First PrEPVacc SIV held at Masaka site

Masaka SIV attendees seen via the Zoom interface

PrEPVacc’s first Site Initiation Visit has taken place at the Masaka site of MRC / UVRI and LSHTM Uganda Research Unit on 20 and 21 October 2020.

Unusually for an SIV, which is the final training and preparation for a site before it begins a clinical trial, its attendees met both in-person at the site, observing safe-distancing guidelines, and virtually, via Zoom.

Over two days, the SIV covered the full range of study processes and capabilities including the Protocol, Investigator responsibilities, Community Engagement, Safety Reporting, Informed Consent, Data Management and Pharmacy procedures, as well as Site Laboratory Procedures and Regulatory Requirements.

On the second day in-depth break-out sessions were held for the different clinic, community engagement, communications, social science, lab, pharmacy and data management teams, before plenary sessions to bring together outstanding questions and lessons learned from the Registration Cohort.

Sheena McCormack, PrEPVacc Project Lead, said: “Throughout the SIV, the Masaka team demonstrated their full engagement with PrEPVacc and raised many insightful questions during the training. For those participating remotely in the SIV it was enjoyable to see everyone assembled for the training and to feel their energy and enthusiasm for beginning the clinical trial.”