- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02556242
Targeted Indoor Residual Spraying Against Malaria (TIRS)
From Malaria Control to Sustainable Elimination: Cluster Randomised Trial Comparing Targeted Versus Generalised Vector Control in South Africa
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Two methods of IRS delivery for malaria prevention, targeted spraying versus annual generalised spraying, will be compared through an open-label cluster randomised trial consisting of two trial arms with 30 clusters per arm. Clusters will be artificial constructs made up of groups of spray localities or complete wards to comprise populations of about 5,000 to 10,000 persons. The unit of randomisation will be the cluster.
The intervention arm of the trial will receive IRS delivery through targeted reactive spraying in the neighbourhood of recent local cases only; the reference (control) arm of the trial will receive IRS through generalised annual spraying of all structures as per standard current practice.
Comparison will be 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 sprayed, of those 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 malarial parasites.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Limpopo
-
Tzaneen, Limpopo, South Africa
- Provincial Malaria Control Programme
-
-
Mpumalnga
-
Nelspruit, Mpumalnga, South Africa
- Provincial Malaria Control Programme
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- Entire communities of approximately 8000 persons
- Residents in malaria endemic districts of Limpopo and Mpumalanga Province
- Areas with local malaria incidence <5 cases per 1000 per year on average over 5 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Targeted indoor residual spraying
The intervention arm of the trial will receive Indoor Residual Spraying delivery through targeted spraying in the neighbourhood of recent local cases only.
|
IRS is carried out in neighbourhoods of cases
|
ACTIVE_COMPARATOR: Generalised Indoor residual spraying
The reference (control) arm of the trial will receive Indoor Residual Spraying through generalised annual spraying of all structures, as is the current standard practice.
|
IRS is carried out as normally practiced
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Malaria incidence, by routine passive case detection, of clinical malaria (fever ≥37.5°C, or history of fever (48 hours), in the presence of parasitaemia confirmed by RDT or microscopy).
Time Frame: Communities will be followed for up to 20 months
|
Communities will be followed for up to 20 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention costs per 1,000 households and cost-effectiveness of reactive, targeted indoor residual spraying (TIRS) compared to generalised IRS (GIRS)
Time Frame: Up to 20 months
|
Cost of spray operations will be determined in each study arm
|
Up to 20 months
|
Proportion of structures targeted for IRS unsprayed
Time Frame: Up to 20 months whenever reactive spraying is triggered
|
Up to 20 months whenever reactive spraying is triggered
|
|
Household compliance (not painting, washing, re-plastering )
Time Frame: By cross sectional household survey after 18 months
|
In a representative sample household survey in all clusters, a questionnaire will be used in which householders will be asked whether they painted, re-plastered or washed walls after spraying
|
By cross sectional household survey after 18 months
|
Householder acceptability of IRS
Time Frame: By cross sectional household survey after 18 months
|
In a representative sample household survey in all clusters, a questionnaire will be used in which householders will be asked whether they want their house sprayed with insecticide in future
|
By cross sectional household survey after 18 months
|
If unsprayed, proportions due to refusals, spray teams not making contact and spray teams not calling back
Time Frame: By cross sectional household survey after 18 months
|
In a representative sample household survey in all clusters, a questionnaire will be used in which householders whose houses remained unsprayed will be asked whether this was because they refused or because spray teams did not make contact or did not call back if they were away
|
By cross sectional household survey after 18 months
|
Sero-prevalence of antibodies to malaria antigens AMA-1 and MSP-1-19
Time Frame: By cross sectional household survey after 18 months
|
In a representative sample household survey in all clusters, a filter paper dried blood spot a will be taken from a sample of individuals of all ages, subject to informed written consent
|
By cross sectional household survey after 18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Maureen Coetzee, Phd, University of Witwatersrand, South Africa
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPIDZC8610
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malaria
-
University of California, San FranciscoCenters for Disease Control and Prevention; University of Massachusetts, Amherst and other collaboratorsRecruitingPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaLao People's Democratic Republic
-
University of OxfordWellcome Trust; Ministry of public Health AfghanistanCompletedVivax Malaria | Uncomplicated Falciparum MalariaAfghanistan
-
Menzies School of Health ResearchInternational Centre for Diarrhoeal Disease Research, Bangladesh; Addis Ababa... and other collaboratorsCompletedMalaria | Vivax Malaria | Falciparum MalariaEthiopia, Bangladesh, Indonesia
-
Medicines for Malaria VentureAsociacion Civil Selva AmazonicaCompletedPlasmodium Falciparum Malaria | Plasmodium Vivax MalariaPeru
-
Gadjah Mada UniversityMenzies School of Health Research; Eijkman Institute for Molecular Biology; Timika...Completed
-
Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...CompletedVivax Malaria | Falciparum MalariaIndonesia
-
London School of Hygiene and Tropical MedicineWorld Health Organization; United Nations High Commissioner for Refugees; HealthNet... and other collaboratorsCompletedMalaria | Vivax Malaria | Falciparum MalariaPakistan
-
Menzies School of Health ResearchNational Health and Medical Research Council, Australia; Wellcome Trust; National...CompletedVivax Malaria | Falciparum MalariaIndonesia
-
University of IbadanShin Poong Pharm Co Ltd 161 yoksam-ro, Gangnam-Gu Seoul 135-925, Korea; Institute...CompletedPlasmodium Falciparum Malaria | Uncomplicated Malaria | Malaria FeverNigeria
-
Research Institute for Tropical Medicine, PhilippinesWorld Health OrganizationCompletedTES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014 (TES)Malaria | Vivax Malaria | Falciparum Malaria | Malaria Recrudescence
Clinical Trials on Targeted indoor residual spraying
-
Emory UniversityNational Institute of Allergy and Infectious Diseases (NIAID)Active, not recruitingDengue | Chikungunya | Zika | Aedes-borne DiseasesMexico
-
London School of Hygiene and Tropical MedicineNational Institute for Medical Research, Tanzania; Kilimanjaro Christian Medical...Unknown
-
London School of Hygiene and Tropical MedicineWorld Health Organization; Liverpool School of Tropical Medicine; Federal Ministry...Unknown
-
PATHLiverpool School of Tropical Medicine; University of Rwanda; Rwanda Biomedical...Completed
-
University of California, IrvineRecruitingLLIN, PBO LLIN, IRS, LarvicidingUnited States, Kenya
-
London School of Hygiene and Tropical MedicineCompletedMalaria | AnaemiaTanzania
-
Radboud University Medical CenterLondon School of Hygiene and Tropical Medicine; Centers for Disease Control... and other collaboratorsCompleted
-
University of California, San FranciscoLondon School of Hygiene and Tropical Medicine; University of Texas Southwestern... and other collaboratorsCompleted