Uganda Housing Modification Study (UHMS)

Infectious Diseases Research Collaboration, Uganda

Status: Active, not recruiting

Conditions: Anemia; Malaria

Treatments: Other: Full House Screening; Other: Eave Ribbons; Other: Eave Tubes; Other: Partial House Screening

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04622241

72061720FA00002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,422 patients

Sex: All

Ages: Under 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,422 participants in 10 patient groups

Eave Tubes - Traditional House

Experimental group

Description:

Installation of eave tubes in traditional homes.

Treatment:

Other: Eave Tubes

Eave Tubes - Modern House

Experimental group

Description:

Installation of eave tubes in modern homes.

Treatment:

Other: Eave Tubes

Eave Ribbons - Traditional House

Experimental group

Description:

Installation of eave ribbons in traditional homes.

Treatment:

Other: Eave Ribbons

Eave Ribbons - Modern House

Experimental group

Description:

Installation of eave ribbons in modern homes.

Treatment:

Other: Eave Ribbons

Full House Screening - Traditional House

Experimental group

Description:

Installation of full house screening, includes screening eaves and windows, in traditional homes.

Treatment:

Other: Full House Screening

Full House Screening - Modern House

Experimental group

Description:

Installation of full house screening, includes screening eaves and windows, in modern homes.

Treatment:

Other: Full House Screening

Partial House Screening - Traditional House

Experimental group

Description:

Installation of partial screening, includee either screening of the eaves or installing a screened ceiling, in traditional homes.

Treatment:

Other: Partial House Screening

Partial House Screening - Modern House

Experimental group

Description:

Installation of partial screening, includee either screening of the eaves or installing a screened ceiling, in modern homes.

Treatment:

Other: Partial House Screening

Control - Traditional House

No Intervention group

Description:

Control group with no intervention in traditional homes

Control - Modern House

No Intervention group

Description:

Control group with no intervention in modern homes.