PRe-Exposure Prophylaxis Acceptability & Readiness Assessments for Toronto gaY, Bisexual and Other Men Who Have Sex With Men-5 (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 TDF/FTC-based PrEP Among High-risk Toronto MSM: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 volume, rate and HIV risk levels of patient referrals to the PrEP clinic 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).
- Pilot testing study instruments [ Time Frame: 12 months ] [ Designated as safety issue: No ]Outcomes related to pilot testing study instruments will include numbers of minutes required and participant-reported acceptability for each procedure
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (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
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator:||Darrell Tan, MD FRCPC PhD||St. Michael's Hospital, Toronto|