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

The objective is to test the protective effect of permethrin-treated and etofenprox-treated lesus against malaria in young children

The proposed study is a double-blind, randomized control trial of permethrin-treated and etofenprox-treated lesus to prevent P. falciparum malaria in children 2-4 months of age conducted at three sites in rural Uganda. Participating mother-infant pairs will receive a new bed net and two permethrin-treated or untreated lesus at enrollment. The total sample size will be 1,296 mother-infant pairs with 144 pairs in each group. The investigators will follow participants longitudinally for three years. Participants will be instructed and incentivized to present to one of the study clinics when a fever develops, where they will be evaluated, tested, and treated, if positive, for malaria. Participants will also attend scheduled clinic visits every two months for routine surveillance of adverse effects and to test for asymptomatic infection. Re-treatment and sham re-treatment of lesus will occur after 1 year of participation. Participants will be asked to return the lesus after 2 years of participation.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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