Impact of directly observed treatment and extended age-range of seasonal malaria chemoprevention with sulfadoxine–pyrimethamine plus amodiaquine in Burkina Faso: A three-arm, open-label, cluster-randomized, controlled trial

Seasonal Malaria Chemoprevention (SMC) currently targets children below 5 years (< 5 yr). It is unclear what the impact of extending SMC to a wider age range will be. We conducted a cluster-randomized trial in Saponé (Burkina Faso) with three study arms: 1) Programmatic SMC-control arm: SMC in children < 5 years; 2) SMC in children < 5 years, with directly observed treatment (DOTu5); 3) SMC in children < 10 years with DOT (DOTu10). The trial involved 61 (programmatic SMC) and 62 (each DOT arms) clusters of 3 compounds (i.e., 183-186 compounds per arm). The primary endpoint was P. falciparum parasite prevalence at the end of the transmission season; secondary endpoints included clinical malaria incidence, drug plasma levels, and gametocyte prevalence. This trial is complete and is registered with ClinicalTrials.gov, NCT05878366.
, A detailed study protocol is published under DOI: 10.1136/bmjopen-2023-081682
Data collection involved:

Baseline before the start of Seasonal Malaria Chemoprevention (SMC). This was a single time-point survey of parasite carriage and other baseline characteristics in all age groups.
Endline survey at the end of the transmission season, the primary endpoint for the study. This was a single time-point survey of parasite and gametocyte carriage and other baseline characteristics in all age groups.
Passive case detection. This was collected at 2 health facilities, with malaria being diagnosed and linked to the cluster (and thus study arm) of individuals.
Assessment of coverage levels of the intervention. This was collected from caregivers and involved self-reported adherence to the intervention for the SMC-targeted population only.
Surveys after the 4th and last cycle of SMC, conducted 3, 4, and 5 weeks after drug administration. For this, the study population was divided in thre..., This readme file was generated on 25-02-2026 by Marta Moreno and Teun Bousema

GENERAL INFORMATION

Title of Dataset:

# Impact of directly observed treatment and extended age-range of seasonal malaria chemoprevention with sulfadoxine–pyrimethamine plus amodiaquine in Burkina Faso: a three-arm, open-label, cluster-randomized, controlled trial

Author/Principal Investigator Information
Name: Teun Bousema
ORCID: [https://orcid.org/0000-0003-2666-094X](https://orcid.org/0000-0003-2666-094X)
Institution: Department of Medical Microbiology, Radboudumc
Address: Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands
Email: [[e-mail]](mailto:[e-mail])

Author/Associate or Co-investigator Information
Name: Alfred Bewendtaore Tiono
ORCID:[https://orcid.org/0000-0002-5104-3946](https://orcid.org/0000-0002-5104-3946)
Institution: Groupe de Recherche Action en Santé (GRAS)
Address: N3, Somgandé, Ouagadougou, Burkina Faso
Email: [[e-mail]](mailto:a.tio..., Data are de-indentified. During informed consent, study participants gave approval for depositing data in a public repository.,