IGHID 11829 - Getting Malaria "Off the Back" of Women and Children in Western Uganda
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Reported change in frequency of use of lesu
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts 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)
Arms & Interventions
Intervention Group
Participants in this arm receive Lesu (baby wrap) treated with 0.5% permethrin
Intervention: Permethrin-treated Lesu (baby wrap) (Other)
Control Group
Participants in this arm receive Lesu (baby wrap) soaked with water only to mimic re-treatment and mask allotment
Intervention: Untreated Lesu (baby wrap) (Other)
Outcomes
Primary Outcomes
Reported change in frequency of use of lesu
Time Frame: Baseline, 12 weeks
Self-reported, includes discontinuation of use
Secondary Outcomes
- Incidence of symptomatic malaria episodes among children(12 weeks)
- Incidence of P. falciparum malaria parasitemia among children(12 weeks)
- Change in mosquito salivary antigen response among children(Baseline, 12 weeks)
- 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)