[Katharine Kripke]

This would definitely be something that would impact future trial design and can be modeled once the assumptions about maximum PrEP uptake (

[Katharine Kripke]

This would definitely be something that would impact future trial design. It can be modeled once the assumptions about maximum PrEP uptake (for each form of PrEP, all of which would have different efficacy/adherence and uptake rates) are defined. The question I would have is how many people would volunteer for a vaccine trial that wouldn’t also want to take a convenient, long-acting form of PrEP? The design of screening out people who do not want to take PrEP is helpful to researchers because it focuses the trial participant population on those who are at the greatest risk of HIV. Since the size of th trial depends on the HIV incidence in the trial population, this strategy (of excluding people who want to take PrEP) would in theory select for the highest risk population. Including PrEP users means including a lot of people who (assuming they are adherent to PrEP) are pretty unlikely to get infected and therefore don’t contribute much to knowledge about vaccine effectiveness.

[Katharine Kripke]

This would definitely something that would impact future trial design and can be modeled once the assumptions about maximum PrEP uptake (for each form of PrEP, all of which would have different efficacy/adherence and uptake) are defined. The question I would have is how many people would volunteer for a vaccine trial that wouldn’t also want to take a convenient, long-acting form of PrEP? The design of screening out people who do not want to take PrEP is helpful to researchers because it focuses the trial participant population on those who are at the greatest risk of HIV. Since the size of the trial depends on the HIV incidence in the trial population, this strategy (of excluding people who want to take PrEP) would in theory select for the highest risk population. Including PrEP users means including a lot of people who (assuming they are adherent to PrEP) are pretty unlikely to get infected and therefore don’t contribute much to knowledge about vaccine effectiveness.