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

NCT02149888 | Completed Phase 4 DMC

• 1 other identifier: PREPARATORY-5
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Human Immunodeficiency Virus

Keywords

HIV; Pre-Exposure Prophylaxis; PrEP; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (2)

• Participants' self-reported overall acceptability of PrEP

  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.

  12 months

• The level of community interest in PrEP

  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

  12 months

Secondary Outcomes (9)

• Adherence to daily TDF/FTC-based PrEP

  12 months

• Time required by the patient, physician and research coordinator for each type of study visit.

  12 months

• HIV infection

  12 months

• Sexually transmitted infections

  12 months

• Burden of syndemic health problems

  12 months

Study Arms (1)

Tenofovir/emtricitabine

EXPERIMENTAL

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

Drug: Tenofovir/emtricitabine

Interventions

Tenofovir/emtricitabine DRUG

Once daily Tenofovir/emtricitabine (Truvada®)

Also known as: Truvada®

Tenofovir/emtricitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Hassle Free Clinic: collaborator
• Maple Leaf Research: collaborator
• Toronto Metropolitan University: collaborator
• AIDS Committee of Toronto: collaborator
• Canadian AIDS Treatment Information Exchange: collaborator
• Gilead Sciences: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (2)

• Tan DHS, Schnubb A, Lawless J, Szadkowski L, Grennan T, Wilton J, Fowler S, Hart TA, Maxwell J, Raboud JM. Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study. CMAJ Open. 2018 Dec 10;6(4):E611-E617. doi: 10.9778/cmajo.20180068. Print 2018 Oct-Dec.

  PMID: 30530721 DERIVED

• Wilton J, Noor SW, Schnubb A, Lawless J, Hart TA, Grennan T, Fowler S, Maxwell J, Tan DHS. High HIV risk and syndemic burden regardless of referral source among MSM screening for a PrEP demonstration project in Toronto, Canada. BMC Public Health. 2018 Feb 27;18(1):292. doi: 10.1186/s12889-018-5180-8.

  PMID: 29486737 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Darrell Tan, MD FRCPC PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 29, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

CA (1)