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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Human Immunodeficiency Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tenofovir/emtricitabine

MSM receiving once daily TDF/FTC-based (Truvada®) pre-exposure prophylaxis

Group Type EXPERIMENTAL

Tenofovir/emtricitabine

Intervention Type DRUG

Once daily Tenofovir/emtricitabine (Truvada®)

Interventions

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Tenofovir/emtricitabine

Once daily Tenofovir/emtricitabine (Truvada®)

Intervention Type DRUG

Other Intervention Names

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Truvada®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes