This is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the incidence of P. falciparum malaria among infants in a rural area of western Uganda. Participants will be recruited from four villages immediately adjacent to the Bugoye Level III Health Centre (Bugoye, Kanyanamigho, Izinga, Rwakingi 1a) in the Kasese District of western Uganda. The purpose of the study is to assess the feasibility and tolerability of using insecticide-treated lesus to reduce the incidence of P. falciparum malaria infection among infants.
This is a two-phase, mixed-methods pilot study of insecticide-treated lesus to reduce the incidence of P. falciparum malaria among infants in a rural area of western Uganda. Participants will be recruited from four villages immediately adjacent to the Bugoye Level III Health Centre (Bugoye, Kanyanamigho, Izinga, Rwakingi 1a) in the Kasese District of western Uganda. The first phase will consist of a series of focus group sessions with mothers of young children and their male partners to gain further insight into lesu use, to include location of purchase and frequency of washing, as well as exploring initial perceptions of insecticide-treated clothing and inform the protocols for the open-label study. The second phase will consist of a prospective, open-label study. Twenty-five (25) mothers and their young children will be provided with insecticide-treated lesus and twenty-five (25) controls who will be provided untreated lesus. After an initial visit, bi-weekly follow up, including finger-prick blood collections will continue for a period of twelve (12) weeks. Collected blood spots will be transported to Epicentre for real-time PCR to identify sub-microscopic parasitemia and to the French Research Institute for Development (https://en.ird.fr) in Marseille, France for quantification of the mosquito salivary antigen (gSG6-P1 peptide). Remaining samples will be stored for future analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
0.5% permethrin application
Matching untreated lesu
Bugoye Level III Health Centre
Bugoye, Kasese, Uganda
Reported change in frequency of use of lesu
Self-reported, includes discontinuation of use
Time frame: Baseline, 12 weeks
Incidence of symptomatic malaria episodes among children
As defined by typical symptoms including fever, malaise, and convulsions.
Time frame: 12 weeks
Incidence of P. falciparum malaria parasitemia among children
As determined by quantitative PCR
Time frame: 12 weeks
Change in mosquito salivary antigen response among children
Time frame: Baseline, 12 weeks
Change in mosquito salivary antigen response among mothers
Time frame: Baseline, 12 weeks
Changes in hemoglobin levels among children
Time frame: Baseline, 12 weeks
Changes in hemoglobin levels among mothers
Time frame: Baseline, 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
52