MalariaWinMalNCT07912528
Three-arm Cluster Randomised Control Trial Evaluation of Guardian Spatial Emanator as a Complimentary Vector Control Tool in Papua New Guinea
A study testing Spatial emanator outdoor and Spatial emanator indoor in people with Malaria, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 1 site in Papua New Guinea.
Trial summary
Malaria cases are increasing in Papua New Guinea, partly because insecticide-treated nets do not fully protect people, especially from mosquitoes that bite outdoors. Spatial emanators are new devices that release insecticide into the air to repel or kill mosquitoes. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Spatial emanator outdoor and Spatial emanator indoor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,350 participants
- Where
- 1 sitePapua New Guinea
- Study dates
- Feb 2027to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 9-14 years at enrolment
- Sleeps in a household within allocated cluster >90% of the nights during any given month
Who cannot join
- Dissent (by child) to participate in the study
- No parental consent provided through the signing of informed consent form
- Unwillingness to take G6PD-guided radical cure treatment at enrolment with no previous ADRs to AL or PQ
- Plans for extended travel (>2 weeks) outside of household/cluster during the study
- G6PD activity ≤6.0 U/g Hb at screening
- Measured baseline of ≤8 mg/dL or who have signs of clinical decompensation
- Participating or planning to participate in another clinical trial investigating a drug, vaccine, medical device, or procedure during the study period
- Currently taking malaria prophylaxis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Papua New Guinea1 site
Sumkar, Bogia, Rai Coast and Madang Districts of Madang Province, Papua New Guinea
Madang, Madang Province
About this study
Official title: WinMal Trial: Spatial Emanator Deployment Strategies for Malaria Control in Papua New Guinea
Malaria cases are increasing in Papua New Guinea, partly because insecticide-treated nets do not fully protect people, especially from mosquitoes that bite outdoors. Spatial emanators are new devices that release insecticide into the air to repel or kill mosquitoes. This study will test whether these devices reduce malaria infections in rural villages in Madang Province by comparing households using indoor or outdoor devices with those without them. The results will help guide national malaria control strategies.
Read the detailed description
The WinMal trial is a large-scale cluster randomised control trial investigating whether spatial emanators reduce transmission of malaria infections. The study is being conducted with 150 rural villages in Bogia, Sumkar, Madang and Rai Coast districts of Madang Province, Papua New Guinea.
The trial will address the question: 'Do Guardian spatial emanators reduce malaria transmission when deployed in protected outdoor spaces or inside houses in PNG?'
The trial will evaluate the effectiveness, acceptability and feasibility of Guardian SE deployed indoors and outdoors for malaria prevention in PNG.
The WinMal trial will provide evidence to guide PNG National Department of Health decisions on how spatial emanators could be deployed alongside ITNs to address gaps in protection from outdoor biting.
- Conditions
- Malaria
- Being tested
- Spatial emanator outdoor, Spatial emanator indoor
- Keywords
- Prevention, Malaria, Vivax, Falciparum, Spatial Emanator, Guardian, cRCT, Papua New Guinea, PNG, Madang, Outdoor transmission, Indoor transmission, Vector control tool, Transfluthrin, Repellant
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatial emanator outdoorDevice
Guardian spatial emanators deployed in protected outdoor spaces
Spatial emanator indoorDevice
Guardian spatial emanators deployed inside houses
| Study group | Role | What they receive |
|---|---|---|
| Outdoor intervention arm | Experimental | Guardian spatial emanators deployed in protected outdoor spaces, households will continue to use ITNs as per routine National Malaria Control Program Receives: Device: Spatial emanator outdoor |
| Indoor intervention arm | Experimental | Guardian spatial emanators deployed inside houses, households will continue to use ITNs as per routine National Malaria Control Program Receives: Device: Spatial emanator indoor |
| Control arm | No intervention | No spatial emanators deployed, households will continue to use ITNs as per routine National Malaria Control Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Guardian Spatial Emanator
Time to first Plasmodium spp. infection detected by PCR at monthly follow-up visits or symptomatic ad-hoc visit between follow-ups over the 12-month intervention period in cohort participants from the core of the clusters.
Measured: 12 months
Secondary outcomes (13)
Effectiveness of Guardian Spatial Emanator
Time to first PCR-confirmed P. falciparum infection over the 12 months of follow-up.
Time to first PCR-confirmed P. vivax infection over the 12 months of follow-up.
Measured: 12 months
Effectiveness of Guardian Spatial Emanator
Time to first PCR-confirmed Plasmodium spp infection over the first 6 months of follow-up.
Time to first PCR-confirmed P. falciparum infection over the first 6 months of follow-up.
