Targeted Indoor Residual Spraying Against Malaria
NCT02556242 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 393387
Last updated 2020-07-23
Summary
Since 2000, annual numbers of malaria cases in South Africa have sharply declined to about 5,000, with case numbers fairly stable since 2007. The principal malaria prevention strategy has consisted of generalised Indoor Residual Spraying (IRS) of all houses in malaria endemic districts. As recent case data indicate that the levels of transmission in many districts have been reduced to very low levels, the continuation of untargeted IRS in areas where there is little or no evidence of recent transmission may be unwarranted. Efforts to eliminate malaria will only be sustainable if mass prevention efforts can be scaled down in an evidence-based manner, whilst maintaining or enhancing high sensitivity of the surveillance system of the disease. This trial will provide scientific evidence for targeted malaria prevention responding to localised transmission in pre-elimination settings, compared to continuation of generalised IRS of all houses.
Two methods of IRS delivery for community malaria prevention will be compared through an open-label cluster-randomised trial consisting of two study arms with 30 clusters per arm of approximately 8,000 inhabitants per cluster.
Comparison is on the basis of non-inferiority by showing that malaria incidence in the targeted IRS arm is no higher than malaria incidence in the generalised IRS arm within a specified margin of difference, and on the basis of superiority showing that the proportion of houses targeted for spraying is higher in the intervention than the reference arm. Neighbourhood investigation in response to each locally acquired case in the intervention arm, and comparison neighbourhoods in the reference arm, will include testing for antibody sero-conversion to malarial antigens to assess whether cases arise in communities with long term exposure to malaria parasites.
The trial will be carried out in the South African provinces of Limpopo and Mpumalanga, in localities which have average reported incidence of malaria of \<5 cases per 1000 per annum over the past five years.
Conditions
Interventions
- OTHER
-
Targeted indoor residual spraying
IRS is carried out in neighbourhoods of cases
- OTHER
-
Generalised Indoor residual spraying
IRS is carried out as normally practiced
Sponsors & Collaborators
-
University of Witwatersrand, South Africa
collaborator OTHER -
National Department of Health, South Africa
collaborator UNKNOWN - collaborator OTHER_GOV
-
National Institute for Communicable Diseases, South Africa
collaborator OTHER -
London School of Hygiene and Tropical Medicine
lead OTHER
Principal Investigators
-
Maureen Coetzee, Phd · University of Witwatersrand, South Africa
-
Immo Kleinschmidt, Phd · London School of Hygiene and Tropical Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2017-06-30
- Completion
- 2017-07-31
Countries
- South Africa
Study Locations
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