ISRCTN ISRCTN51184253
DOI https://doi.org/10.1186/ISRCTN51184253
Secondary identifying numbers G0400031
Submission date
27/06/2006
Registration date
31/08/2006
Last edited
25/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof S Lindsay
Scientific

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

Email S.W.Lindsay@durham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Scientific title
Study objectivesA 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(s)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.
Health condition(s) or problem(s) studiedMalaria
InterventionThis 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 typeOther
Primary outcome measure1. Number of female mosquitoes (Anopheles gambiae) s.l./light trap/night
2. Haemoglobin density (g/dl)
Secondary outcome measuresAdded 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 study start date01/05/2005
Completion date31/10/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants500 homes
Key inclusion criteriaHomes in Farafenni town and surrounding peri-urban villages in which at least one child sleeps.
Key exclusion criteriaHouses that are:
1. More than a single storey
2. More than four rooms or that have a ceiling, screening or closed eaves
Date of first enrolment01/05/2005
Date of final enrolment31/10/2008

Locations

Countries of recruitment

  • England
  • Gambia
  • United Kingdom

Study participating centre

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

Sponsor information

Medical Research Council Laboratories (The Gambia)
Research council

Fajara
Banjul
-
Gambia

Email tcorrah@mrc.gm
ROR logo "ROR" https://ror.org/025wfj672

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 19/09/2009 Yes No