Background High burden of Tuberculosis (TB) in Africa justify continued need for development of safe, efficacious, accessible and affordable anti-TB. Paradoxically, the continent contributes <3% of global clinical trial outputs. Lack of appropriate trainings has been cited as important factor. Therefore, this project aimed to strengthen capacity of the fellow and peers in clinical trial designs, operational planning, conducting, management and reporting.

Methods EDCTP funded and linked the fellow to Pan-African Consortium for Evaluation of Antituberculosis Antibiotics (PanACEA) at University of St. Andrews. The fellow and supervisors developed 12 months training plan with five objectives fitting precisely into the ongoing SimpliciTB-OptiRiMoxTB trial to evaluate short treatment regimen for drug-susceptible TB. Intensive field work activities have been conducted at Kibong’oto Infectious Diseases Hospital-Tanzania, followed by National Health Services (NHS) Scotland, Helse-Nord TB-Initiative (HNTI)-Malawi and other PanACEA sites. The fellow attended meetings including PanACEA Annual 2022 meeting and The Union World Conference on Lung Health.

Results Skills of clinical trial designing and operational planning were imparted during development of OptiRiMoxTB protocol version 1.0. Developed drug management plan provided skills on handling of investigational medicinal products to ensure quality, safety and efficacy. Obtained ethical and regulatory approvals and reflective report on community engagement during clinical trials transformed the fellow on ethical consideration and safety. Reflective report from experiential visits at NHS and HNTI, in-person Good Clinical Trial training and developed Manual of Procedures have imparted clinical trial conducting and management skills. Developed manuscript of OptiRiMoxTB protocol has strengthen fellow’s scientific reporting skills during clinical trials.

Conclusion The acquired transformative skills prepared the fellow for further sustaining chain reaction-like model of expanding human capital with clinical trial skills for TB and other poverty related diseases through short course trainings of almost 100 peers and personal career development hence increasing clinical trials leadership in Africa.