MalariaPhase 4TIRSNCT02556242
Targeted Indoor Residual Spraying Against Malaria
A Phase 4 study testing Targeted indoor residual spraying and Generalised Indoor residual spraying in people with Malaria, run by London School of Hygiene and Tropical Medicine at 2 sites in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Targeted indoor residual spraying and Generalised Indoor residual spraying
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393,387 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Oct 2015to Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Provincial Malaria Control Programme
Mbombela, Mpumalnga
Provincial Malaria Control Programme
Tzaneen, Limpopo
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- Targeted indoor residual spraying, Generalised Indoor residual spraying
- Keywords
- vector control, insecticide
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted indoor residual sprayingOther
IRS is carried out in neighbourhoods of cases
Generalised Indoor residual sprayingOther
IRS is carried out as normally practiced
| Study group | Role | What they receive |
|---|---|---|
| Targeted indoor residual spraying | Experimental | The intervention arm of the trial will receive Indoor Residual Spraying delivery through targeted spraying in the neighbourhood of recent local cases only. Receives: Other: Targeted indoor residual spraying |
| Generalised Indoor residual spraying | Active comparator | 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. Receives: Other: Generalised Indoor residual spraying |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Communities will be followed for up to 20 months
Secondary outcomes (6)
Intervention costs per 1,000 households and cost-effectiveness of reactive, targeted indoor residual spraying (TIRS) compared to generalised IRS (GIRS)
Cost of spray operations will be determined in each study arm
Measured: Up to 20 months
Proportion of structures targeted for IRS unsprayed
Measured: Up to 20 months whenever reactive spraying is triggered
Household compliance (not painting, washing, re-plastering )
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
Measured: By cross sectional household survey after 18 months
Householder acceptability of IRS
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
Measured: 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
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
Measured: By cross sectional household survey after 18 months
Sero-prevalence of antibodies to malaria antigens AMA-1 and MSP-1-19
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
Measured: By cross sectional household survey after 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 393,387 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, National Department of Health, South Africa, Medical Research Council, National Institute for Communicable Diseases, South Africa
- Responsible party
- Sponsor
- Investigators
- Maureen Coetzee, Phd, Principal investigator, University of Witwatersrand, South AfricaImmo Kleinschmidt, Phd, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556242
- Sponsor's protocol ID
- EPIDZC8610
- Acronym
- TIRS
- Status last verified
- Jul 2020
- First submitted
- 7 Sep 2015
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bath D, Cook J, Govere J, Mathebula P, Morris N, Hlongwana K, Raman J, Seocharan I, Zitha A, Zitha M, Mabuza A, Mbokazi F, Machaba E, Mabunda E, Jamesboy E, Biggs J, Drakeley C, Moonasar D, Maharaj R, Coetzee M, Pitt C, Kleinschmidt I. Effectiveness and cost-effectiveness of reactive, targeted indoor residual spraying for malaria control in low-transmission settings: a cluster-randomised, non-inferiority trial in South Africa. Lancet. 2021 Feb 27;397(10276):816-827. doi: 10.1016/S0140-6736(21)00251-8.
PubMed 33640068
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Malaria Control to Sustainable Elimination: Cluster Randomised Trial Comparing Targeted Versus Generalised Vector Control in South Africa
- ClinicalTrials.gov ID
- NCT02556242
- Acronym / sponsor ID
- TIRS / EPIDZC8610
- Conditions
- Malaria
- Keywords
- vector control, insecticide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393,387 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa, National Department of Health, South Africa, Medical Research Council, National Institute for Communicable Diseases, South Africa
- Study start
- Oct 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted indoor residual spraying | Experimental | Other: Targeted indoor residual sprayingThe intervention arm of the trial will receive Indoor Residual Spraying delivery through targeted spraying in the neighbourhood of recent local cases only. |
| Generalised Indoor residual spraying | Active comparator | Other: Generalised Indoor residual sprayingThe reference (control) arm of the trial will receive Indoor Residual Spraying through generalised annual spraying of all structures, as is the current standard practice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted indoor residual sprayingIRS is carried out in neighbourhoods of cases | Other | Targeted indoor residual spraying |
| Generalised Indoor residual sprayingIRS is carried out as normally practiced | Other | Generalised Indoor residual spraying |
Primary outcome
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
6 secondary outcomes
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
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
Householder acceptability of IRS
Time frame: 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
Sero-prevalence of antibodies to malaria antigens AMA-1 and MSP-1-19
Time frame: By cross sectional household survey after 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Derived from this study: PubMed 33640068Bath D, Cook J, Govere J, Mathebula P, Morris N, Hlongwana K, Raman J, Seocharan I, Zitha A, Zitha M, Mabuza A, Mbokazi F, Machaba E, Mabunda E, Jamesboy E, Biggs J, Drakeley C, Moonasar D, Maharaj R, Coetzee M, Pitt C, Kleinschmidt I. Effectiveness and cost-effectiveness of reactive, targeted indoor residual spraying for malaria control in low-transmission settings: a cluster-randomised, non-inferiority trial in South Africa. Lancet. 2021 Feb 27;397(10276):816-827. doi: 10.1016/S0140-6736(21)00251-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen Coetzee, Phd principal investigator
University of Witwatersrand, South Africa
Immo Kleinschmidt, Phd principal investigator
London School of Hygiene and Tropical Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Targeted indoor residual spraying and Generalised Indoor residual spraying in people with Malaria, run by London School of Hygiene and Tropical Medicine at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02556242, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.