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Uganda Housing Modification Study (UHMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04622241
Recruitment Status : Active, not recruiting
First Posted : November 9, 2020
Last Update Posted : August 4, 2022
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
United States Agency for International Development (USAID)
London School of Hygiene and Tropical Medicine
University of California, San Francisco
Information provided by (Responsible Party):
Infectious Diseases Research Collaboration, Uganda

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.

Condition or disease Intervention/treatment Phase
Malaria Anemia Other: Eave Tubes Other: Eave Ribbons Other: Full House Screening Other: Partial House Screening Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description: Masking is not possible due to the nature of the intervention.
Primary Purpose: Prevention
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
Actual Study Start Date : January 29, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Eave Tubes - Traditional House
Installation of eave tubes in traditional homes.
Other: Eave Tubes
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.

Experimental: Eave Tubes - Modern House
Installation of eave tubes in modern homes.
Other: Eave Tubes
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.

Experimental: Eave Ribbons - Traditional House
Installation of eave ribbons in traditional homes.
Other: Eave Ribbons

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.


Experimental: Eave Ribbons - Modern House
Installation of eave ribbons in modern homes.
Other: Eave Ribbons

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.


Experimental: Full House Screening - Traditional House
Installation of full house screening, includes screening eaves and windows, in traditional homes.
Other: Full House Screening
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.

Experimental: Full House Screening - Modern House
Installation of full house screening, includes screening eaves and windows, in modern homes.
Other: Full House Screening
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.

Experimental: Partial House Screening - Traditional House
Installation of partial screening, includee either screening of the eaves or installing a screened ceiling, in traditional homes.
Other: Partial House Screening
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.

Experimental: Partial House Screening - Modern House
Installation of partial screening, includee either screening of the eaves or installing a screened ceiling, in modern homes.
Other: Partial House Screening
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.

No Intervention: Control - Traditional House
Control group with no intervention in traditional homes
No Intervention: Control - Modern House
Control group with no intervention in modern homes.



Primary Outcome Measures :
  1. Incidence of malaria [ Time Frame: 12 months following housing modification ]
    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


Secondary Outcome Measures :
  1. Parasite prevalence [ Time Frame: 12 months following housing modification ]
    Proportion of study participants with a thick blood smear positive for asexual parasites as measured by microscopy

  2. Prevalence of anaemia [ Time Frame: 12 months following housing modification ]
    Proportion of haemoglobin measurements categorised as anaemia as per WHO age-stratified guidelines

  3. Vector density [ Time Frame: 12 months following housing modification ]
    Number of female Anopheles mosquitoes captured/room per night by CDC light traps

  4. Sporozoite rate [ Time Frame: 12 months following housing modification ]
    Proportion of captured female Anopheles mosquitoes that test positive for sporozoites

  5. Annual entomological inoculation rate [ Time Frame: 12 months following housing modification ]
    Number of infected bites per person per year (human biting rate x sporozoite rate x 365 days/year)

  6. Proportion of mosquitoes with insecticide resistance [ Time Frame: 12 months following housing modification ]
    Proportion of mosquitoes with phenotypic expression of insecticide resistance or containing genetic polymorphisms associated with resistance to insecticides of interest as identified by PCR

  7. Proportion of individuals satisfied with the interventions [ Time Frame: 12 months following housing modification ]
    Indicator of acceptability

  8. Proportion of households that require minimal maintenance of the implemented intervention over the period of the study, by study intervention [ Time Frame: 12 months following housing modification ]
    Indicator of durability

  9. Longer term cost of the maintenance and upkeep of the implemented intervention, by study intervention [ Time Frame: 12 months following housing modification ]
    Indicator of durability

  10. Costs of housing improvements, including maintenance, by improvement type [ Time Frame: 12 months following housing modification ]
    Indicator of feasibility

  11. Incremental cost-effectiveness ratios (ICER) of each package [ Time Frame: 12 months following housing modification ]
    Cost per malaria case averted, Cost per DALY averted

  12. Proportion of households that received the assigned housing modification [ Time Frame: 12 months following housing modification ]
    Indicator of fidelity

  13. Proportion of households that received 1 PBO LLIN for every 2 residents [ Time Frame: 12 months following housing modification ]
    Indicator of fidelity

  14. Proportion of households that received full/partial/no housing modifications [ Time Frame: 12 months following housing modification ]
    Dose delivered

  15. Proportion of households that received adequate/inadequate/no PBO LLINs [ Time Frame: 12 months following housing modification ]
    Dose delivered

  16. Proportion of households that utilized full/partial/no housing modifications [ Time Frame: 12 months following housing modification ]
    Dose received

  17. Proportion of household residents that slept under a PBO LLIN the previous night [ Time Frame: 12 months following housing modification ]
    Dose received

  18. Proportion of households that were fully covered by the assigned housing modification [ Time Frame: 12 months following housing modification ]
    Indicator of reach

  19. Proportion of household residents that were fully covered by the PBO LLINs [ Time Frame: 12 months following housing modification ]

    Indicator of reach

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


  20. Proportion of households fully covered by both the modifications & PBO LLINs [ Time Frame: 12 months following housing modification ]
    Indicator of reach



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Phase I

Inclusion criteria

  • 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

Inclusion Criteria:

  • 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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Dwelling destroyed or not found
  • Household vacant
  • No adult resident home on more than 3 occasions

Cross-sectional Community Survey - Clinical Survey

Inclusion Criteria:

  • 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

Exclusion Criterion:

  • Child not home on day of survey

Recruitment of Field Workers for entomology activities (human landing catches).

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622241


Locations
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Uganda
Infectious Diseases Research Collaboration
Kampala, Central Region, Uganda
Sponsors and Collaborators
Infectious Diseases Research Collaboration, Uganda
Centers for Disease Control and Prevention
United States Agency for International Development (USAID)
London School of Hygiene and Tropical Medicine
University of California, San Francisco
Investigators
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Principal Investigator: Nelli Westercamp, PhD MBA Centers for Disease Control and Prevention
Principal Investigator: Moses Kamya, MBChB PhD Infectious Diseases Research Collaboration
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Responsible Party: Infectious Diseases Research Collaboration, Uganda
ClinicalTrials.gov Identifier: NCT04622241    
Other Study ID Numbers: 72061720FA00002
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Infectious Diseases Research Collaboration, Uganda:
Housing Modification
Vector Control
Uganda
Malaria Control
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases