UHMS: Uganda Housing Modification Study

Sponsor

Infectious Diseases Research Collaboration, Uganda (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04622241

Collaborator

Centers for Disease Control and Prevention (U.S. Fed), United States Agency for International Development (USAID) (U.S. Fed), London School of Hygiene and Tropical Medicine (Other), University of California, San Francisco (Other)

2,422

Enrollment

Location

Arms

Anticipated Duration (Months)

83.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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.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 :

Jan 29, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Incidence of malaria [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

Parasite prevalence [12 months following housing modification]
Proportion of study participants with a thick blood smear positive for asexual parasites as measured by microscopy
Prevalence of anaemia [12 months following housing modification]
Proportion of haemoglobin measurements categorised as anaemia as per WHO age-stratified guidelines
Vector density [12 months following housing modification]
Number of female Anopheles mosquitoes captured/room per night by CDC light traps
Sporozoite rate [12 months following housing modification]
Proportion of captured female Anopheles mosquitoes that test positive for sporozoites
Annual entomological inoculation rate [12 months following housing modification]
Number of infected bites per person per year (human biting rate x sporozoite rate x 365 days/year)
Proportion of mosquitoes with insecticide resistance [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
Proportion of individuals satisfied with the interventions [12 months following housing modification]
Indicator of acceptability
Proportion of households that require minimal maintenance of the implemented intervention over the period of the study, by study intervention [12 months following housing modification]
Indicator of durability
Longer term cost of the maintenance and upkeep of the implemented intervention, by study intervention [12 months following housing modification]
Indicator of durability
Costs of housing improvements, including maintenance, by improvement type [12 months following housing modification]
Indicator of feasibility
Incremental cost-effectiveness ratios (ICER) of each package [12 months following housing modification]
Cost per malaria case averted, Cost per DALY averted
Proportion of households that received the assigned housing modification [12 months following housing modification]
Indicator of fidelity
Proportion of households that received 1 PBO LLIN for every 2 residents [12 months following housing modification]
Indicator of fidelity
Proportion of households that received full/partial/no housing modifications [12 months following housing modification]
Dose delivered
Proportion of households that received adequate/inadequate/no PBO LLINs [12 months following housing modification]
Dose delivered
Proportion of households that utilized full/partial/no housing modifications [12 months following housing modification]
Dose received
Proportion of household residents that slept under a PBO LLIN the previous night [12 months following housing modification]
Dose received
Proportion of households that were fully covered by the assigned housing modification [12 months following housing modification]
Indicator of reach
Proportion of household residents that were fully covered by the PBO LLINs [12 months following housing modification]
Indicator of reach Proportion of households fully covered by both the modifications & PBO LLINs
Proportion of households fully covered by both the modifications & PBO LLINs [12 months following housing modification]
Indicator of reach

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Nelli Westercamp, PhD MBA, Centers for Disease Control and Prevention
Principal Investigator: Moses Kamya, MBChB PhD, Infectious Diseases Research Collaboration