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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02149888
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : October 17, 2016
Hassle Free Clinic
Maple Leaf Medical Clinic
Ryerson University
AIDS Committee of Toronto
Canadian AIDS Treatment Information Exchange
Gilead Sciences
Information provided by (Responsible Party):
Unity Health Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Human Immunodeficiency Virus Drug: Tenofovir/emtricitabine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM:The PREPARATORY-5 Study
Study Start Date : October 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Tenofovir/emtricitabine
MSM receiving once daily TDF/FTC-based (Truvada®) pre-exposure prophylaxis
Drug: Tenofovir/emtricitabine
Once daily Tenofovir/emtricitabine (Truvada®)
Other Name: Truvada®

Primary Outcome Measures :
  1. Participants' self-reported overall acceptability of PrEP [ Time Frame: 12 months ]
    Participants' self-reported overall acceptability of PrEP over the full one-year follow-up period (including the use of the medication, clinic visits, and their impact on the participant's life) will be quantified using a Likert scale.

  2. The level of community interest in PrEP [ Time Frame: 12 months ]
    The level of community interest in PrEP will be measured by quantifying the volume, rate and HIV risk levels of patient referrals to the PrEP clinic from each key referral source

Secondary Outcome Measures :
  1. Adherence to daily TDF/FTC-based PrEP [ Time Frame: 12 months ]
    Adherence will be measured by self-report, pill count, and intra-RBC tenofovir diphosphate levels.

  2. Time required by the patient, physician and research coordinator for each type of study visit. [ Time Frame: 12 months ]
    The time required by the patient, physician and research coordinator will be measured for each type of study visit.

  3. HIV infection [ Time Frame: 12 months ]
    HIV infection will be detected using point-of-care tests, standard serology and HIV RNA testing.

  4. Sexually transmitted infections [ Time Frame: 12 months ]
    Testing will be performed at each study visit to screen for gonorrhea, chlamydia and syphilis infection, including pharyngeal swab cultures, rectal swab cultures and urine NAAT tests.

  5. Burden of syndemic health problems [ Time Frame: 12 months ]
    The burden of specific syndemic health problems (depression, social anxiety, substance abuse, sexual addiction, childhood sexual abuse, partner violence) will be quantified using standardized, validated psychometric tools.

  6. Change in estimated glomerular filtration rate [ Time Frame: 12 months ]
    Estimated by the Modified Diet in Renal Disease (MDRD) formula

  7. Percentage change in bone mineral density at the lumbar spine and total hip [ Time Frame: 12 months ]
  8. Adverse events [ Time Frame: 12 months ]
    Adverse events will be assessed at each visit via clinical assessment and laboratory monitoring (CBC, phosphate, urinalysis).

  9. Pilot testing study instruments [ Time Frame: 12 months ]
    Outcomes related to pilot testing study instruments will include numbers of minutes required and participant-reported acceptability for each procedure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02149888

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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Unity Health Toronto
Hassle Free Clinic
Maple Leaf Medical Clinic
Ryerson University
AIDS Committee of Toronto
Canadian AIDS Treatment Information Exchange
Gilead Sciences
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Principal Investigator: Darrell Tan, MD FRCPC PhD Unity Health Toronto
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Unity Health Toronto Identifier: NCT02149888    
Other Study ID Numbers: PREPARATORY-5
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Keywords provided by Unity Health Toronto:
Pre-Exposure Prophylaxis
Human Immunodeficiency Virus
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents