Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial
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 falcip...
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BMJ Publishing Group
2024-03-01
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| Online Access: | https://bmjopen.bmj.com/content/14/3/e081682.full |
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| author | John Bradley Alphonse Ouedraogo Issiaka Soulama Chris Drakeley Teun Bousema Alfred B Tiono Denise Hien Sodiomon Bienvenu Sirima Issa N Ouedraogo Jean Baptist Yaro Aïssata Barry Seyi Soremekun Marta Moreno Jean Sawadogo Markus Gmeiner Samuel S Sermé Isabel Byrne Jordache Ramjith Lynn Grignard Simon Koele Rob ter Heine Amidou Z Ouedraogo Edith Sanogo |
| author_facet | John Bradley Alphonse Ouedraogo Issiaka Soulama Chris Drakeley Teun Bousema Alfred B Tiono Denise Hien Sodiomon Bienvenu Sirima Issa N Ouedraogo Jean Baptist Yaro Aïssata Barry Seyi Soremekun Marta Moreno Jean Sawadogo Markus Gmeiner Samuel S Sermé Isabel Byrne Jordache Ramjith Lynn Grignard Simon Koele Rob ter Heine Amidou Z Ouedraogo Edith Sanogo |
| author_sort | John Bradley |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-804b6c533d6146cfac0e8bf2d965d29d |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-804b6c533d6146cfac0e8bf2d965d29d2025-08-20T03:11:34ZengBMJ Publishing GroupBMJ Open2044-60552024-03-0114310.1136/bmjopen-2023-081682Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trialJohn Bradley0Alphonse Ouedraogo1Issiaka Soulama2Chris Drakeley3Teun Bousema4Alfred B Tiono5Denise Hien6Sodiomon Bienvenu Sirima7Issa N Ouedraogo8Jean Baptist Yaro9Aïssata Barry10Seyi Soremekun11Marta Moreno12Jean Sawadogo13Markus Gmeiner14Samuel S Sermé15Isabel Byrne16Jordache Ramjith17Lynn Grignard18Simon Koele19Rob ter Heine20Amidou Z Ouedraogo21Edith Sanogo22Department of Infection Biology, London School of Hygiene & Tropical Medicine, London, UKGroupe de Recherche Action en Santé, Ouagadougou, Burkina FasoGroupe de Recherche Action en Santé, Ouagadougou, Burkina Faso2 Department of Infection Biology, London School of Hygiene and Tropical Medicine, London, UKDepartment of Medical Microbiology, Radboud University Nijmegen, Nijmegen, The NetherlandsGroupe de Recherche Action en Santé, Ouagadougou, Burkina FasoGroupe de Recherche Action en Santé, Ouagadougou, Burkina FasoGroupe de Recherche Action en Santé, Ouagadougou, Burkina FasoGroupe de Recherche Action en Santé, Ouagadougou, Burkina FasoGroupe de Recherche Action en Santé, Ouagadougou, Burkina FasoGroupe de Recherche Action en Santé, Ouagadougou, Burkina FasoDepartment of Infection Biology, London School of Hygiene & Tropical Medicine, London, UKDepartment of Infection Biology, London School of Hygiene & Tropical Medicine, London, UKGroupe de Recherche Action en Santé, Ouagadougou, Burkina FasoDepartment of Medical Microbiology, Radboud University Nijmegen, Nijmegen, The NetherlandsGroupe de Recherche Action en Santé, Ouagadougou, Burkina Faso2 Department of Infection Biology, London School of Hygiene and Tropical Medicine, London, UKDepartment of Medical Microbiology, Radboud University Nijmegen, Nijmegen, The NetherlandsDepartment of Infection Biology, London School of Hygiene & Tropical Medicine, London, UKDepartment of Medical Microbiology, Radboud University Nijmegen, Nijmegen, The NetherlandsPharmacy, Radboudumc, Nijmegen, The NetherlandsGroupe de Recherche Action en Santé, Ouagadougou, Burkina FasoGroupe de Recherche Action en Santé, Ouagadougou, Burkina FasoIntroduction 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.https://bmjopen.bmj.com/content/14/3/e081682.full |
| spellingShingle | John Bradley Alphonse Ouedraogo Issiaka Soulama Chris Drakeley Teun Bousema Alfred B Tiono Denise Hien Sodiomon Bienvenu Sirima Issa N Ouedraogo Jean Baptist Yaro Aïssata Barry Seyi Soremekun Marta Moreno Jean Sawadogo Markus Gmeiner Samuel S Sermé Isabel Byrne Jordache Ramjith Lynn Grignard Simon Koele Rob ter Heine Amidou Z Ouedraogo Edith Sanogo 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 |
| title | Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial |
| title_full | Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial |
| title_fullStr | Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial |
| title_full_unstemmed | Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial |
| title_short | Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial |
| title_sort | understanding and maximising the community impact of seasonal malaria chemoprevention in burkina faso indie smc study protocol for a cluster randomised evaluation trial |
| url | https://bmjopen.bmj.com/content/14/3/e081682.full |
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