Getting Malaria Off the Back of Women and Children in Western Uganda

Study Overview
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Brief Summary
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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
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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.

Official Title
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IGHID 11829 - Getting Malaria Off the Back of Women and Children in Western Uganda

Conditions
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Malaria

Intervention / Treatment
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* Other: Permethrin-treated Lesu (baby wrap)
* Other: Untreated Lesu (baby wrap)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to control (25) or intervention group (25)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants in this arm receive Lesu (baby wrap) treated with 0.5% permethrin | Other: Permethrin-treated Lesu (baby wrap)<br>* 0.5% permethrin application<br>|
| Placebo Comparator: Control Group<br>Participants in this arm receive Lesu (baby wrap) soaked with water only to mimic re-treatment and mask allotment | Other: Untreated Lesu (baby wrap)<br>* Matching untreated lesu<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported change in frequency of use of lesu | Self-reported, includes discontinuation of use | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic malaria episodes among children | As defined by typical symptoms including fever, malaise, and convulsions. | 12 weeks | 
| Incidence of P. falciparum malaria parasitemia among children | As determined by quantitative PCR | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria, P. Falciparum, Permethrin, Rapid diagnostic test