Actively Recruiting

Phase Not Applicable
Age: 0 - 5Years
All Genders
Healthy Volunteers
ID06232954

Evaluation of the Protective Efficacy of a Spatial Repellent to Reduce Malaria Prevalence in Children 5 Years and Younger in Uganda: A Cluster-Randomized Double-Blinded Control Trial of the Mossie-GO Device

Led by Africa Power Limited · Updated on 2024-06-21

5600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Africa Power Limited

Lead Sponsor

M

Malaria Consortium

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the protective efficacy of Mossie-GO, an active spatial repellent device that releases transfluthrin, to reduce malaria prevalence in children 5 years old and younger in Uganda. This cluster-randomized, double-blinded control trial aims to measure how well the device lowers malaria cases confirmed by rapid diagnostic tests and microscopy, while also assessing its impact on mosquito behavior, resistance, and diversion effects on nearby unprotected individuals. The study includes surveys and safety monitoring. The Mossie-GO device is a small solar-powered fan unit that holds repellent discs treated with transfluthrin, designed to prevent mosquito bites and reduce mosquito populations when used overnight for 8 to 12 hours. Households in the intervention group receive devices with treated discs and monthly refills, while control households receive devices with untreated blank discs and refills to maintain blinding. The device is placed in the room where the enrolled child sleeps. Participants continue standard malaria prevention such as bed nets. Participants are monitored at baseline and followed for up to 18 months, covering two malaria transmission seasons. Assessments include malaria testing in children using blood tests, household surveys, mosquito collection with light traps and human landing catches, air sampling to measure repellent concentration, and acceptability surveys. Data on adverse events and intervention safety are collected. The trial involves 56 clusters with about 100 households sampled for detailed evaluation in core zones, plus additional monitoring in buffer zones.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 5Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Cluster includes more than 100 households
  • Household has a child 5 years old or younger at enrollment
  • Adult head of household agrees to receive and use the device as instructed
  • Adult head of household agrees to data collection visits and household surveys
  • Child sleeps in the household at least 90% of nights each month
  • Child is 5 years old or younger at enrollment
  • No plans for extended travel longer than 1 month during the study
  • Not participating in another clinical trial involving a vaccine, drug, device, or procedure
  • Informed consent provided by parent or guardian
  • Participant is not on regular malaria prophylaxis
Not Eligible

You will not qualify if you...

  • Cluster includes fewer than 100 households
  • Household has a child older than 5 years at enrollment
  • Adult head of household does not agree to data collection visits and surveys
  • Child sleeps in the household fewer than 90% of nights each month
  • Household considered a security risk by study personnel
  • Participant is older than 5 years at enrollment
  • Plans for extended travel longer than 1 month during the study
  • Participating or planning participation in another clinical trial involving a vaccine, drug, device, or procedure
  • No informed consent provided by parent or guardian
  • Participant is on regular malaria prophylaxis

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 18 months

Participants’ households receive the Mossie-GO device with either treated or untreated discs which are replaced monthly to provide sustained protection. Participants continue using other malaria prevention practices as recommended by national policy.

Device distribution at baseline and monthly visits to replace discs

Monitoring

Duration - Up to 18 months

Participants are monitored every 6 months for malaria testing using rapid diagnostic tests and microscopy. Additional entomological sampling, air sampling, and household surveys are conducted to evaluate the intervention and its effects.

Quarterly visits every 6 months for malaria testing and surveys; mosquito and air sampling conducted during these intervals

Acceptability Survey

Duration - At study end (around 18 months)

Participants complete a survey assessing the acceptability of the Mossie-GO device at the final data collection time point.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Malaria Consortium

Jinja, Uganda

Actively Recruiting

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Research Team

R

Robert Jones, PhD

J

Jane Achan, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

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.

Jessica Dennehy, Will Dyall, Akin Jenkins...

https://pubmed.ncbi.nlm.nih.gov/41634736