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MalariaUHMSNCT04622241

Uganda Housing Modification Study

A study testing Eave Tubes, Eave Ribbons and Full House Screening in people with Malaria and Anemia, run by Infectious Diseases Research Collaboration, Uganda at 1 site in Uganda.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 14 yearsHealthy volunteers can take part
Conditions the study is for
Malaria, Anemia
What is being tested?
Eave Tubes, Eave Ribbons and Full House Screening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,422 participants
Where
1 siteUganda
Study dates
29 Jan 2021to Jul 2023
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 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 21Show fewer
  • 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
  • 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
  • Willingness to take chemoprophylaxis for malaria
  • Willingness to abstain from alcohol during working hours
  • No significant past medical history.

Who cannot join

  • Dwelling destroyed or not found
  • Household vacant
  • No adult resident home on more than 3 occasions
  • Cross-sectional Community Survey - Clinical Survey
  • Child not home on day of survey
  • Recruitment of Field Workers for entomology activities (human landing catches).

Trial locations and contacts

1 site in 1 country.

Uganda1 site
  • Infectious Diseases Research Collaboration

    Kampala, Central Region

Other trials in Uganda

About this study

Official title: Impact of Housing Modifications Combined With Piperonyl Butoxide (PBO) Long-lasting Insecticidal Nets (LLINs) on the Malaria Burden in Uganda: a Cluster-randomised Trial

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.

Read the detailed description

The study will be conducted in two phases, beginning with a pilot (Phase I). The aim of the pilot will be to develop and test four types of housing modifications in both modern houses (those with brick or stone walls) and traditionally constructed houses (those with mud walls). The housing modifications will include: (1) full house screening (eaves and windows), (2) partial house screening (eaves or ceiling), (3) eave tubes, and (4) eave ribbons. Community input will be sought during the development of the housing prototypes.

In the pilot, all 4 interventions will be implemented in both modern and traditional houses, plus a control arm in each group. All households will have access to PBO LLINs. Community input will be sought during the development of the housing prototypes. The pilot will include 10 arms in total, each consisting of 20 households, equal to 200 households (160 in the intervention and 40 in the control arm) in total. The feasibility and effectiveness of the interventions will be assessed through a qualitative study (FGDs and interviews), evaluation of the costs and implementation of the interventions, and entomology surveys (using CDC light traps). One to two housing interventions will be selected for Phase II following the review and discussion of the pilot results with the trial steering committee.

Phase II will include a cluster-randomised trial. A cluster will be defined as a village (or segment of a village consisting of ~100 households). In the cluster-randomised trial, up to 2 interventions vs 1 control arm will be assessed in 20 clusters per arm (60 clusters total). The clusters will be non-contiguous, with a buffer zone of 300-500m. All households in the selected clusters will have PBO LLINs; households in intervention clusters will also receive the specified housing modifications. The impact of the interventions 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 as measured in the cohort study.

Conditions
Malaria, Anemia
Being tested
Eave Tubes, Eave Ribbons, Full House Screening, Partial House Screening
Keywords
Housing Modification, Vector Control, Uganda, Malaria Control
Medical subject headings
Malaria, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eave TubesOther

    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 RibbonsOther

    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.

  • Full House ScreeningOther

    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.

  • Partial House ScreeningOther

    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.

Study groups in NCT04622241
Study groupRoleWhat they receive
Eave Tubes - Traditional HouseExperimentalInstallation of eave tubes in traditional homes.
Receives: Other: Eave Tubes
Eave Tubes - Modern HouseExperimentalInstallation of eave tubes in modern homes.
Receives: Other: Eave Tubes
Eave Ribbons - Traditional HouseExperimentalInstallation of eave ribbons in traditional homes.
Receives: Other: Eave Ribbons
Eave Ribbons - Modern HouseExperimentalInstallation of eave ribbons in modern homes.
Receives: Other: Eave Ribbons
Full House Screening - Traditional HouseExperimentalInstallation of full house screening, includes screening eaves and windows, in traditional homes.
Receives: Other: Full House Screening
Full House Screening - Modern HouseExperimentalInstallation of full house screening, includes screening eaves and windows, in modern homes.
Receives: Other: Full House Screening
Partial House Screening - Traditional HouseExperimentalInstallation of partial screening, includee either screening of the eaves or installing a screened ceiling, in traditional homes.
Receives: Other: Partial House Screening
Partial House Screening - Modern HouseExperimentalInstallation of partial screening, includee either screening of the eaves or installing a screened ceiling, in modern homes.
Receives: Other: Partial House Screening
Control - Traditional HouseNo interventionControl group with no intervention in traditional homes
Control - Modern HouseNo interventionControl group with no intervention in modern homes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months following housing modification

