NCT05159531

Virtual PrEP: Rendering PrEP Delivery More Efficient

Virtual PrEP: Rendering PrEP Delivery More Efficient Using an mHealth Intervention and TAF/FTC

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: Male
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	PrEP	Participants will receive Descovy® 200/25mg 1 tablet once daily for 72 weeks.
OTHER	mHealth Model of Care	Freddie® allows for asynchronous contact between patients and care providers, meaning that it does not require both groups to be connected in real time, instead allowing communication over a number of days.
OTHER	Standard of Care	Delivery of PrEP care through the local standard of care

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-06-08
• Completion: 2023-06-08
• First posted: 2021-12-16
• Last updated: 2024-04-18

Locations

5 sites across 1 country: Canada