Getting Malaria "Off the Back" of Women and Children in Western Uganda
- Conditions
- Malaria
- Interventions
- Other: Permethrin-treated Lesu (baby wrap)Other: Untreated Lesu (baby wrap)
- Registration Number
- NCT04102592
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 52
- 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
- Mother or child with HIV (and thus taking cotrimoxazole prophylaxis)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Permethrin-treated Lesu (baby wrap) Participants in this arm receive Lesu (baby wrap) treated with 0.5% permethrin Control Group Untreated Lesu (baby wrap) Participants in this arm receive Lesu (baby wrap) soaked with water only to mimic re-treatment and mask allotment
- Primary Outcome Measures
Name Time Method Reported change in frequency of use of lesu Baseline, 12 weeks Self-reported, includes discontinuation of use
- Secondary Outcome Measures
Name Time Method Change in mosquito salivary antigen response among mothers Baseline, 12 weeks Changes in hemoglobin levels among children Baseline, 12 weeks Changes in hemoglobin levels among mothers Baseline, 12 weeks Incidence of symptomatic malaria episodes among children 12 weeks As defined by typical symptoms including fever, malaise, and convulsions.
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
Trial Locations
- Locations (1)
Bugoye Level III Health Centre
🇺🇬Bugoye, Kasese, Uganda