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

NCT06232954 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5600

Last updated 2024-06-21

No results posted yet for this study

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

Interventions

DEVICE

Mossie-Go containing treated transfluthrin disc

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.

DEVICE

Mossie-Go containing untreated blank disc

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.

Sponsors & Collaborators

  • Malaria Consortium

    collaborator OTHER
  • ARCTECH INNOVATION LIMITED

    collaborator UNKNOWN
  • Africa Power Limited

    lead INDUSTRY

Principal Investigators

  • Robert Jones, PhD · Arctech Innovation

  • Jane Achan, PhD · Malaria Consortium

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-05
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06232954 on ClinicalTrials.gov