Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Uganda

NCT06232954 | Recruiting DMC

• 1 other identifier: 1577
• Study Type: interventional
• Target: 5,600
• Locations: 1 country
• Sites: 1

Brief Summary

A cluster-randomized double-blinded control trial will be conducted in Uganda to demonstrate and quantify the protective efficacy (PE) of Mossie-GO, an active spatial repellent system disseminating transfluthrin, in reducing the prevalence of malaria in children ≤ 5 years of age, as determined by RDT positivity and confirmed by microscopy. The study's secondary objective is to measure the diversionary impact of the intervention on locally unprotected individuals and impact of the intervention on entomological correlates of transmission including vector densities, host seeking behaviour and insecticide resistance. This will be conducted using Centre of Disease Control (CDC) light traps in households, human landing catches and World Health Organisation (WHO) tube tests. Further data collection include household behavioural surveys, air sampling to quantify concentration of transfluthrin present in air, acceptability surveys and intervention safety monitoring. Recruited households will be monitored across baseline data collection and followed up for 2 disease transmission seasons, for up to 18 months. The devices will be distributed to all consented eligible households in the two study arms: intervention and control. Intervention arm devices will be provided with transfluthrin treated discs and refill transfluthrin discs at frequent enough intervals to provide sustained protection. Households in the control arm will receive blank discs with no active ingredient. Households will be asked to continue using other malaria prevention practices, such as the use of bed nets, as recommended by national policy.

Conditions

Malaria; Mosquito-Borne Disease

Keywords

malaria; spatial repellent; vector control; transfluthrin; randomised control trial

Outcome Measures

Primary Outcomes (1)

• Malaria prevalence

  Malaria prevalence among children ≤ 5 years of age as determined by Rapid Diagnostic Test (RDT) positivity and confirmed by microscopy.

  18 months

Secondary Outcomes (6)

• Assessment of the diversionary effect of spatial repellent in the buffer zone using RDT and microscopy

  18 months

• Entomological correlates of transmission

  18 months

• Household surveys

  18 months

• Air sampling

  18 months

• Safety of intervention

  18 months

Study Arms (2)

Intervention

EXPERIMENTAL

All recruited households within the intervention arm will receive the Mossie-Go device containing transfluthrin treated discs and will be provided with refill transfluthrin discs at monthly intervals to provide sustained protection.

Device: Mossie-Go containing treated transfluthrin disc

Control

PLACEBO COMPARATOR

All recruited households within the control arm will receive the Mossie-Go device containing untreated blank discs and will be provided with refill untreated blank discs at monthly intervals.

Device: Mossie-Go containing untreated blank disc

Interventions

Mossie-Go containing treated transfluthrin disc DEVICE

The Mossie-GO repellent device is approximately 8 cm3 and can be fitted with repellent discs impregnated with transfluthrin and a carrier oil. These discs sit above a fan that is powered by a small motor charged by solar energy. The device is expected to both prevent bites and cause some mortality to mosquitoes when switched on for 8-12 hours overnight for up to 1 calendar month. The discs then need to be replaced.

Intervention

Mossie-Go containing untreated blank disc DEVICE

The Mossie-GO repellent device is approximately 8 cm3 and can be fitted with a blank untreated disc. These discs sit above a fan that is powered by a small motor charged by solar energy. The device containing the untreated disc is not expected to prevent mosquito bites. The discs will still be replaced monthly for blinding purposes.

Control

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Cluster level:
• Number of households \> 100
• Household level:
• Presence of a child ≤ 5 years of age at point of enrolment in the study
• Adult head of household agrees to receiving and using the device as per manual instructions
• Adult head of household agrees to data collection visits and household surveys
• Children within household sleeps in cluster \> 90% of nights during any given month
• Individual level:
• ≤ 5 years of age when enrolled into the study
• No plans for extended travel (\> 1 month) outside of home during study
• Not participating in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
• Provision of informed consent form (ICF) by the parent(s) or guardian
• Participants not on regular malaria prophylaxis

You may not qualify if:

• Cluster level:
• Number of households \< 100
• Household level:
• Presence of a child \> 5 years of age at point of enrolment in the study
• Adult head of household does not agree to data collection visits and household surveys
• Children within household sleeps in cluster \< 90% of nights during any given month
• Households where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
• Individual level:
• \>5 years of age when enrolled into the study
• Plans for extended travel (\> 1 month) outside of home during study
• Participating or planned participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure during the trial
• No provision of ICF signed by the parent(s) or guardian
• Participants on regular malaria prophylaxis

Sponsors & Collaborators

• Africa Power Limited: lead
• Malaria Consortium: collaborator
• ARCTECH INNOVATION LIMITED: collaborator

Study Sites (1)

Malaria Consortium

Jinja, Uganda

RECRUITING

Related Publications (1)

• Dennehy J, Dyall W, Jenkins A, Bradley J, Sserwanga A, Kigozi R, Bwanika JB, Nuwa A, Mawejje H, Turner MA, Wallace R, Lyle FGA, Hiscox A, Livesey AK, Logan JG, Achan J, Jones RT. Evaluation of the protective efficacy of a transfluthrin-based spatial repellent product to reduce malaria prevalence in Uganda: study protocol for a cluster-randomised double-blinded control trial-the Mossie-GO trial. Trials. 2026 Feb 3. doi: 10.1186/s13063-025-09365-w. Online ahead of print.

  PMID: 41634736 DERIVED

MeSH Terms

Conditions

Malaria; Mosquito-Borne Diseases

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Officials

• Robert Jones, PhD

  Arctech Innovation

  PRINCIPAL INVESTIGATOR

• Jane Achan, PhD

  Malaria Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Jones, PhD

CONTACT

+447745845880; robert.jones@arctechinnovation.com

Jane Achan, PhD

CONTACT

j.achan@malariaconsortium.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: In exception of the data management personnel responsible for coordinating the manufacture and distribution of the Mossie-GO and independent statistician preparing the Data Safety and Monitoring Board (DSMB) report, all study staff will remain blinded to the household treatment allocation, until the completion of data collection and the locking of the database at the end of the study. Unblinded study staff will have no role in study implementation or outcome assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cluster-randomised placebo-controlled trial

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 31, 2024
• Study Start: June 5, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)