Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Mar 12;14(3):e081682.
doi: 10.1136/bmjopen-2023-081682.

Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial

Marta Moreno #  1 , Aissata Barry #  2 , Markus Gmeiner #  3 , Jean Baptist Yaro  2 , Samuel S Sermé  2 , Isabel Byrne  1 , Jordache Ramjith  3 , Alphonse Ouedraogo  2 , Issiaka Soulama  2 , Lynn Grignard  1 , Seyi Soremekun  1 , Simon Koele  3 , Rob Ter Heine  4 , Amidou Z Ouedraogo  2 , Jean Sawadogo  2 , Edith Sanogo  2 , Issa N Ouedraogo  2 , Denise Hien  2 , Sodiomon Bienvenu Sirima  2 , John Bradley  1 , Teun Bousema  3 , Chris Drakeley #  1 , Alfred B Tiono #  5
Affiliations

Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial

Marta Moreno et al. BMJ Open. .

Abstract

Introduction: Seasonal malaria chemoprevention (SMC) involves repeated administrations of sulfadoxine-pyrimethamine plus amodiaquine to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. While highly impactful in reducing Plasmodium falciparum malaria burden in controlled research settings, the impact of SMC on infection prevalence is moderate in real-life settings. It remains unclear what drives this efficacy decay. Recently, the WHO widened the scope for SMC to target all vulnerable populations. The Ministry of Health (MoH) in Burkina Faso is considering extending SMC to children below 10 years old. We aim to assess the impact of SMC on clinical incidence and parasite prevalence and quantify the human infectious reservoir for malaria in this population.

Methods and analysis: We will perform a cluster randomised trial in Saponé Health District, Burkina Faso, with three study arms comprising 62 clusters of three compounds: arm 1 (control): SMC in under 5-year-old children, implemented by the MoH without directly observed treatment (DOT) for the full course of SMC; arm 2 (intervention): SMC in under 5-year-old children, with DOT for the full course of SMC; arm 3 (intervention): SMC in under 10-year-old children, with DOT for the full course of SMC. The primary endpoint is parasite prevalence at the end of the malaria transmission season. Secondary endpoints include the impact of SMC on clinical incidence. Factors affecting SMC uptake, treatment adherence, drug concentrations, parasite resistance markers and transmission of parasites will be determined.

Ethics and dissemination: The London School of Hygiene & Tropical Medicine's Ethics Committee (29193) and the Burkina Faso National Medical Ethics Committee (Deliberation No 2023-05-104) approved this study. The findings will be presented to the community; disease occurrence data and study outcomes will also be shared with the Burkina Faso MoH. Findings will be published irrespective of their results.

Trial registration number: NCT05878366.

Keywords: EPIDEMIOLOGIC STUDIES; Malaria; Tropical medicine.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Cascade in efficacy decay in seasonal malaria chemoprevention (SMC) effectiveness. Coverage, compliance and drug absorption will all influence the actual efficiency that is observed when SMC is implemented under programmatic conditions. DOT, directly observed treatment.
Figure 2
Figure 2
Study design. The study will be implemented in clusters. Each cluster consists of three compounds where each compound has at least one child aged 3–59 months and one child aged 5–9 years. All age groups will take part in the evaluation of the study to assess the impact of the intervention on the infectious reservoir in the community and compare parasite carriage in targeted and untargeted populations. SMC, seasonal malaria chemoprevention. (Figure was created with BioRender.com.)
Figure 3
Figure 3
Surveys and sampling schedule. Cluster randomisation was performed prior to the baseline study. Adherence to and perceptions about seasonal malaria chemoprevention (SMC) strategy will be collected throughout the study in the three study arms. DMFA, direct membrane feeding assay, done up to 21 days from first SMC dose; DOT, directly observed treatment; MoH, Ministry of Health; PCD, passive case detection; PK surveys, pharmacokinetic analysis. (Figure was created with BioRender.com.)
See this image and copyright information in PMC

References

    1. Organization WH . World malaria report 2022. Contract no.: CC BY-NC-SA 3.0 IGO; 2022.
    1. Das S, Saha B, Hati AK, et al. . Evidence of artemisinin-resistant plasmodium falciparum malaria in Eastern India. N Engl J Med 2018;379:1962–4. 10.1056/NEJMc1713777 - DOI - PubMed
    1. ACCESS-SMC Partnership . Effectiveness of seasonal malaria Chemoprevention at scale in West and central Africa: an observational study. Lancet 2020;396:1829–40.:S0140-6736(20)32227-3. 10.1016/S0140-6736(20)32227-3 - DOI - PMC - PubMed
    1. Ashley EA, Poespoprodjo JR. Treatment and prevention of malaria in children. Lancet Child Adolesc Health 2020;4:775–89. 10.1016/S2352-4642(20)30127-9 - DOI - PubMed
    1. Cairns M, Ceesay SJ, Sagara I, et al. . Effectiveness of seasonal malaria chemoprevention (SMC) treatments when SMC is implemented at scale: case-control studies in 5 countries. PLoS Med 2021;18:e1003727. 10.1371/journal.pmed.1003727 - DOI - PMC - PubMed

Publication types

Associated data