The PREGART clinical trial project conducted an amended protocol popularization workshop from March 15–16, 2024. The PREGART Project Office in Ethiopia organized the workshop to clarify some amendments approved by the regulatory bodies for implementation. Twenty-six participants (health professionals participating in the trial at the study hospitals and focal persons from regional health bureaus) participated in the workshop. The main issues discussed included the dropping of the EFV 600 arm, the no-cost extension of the trial for an additional 18 months, inclusion and exclusion criteria, informed consent, and clinical and laboratory schedules. Moreover, CRF completion and data quality management, including problems identified during monitoring of the trial, were discussed.

Participants of PREGART amended protocol popularization workshop in Ethiopia, March 15-16, 2024