the intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Phase II will be carried out as a cluster-randomized trial with 3 arms (2 interventions selected from the pilot study, and 1 control). There will be 20 clusters per arm (60 clusters total) and a cluster will be defined as an enumeration area within a village. All participating households in the selected clusters will have PBO LLINs, and households in intervention clusters will also receive the specified housing modifications. The impact of the interventions on malaria burden will be assessed through a cohort study, cross-sectional community surveys, entomology surveillance, a qualitative study, and an economic evaluation. The primary outcome of the trial will be clinical malaria incidence in children aged \< 60 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 9, 2020

Study Start

January 29, 2021

Primary Completion

May 1, 2023

Study Completion

July 1, 2023

Last Updated

August 4, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations