Factory-treated, long-lasting permethrin baby wraps for the prevention of malaria: a phase III randomized controlled trial

The National Institute of Allergy and Infectious Diseases awarded Mbarara University of Science and Technology $1,235,114 on June 10, 2026, under the Allergy and Infectious Diseases Research program (CFDA 93.855) to conduct a Phase III randomized controlled trial of factory-treated, long-lasting permethrin-treated baby wraps for malaria prevention in children.

The trial will enroll 750 mother-infant pairs (~3 months of age) from routine immunization visits at three sites across Uganda with varying malaria transmission intensity. All participants will receive dual active ingredient bed nets and be randomized 1:1 to either factory-treated, long-lasting (FTLL) permethrin wraps or untreated wraps. The primary outcome is clinical malaria incidence during the wrap-use period, measured by fever and positive malaria rapid diagnostic test results comparing FTLL and untreated arms. A secondary aim confirms the safety of extended permethrin exposure in young children. Factory-treated materials eliminate the need for monthly retreatment over up to 12 months and result in less skin absorption of chemicals compared to the retreated wraps used in prior feasibility work.

The award funds research performed in Uganda with a period of performance from June 10, 2026, through May 31, 2031.

Abstract

Progress against malaria has stalled. Novel interventions - particularly those targeting outdoor and daytime biting - are needed. In a randomized, placebo-controlled trial of permethrin- VS. Sham-treated baby wraps in uganda, we found a significant reduction in clinical malaria incidence among children carried in permethrin- as compared to sham-treated wraps (boyce ET AL, nejm, 2025). Despite these promising results, our trial incorporated a monthly RE-treatment strategy that would be difficult to operationalize at scale. Furthermore, we only followed participants for 6 months, which is shorter than the expected period of use. Therefore, implementation studies - and specifically trials of long-lasting, factory-treated textiles - are now needed. Factory-treated materials would not only eliminate the need for retreatment for up to 12 months, but because the chemicals are more tightly bound, result in less absorption across the skin. Therefore, we now propose to conduct a randomized, double-blind trial of factory-treated, long-lasting (ftll) wraps. Aim 1: determine the effectiveness of ftll permethrin wraps in combination with existing interventions for the prevention of malaria in children. We will enroll 750 mother-infant pairs from routine immunization visits (~3 months of age) at 3 sites of varying transmission intensity across uganda. All participants will receive new dual active ingredient (AI) bed nets and be randomized (1:1) to either ftll or untreated wraps. The primary outcome will be clinical malaria incidence during the period of wrap use, defined as fever a positive malaria rapid diagnostic test (RDT) between the ftll and untreated arms. Aim 2: confirm the safety of extended exposure to ftll permethrin wraps for use in young children. Although a review of factory-treated clothing by the US environmental protection agency, including clothing for children and toddlers, did not identify scenarios of concern, the frequency of use envisioned here may be beyond that modeled. To accomplish this, we will perform semi-annual assessments of growth (e.g., height-for-weight) and neurodevelopment (ND) during the period of use and 12-months after discontinuation. Aim 3: assess the effect of ftll permethrin wraps on anopheles mosquito indices and blood-meal seeking behaviors. We will conduct longitudinal entomological surveillance, including CDC-light trap and aspirator collections, supplemented by human landing catches at sentinel households (~10-15%) from both the ftll and untreated arms. This work tests a novel intervention, which leverages technology developed by the US military, to reduce the burden of malaria in endemic countries. Addressing malaria in these countries minimizes the risk of importation into the US. If successful, the project will provide additional evidence for treated textiles, which may be used to protect american travelers and deployed military servicemembers. The project will be conducted in uganda, where malaria is highly endemic and IT will be possible to enroll at-risk women-infant pairs.