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Authors
Mlyuka, Hamu J.
Liyoyo, Alphonce
Nyaulingo, Belinda
Mpolya, Emmanuel
Kaswaga, Oscar L.
Semvua, Hadija
Lwambura, Samwel
McHugh, Tim D.
Wildner, Leticia
Sabiiti, Wilber
Adegbite, Bayode R.
Nliwasa, Marriot
Khosa, Celso
Mbelele, Peter
Mbeya, Benno
Jeremiah, Kidola
Boeree, Martin J.
Gillespie, Stephen H.
Sloan, Derek J.
Mpagama, Stellah G.
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Funding
Funding for this research was provided by:
European and Developing Countries Clinical Trials Partnership (EDCTP)-2 (RIA2017S-2012)
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Article History
Received: 28 July 2025
Accepted: 14 January 2026
First Online: 30 January 2026
Declarations
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: Ethical approvals for this trial have been sought from all sites’ local and/or national ethical committees; Tanzania (KIDH and National Institute of Medical Research (NIMR)), Gabon (CERMEL and National Research Ethics Committee), Malawi (KUHeS Ethical Committee), and Mozambique (INS Institutional Review Board and Comité Nacional de Bioética para Saúde). Also, the trial has received clinical trial authorization from medicines regulatory authorities in all participating countries, namely; Tanzania Medicines and Medical Devices Authority (TMDA), Malawi Pharmacy and Medicines Regulatory Authority (PMRA), Gabon Directorate of Medicines and Pharmacy (DMP) and Mozambique Autoridade Nacional Regulatoria de Medicamentos (ANARME).
: Written informed consent will be obtained from all participants prior to enrolment. Original ICFs will be kept in regulatory binders at each site and will be available on request.
: None of the authors has any competing interest to declare. In addition, the funder has no influence on design, implementation and reporting of this clinical trial research.
