Condition category
Infections and Infestations
Date applied
27/06/2006
Date assigned
31/08/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof S Lindsay

ORCID ID

Contact details

School of Biological and Biomedical Sciences
University of Durham
South Road
Durham
DH1 3LE
United Kingdom
S.W.Lindsay@durham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0400031

Study information

Scientific title

Acronym

Study hypothesis

A randomised-controlled trial will be conducted in Farafenni town in The Gambia to assess whether screening windows, doors and eaves or installing netting ceilings to local houses can substantially reduce exposure to malaria vectors compared to homes with no screening. Risk of malaria transmission will be assessed in each house by routine collections of mosquitoes using light traps and identifying which of the vectors are carrying malaria parasites. The acceptability of the interventions will be assessed through focus groups and questionnaires. Experimental huts will be used to determine whether any additional benefit can be achieved by impregnating torn screens with insecticide.

Therefore, the aims of this study are to:
1. Determine whether house screening will reduce house-entry by malaria mosquitoes by 50% in Gambian homes
2. Assess whether the protection differs in the two types of screening by more than 17%
3. Determine whether house screening will reduce severe anaemia by 50% in children sleeping in these homes
4. Find out whether these interventions are comfortable, durable and acceptable to local communities
5. Assess whether insecticide-treatment of the screens prolong protection if the screens are torn

Ethics approval

House screening intervention reviewed and approved by Gambian Government and Medical Research Council Laboratories Joint Ethics Committee (30/10/2004) and Durham University Ethics Advisory Committee (18/05/2005).
The anaemia prevalence study was reviewed and approved by the same committees on 10/02/2006 and 27/03/2006 respectively.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Malaria

Intervention

This is a three-armed trial comprising of two screening interventions (full screening of 200 homes and netting ceilings of 200 homes) and a control group without screening of 100 homes.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Number of female mosquitoes (Anopheles gambiae) s.l./light trap/night
2. Haemoglobin density (g/dl)

Secondary outcome measures

Added as of 22/02/2007:
1. Prevalence of severe anaemia (defined as haemoglobin less than or equal to 8 g/dL)
2. Proportion of children with maleria parasites (Plasmodium falciparum prevalence)
3. Prevalence of high parasitemia (defined as equal to or greater than 5000 parasites/ul
4. Sporozoite rate estimations in trapped mosquitoes
5. Estimated entomological inoculation rate (EIR) i.e. mean number of sporozoite infective mosquitoes/house/season
6. Acceptability
7. Average indoor nightly temprature
8. Average rate of evaportaion indoors at night
9. Qualitative data from focus group discussions with household members
10. Proportion of residents willing to contimue use of intervention
11. Proportion of residents willing to invest in intervention installation
12. Durability
13. Number of screens showing damage at 6 and 12 months after installation
14. Other
15. Number of Culex quinquefasciatus /light trap/night

Overall trial start date

01/05/2005

Overall trial end date

31/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Homes in Farafenni town and surrounding peri-urban villages in which at least one child sleeps.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

500 homes

Participant exclusion criteria

Houses that are:
1. More than a single storey
2. More than four rooms or that have a ceiling, screening or closed eaves

Recruitment start date

01/05/2005

Recruitment end date

31/10/2008

Locations

Countries of recruitment

Gambia

Trial participating centre

School of Biological and Biomedical Sciences
Durham
DH1 3LE
United Kingdom

Sponsor information

Organisation

Medical Research Council Laboratories (The Gambia)

Sponsor details

Fajara
Banjul
-
Gambia
tcorrah@mrc.gm

Sponsor type

Research council

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19732949

Publication citations

  1. Results

    Kirby MJ, Ameh D, Bottomley C, Green C, Jawara M, Milligan PJ, Snell PC, Conway DJ, Lindsay SW, Effect of two different house screening interventions on exposure to malaria vectors and on anaemia in children in The Gambia: a randomised controlled trial., Lancet, 2009, 374, 9694, 998-1009, doi: 10.1016/S0140-6736(09)60871-0.

Additional files

Editorial Notes