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 measure
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 (if study stopped)
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
government organisation
Funding Body Subtype
Federal/National Government
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19732949
Publication citations
-
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.