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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Michael's Hospital, Toronto; Unity Health Toronto
• Collaborators: AIDS Committee of Toronto; Canadian AIDS Treatment Information Exchange; Gilead Sciences; Hassle Free Clinic; Maple Leaf Medical Clinic; Ryerson University
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

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