Koita, Kadiatou
Bognini, Joel D.
Agboraw, Efundem
Dembélé, Mahamadou
Yabré, Seydou
Bihoun, Biébo
Coulibaly, Oumou
Niangaly, Hamidou
N’Takpé, Jean-Batiste
Lesosky, Maia
Scaramuzzi, Dario
Worrall, Eve
Hill, Jenny
Briand, Valérie
Tinto, Halidou
Kayentao, Kassoum
Funding for this research was provided by:
European and Developing Countries Clinical Trials Partnership (RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302, RIA2020S-3302)
Article History
Received: 16 September 2023
Accepted: 18 December 2023
First Online: 2 January 2024
Declarations
:
: This study was reported to the respective National Competent Health Authorities in Burkina Faso and Mali. The clinical protocol was approved by the Institutional Review Boards (IRB)/Ethics committees and local Health Authorities in each country of the study and that of the Liverpool School of Tropical Medicine. Copies of the national Competent Health Authority and of the relevant Ethics Committee’s approvals (No 2022/83/CE/USTTB for Mali, No 2022/000143/MSHP/MESRI/CERS for Burkina Faso) were transmitted from the Investigator to the Sponsor prior to the study start. Protocol violation will be also reported to the sponsor, and corrective action will be taken accordingly.Written informed consent will be obtained from all participants, including parents or guardians of minors from different HHS and other interviews including FGDs, and assents will be obtained from emancipated minors. All study documents are provided by the Sponsor (University of Sciences, Techniques and Technologies of Bamako) confidentially to the investigators and their appointed staff. None of this material may be disclosed to any party not directly involved in the study without written permission from the sponsor. The consortium will ensure that all personal data collected during the study are restricted to meet the objectives of the project and appropriately protected. All study data will be stored on a password-protected central study server.All paper-based source documents will be treated as confidential and kept in lockable cabinets in lockable rooms with access limited to approved staff as recorded in the Trial Delegation Log. All staff will receive formal Good Clinical Practice training before the study initiation and retrained afterward. Only the participant’s anonymous study ID will be captured in the database. None of the results will be published with personal identifiers. At the end of the project, all personal information will be destroyed. Signed informed consent forms and other personalized information will be kept under lock and key and will be accessible only to authorized persons including the project coordinator, principal investigators and data managers. Information stored in electronic databases will be protected by unique usernames and passwords, accessible only to appropriate authorized personnel.Two committees will oversee the trial implementation: the trial steering committee and the data safety and monitoring board. The two committees include malaria specialists, gynecologists, epidemiologists from around the world, independent from the trial sponsor. The committees meet quarterly. Further details on the two committees are available in the trail charter accessible upon request.Any modification to the protocol will be submitted to the study sites’ respective institutional review boards for review and approval prior to implementation. All amendments will be communicated to relevant parties.Study results will be disseminated through conference presentations, and publications in relevant peer-reviewed journals.
: Not applicable.
: The authors declare no competing interests.