Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition
- Conditions
- Malaria IncidenceSeasonal Malaria ChemopreventionNutrition AssessmentAcute Malnutrition in ChildhoodAcute MalnutritionIntegrated Community-based Intervention Package
- Interventions
- Dietary Supplement: SQ-LNSOther: Integrated Nutritional Screening
- Registration Number
- NCT06599593
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
In the Sahel, the malaria and malnutrition seasons overlap during the rainy season, from approximately July through October. Malaria transmission increases due to the rain and collection of standing water and malnutrition risk increases because this period is the growing season, leading up to the annual harvest in November. Seasonal malaria chemoprevention (SMC) is an antimalarial intervention that involves monthly distribution of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) to children aged 3-59 months during the high malaria transmission season. SMC is distributed to millions of children annually in 13 countries in the Sahel, including Burkina Faso. Although SMC distribution is highly effective against clinical malaria in children, malaria remains a major cause of childhood mortality and morbidity in Burkina Faso. The SMC platform, which involves monthly door-to-door delivery of SP-AQ, is an attractive platform for delivery of additional interventions that may augment child health during this vulnerable season. Malaria and malnutrition co-occur in children and communities, and interventions for one may affect the other. For example, previous work by our group and others has shown that antimalarial treatments may improve weight gain in children with malnutrition. Here, we propose a pilot trial designed to evaluate how the SMC platform may be leveraged to deliver co-interventions with SMC that may augment its efficacy and reduce the incidence of malaria and malnutrition. We anticipate that the results of this study will provide formative data for the development and implementation of a full-scale study evaluating the effects of integration of nutritional interventions on the SMC platform. We anticipate that such a strategy may provide optimal protection for children during the most vulnerable period of the year by delivering interventions monthly on an existing platform that directly reaches millions of children each month.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutrition-Intervention-SMC Integration SQ-LNS In conjunction with SMC administration, CHWs screen children for MUAC. CHW refers children with MUAC \<12.5 to the CSPS for MAM/SAM care and to receive all standard nutritional program. CHW provides all children ages 6-24 months who do not have acute malnutrition with SQ-LNS (Enov'nutributter; Nutriset; 20 g/day, approximately 100-120 calories). Nutrition-Intervention-SMC Integration Integrated Nutritional Screening In conjunction with SMC administration, CHWs screen children for MUAC. CHW refers children with MUAC \<12.5 to the CSPS for MAM/SAM care and to receive all standard nutritional program. CHW provides all children ages 6-24 months who do not have acute malnutrition with SQ-LNS (Enov'nutributter; Nutriset; 20 g/day, approximately 100-120 calories). Standard of Care Plus SQ-LNS Provision SQ-LNS Separately from SMC administration, CHWs screen children ages 6-59 months for MUAC as part of their routine program. CHW refers children with MUAC \<12.5 to the CSPS for MAM/SAM care and to receive all standard nutritional program. CHW provides all children ages 6-24 months who do not have acute malnutrition with SQ-LNS (Enov'nutributter; Nutriset; 20 g/day, approximately 100-120 calories).
- Primary Outcome Measures
Name Time Method Clinical malaria incidence 5 months The primary outcome will be the cumulative incidence of clinical malaria, defined as fever (axillary temperature ≥37.5°C) plus a positive RDT, over the course of one SMC season. The primary outcome will be measured in two ways: active case detection and passive detection. For active surveillance, we will randomly select 25 children aged 6-24 months per community (N=500 total) for weekly monitoring for malaria using an HRP2-based RDT.41 For passive surveillance, we will record all uncomplicated malaria diagnoses at primary healthcare facilities.
- Secondary Outcome Measures
Name Time Method Alternative malaria Indicators 5 months For children enrolled in active surveillance across both arms, the team will assess the cumulative incidence of malaria parasitemia by RDT with or without fever, thin/thick smears, and/or via PCR (via dried blood spots).
Severe malaria 5 months Severe malaria will be diagnosed at participating healthcare facilities and defined as vital organ dysfunction and/or hyperparasitemia (\>5% of red blood cells infected by malaria parasites).
Anemia 5 months Anemia will be measured in the active surveillance cohort monthly using the HemoCue Hb 301 system.
All-cause clinic visits. 5 months Primary healthcare data collected via passive surveillance will include all sick child visits during the study period and will include information related to diagnoses and treatments.
Trial Locations
- Locations (1)
Centre de Recherche en Sante de Nouna
🇧🇫Nouna, Burkina Faso