MalariaPhase 3NCT06179732
Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities
A Phase 3 study testing Mesh - spatial repellent impregnated with transfluthrin (2500mg), Information and Education Campaigns (IEC) and test and treat malaria cases in people with Malaria and Childhood ALL, run by The Mentor Initiative at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine the effectiveness of a new spatial repellent (called Mesh) at repelling multiple disease vectors and, reducing clinical malaria rates in temporary shelters and camp settings. The design of the study will be a two-armed cluster randomised trial. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria, Childhood ALL, Vector Borne Diseases
- What is being tested?
- Mesh - spatial repellent impregnated with transfluthrin (2500mg), Information and Education Campaigns (IEC) and test and treat malaria cases
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jun 2023to 31 Dec 2023
- Phase
- Phase 3
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Shelters with 1 or more children from 6-10 years old
- Shelters with an adult/head of the household
Who cannot join
- Shelters without children from 6-10 years old
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sara Estecha Querol
Haywards Heath, West Sussex, RH16 1PG
About this study
Official title: Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities:A Cluster Randomised Trial
The aim of this study is to determine the effectiveness of a new spatial repellent (called Mesh) at repelling multiple disease vectors and, reducing clinical malaria rates in temporary shelters and camp settings. The design of the study will be a two-armed cluster randomised trial.
By conducting the research in challenging camp settings in the north of Nigeria, the MENTOR Initiative aims to determine whether Mesh can be effective in harsh camp conditions where communities are living in conflict area temporary shelters.
- Conditions
- Malaria, Childhood ALL, Vector Borne Diseases
- Being tested
- Mesh - spatial repellent impregnated with transfluthrin (2500mg), Information and Education Campaigns (IEC), test and treat malaria cases
- Keywords
- malaria, cluster randomised trial, children, vector borne diseases, Nigeria, Internally Displaced People camps
- Medical subject headings
- Malaria, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Vector Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh - spatial repellent impregnated with transfluthrin (2500mg)Combination product
Mesh is one of the first spatial repellent tools to provide long-lasting protection to users, with predicted efficacy of 6-months. The active ingredient of Mesh is transfluthrin, a fast-acting volatile pyrethroid with low persistency, which can act either by killing or via sublethal toxicity that causes deviation (repellency) in host attraction, reducing host-contact and risk of infectious bites. The chemical passively releases into the air and interacts with vector odour receptors causing irritation. The design of Mesh is simple with a transfluthrin-infused sheet protected by plastic mesh and encased in a plastic frame.
Mesh will be distributed to the intervention arm only.
Information and Education Campaigns (IEC)Behavioural
IEC campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home) using leaflets and word of mouth. IEC will be conducted in both arms.
test and treat malaria casesDiagnostic test
All children in the cohort (both arms) will be tested by rapid diagnostic testing (RDT) monthly. If any children test positive, they will be treated with a course of 3-day artemisinin combination therapy (ACT) according to standard protocol and local guidelines. All children in the cohort will receive ACT to provide clearance of any malaria parasites during the baseline of the study.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home). 2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age |
| Mesh | Experimental | 1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home).
2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age
3. Mesh product distributed to households Receives: Combination Product: Mesh - spatial repellent impregnated with transfluthrin (2500mg); Behavioral: Information and Education Campaigns (IEC); Diagnostic Test: test and treat malaria cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
entomological outcome: vector density
the relative infestation rate of disease vectors (females of any of Anopheles malaria vectors, Aedes aegypti, or phlebotomine sand flies
Measured: 7 months
epidemiological outcome: malaria incidence
Malaria incidence will be estimated as the total number of malaria episodes per person over the course of the trial.
Measured: 7 months
Secondary outcomes (1)
feasibility, acceptance and uptake of Mesh
To measure community and household acceptance and uptake of Mesh, a questionnaire will be conducted with the Mesh-receiving households.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start5 Jun 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Mentor Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool School of Tropical Medicine, University of Maiduguri, US government, SCJohnson
- Responsible party
- Sponsor
- Investigators
- Richard Allan, Principal investigator, The Mentor Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179732
- Sponsor's protocol ID
- USDA01YEM - Nigeria
- Status last verified
- Jun 2023
- First submitted
- 10 Nov 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allan RJ, Scherrer R, Estecha-Querol S, Weetman D, Paris L, Ba'abba Goni U, Idris Abdulhamid F, Nfornuh Alenwi B, Ahmad S, Cross CL, Ashir GM, Waziri M, Ntadom G, Messenger LA. The effectiveness of long-lasting spatial repellent emanators against malaria in humanitarian crisis settings in northern Nigeria: a two-arm pragmatic, open-label, controlled trial. Lancet Infect Dis. 2026 May;26(5):464-474. doi: 10.1016/S1473-3099(25)00684-X. Epub 2026 Jan 8.
