A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM: The PREPARATORY-5 Study (PREP-5)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by St. Michael's Hospital, Toronto
Sponsor:
Collaborators:
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):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT02149888
First received: May 12, 2014
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
HIV
Human Immunodeficiency Virus
Drug: Tenofovir/emtricitabine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of Daily Tenofovir/Emtricitabine-based Pre-exposure Prophylaxis Among High-risk Toronto Men Who Have Sex With Men: The PREPARATORY-5 Study

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Participants' self-reported overall acceptability of PrEP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • The level of community interest in PrEP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The level of community interest in PrEP will be measured by quantifying the rate of patient referrals to the PrEP clinic per unit time from each key referral source.


Secondary Outcome Measures:
  • Adherence to daily TDF/FTC-based PrEP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Adherence will be measured by self-report, pill count, and intra-RBC tenofovir diphosphate levels.

  • Time required by the patient, physician and research coordinator for each type of study visit. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The time required by the patient, physician and research coordinator will be measured for each type of study visit.

  • HIV infection [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    HIV infection will be detected using point-of-care tests, standard serology and HIV RNA testing.

  • Sexually transmitted infections [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Burden of syndemic health problems [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Change in estimated glomerular filtration rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Estimated by the Modified Diet in Renal Disease (MDRD) formula

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


Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02149888

Contacts
Contact: James C Lawless, BSc 416-864-6060 ext 77426 lawlessj@smh.ca

Locations
Canada, Ontario
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Darrell Tan, MD, PhD, FRCPC         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Hassle Free Clinic
Maple Leaf Medical Clinic
Ryerson University
AIDS Committee of Toronto
Canadian AIDS Treatment Information Exchange
Gilead Sciences
Investigators
Principal Investigator: Darrell Tan, MD FRCPC PhD St. Michael's Hospital, Toronto
Study Chair: Shawn Fowler Hassle Free Clinic
Study Chair: Troy Grennan, MD, FRCPC Maple Leaf Medical Clinic
Study Chair: Trevor Hart, PhD Ryerson University
Study Chair: John Maxwell, BA AIDS Committee of Toronto
Study Chair: James Wilton, BSc Canadian AIDS Treatment Information Exchange
Study Chair: Alan Li, MD Committee for Accessible AIDS Treatment
Study Director: Janet M Raboud, PhD Dalla Lana School of Public Health
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02149888     History of Changes
Other Study ID Numbers: PREPARATORY-5
Study First Received: May 12, 2014
Last Updated: May 23, 2014
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
HIV
Pre-Exposure Prophylaxis
PrEP
Human Immunodeficiency Virus

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 18, 2014