Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition

NCT06599593 | Active Not Recruiting

• 2 other identifiers: 24-424931R21AI182714
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

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. The pilot trial is 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. It is anticipated 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. It is anticipated 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.

Conditions

Malaria Incidence; Seasonal Malaria Chemoprevention; Nutrition Assessment; Acute Malnutrition in Childhood; Acute Malnutrition; Integrated Community-based Intervention Package

Keywords

integrated nutritional screening, seasonal malaria chemoprevention, acute malnutrition, malaria

Outcome Measures

Primary Outcomes (1)

• Clinical malaria incidence

  The primary outcome will be the cumulative incidence of clinical malaria, defined as fever (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, 25 children aged 6-24 months per community (N=500 total) will be randomly selected for biweekly monitoring for malaria using an HRP2-based RDT. For passive surveillance, we will record all uncomplicated malaria diagnoses at primary healthcare facilities.

  5 months

Secondary Outcomes (3)

• Alternative malaria Indicators

  5 months

• Severe malaria

  5 months

• All-cause clinic visits.

  5 months

Study Arms (2)

Nutrition-Intervention-SMC Integration

EXPERIMENTAL

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).

Dietary Supplement: SQ-LNS; Other: Integrated Nutritional Screening

Standard of Care Plus SQ-LNS Provision

ACTIVE COMPARATOR

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).

Dietary Supplement: SQ-LNS

Interventions

SQ-LNS DIETARY_SUPPLEMENT

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; Standard of Care Plus SQ-LNS Provision

Integrated Nutritional Screening OTHER

In conjunction with SMC administration, CHWs screen children for MUAC. CHW refers children with MUAC \&lt;12.5 to the CSPS for MAM/SAM care and to receive all standard nutritional program.

Nutrition-Intervention-SMC Integration

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Children will be eligible for inclusion in the trial if they meet all of the following criteria: * Live in the study community * Eligible for SMC * No allergy to peanuts or cow's milk * Able to orally feed * Within the eligible age ranges: * 6-59 months for passive surveillance * 6-24 months for SQ-LNS provision * Written informed consent from at least one caregiver * Caregiver is at least 18 years of age Children will be recruited during normal distribution (via door-to-door delivery) for SMC, which occurs monthly during the malaria season (July through October). Children ages 3-6 months are eligible for SMC and will be included in nutritional screening and monitoring by default but will not be eligible for SQ-LNS, which is designed for children ages 6-24 months and will not be part of the passive surveillance. A random sample of children ages 6-24 months during the first month of distribution will be asked to participate in an active surveillance cohort. These children will be followed biweekly for screening for malaria with a rapid diagnostic test and temperature and monthly for dried blood spot and anthropometric measurements.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Centre de Recherche en Sante de Nouna, Burkina Faso: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Centre de Recherche en Sante de Nouna

Nouna, Burkina Faso

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Catherine Oldenburg

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: July 3, 2025
• Primary Completion: November 12, 2025
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

BU (1)