A Phase 4 interventional study of Tenofovir/emtricitabine in HIV and Human Immunodeficiency Virus, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-17.
Sponsored by Unity Health Toronto · Phase 4, Interventional, and Prevention
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 52 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MSM receiving once daily TDF/FTC-based (Truvada®) pre-exposure prophylaxis
Drug: Tenofovir/emtricitabine
Once daily Tenofovir/emtricitabine (Truvada®)
Also known as: Truvada®
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.
Time frame: 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
Time frame: 12 months
Adherence to daily TDF/FTC-based PrEP
Adherence will be measured by self-report, pill count, and intra-RBC tenofovir diphosphate levels.
Time frame: 12 months
Time required by the patient, physician and research coordinator for each type of study visit.
The time required by the patient, physician and research coordinator will be measured for each type of study visit.
Time frame: 12 months
HIV infection
HIV infection will be detected using point-of-care tests, standard serology and HIV RNA testing.
Time frame: 12 months
Sexually transmitted infections
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.
Time frame: 12 months
Burden of syndemic health problems
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.
Time frame: 12 months
Change in estimated glomerular filtration rate
Estimated by the Modified Diet in Renal Disease (MDRD) formula
Time frame: 12 months
Percentage change in bone mineral density at the lumbar spine and total hip
Time frame: 12 months
Adverse events
Adverse events will be assessed at each visit via clinical assessment and laboratory monitoring (CBC, phosphate, urinalysis).
Time frame: 12 months
Pilot testing study instruments
Outcomes related to pilot testing study instruments will include numbers of minutes required and participant-reported acceptability for each procedure
Time frame: 12 months
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Unity Health Toronto