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

NCT02149888 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2016-10-17

No results posted yet for this study

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.

Conditions

  • HIV
  • Human Immunodeficiency Virus

Interventions

DRUG

Tenofovir/emtricitabine

Once daily Tenofovir/emtricitabine (Truvada®)

Sponsors & Collaborators

  • Hassle Free Clinic

    collaborator UNKNOWN

  • Maple Leaf Research

    collaborator OTHER

  • Toronto Metropolitan University

    collaborator OTHER

  • AIDS Committee of Toronto

    collaborator OTHER

  • Canadian AIDS Treatment Information Exchange

    collaborator UNKNOWN

  • Gilead Sciences

    collaborator INDUSTRY

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Darrell Tan, MD FRCPC PhD · Unity Health Toronto

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02149888 on ClinicalTrials.gov