On the 20th and 21st of Oct MUJHU Care ltd hosted a team of Clinical research managers from Merck Sharp and Dohme corporation for a site initiation visit (SIV). The team included Miriam Nakitto, Joe Voogt, and Susan Vaz Jean. This activity was a part of the study staff capacity-building requirements conducted in preparation for the EMPOWER-022 study, which will be funded by Merck, Sharp & Dohme (MSD) among others.
This visit incorporated protocol training/overview on key issues like; recruitment & retention strategies, participant consenting & assenting, privacy in clinical trials (emergency unblinding), specimen handling, data quality management, Adverse events, and Participant Reported outcomes among others. The visiting team also took a tour of some site facilities including the MSD clinic and the IDI Core Laboratory that will be handling the study samples.
The IMPOWER-022 study, which commences in November 2021 is a Phase 3 Randomized, Active-Controlled, Double-blind Clinical Study to evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Pre-Exposure Prophylaxis in cisgender women who are at high risk of HIV-1 infection.