Malaria IncidenceINSPIRENCT06599593
Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition
A study testing SQ-LNS and Integrated Nutritional Screening in people with Malaria Incidence and Seasonal Malaria Chemoprevention, run by University of California, San Francisco at 1 site in Burkina Faso.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria Incidence, Seasonal Malaria Chemoprevention, Nutrition Assessment
- What is being tested?
- SQ-LNS and Integrated Nutritional Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 3 Jul 2025to 30 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- SQ-LNS, Integrated Nutritional Screening
- Keywords
- integrated nutritional screening, seasonal malaria chemoprevention, acute malnutrition, malaria
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQ-LNSDietary 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).
Integrated Nutritional ScreeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: SQ-LNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (3)
Alternative malaria Indicators
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
Measured: 5 months
Severe malaria
Severe malaria will be diagnosed at participating healthcare facilities and defined as vital organ dysfunction and/or hyperparasitemia. Data on severe malaria cases will be collected by passive surveillance.
Measured: 5 months
All-cause clinic visits.
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Jul 2025
- Primary completion12 Nov 2025
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria IncidenceStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Catherine Oldenburg, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599593
- Sponsor's protocol ID
- 24-42493
- Other IDs
- 1R21AI182714
- Acronym
- INSPIRE
- Status last verified
- Mar 2026
- First submitted
- 13 Sep 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Informed consent documents for the proposed aims will include explicit language informing the participant's caregiver(s) that residual biological specimens, including DNA, may be stored in a biorepository for other scientific investigators. The informed consent documents will contain language permitting secondary use with broad data sharing under controlled access with general use restrictions in GitHub and OSF. Any data shared will be de-identified. Participants will not be contacted or re-consented for future sharing or accessing data through repositories. Privacy and confidentiality protections will be consistent with applicable local laws in Burkina Faso. Data will be de-identified by removing all 18 HIPAA identifiers prior to sharing. All data sharing plans will be reviewed and approved by the respective institutional review boards at all participating institutions and will be reviewed during the informed consent process with caregivers. Caregivers may opt out of data sharing, for