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Targeted Indoor Residual Spraying Against Malaria (TIRS)

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ClinicalTrials.gov Identifier: NCT02556242
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : July 23, 2020
Sponsor:
Collaborators:
University of Witwatersrand, South Africa
National Department of Health, South Africa
Medical Research Council
National Institute for Communicable Diseases, South Africa
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE September 7, 2015
First Posted Date  ICMJE September 22, 2015
Last Update Posted Date July 23, 2020
Study Start Date  ICMJE October 2015
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2020)
  • 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
  • Proportion of structures targeted for IRS unsprayed [ Time Frame: 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2015)
  • Proportion of structures targeted for IRS unsprayed [ Time Frame: 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
  • 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
  • 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
  • Intervention costs per 1,000 households [ Time Frame: Up to 20 months ]
    Cost of spray operations will be determined in each study arm
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Targeted Indoor Residual Spraying Against Malaria
Official Title  ICMJE From Malaria Control to Sustainable Elimination: Cluster Randomised Trial Comparing Targeted Versus Generalised Vector Control in South Africa
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Malaria
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Targeted indoor residual spraying
  • 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.
    Intervention: Other: Generalised Indoor residual spraying
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2019)
393387
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2015)
500000
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  1. Entire communities of approximately 8000 persons
  2. Residents in malaria endemic districts of Limpopo and Mpumalanga Province
  3. Areas with local malaria incidence <5 cases per 1000 per year on average over 5 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02556242
Other Study ID Numbers  ICMJE EPIDZC8610
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party London School of Hygiene and Tropical Medicine
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • University of Witwatersrand, South Africa
  • National Department of Health, South Africa
  • Medical Research Council
  • National Institute for Communicable Diseases, South Africa
Investigators  ICMJE
Principal Investigator: Maureen Coetzee, Phd University of Witwatersrand, South Africa
Principal Investigator: Immo Kleinschmidt, Phd London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP