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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02556242 |
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Date of registration:
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07/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Targeted Indoor Residual Spraying Against Malaria
TIRS |
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Scientific title:
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From Malaria Control to Sustainable Elimination: Cluster Randomised Trial Comparing Targeted Versus Generalised Vector Control in South Africa |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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393387 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02556242 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Immo Kleinschmidt, Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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London School of Hygiene and Tropical Medicine |
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Name:
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Maureen Coetzee, Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Witwatersrand, South Africa |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Other: Generalised Indoor residual spraying
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Other: Targeted indoor residual spraying
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Householder acceptability of IRS
[Time Frame: By cross sectional household survey after 18 months]
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Proportion of structures targeted for IRS unsprayed
[Time Frame: Up to 20 months whenever reactive spraying is triggered]
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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]
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Sero-prevalence of antibodies to malaria antigens AMA-1 and MSP-1-19
[Time Frame: By cross sectional household survey after 18 months]
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Household compliance (not painting, washing, re-plastering )
[Time Frame: By cross sectional household survey after 18 months]
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Secondary ID(s)
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EPIDZC8610
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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