Malaria
Conditions
Keywords
Malaria, P. Falciparum, Permethrin, Rapid diagnostic test
Brief summary
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.
Detailed description
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.
Interventions
OTHERPermethrin-treated Lesu (baby wrap)
0.5% permethrin application
OTHERUntreated Lesu (baby wrap)
Matching untreated lesu
Sponsors
Conservation, Food, and Health Foundation
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomized to control (25) or intervention group (25)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult women (age greater or equal to 18 years) with a healthy child between the ages of 6 months to 18 months from one of four eligible villages
Exclusion criteria
* Mother or child with HIV (and thus taking cotrimoxazole prophylaxis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reported change in frequency of use of lesu | Baseline, 12 weeks | Self-reported, includes discontinuation of use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of P. falciparum malaria parasitemia among children | 12 weeks | As determined by quantitative PCR |
| Change in mosquito salivary antigen response among children | Baseline, 12 weeks | — |
| Incidence of symptomatic malaria episodes among children | 12 weeks | As defined by typical symptoms including fever, malaise, and convulsions. |
| Changes in hemoglobin levels among children | Baseline, 12 weeks | — |
| Changes in hemoglobin levels among mothers | Baseline, 12 weeks | — |
| Change in mosquito salivary antigen response among mothers | Baseline, 12 weeks | — |
Countries
Uganda
Outcome results
None listed