HIV Clinical Trial
Official title:
A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM:The PREPARATORY-5 Study
Canada continues to see an unrelenting stream of new HIV diagnoses, with a disproportionate
burden among gay, bisexual, and other MSM in major centers such as Toronto. Pre-exposure
prophylaxis (PrEP) with oral, daily tenofovir/emtricitabine (TDF/FTC, Truvada®) is a novel
biomedical approach to HIV prevention shown in the iPrEx trial to be safe and efficacious in
reducing HIV acquisition by 44% among MSM, when provided in a comprehensive package of HIV
prevention interventions including counseling, testing/treatment of sexually transmitted
infections (STIs), and condoms. There is now widespread mobilization to assess the
feasibility of PrEP roll-out worldwide, with urgent calls for 'demonstration projects'
addressing real-world PrEP implementation issues.
PREPARATORY-5 is Canada's first PrEP demonstration project, and will examine real-world PrEP
implementation issues including acceptability, effectiveness, impact on sexually transmitted
infections, and strategies for supporting adherence outside the clinical trial setting. The
investigators have also established a comprehensive community-based research program
investigating the role of community-based organizations in PrEP implementation and delivery.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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