Secondary outcomes (20)
  1. Parasite prevalence

    Proportion of study participants with a thick blood smear positive for asexual parasites as measured by microscopy

    Measured: 12 months following housing modification

  2. Prevalence of anaemia

    Proportion of haemoglobin measurements categorised as anaemia as per WHO age-stratified guidelines

    Measured: 12 months following housing modification

  3. Vector density

    Number of female Anopheles mosquitoes captured/room per night by CDC light traps

    Measured: 12 months following housing modification

  4. Sporozoite rate

    Proportion of captured female Anopheles mosquitoes that test positive for sporozoites

    Measured: 12 months following housing modification

  5. Annual entomological inoculation rate

    Number of infected bites per person per year (human biting rate x sporozoite rate x 365 days/year)

    Measured: 12 months following housing modification

  6. Proportion of mosquitoes with insecticide resistance

    Proportion of mosquitoes with phenotypic expression of insecticide resistance or containing genetic polymorphisms associated with resistance to insecticides of interest as identified by PCR

    Measured: 12 months following housing modification

  7. Proportion of individuals satisfied with the interventions

    Indicator of acceptability

    Measured: 12 months following housing modification

  8. Proportion of households that require minimal maintenance of the implemented intervention over the period of the study, by study intervention

    Indicator of durability

    Measured: 12 months following housing modification

  9. Longer term cost of the maintenance and upkeep of the implemented intervention, by study intervention

    Indicator of durability

    Measured: 12 months following housing modification

  10. Costs of housing improvements, including maintenance, by improvement type

    Indicator of feasibility

    Measured: 12 months following housing modification

  11. Incremental cost-effectiveness ratios (ICER) of each package

    Cost per malaria case averted, Cost per DALY averted

    Measured: 12 months following housing modification

  12. Proportion of households that received the assigned housing modification

    Indicator of fidelity

    Measured: 12 months following housing modification

  13. Proportion of households that received 1 PBO LLIN for every 2 residents

    Indicator of fidelity

    Measured: 12 months following housing modification

  14. Proportion of households that received full/partial/no housing modifications

    Dose delivered

    Measured: 12 months following housing modification

  15. Proportion of households that received adequate/inadequate/no PBO LLINs

    Dose delivered

    Measured: 12 months following housing modification

  16. Proportion of households that utilized full/partial/no housing modifications

    Dose received

    Measured: 12 months following housing modification

  17. Proportion of household residents that slept under a PBO LLIN the previous night

    Dose received

    Measured: 12 months following housing modification

  18. Proportion of households that were fully covered by the assigned housing modification

    Indicator of reach

    Measured: 12 months following housing modification

  19. Proportion of household residents that were fully covered by the PBO LLINs

    Indicator of reach

    Proportion of households fully covered by both the modifications \& PBO LLINs

    Measured: 12 months following housing modification

  20. Proportion of households fully covered by both the modifications & PBO LLINs

    Indicator of reach

    Measured: 12 months following housing modification

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start29 Jan 2021
  3. Primary completionMay 2023 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

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
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.
Masking
None (open label)
Enrolment
2,422 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04622241
Sponsor's protocol ID
72061720FA00002
Acronym
UHMS
Status last verified
Aug 2022
First submitted
4 Nov 2020
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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;25(1):60. doi: 10.1186/s12936-025-05757-0.

    PubMed 41444546
  • 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.

    PubMed 37626312

Questions about this trial

What is this clinical trial studying?

A study testing Eave Tubes, Eave Ribbons and Full House Screening in people with Malaria and Anemia, run by Infectious Diseases Research Collaboration, Uganda at 1 site in Uganda.

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 21 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Aug 2022. 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 Uganda. 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?

Results are not available in the source record.

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 (time frame: 12 months following housing modification). 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 NCT04622241, which also lists 2 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 Aug 2022.

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