Clinical trial NCT02149888: PRe-Exposure Prophylaxis Acceptability & Readiness Assessments for Toronto gaY, Bisexual and Other Men Who Have Sex With Men-5
Official title: A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM:The PREPARATORY-5 Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Human Immunodeficiency Virus
Keywords: HIV
Pre-Exposure Prophylaxis
PrEP
Human Immunodeficiency Virus
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Hassle Free Clinic
name: Maple Leaf Research
name: Toronto Metropolitan University
name: AIDS Committee of Toronto
name: Canadian AIDS Treatment Information Exchange
name: Gilead Sciences
First posted: 2014-05-29
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Participants' self-reported overall acceptability of PrEP
timeFrame: 12 months
measure: The level of community interest in PrEP
timeFrame: 12 months
Secondary outcomes:
measure: Adherence to daily TDF/FTC-based PrEP
timeFrame: 12 months
measure: Time required by the patient, physician and research coordinator for each type of study visit.
timeFrame: 12 months
measure: HIV infection
timeFrame: 12 months
measure: Sexually transmitted infections
timeFrame: 12 months
measure: Burden of syndemic health problems
timeFrame: 12 months
measure: Change in estimated glomerular filtration rate
timeFrame: 12 months
measure: Percentage change in bone mineral density at the lumbar spine and total hip
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: Pilot testing study instruments
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Darrell Tan, MD FRCPC PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.