Speed of recruitment and demand for a trial assessing the impact of HIV prevention therapy PrEP has significantly exceeded initial predictions, leading researchers to consider increasing the number of participants from 13,000 to up to 26,000.
Implementation of the PrEP Impact trial - launched in October 2017 - has been a huge success with over 10,000 participants already enrolled. NHS England says it is now planning to commit to fund additional places in line with existing trial funding arrangements.
Researchers argue that recruitment in the trial needs to reach a “steady state’ in order to ensure the trial can robustly and scientifically inform the design and rollout of a full national programme in partnership with local authorities, and that increasing the number of participants will be important for addressing emerging questions from the trial about the need for PrEP amongst women and other groups.
Later this month, their proposal will be considered by the Trial Oversight Board, which includes representatives from Public Health England, local authorities and community groups, alongside NHS England.
Local authorities will continue to decide how many additional places they wish to take up and to give the green light to clinics to expand recruitment.
“Through the PrEP trial, over 10,000 people are already receiving access to this important HIV prevention measure," said John Stewart, director of specialised commissioning at NHS England.
"The trial researchers have submitted a case for increasing trial places and NHS England will play its part in delivering on this recommendation by committing to fund additional places in line with existing funding arrangements.
He continued: “This will help ensure the learning from the trial is robust enough to fully inform the planning of a national PrEP programme in partnership with local authorities for the future, as well as protecting more people from HIV right now”.