The PREGART Clinical trial in Ethiopia has been enrolling participants since May 2021. The participant recruitment was initiated after 18 months of delay from the initially planned date due to the Covid-19 pandemic’s impact on the regulatory approval and investigational drug procurement process. Moreover, the recruitment rate was further affected by the Northern Ethiopia war. Three well-prepared trial hospitals for recruitment were canceled due to the ongoing war in the districts where the hospitals were located. However, amendment approval was secured on September 2022 to increase the trial hospital numbers and the replacement of the northern hospitals with the central and southern hospitals to fasten the recruitment rate. Before the end of 2022, 229 (25%) participants were recruited. The implementation team designed different strategies like primary health care facility-trial hospital linkage to achieve 75% recruitment in 2023.
