Clinical trial NCT04622241: Uganda Housing Modification 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malaria
Anemia
Keywords: Housing Modification
Vector Control
Uganda
Malaria Control
Lead sponsor: Infectious Diseases Research Collaboration, Uganda
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: United States Agency for International Development (USAID)
name: London School of Hygiene and Tropical Medicine
name: University of California, San Francisco
First posted: 2020-11-09
Enrollment: 2422
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of malaria
timeFrame: 12 months following housing modification
Secondary outcomes:
measure: Parasite prevalence
timeFrame: 12 months following housing modification
measure: Prevalence of anaemia
timeFrame: 12 months following housing modification
measure: Vector density
timeFrame: 12 months following housing modification
measure: Sporozoite rate
timeFrame: 12 months following housing modification
measure: Annual entomological inoculation rate
timeFrame: 12 months following housing modification
measure: Proportion of mosquitoes with insecticide resistance
timeFrame: 12 months following housing modification
measure: Proportion of individuals satisfied with the interventions
timeFrame: 12 months following housing modification
measure: Proportion of households that require minimal maintenance of the implemented intervention over the period of the study, by study intervention
timeFrame: 12 months following housing modification
measure: Longer term cost of the maintenance and upkeep of the implemented intervention, by study intervention
timeFrame: 12 months following housing modification
measure: Costs of housing improvements, including maintenance, by improvement type
timeFrame: 12 months following housing modification
measure: Incremental cost-effectiveness ratios (ICER) of each package
timeFrame: 12 months following housing modification
measure: Proportion of households that received the assigned housing modification
timeFrame: 12 months following housing modification
measure: Proportion of households that received 1 PBO LLIN for every 2 residents
timeFrame: 12 months following housing modification
measure: Proportion of households that received full/partial/no housing modifications
timeFrame: 12 months following housing modification
measure: Proportion of households that received adequate/inadequate/no PBO LLINs
timeFrame: 12 months following housing modification
measure: Proportion of households that utilized full/partial/no housing modifications
timeFrame: 12 months following housing modification
measure: Proportion of household residents that slept under a PBO LLIN the previous night
timeFrame: 12 months following housing modification
measure: Proportion of households that were fully covered by the assigned housing modification
timeFrame: 12 months following housing modification
measure: Proportion of household residents that were fully covered by the PBO LLINs
timeFrame: 12 months following housing modification
measure: Proportion of households fully covered by both the modifications & PBO LLINs
timeFrame: 12 months following housing modification
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Diseases Research Collaboration
state: Central Region
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Nelli Westercamp, PhD MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious Diseases Research Collaboration
name: Moses Kamya, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References: