Uganda Housing Modification Study
- Conditions
- AnemiaMalaria
- Interventions
- Other: Eave RibbonsOther: Partial House ScreeningOther: Eave TubesOther: Full House Screening
- Registration Number
- NCT04622241
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2422
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Eave Ribbons - Traditional House Eave Ribbons Installation of eave ribbons in traditional homes. Partial House Screening - Traditional House Partial House Screening Installation of partial screening, includee either screening of the eaves or installing a screened ceiling, in traditional homes. Eave Tubes - Traditional House Eave Tubes Installation of eave tubes in traditional homes. Eave Tubes - Modern House Eave Tubes Installation of eave tubes in modern homes. Full House Screening - Modern House Full House Screening Installation of full house screening, includes screening eaves and windows, in modern homes. Eave Ribbons - Modern House Eave Ribbons Installation of eave ribbons in modern homes. Full House Screening - Traditional House Full House Screening Installation of full house screening, includes screening eaves and windows, in traditional homes. Partial House Screening - Modern House Partial House Screening Installation of partial screening, includee either screening of the eaves or installing a screened ceiling, in modern homes.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Parasite prevalence 12 months following housing modification Proportion of study participants with a thick blood smear positive for asexual parasites as measured by microscopy
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
Proportion of households that received the assigned housing modification 12 months following housing modification Indicator of fidelity
Proportion of households that received adequate/inadequate/no PBO LLINs 12 months following housing modification Dose delivered
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 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 household residents that slept under a PBO LLIN the previous night 12 months following housing modification Dose received
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
Proportion of individuals satisfied with the interventions 12 months following housing modification Indicator of acceptability
Proportion of households that utilized full/partial/no housing modifications 12 months following housing modification Dose received
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 LLINsProportion of households that were fully covered by the assigned housing modification 12 months following housing modification Indicator of reach
Proportion of households fully covered by both the modifications & PBO LLINs 12 months following housing modification Indicator of reach
Trial Locations
- Locations (1)
Infectious Diseases Research Collaboration
🇺🇬Kampala, Central Region, Uganda