Virtual PrEP: Rendering PrEP Delivery More Efficient
Status:
Not yet recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
Gay, bisexual and other men who have sex with men (GBM) account for over half of new HIV
infections in Canada each year, and have a 131-fold higher risk of HIV than other Canadian
men. HIV pre-exposure prophylaxis (PrEP) using regular oral tenofovir disoproxil
fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC) is an
effective and safe HIV prevention option.
Despite growing interest, awareness and willingness to use PrEP there has been numerous
challenges to the broader rollout of PrEP. This study will address some of these challenges
by assessing participant satisfaction,feasibility and clinical outcomes associated with a
web-based mobile health (mHealth) model of care for daily oral TAF/FTC PrEP compared to
standard of care delivery of TAF/FTC PrEP in Canadian GBM/TGW, in the era of COVID-19.
The ultimate goal of this study is to provide a scalable model for remote PrEP delivery that
minimizes the need for in-person interactions; respects guideline recommendations regarding
how to optimally monitor patients; and is attractive to both patients and providers.
This study is a 1:1 open-label, pragmatic randomized controlled trial using a AB:BA crossover
design, comparing the standard of care to an mHealth based model of care (Freddie® ) for
TAF/FTC PrEP delivery over 72 weeks.