Time to first PCR-confirmed P. vivax infection over the first 6 months of follow-up.
Measured: 6 months
Effectiveness of Guardian Spatial Emanator
Incidence of PCR-confirmed Plasmodium spp infections (first-time \& recurrent together) in first 6m \& full 12m.
Incidence of PCR-confirmed Pf infections (first-time \& recurrent together) in first 6m \& full 12m.
Incidence of PCR-confirmed Pv infections (first-time \& recurrent together) in first 6m \& full 12m Incidence of clinical episodes of malaria (first-time \& recurrent together) in first 6m \& full 12m Incidence of Pf clinical episodes of malaria (first-time \& recurrent together) in first 6m \& full 12m Incidence of Pv clinical episodes of malaria (first-time \& recurrent together) in first 6m \& full 12m Incidence of new Pf blood stage infections (molecular force of blood-stage infection - Pf molFOB) in first 6m \& full 12m Incidence of new Pv blood stage infections (molecular force of blood-stage infection - Pv molFOB) in first 6m \& full 12m Incidence of new blood stage infections (molecular force of blood-stage infection for Pf and Pv molFOB combined) in first 6m \& full 12m
Measured: 12 months
Difference between indoor and outdoor arms
Time to first Plasmodium spp. infection detected by PCR at monthly follow-up or symptomatic ad-hoc visit between follow-ups visits over the 12-month intervention period in cohort participants from the core of the clusters.
Measured: 12 months
Sensitivity of the estimates for epidemiological outcomes
Spillover-adjusted estimates of intervention effectiveness for epidemiological endpoints, incorporating data from cluster buffer zone participants.
Measured: 12 months
Anopheles species composition
Anopheles species composition in a subset of clusters, in the pre-deployment baseline period and at the end of the intervention.
Measured: 12 months
Presence of insecticide resistance mutations
Prevalence of insecticide resistance markers in a subset of clusters in the pre-deployment baseline period and at the end of the intervention.
Measured: 12 months
Acceptability of spatial emanators
Qualitative outcomes from Photovoice methodology, and associated focus group discussions with community members, followed by thematic analysis of drivers of behaviour change, barriers and enablers of spatial emanator acceptance and consistent use.
Measured: 12 months
Feasibility of spatial emanators
Qualitative outcomes from key informant interviews with key study staff and health system stakeholders at district, provincial, and national level followed by descriptive summary of barriers and enablers to distribution, implementation \& scale-up.
Measured: 12 months
Cost effectiveness of Guardian spatial emanators
The costs of deploying spatial emanators (either indoor or outdoor) and the incremental cost-effectiveness ratios when compared with current practice.
Measured: 12 months
Self-reported adverse events
Incidence of self-reported adverse events (AEs) and/or serious adverse events (SAEs) assessed as possibly or likely related to Guardian spatial emanators among cohort participants (through monthly follow-up) and wider community through passive surveillance.
Measured: 12 months
Coverage, attrition and re-location of spatial emanators
Proportion of households with emanators in place at scheduled monitoring visits, the attrition rate per cluster per scheduled monitoring visit period, timing of redistribution events recorded per cluster.
Measured: 12 months
Transfluthrin quantity, installation environment and bioefficacy
Mass percent transfluthrin retained in the spatial emanators related to installation environment and bioefficacy measure/s (e.g., knock down and mortality of colony mosquitoes exposed to spatial emanators).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startFeb 2027 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm cluster-randomised controlled trial (cRCT)
- Masking
- None (open label)
- Enrolment
- 4,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, National Department of Health, Papua New Guinea, James Cook University, Queensland, Australia, Menzies School of Health Research, Swiss Tropical & Public Health Institute, Innovative Vector Control Consortium, Department of Foreign Affairs and Trade (DFAT), Australia
- Responsible party
- Sponsor
- Investigators
- Leanne Robinson, MPH PhD, Principal investigator, Burnet InstituteMoses Laman, MBBS PHD, Principal investigator, Papua New Guinea Institute of Medical ResearchStephan Karl, PhD, Principal investigator, James Cook University, Queensland, AustraliaJacob Kisomb, MBBS, Principal investigator, National Department of Health, Papua New GuineaMaria Ome-Kaius, MBBS PhD, Principal investigator, Papua New Guinea Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912528
- Sponsor's protocol ID
- NATNAT WinMal cRCT
- Acronym
- WinMal
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WinMal Trial: Spatial Emanator Deployment Strategies for Malaria Control in Papua New Guinea
- ClinicalTrials.gov ID
- NCT07912528
- Acronym / sponsor ID
- WinMal / NATNAT WinMal cRCT
- Conditions
- Malaria
- Keywords
- Prevention, Malaria, Vivax, Falciparum, Spatial Emanator, Guardian, cRCT, Papua New Guinea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,350 participants (estimated)
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health LtdUniversity, hospital or other
- Collaborators
- Papua New Guinea Institute of Medical Research, National Department of Health, Papua New Guinea, James Cook University, Queensland, Australia, Menzies School of Health Research, Swiss Tropical & Public Health Institute, Innovative Vector Control Consortium, Department of Foreign Affairs and Trade (DFAT), Australia
- Study start
- Feb 2027 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- 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.
