Spatial Repellents for Malaria Control (AEGIS Uganda)

March 4, 2025 updated by: University of Notre Dame

Advancing Spatial Repellents for Malaria Control: Effectiveness and Cost-Effectiveness of a Spatial Repellent Under Operational Use in Northern Uganda

The primary objective of the study is to demonstrate and quantify the effectiveness of a spatial repellent (SR) product, in reducing malaria infection in humans under operational program conditions in a humanitarian assistance context. The design will be a cluster Randomized Control Trial (cRCT) representing an operational research study.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Spatial repellents (SRs) have been widely used for the prevention of mosquito bites, and preliminary findings suggest efficacy against both malaria and Aedes-borne viruses but their effectiveness in reducing mosquito borne diseases under operational use has never been evaluated. SRs have the potential of being critical tools in the prevention of mosquito borne diseases in contexts where typical vectors control strategies, such as Insecticide-Treated Nets (ITNs) and indoor residual spray (IRS), are inaccessible or underutilized such as among displaced peoples or in emergency relief settings. To address this knowledge gap, the Bidibidi refugee settlement in the Yumbe District of North West Uganda was selected as the study site to estimate the impact of the SR on malaria related outcomes under operational use conditions given ongoing humanitarian relief efforts. Children will be enrolled in 3 separate cohorts to establish effectiveness of SRs in reducing malaria infection in distribution channels. One cohort will estimate the direct effect of the SR distributed through a reference channel (study personnel distribution). The two remaining cohorts will estimate the protection of the SR distributed through a voucher channel and village health team (VHT) channel. Cohorts will be followed twice a month (approximately every 15 days) during the first scheduled household visit in the month, a blood sample will be taken for malaria rapid diagnostic test (RDT) (Monthly Visit #1); and, during the second scheduled household visit, a blood sample will only be taken if the participant has a recent history of fever (Monthly Visit #2). The incidence of malaria in each cohort will be estimated and compared to the reference cohort to determine the benefit of using an SR in an area with high, year-round transmission of malaria.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Catholic Relief Services
      • Kampala, Uganda
        • Infectious Disease Research Collaboration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children ≥ 6 months to ≤ 59 months
  • Children ≥ 6 months to ≤ 59 months with Hb > 7g/dL and no other serious illness
  • Sleeps in cluster (i.e. study area) ≥ 90% of nights during any given month
  • 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) signed by the parent(s) or guardian

Exclusion Criteria:

  • Children < 6 months and > 59 months
  • Children ≥ 6 months to ≤ 59 months with Hb ≤ 7g/dL with signs of other serious illness or Hb ≤ 7 g/dL with signs of clinical decompensation
  • Sleeps in cluster (i.e. study area) < 90% of nights during any given month
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study personnel distribution channel
SR product will be delivered by paid study personnel.
Device: Transfluthrin - delivery by paid study personnel
Passive emanator with formulated transfluthrin, SR product will be delivered by paid study personnel
Experimental: Voucher distribution channel
Voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household.
Device: Transfluthrin - delivery by voucher system
Passive emanator with formulated transfluthrin, voucher which will be used to redeem for SR product(s) on a monthly basis for each head of household.
Experimental: Village health team distribution channel
Village health teams will distribute SR products.
Device: Transfluthrin - delivery by village health teams
Passive emanator with formulated transfluthrin, village health teams will distribute SR products.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of SR against malaria infection (both first-time and recurrent).
Time Frame: 12 months
Measured by rapid diagnostic tests in children aged between 6 months to 59 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness of SR distribution.
Time Frame: 12 months
Measure cost of SR implementation in relation to manufacturing, efficacy, and coverage to model projections of cost-effectiveness.
12 months
Adverse Events and Serious Adverse Events.
Time Frame: 12 months
Measured by solicited and unsolicited reports during the intervention period. Mean, minimum and maximum frequency and percentage of Adverse Events and Serious Adverse Eventss across clusters among enrolled subjects will be summarized by distribution channel arm.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Notre Dame

Collaborators

Infectious Diseases Research Collaboration, Uganda
SC Johnson, A Family Company
Catholic Relief Services

Investigators

  • Study Director: John P Grieco, Ph.D., University of Notre Dame
  • Principal Investigator: Suzanne Van Hulle, M.H.S., Catholic Relief Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-05-7909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Analytical data will be anonymized and GPS tag-blurred to remove sensitive information prior to sharing.

IPD Sharing Time Frame

The data and supporting information will be made available 12 months following completion of data analysis and will remain open access in the public domain.

IPD Sharing Access Criteria

Open-access repository distributed under the terms of the Creative Commons Attribution (CC-BY) License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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