Today marks an important step in the set-up of the DolPHIN 2 trial, as key members of the Liverpool team make their way to Uganda for a Site Initiation Visit (SIV).
Chief Investigator Saye Khoo, Programme Manager Helen Reynolds and Trial Manager Kelly Byrne will spend this week with the Ugandan trial team, at the Infectious Diseases Institute in Kampala, ensuring everything is ready for the first patient to be recruited to the DolPHIN 2 trial.
A busy week is planned for the team, in which training in key trial management processes will take place and the trial participant pathway will be reviewed in detail.
External monitor Angela Colbers, from Radboud University Medical Centre, the Netherlands, will also attend the visit. This will be the first of several monitoring visits from Angela, all of which will serve to ensure the trial is completed to the highest standards of quality.
The DolPHIN 2 trial is a large element of the overall DolPHIN 2 programme, which aims to establish high-quality evidence and operational guidance for the use of dolutegravir (DTG) in late pregnancy.
For the last 10 months, our multinational team – in Liverpool, Uganda, South Africa and the Netherlands – has been working hard to set up the trial, including obtaining all necessary ethical and regulatory approvals, ensuring we have the right team and the processes in place and establishing an efficient drug supply chain. We are ever closer to beginning the trial and recruiting the first participant and the Site Initiation Visit is one of the final tasks to complete before we can begin.
This multi-site trial will take place in Cape Town and well as Kampala, and a site initiation visit to South Africa is also planned for the end of the month.