Permethrin-treated Baby-wraps for the Prevention of Malaria in Children

Study Overview
=================
Brief Summary
-----------------
The scientific objective of this study is to test the protective effect of permethrin-treated lesus against P. falciparum malaria in infants and young children.

Detailed Description
-----------------
General Study Design: The proposed study is a double-blind, randomized control trial of permethrin-treated lesus to prevent P. falciparum malaria in children 6-24 months of age conducted at two sites in rural western Uganda. Participating mother-infant pairs will receive a new bed net and two permethrin-treated or untreated lesus at enrollment. The total sample size will be 400 mother-infant pairs with 200 pairs in each group. The investigators will follow participants longitudinally for six months. Participants will be instructed and incentivized to present to one of the two study clinics when a fever develops, where they will be evaluated, tested, and treated, if positive, for malaria. Participants will also attend scheduled clinic visits every two weeks for routine surveillance of adverse effects and to test for asymptomatic infection. Re-treatment and sham re-treatment of lesus will occur each month. Outcome Measures: The primary outcome measure is the incidence rate ratio of clinical (i.e., symptomatic) P. falciparum malaria in infants and children 6 - 24 months of age. Differences in malaria infection between treatment groups will be estimated with the incidence rate ratio, defined as the ratio of the number of clinical malaria episodes per 100 person-weeks at risk in the intervention group relative to the control group. This measure was chosen as it represents the most patient-centered measure of malaria burden, reflecting not only the potential negative health consequences, but also opportunity costs associated with care seeking and treatment.

Official Title
-----------------
IGHID 12128 - Getting Malaria Off the Backs of Women and Children in Western Uganda

Conditions
-----------------
Malaria, P. Falciparum

Intervention / Treatment
-----------------
* Other: Permethrin-treated lesu
* Other: Untreated lesu


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide signed and dated informed consent form (ICF) Willing to comply with all study procedures and be available for the duration of the study Female of any age with a child 6 to 18 months of age at the time of enrollment Resident of village located in Bugoye, Maliba, or Mubuku sub-counties. Recruitment will initially focus on residents of villages within 2 km of study clinics in order to facilitate attendance, but we will not restrict enrollment to residents of these villages. Exclusion Criteria: Mother or child taking any malaria chemoprevention regimen, including individuals living with HIV or exposed children who are taking cotrimoxazole that may modify risk of malaria Child with known sickle cell disease Known allergic reactions to components of the study product(s) Treatment with another investigational drug or other intervention Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a double-blind, randomized controlled trial of permethrin-treated lesus to prevent P. falciparum malaria in children 6-18 months of age. Study enrollment conducted at two sites in rural western Uganda. Participants will be randomized to one of two arms: permethrin-treated (intervention) or untreated (control) lesus. Participating mother-infant pairs will receive a new Long-lasting Insecticidal Net and two permethrin-treated or untreated lesus at enrollment. Total sample size will be 400 mother-infant pairs with 200 pairs in each arm. Participants will be followed longitudinally for six months, instructed and incentivized to present to one of the two study clinics when a fever develops, where they will be evaluated, tested, and treated, if positive, for malaria. Participants will attend scheduled clinic visits every two weeks for routine surveillance of adverse effects and tested for asymptomatic infection. Re-treatment and sham re-treatment of lesus will occur monthly.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm : Arm that received permethrin-treated lesu<br>Intervention Arm is the group that receives permethrin-treated lesu for use. The lesus of participants in the intervention group will be treated and subsequently retreated each month with 0.5% permethrin (Sawyer Products, Safety Harbor, FL). | Other: Permethrin-treated lesu<br>* 0.5% permethrin soaked baby wraps (lesus)<br>|
| Sham Comparator: Control Arm: Arm that received none permethrin-treated lesu<br>The lesus of participants in the control group will undergo sham treatment and re-treatment in which the cloth is soaked in water for a period of time similar to that of the intervention group. Participants and clinical staff (but not administrative staff) will be blinded to group assignments. | Other: Untreated lesu<br>* Water soaked baby wraps (lesus)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinical malaria in child | The presence of typical symptoms (e.g., fever, lethargy) and a positive malaria Rapid Diagnostic Test (RDT) during observation | 7 days after onset of symptoms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child's hemoglobin level | Change in child's hemoglobin as measured by HemoCue® device | (Week 0), Week 12, and Week 24 visits | 
| Change in child's growth parameters | Change in child's height and weight (e.g., weight and height will be combined to report BMI in kg/m^2). | (Week 0), Week 12, and Week 24 visits | 
| Change in child's nutritional status | Change in child's mid-upper arm circumference (MUAC) | (Week 0), Week 12, and Week 24 visits using MUAC tape | 
| Prevalence of asymptomatic parasitemia | Presence of malaria parasites on bi-weekly dried blood spot (DBS) as determined by quantitative polymerase chain reaction(qPCR). | Every two weeks | 
| Malaria hospitalization | Child admitted to inpatient ward for treatment of malaria | 14 days after onset of symptoms | 
| Incidence of clinical malaria in mother | The presence of typical symptoms (e.g., fever, lethargy) and a positive malaria RDT during observation | 7 days after onset of symptoms | 
| Change in mother's hemoglobin level | Change in child's hemoglobin as measured by HemoCue® device | (Week 0), Week 12, and Week 24 visits | 
| Adverse reaction to permethrin treatment | Self-reported history on bi-weekly questionnaire and confirmation by clinical staff. | 7 days after onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Permethrin, Plasmodium Falciparum Infection, Insecticide, Malaria