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

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM:The PREPARATORY-5 Study

Conditions
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HIV, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: Tenofovir/emtricitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tenofovir/emtricitabine<br>MSM receiving once daily TDF/FTC-based (Truvada®) pre-exposure prophylaxis | Drug: Tenofovir/emtricitabine<br>* Once daily Tenofovir/emtricitabine (Truvada®)<br>* Other names: Truvada®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to daily TDF/FTC-based PrEP | Adherence will be measured by self-report, pill count, and intra-RBC tenofovir diphosphate levels. | 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. | 12 months | 
| HIV infection | HIV infection will be detected using point-of-care tests, standard serology and HIV RNA testing. | 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. | 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. | 12 months | 
| Change in estimated glomerular filtration rate | Estimated by the Modified Diet in Renal Disease (MDRD) formula | 12 months | 
| Percentage change in bone mineral density at the lumbar spine and total hip |  | 12 months | 
| Adverse events | Adverse events will be assessed at each visit via clinical assessment and laboratory monitoring (CBC, phosphate, urinalysis). | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Pre-Exposure Prophylaxis, PrEP, Human Immunodeficiency Virus