A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM: The PREPARATORY-5 Study (PREP-5)
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.
|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|
- 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.
- 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).
|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)|
MSM receiving once daily TDF/FTC-based (Truvada®) pre-exposure prophylaxis
Once daily Tenofovir/emtricitabine (Truvada®)
Other Name: Truvada®
Please refer to this study by its ClinicalTrials.gov identifier: NCT02149888
|Contact: James C Lawless, BSc||416-864-6060 ext email@example.com|
|St. Michael's Hospital||Not yet recruiting|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator: Darrell Tan, MD, PhD, FRCPC|
|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|