Insecticide-Treated Baby Wraps for the Prevention of Malaria
Factory-Treated, Long-Lasting Insecticide-Treated Baby Wraps for the Prevention of Malaria: A Phase III Clinical Trial
1 other identifier
interventional
1,296
1 country
1
Brief Summary
The objective is to test the protective effect of permethrin-treated and etofenprox-treated lesus against malaria in young children
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2027
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2026
CompletedFirst Posted
Study publicly available on registry
August 19, 2026
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
Study Completion
Last participant's last visit for all outcomes
January 1, 2031
August 19, 2026
August 1, 2026
3 years
August 14, 2026
August 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of clinical malaria in children between the etofenprox and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria rapid diagnostic test (RDT) at a scheduled or unscheduled study visit.
From enrollment through Month 24
Incidence of clinical malaria in children between the permethrin and control arms
Incidence of participants experiencing acute febrile illness AND positive malaria RDT at a scheduled or unscheduled study visit.
From enrollment through Month 24
Secondary Outcomes (67)
Incidence of clinical malaria in children between the permethrin and control arms per site
From enrollment through Month 24
Incidence of clinical malaria in children between the etofenprox and control arms per site
From enrollment through Month 24
Incidence of hospitalizations due to malaria between the permethrin and control arms
From enrollment to Month 36
Incidence of hospitalizations due to malaria between the etofenprox and control arms
From enrollment to Month 36
Number of deaths from any cause between the permethrin and control arms during wrap use
From enrollment to Month 24
- +62 more secondary outcomes
Study Arms (3)
Receives permethrin-treated lesu
EXPERIMENTALReceives permethrin-treated lesu for 2 years
Receives etofenprox-treated lesu
EXPERIMENTALReceives etofenprox-treated lesu for 2 years
Receives non-treated lesu
SHAM COMPARATORReceives the non-treated lesu for 2 years
Interventions
Patterned cotton-blend fabric will be obtained and treated with permethrin at Perimeter Insect Guard. After treatment, the material will be cut into 2 x 1 meter swathes
Patterned cotton-blend fabric will be obtained and treated with etofenprox at Perimeter Insect Guard. After treatment, the material will be cut into 2 x 1 meter swathes
Untreated fabric of identical appearance (i.e., color and pattern) will be similarly cut and packaged for use
Eligibility Criteria
You may qualify if:
- Mother is at least 18 years old
- Mother has access to a working phone with a known number
- Mother is the parent or legal guardian of a singleton (i.e., not a twin) infant 2-4 months of age
- Has the ability to travel to a designated study site for visits and evaluation
- Mother/Infant pair presents to their 10-week immunization visit at one of the designated study sites
You may not qualify if:
- Participation in another study of malaria prevention
- Known allergic reaction to permethrin or etofenprox
- Infant has a known HIV diagnosis (or exposure) or sickle cell disease that would be an indication for malaria prophylaxis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mbarara University of Science and Technology
Mbarara, Uganda
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ross Boyce, MD, MSc
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2026
First Posted
August 19, 2026
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2031
Last Updated
August 19, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- beginning 9 and continuing for 36 months following publication
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Deidentified individual data that supports the results may be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.