Uganda Housing Modification Study

NCT ID: NCT04622241

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-29
• Study Completion Date: 2023-07-31

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.

Conditions

Malaria; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Eave Tubes - Traditional House

Installation of eave tubes in traditional homes.

Group Type: EXPERIMENTAL

Eave Tubes

Intervention Type: OTHER

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.

Eave Tubes - Modern House

Installation of eave tubes in modern homes.

Group Type: EXPERIMENTAL

Eave Tubes

Intervention Type: OTHER

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.

Eave Ribbons - Traditional House

Installation of eave ribbons in traditional homes.

Group Type: EXPERIMENTAL

Eave Ribbons

Intervention Type: OTHER

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.

Eave Ribbons - Modern House

Installation of eave ribbons in modern homes.

Group Type: EXPERIMENTAL

Eave Ribbons

Intervention Type: OTHER

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.

Full House Screening - Traditional House

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

Group Type: EXPERIMENTAL

Full House Screening

Intervention Type: OTHER

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.

Full House Screening - Modern House

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

Group Type: EXPERIMENTAL

Full House Screening

Intervention Type: OTHER

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.

Partial House Screening - Traditional House

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

Group Type: EXPERIMENTAL

Partial House Screening

Intervention Type: OTHER

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.

Partial House Screening - Modern House

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

Group Type: EXPERIMENTAL

Partial House Screening

Intervention Type: OTHER

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.

Control - Traditional House

Control group with no intervention in traditional homes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Control - Modern House

Control group with no intervention in modern homes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

Phase II

Cohort Study

• 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

• 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

• 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).

• Willingness to take chemoprophylaxis for malaria
• Willingness to abstain from alcohol during working hours
• No significant past medical history.

Exclusion Criteria

• Dwelling destroyed or not found
• Household vacant
• No adult resident home on more than 3 occasions

Cross-sectional Community Survey - Clinical Survey

• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Infectious Diseases Research Collaboration, Uganda

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nelli Westercamp, PhD MBA

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Moses Kamya, MBChB PhD

Role: PRINCIPAL_INVESTIGATOR

Infectious Diseases Research Collaboration

Locations

Infectious Diseases Research Collaboration

Kampala, Central Region, Uganda

Countries

Uganda

References

Kayendeke M, Nabirye C, Nayiga S, Westercamp N, Gonahasa S, Katureebe A, Kamya MR, Staedke SG, Hutchinson E. House modifications as a malaria control tool: how does local context shape participants' experience and interpretation in Uganda? Malar J. 2023 Aug 25;22(1):244. doi: 10.1186/s12936-023-04669-1.

Reference Type: DERIVED

PMID: 37626312 (View on PubMed)

Other Identifiers

72061720FA00002

Identifier Type: -

Identifier Source: org_study_id