Data from: 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
Data files
Mar 19, 2026 version files 1.42 MB
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Baseline_survey_INDIE-SMC_variable_descriptions.csv
826 B
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Baseline_survey_INDIE-SMC.csv
339.52 KB
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Clinical_Malaria_Incidence_INDIE-SMC_variable_descriptions.csv
774 B
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Clinical_Malaria_Incidence_INDIE-SMC.csv
412.56 KB
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Coverage_levels_INDIE-SMC_variable_descriptions.csv
1.44 KB
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Coverage_levels_INDIE-SMC.csv
198.11 KB
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Endline_survey_(primary_endpoint)_INDIE-SMC-variable_descriptions.csv
1.14 KB
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Endline_survey_(primary_endpoint)_INDIE-SMC.csv
381.49 KB
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README.md
8.83 KB
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Week_3.4.5_after_last_SMC_cycle_surveys_INDIE-SMC_variable_descriptions.csv
739 B
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Week_3.4.5_after_last_SMC_cycle_surveys_INDIE-SMC.csv
70.25 KB
Abstract
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.
This readme file was generated on 25-02-2026 by Marta Moreno and Teun Bousema
GENERAL INFORMATION
Title of Dataset:
Author/Principal Investigator Information
Name: Teun Bousema
ORCID: https://orcid.org/0000-0003-2666-094X
Institution: Department of Medical Microbiology, Radboudumc
Address: Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands
Email: teun.bousema@radboudumc.nl
Author/Associate or Co-investigator Information
Name: Alfred Bewendtaore Tiono
ORCID:https://orcid.org/0000-0002-5104-3946
Institution: Groupe de Recherche Action en Santé (GRAS)
Address: N3, Somgandé, Ouagadougou, Burkina Faso
Email: a.tiono@gras.bf
Date of data collection: June 2023- February 2024
Geographic location of data collection: Health District of Saponé, Bazega Province, Ouagadougou, Burkina Faso
Information about funding sources that supported the collection of the data:
This work is supported by Bill & Melinda Gates Foundation grant (INV-053846)
SHARING/ACCESS INFORMATION
Licenses/restrictions placed on the data: No
Links to publications that cite or use the data:
Yaro, Jean & Ouedraogo, Alphonse & Moreno, Marta & Tiono, Alfred & PDF, See. (2025). 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. 10.2139/ssrn.5957662.
Was data derived from another source?
No
DATA & FILE OVERVIEW
File List:
Baseline_survey_INDIE-SMC.csv: Data collected in the baseline cross-sectional survey
Clinical_Malaria_Incidence_INDIE-SMC.csv: Clinical malaria incidence collected by Passive Case Detection during the study duration
Coverage_levels_INDIE-SMC.csv: Coverage levels of SMC drug intake in each SMC cycle
Endline_survey_(primary_endpoint)_INDIE-SMC.csv: Data of the endline cross-sectional survey used to calculate the primary endpoint.
Week_3.4.5_after_last_SMC_cycle_surveys_INDIE-SMC.csv: Data collected on survey on weeks 3, 4, and 5 after the last cycle of SMC.
Baseline_survey_INDIE-SMC_variable_descriptions.csv, Clinical_Malaria_Incidence_INDIE-SMC_variable_descriptions.csv, Coverage_levels_INDIE-SMC_variable_descriptions.csv, Endline_survey_(primary_endpoint)_INDIE-SMC-variable_descriptions.csv, Week_3.4.5_after_last_SMC_cycle_surveys_INDIE-SMC_variable_descriptions.csv: variable descriptions for the associated file based on filename
Are there multiple versions of the dataset? No
METHODOLOGICAL INFORMATION
Description of methods used for collection/generation of data:
Moreno M, Barry A, Gmeiner M, Yaro JB, Sermé SS, Byrne I, Ramjith J, Ouedraogo A, Soulama I, Grignard L, Soremekun S, Koele S, Ter Heine R, Ouedraogo AZ, Sawadogo J, Sanogo E, Ouedraogo IN, Hien D, Sirima SB, Bradley J, Bousema T, Drakeley C, Tiono AB. Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial. BMJ Open. 2024 Mar 12;14(3):e081682. doi: 10.1136/bmjopen-2023-081682. PMID: 38479748; PMCID: PMC10936478.
Instrument- or software-specific information needed to interpret the data: Data analyses were done in Stata version 17.0 (StataCorp, Texas, USA).
