Can improved housing provide additional protection against clinical malaria over current best practice?

• Register: ISRCTN
• Last refreshed on: 26 April 2021
• Main ID: ISRCTN02622179
• Date of registration: 23/09/2014
• Prospective Registration: Yes
• Primary sponsor: Durham University (UK)
• Public title: Can improved housing provide additional protection against clinical malaria over current best practice?
• Scientific title: Can improved housing provide additional protection against clinical malaria over current best practice? A household-randomised controlled study
• Date of first enrolment: 01/01/2015
• Target sample size: 800
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN02622179
• Study type: Interventional
• Study design: Two-armed household clustered-randomised controlled study (Prevention)
• Phase: Not Applicable

Countries of recruitment

Gambia

Contacts

• Name: Steve Lindsay

Key inclusion & exclusion criteria

Inclusion criteria:
Houses must meet the following criteria to be selected:
1. Thatched roofs
2. Intact walls (no cracks)
3. Be single-storey square buildings
4. Open eaves
5. No more than four rooms
6. No ceiling (which is equivalent to closed eaves)
7. No screening
8. At least two resident children aged six months to 13 years old (needed in case the study child leaves the study)

Children must be:
1. Aged 6 months to 13 years old
2. Resident in houses enrolled in the study
3. Whose parents/carers give written, informed consent for their child to be included in the study

Assent will also be sought from eligible children >11 years old after the purpose of the study and what is required has been explained to them according to their capability. In the case of school-age children, only those who live in their village during term-time will be eligible for enrolment. In order for the results from this study to be as generalizable as possible, no distinctions will be made in terms of medical condition or physical health.

Exclusion criteria:
1. Children for whom informed consent is not or cannot be provided
2. Children aged under 6 months or over 13 years on 1st June for the year of survey
3. Children expected to be non-residence during several month of the transmission season


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria
Infections and Infestations

Intervention(s)

All study houses will be provided with a sufficient number of LLINs to be able to cover all sleeping places and we will follow national guidelines to encourage their correct use as this is the current best practice at the beginning of the study. In the intervention arm, representing modern housing, we propose to modify existing thatched roof houses so that they will have metal roofs, closed eaves, screened-air bricks, and screening on the doors and windows (n=400) and the control arm, representing traditional houses, will be left with thatched roofs and open eaves (n=400) until the end of the study.

Primary Outcome(s)

To assess whether improved housing reduces the burden of clinical malaria where coverage of LLINs is high. Incidence of clinical malaria determined by active case detection (ACD) and defined as body (axillary) temperature of =37.5oC, together with the presence of Plasmodium falciparum parasites detected by microscopy. Incidence will be measured from June to December in 2015 and 2016.

Secondary Outcome(s)

1. To determine whether improved housing reduces the rate of parasite infection, parasite density and anaemia in children. Prevalence of malaria infection, splenomegaly and anaemia determined by cross-sectional surveys at the beginning (June) and end of each rainy season (November /December) in 2015 and 2016. The presence of malaria parasites will be determined by microscopy, the presence of an enlarged spleen by palpation and anaemia quantified by measuring haemoglobin using a HemoCue.
2. To find out whether improved housing is associated with a rise in respiratory infections. Measure cough and either a respiratory rate of above the age specific cut-off or chest indrawing during twice weekly visits from June to December in 2015 and 2016.
3. To assess whether improved housing reduces vector density inside houses when compared with LLIN alone. Mean number of female Anopheles gambiae s.l./light trap/night. Estimated entomological inoculation rate (EIR) in each study arm (i.e. mean number of sporozoite infective bites/child/season) from June to December in 2015 and 2016. Collections will be made indoors using CDC light traps and the presence of vectors with sporozoites determined using an ELISA.
4. To determine whether improved housing is acceptable to the residents and sufficiently durable
5. To find out whether these interventions are cost effective
6. To develop a strategy for potential scale-up of improved housing

Secondary ID(s)

Version 0.1

Source(s) of Monetary Support

Global Health Trials (MRC-DfID-Wellcome Trust). MR/M007383/1 (UK)

Ethics review

Status:
Approval date:
Contact:

1. The Gambia Government/MRC Joint Ethics Committee, 29/10/2014, SCC 1390v3 2. Durham University School of Biological and Biomedical Sciences Ethics Committee, 01/12/2014, Ref: SBBS/EC/1401/RooPfs 12 09 14

Results

• Results available: Yes
• Date Completed: 01/02/2017