Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition (INSPIRE)

University of California San Francisco (UCSF)

Status: Active, not recruiting

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

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06599593

24-42493

1R21AI182714 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 438 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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438 participants in 2 patient groups

Nutrition-Intervention-SMC Integration

Experimental group

Description:

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).

Treatment:

Dietary Supplement: SQ-LNS

Other: Integrated Nutritional Screening

Standard of Care Plus SQ-LNS Provision

Active Comparator group

Description:

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).

Treatment:

Dietary Supplement: SQ-LNS