PRe-Exposure Prophylaxis Acceptability & Readiness Assessments for Toronto gaY, Bisexual and Other Men Who Have Sex With Men-5

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.

Inclusion Criteria:

• Self-identified man who has sex with men
• Age 18 years or older
• Able to communicate in both written and oral english
• HIRI-MSM score greater than or equal to 10
• At least one self-reported unprotected receptive anal sex act over the preceding 6 months
• Creatinine clearance greater than or equal to 60mL/min by Modified Diet in Renal Disease (MDRD) formula
• HIV un-infected at screening using standard ELISA and Western Blot testing

Exclusion Criteria:

• Clinical signs or symptoms suggestive of an HIV seroconversion illness within the last 3 months in the opinion of the investigator
• Use of pre- or post-exposure prophylaxis within the last 3 months
• Use of concomitant nephrotoxic drugs
• Use of concomitant immune modulatory drugs
• Hepatitis B surface antigen positivity
• Any condition or concomitant medication portending an increased risk of osteoporosis
• Enrollment in any other HIV prevention program or trial