PubMed 41520670
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities:A Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT06179732
- Acronym / sponsor ID
- USDA01YEM - Nigeria
- Conditions
- Malaria, Childhood ALL, Vector Borne Diseases
- Keywords
- malaria, cluster randomised trial, children, vector borne diseases, Nigeria, Internally Displaced People camps
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- The Mentor InitiativeUniversity, hospital or other
- Collaborators
- Liverpool School of Tropical Medicine, University of Maiduguri, US government, SCJohnson
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Dec 2023 (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.
The aim of this study is to determine the effectiveness of a new spatial repellent (called Mesh) at repelling multiple disease vectors and, reducing clinical malaria rates in temporary shelters and camp settings. The design of the study will be a two-armed cluster randomised trial.
By conducting the research in challenging camp settings in the north of Nigeria, the MENTOR Initiative aims to determine whether Mesh can be effective in harsh camp conditions where communities are living in conflict area temporary shelters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home). 2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age |
| Mesh | Experimental | Combination Product: Mesh - spatial repellent impregnated with transfluthrin (2500mg), Behavioral: Information and Education Campaigns (IEC), Diagnostic Test: test and treat malaria cases1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home). 2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age 3. Mesh product distributed to households |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Shelters with 1 or more children from 6-10 years old
- Shelters with an adult/head of the household
Key exclusion criteria (1 listed)
- Shelters without children from 6-10 years old
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 |
|---|---|---|
| Mesh - spatial repellent impregnated with transfluthrin (2500mg)Mesh is one of the first spatial repellent tools to provide long-lasting protection to users, with predicted efficacy of 6-months. The active ingredient of Mesh is transfluthrin, a fast-acting volatile pyrethroid with low persistency, which can act either by killing or via sublethal toxicity that causes deviation (repellency) in host attraction, reducing host-contact and risk of infectious bites. The chemical passively releases into the air and interacts with vector odour receptors causing irritation. The design of Mesh is simple with a transfluthrin-infused sheet protected by plastic mesh and encased in a plastic frame. Mesh will be distributed to the intervention arm only. | Combination product | Mesh |
| Information and Education Campaigns (IEC)IEC campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home) using leaflets and word of mouth. IEC will be conducted in both arms. | Behavioural | Mesh |
| test and treat malaria casesAll children in the cohort (both arms) will be tested by rapid diagnostic testing (RDT) monthly. If any children test positive, they will be treated with a course of 3-day artemisinin combination therapy (ACT) according to standard protocol and local guidelines. All children in the cohort will receive ACT to provide clearance of any malaria parasites during the baseline of the study. | Diagnostic test | Mesh |
Primary outcome
entomological outcome: vector density
Time frame: 7 months
the relative infestation rate of disease vectors (females of any of Anopheles malaria vectors, Aedes aegypti, or phlebotomine sand flies
epidemiological outcome: malaria incidence
Time frame: 7 months
Malaria incidence will be estimated as the total number of malaria episodes per person over the course of the trial.
1 secondary outcome
feasibility, acceptance and uptake of Mesh
Time frame: 7 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 Apr 2024.
- Derived from this study: PubMed 41520670Allan RJ, Scherrer R, Estecha-Querol S, Weetman D, Paris L, Ba'abba Goni U, Idris Abdulhamid F, Nfornuh Alenwi B, Ahmad S, Cross CL, Ashir GM, Waziri M, Ntadom G, Messenger LA. The effectiveness of long-lasting spatial repellent emanators against malaria in humanitarian crisis settings in northern Nigeria: a two-arm pragmatic, open-label, controlled trial. Lancet Infect Dis. 2026 May;26(5):464-474. doi: 10.1016/S1473-3099(25)00684-X. Epub 2026 Jan 8.
- Individual participant dataSharing planned: No
Related trials for Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
Malaria
RecruitingPhase 1/2
DON in Pediatric Cerebral Malaria
Malaria, Cerebral
Not yet recruitingPhase 1
Safety and Immunogenicity of the Recombinant Malaria Vaccines in Healthy Adults Aged 18-50 Years
Malaria Vaccine
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.
Richard Allan principal investigator
The Mentor Initiative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mesh - spatial repellent impregnated with transfluthrin (2500mg), Information and Education Campaigns (IEC) and test and treat malaria cases in people with Malaria and Childhood ALL, run by The Mentor Initiative at 1 site in United Kingdom.
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 1 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 Apr 2024. 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 United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
entomological outcome: vector density (time frame: 7 months). The study lists 2 primary outcomes in all. 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 NCT06179732, 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 Apr 2024.