Malaria cases are increasing in Papua New Guinea, partly because insecticide-treated nets do not fully protect people, especially from mosquitoes that bite outdoors. Spatial emanators are new devices that release insecticide into the air to repel or kill mosquitoes. This study will test whether these devices reduce malaria infections in rural villages in Madang Province by comparing households using indoor or outdoor devices with those without them. The results will help guide national malaria control strategies.
Detailed description
The WinMal trial is a large-scale cluster randomised control trial investigating whether spatial emanators reduce transmission of malaria infections. The study is being conducted with 150 rural villages in Bogia, Sumkar, Madang and Rai Coast districts of Madang Province, Papua New Guinea.
The trial will address the question: 'Do Guardian spatial emanators reduce malaria transmission when deployed in protected outdoor spaces or inside houses in PNG?'
The trial will evaluate the effectiveness, acceptability and feasibility of Guardian SE deployed indoors and outdoors for malaria prevention in PNG.
The WinMal trial will provide evidence to guide PNG National Department of Health decisions on how spatial emanators could be deployed alongside ITNs to address gaps in protection from outdoor biting.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm cluster-randomised controlled trial (cRCT)
| Arm | Type | Receives |
|---|---|---|
| Outdoor intervention arm | Experimental | Device: Spatial emanator outdoorGuardian spatial emanators deployed in protected outdoor spaces, households will continue to use ITNs as per routine National Malaria Control Program |
| Indoor intervention arm | Experimental | Device: Spatial emanator indoorGuardian spatial emanators deployed inside houses, households will continue to use ITNs as per routine National Malaria Control Program |
| Control arm | No intervention | –No spatial emanators deployed, households will continue to use ITNs as per routine National Malaria Control Program |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 9-14 years at enrolment
- Sleeps in a household within allocated cluster >90% of the nights during any given month
Key exclusion criteria (8 listed)
- Dissent (by child) to participate in the study
- No parental consent provided through the signing of informed consent form
- Unwillingness to take G6PD-guided radical cure treatment at enrolment with no previous ADRs to AL or PQ
- Plans for extended travel (>2 weeks) outside of household/cluster during the study
- G6PD activity ≤6.0 U/g Hb at screening
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 |
|---|---|---|
| Spatial emanator outdoorGuardian spatial emanators deployed in protected outdoor spaces | Device | Outdoor intervention arm |
| Spatial emanator indoorGuardian spatial emanators deployed inside houses | Device | Indoor intervention arm |
Primary outcome
Effectiveness of Guardian Spatial Emanator
Time frame: 12 months
Time to first Plasmodium spp. infection detected by PCR at monthly follow-up visits or symptomatic ad-hoc visit between follow-ups over the 12-month intervention period in cohort participants from the core of the clusters.
13 secondary outcomes
Effectiveness of Guardian Spatial Emanator
Time frame: 12 months
Effectiveness of Guardian Spatial Emanator
Time frame: 6 months
Effectiveness of Guardian Spatial Emanator
Time frame: 12 months
Difference between indoor and outdoor arms
Time frame: 12 months
Sensitivity of the estimates for epidemiological outcomes
Time frame: 12 months
Anopheles species composition
Time frame: 12 months
Presence of insecticide resistance mutations
Time frame: 12 months
Acceptability of spatial emanators
Time frame: 12 months
Feasibility of spatial emanators
Time frame: 12 months
Cost effectiveness of Guardian spatial emanators
Time frame: 12 months
Self-reported adverse events
Time frame: 12 months
Coverage, attrition and re-location of spatial emanators
Time frame: 12 months
Transfluthrin quantity, installation environment and bioefficacy
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes
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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.
Leanne Robinson, MPH PhD principal investigator
Burnet Institute
Moses Laman, MBBS PHD principal investigator
Papua New Guinea Institute of Medical Research
Stephan Karl, PhD principal investigator
James Cook University, Queensland, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spatial emanator outdoor and Spatial emanator indoor in people with Malaria, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 1 site in Papua New Guinea.
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Papua New Guinea. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Daly, MPH MID (+61 3 9282 2111, paul.daly@burnet.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Guardian Spatial Emanator (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.