DATA-SPECIFIC INFORMATION FOR:
Baseline_survey_INDIE-SMC.csv
- village_dss: Village name from DSS
- vill_num: Numeric village ID
- arm: Study Intervention arm; 1, Progr. SMC | 2, DOTu5 | 3, DOTu10
- cl_num: numeric cluster ID
- compounded: Compound ID
- p_num: Unique person identifier
- sex: participant sex; 1, male | 2, female
- age_enrolmt: participant age at enrolment
- agegrp: participant age group (4 cat); 1,<5yrs | 2,5-9yrs | 3,10-15yrs | 4,16-yrs
- present: Participant present at survey
- no_present: reason not present
- datevisit: date of survey visit
- smc_round: Survey prior to this SMC cycle
- malaria: malaria positive >100 trofozoite/uL; 0,0.No | 1,1.Yes
- gametocyte: gametocyte positive >100gametocytes/uL; 0,0.No | 1,1.Yes
- malaria0: malaria positive >0tf/uL; 0,0.No | 1,1.Yes
- gametocyte0: gametocyte positive >0gf/uL; 0,0.No | 1,1.Yes
Clinical_Malaria_Incidence_INDIE-SMC.csv:
- village_dss: Village name from DSS
- nvillage: Numeric village ID
- compounded: Compound ID
- arm: Study Intervention arm; 1,1. MoH | 2,2. DOT 5yrs | 3,3. DOT 10yrs
- ncluster: numeric cluster ID
- p_num: Unique person identifier
- sex: participant sex; 1, male | 2, female
- agegrp: participant age group (4 cat); 1,<5yrs | 2,5-9yrs | 3,10-15yrs | 4,16-yrs
- datefoll: date of clinic visit
- startfoll: start of follow-up
- pcd_data: ever had pcd visit?; 0,never pcd | 1,1+ pcd visit
- fever_all: fever today/in last week?; 0,0. No fever | 1,1. Fever
- mal_rdt: RDT positive; 0,0. Negative | 1,1. Positive
- malaria: fever+RDT positive; 0,0. Negative | 1,1. Positive
- logpml: log parasites per mL
- qpcrdate: qPCR date
Coverage_levels_INDIE-SMC.csv:
- village_dss: Village name from DSS
- compounded: Compound ID
- arm: Study Intervention arm; 1,1. MoH | 2,2. DOT 5yrs | 3,3. DOT 10yrs
- ncluster: numeric cluster ID
- p_num: Unique person identifier
- sex: participant sex; 1, male | 2, female
- age_enrolmt: participant age at enrolment
- agegrp: 1,1. 0-4yrs | 2,2. 5-9yrs | 3,3. 10yrs+
- totdoses: all:total SMC doses
- conf_prsmc_r1: reported SMC (any) prev cycle 1; 0,0.No | 1,1.Yes
- conf_prsmc_r2: reported SMC (any) prev cycle 2; 0,0.No | 1,1.Yes
- conf_prsmc_r3: reported SMC (any) prev round 3; 0,0.No | 1,1.Yes
- d1r1: reported tablets prev cycle 1 day 1
- d2r1: reported tablets prev cycle 1 day 2
- d3r1: reported tablets prev cycle 1 day 3
- totdosesr1: reported total tables prev cycle 1
- d1r2: reported tablets prev cycle 2 day 1
- d2r2: reported tablets prev cycle 2 day 2
- d3r2: reported tablets prev cycle 2 day 3
- totdosesr2: reported total tables prev cycle 2
- d1r3: reported tablets prev cycle 3 day 1
- d2r3: reported tablets prev cycle 3 day 2
- d3r3: reported tablets prev cycle 3 day 3
- totdosesr3: reported total tables prev cycle 3
- smc_thisr1: observed SMC (any) this cycle 1; 0,0.No | 1,1.Yes
- smc_thisr2: observed SMC (any) this cycle 2; 0,0.No | 1,1.Yes
- smc_thisr3: observed SMC (any) this cycle 3; 0,0.No | 1,1.Yes
- smc_thisr4: observed SMC (any) this cycle 4; 0,0.No | 1,1.Yes
Endline_survey_(primary_endpoint)_INDIE-SMC.csv:
- village_dss: Village name from DSS
- vill_num: Numeric village ID
- compounded: Compound ID
- cluster: Cluster unit - string
- cl_num: numeric cluster ID
- arm: Intervention arm; 1,1. Progr. SMC | 2,2. DOTu5 | 3,3. DOTu10
- p_num: Unique person identifier
- datevisit: date of survey visit
- dob: participant's date of birth
- age_new: participant age at survey
- agegrp: categorised age group from age_new; 1,<5yrs | 2,5-9yrs | 3,10-15yrs | 4,16+ yrs
- sex: participant sex; 1,1.Male | 2,2.Female
- present: Participant present at survey
- parasite_raw: raw asexual parasite density (per uL)
- lnpara: log asexual parasite density
- gameto_data: has a non-missing record in gametocyte table; 0,0.No | 1,1.Yes
- gam_per_ul: raw gametocyte density (per uL)
- lngam: log gametocyte density
- mal_inf1: malaria infection: density >100 per uL; 0,0.No | 1,1.Yes
- mal_inf: malaria infection: density >0 per uL; 0,0.No | 1,1.Yes
- gam_inf1: gametocyte infection: density >100 per uL; 0,0.No | 1,1.Yes
- gam_inf: gametocyte infection: density >0 per uL; 0,0.No | 1,1.Yes
- no_present: reason not present
Week_3.4.5_after_last_SMC_cycle_surveys_INDIE-SMC.csv:
- village_dss: Village name from DSS
- compounded: Compound ID
- arm: Intervention arm; 1,1. MoH | 2,2. DOT 5yrs | 3,3. DOT 10yrs
- ncluster; study cluster [numeric]
- p_num: Unique person identifier
- sex: participant sex; 1,male | 2,female
- age_enrolmt: participant age at enrolment
- agegrp: age group (4 cat); 1,<5yrs | 2,5-9yrs | 3,10-15yrs | 4,16-yrs
- datevisit: date of survey visit
- survey_week: week post round 4 SMC
- malaria: microscopy malaria positive >100 trofozoite/uL; 0,0.No | 1,1.Yes
- gametocyte: pcr gametocyte positive >100 gametocyte/uL; 0,0.No | 1,1.Yes
- malaria0: microscopy malaria positive >0 trofozoite/uL; 0,0.No | 1,1.Yes
- gametocyte0: pcr gametocyte positive >0 gametocyte/uL; 0,0.No | 1,1.Yes
Note: blank cells represent missing data or inapplicable.
Human subjects data
Data are de-indentified. During informed consent, study participants gave approval for depositing data in a public repository.
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 three with each participating in one of the surveys (e.g. only in week 4). This was thus a single time-point measurement of parasite carriage by microscopy.