Clinical trial NCT06599593: Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition
Official title: Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Sante de Nouna, Burkina Faso
First posted: 2024-09-19
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Clinical malaria incidence
timeFrame: 5 months
Secondary outcomes:
measure: Alternative malaria Indicators
timeFrame: 5 months
measure: Severe malaria
timeFrame: 5 months
measure: All-cause clinic visits.
timeFrame: 5 months
Other outcomes:
Locations:
city: Nouna
country: Burkina Faso
facility: Centre de Recherche en Sante de Nouna
Study officials:
affiliation: University of California, San Francisco
name: Catherine Oldenburg
role: PRINCIPAL_INVESTIGATOR
References: