Bugoye Level III Health Centre
Bugoye, Kasese, Uganda
NCT Number: NCT04102592
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.
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Notify Me18 year–50 year
Female
Interventional
Not applicable
Bugoye, Kasese, Uganda
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.5% permethrin application
Matching untreated lesu
Other names: Placebo
Time frame: Baseline, 12 weeks
Self-reported, includes discontinuation of use
Time frame: 12 weeks
As defined by typical symptoms including fever, malaise, and convulsions.
Time frame: 12 weeks
As determined by quantitative PCR
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
Time frame: Baseline, 12 weeks
University of North Carolina, Chapel Hill
Other
IGHID 11829 - Getting Malaria "Off the Back" of Women and Children in Western Uganda
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