Impact of Housing Modifications Combined With Piperonyl Butoxide (PBO) Long-lasting Insecticidal Nets (LLINs) on the Malaria Burden in Uganda: a Cluster-randomised Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,422
- Locations
- 1
- Primary Endpoint
- Incidence of malaria
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
Masking is not possible due to the nature of the intervention.
Eligibility Criteria
- Ages
- — to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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.
Arms & Interventions
Eave Tubes - Traditional House
Installation of eave tubes in traditional homes.
Intervention: Eave Tubes (Other)
Eave Tubes - Modern House
Installation of eave tubes in modern homes.
Intervention: Eave Tubes (Other)
Eave Ribbons - Traditional House
Installation of eave ribbons in traditional homes.
Intervention: Eave Ribbons (Other)
Eave Ribbons - Modern House
Installation of eave ribbons in modern homes.
Intervention: Eave Ribbons (Other)
Full House Screening - Traditional House
Installation of full house screening, includes screening eaves and windows, in traditional homes.
Intervention: Full House Screening (Other)
Full House Screening - Modern House
Installation of full house screening, includes screening eaves and windows, in modern homes.
Intervention: Full House Screening (Other)
Partial House Screening - Traditional House
Installation of partial screening, includee either screening of the eaves or installing a screened ceiling, in traditional homes.
Intervention: Partial House Screening (Other)
Partial House Screening - Modern House
Installation of partial screening, includee either screening of the eaves or installing a screened ceiling, in modern homes.
Intervention: Partial House Screening (Other)
Control - Traditional House
Control group with no intervention in traditional homes
Control - Modern House
Control group with no intervention in modern homes.
Outcomes
Primary Outcomes
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 Outcomes
- Proportion of individuals satisfied with the interventions(12 months following housing modification)
- Costs of housing improvements, including maintenance, by improvement type(12 months following housing modification)
- Incremental cost-effectiveness ratios (ICER) of each package(12 months following housing modification)
- Parasite prevalence(12 months following housing modification)
- 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)
- Longer term cost of the maintenance and upkeep of the implemented intervention, by study intervention(12 months following housing modification)
- Proportion of households that received the assigned housing modification(12 months following housing modification)
- Proportion of households that received adequate/inadequate/no PBO LLINs(12 months following housing modification)
- Annual entomological inoculation rate(12 months following housing modification)
- Proportion of mosquitoes with insecticide resistance(12 months following housing modification)
- Proportion of households that received 1 PBO LLIN for every 2 residents(12 months following housing modification)
- Proportion of households that received full/partial/no housing modifications(12 months following housing modification)
- Proportion of household residents that slept under a PBO LLIN the previous night(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)
- Proportion of households that utilized full/partial/no housing modifications(12 months following housing modification)
- Proportion of household residents that were fully covered by the PBO LLINs(12 months following housing modification)
- Proportion of households that were fully covered by the assigned housing modification(12 months following housing modification)
- Proportion of households fully covered by both the modifications & PBO LLINs(12 months following housing modification)