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

Phase 4

Completed

• Conditions: HIV; Human Immunodeficiency Virus
• Interventions: Drug: Tenofovir/emtricitabine

• Registration Number: NCT02149888
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-29
• Study Start: 2014-10
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tenofovir/emtricitabine	Tenofovir/emtricitabine	MSM receiving once daily TDF/FTC-based (Truvada®) pre-exposure prophylaxis

Primary Outcome Measures

Name	Time	Method
Participants' self-reported overall acceptability of PrEP	12 months	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	12 months	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

Secondary Outcome Measures

Name	Time	Method
Sexually transmitted infections	12 months	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.
Adherence to daily TDF/FTC-based PrEP	12 months	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.	12 months	The time required by the patient, physician and research coordinator will be measured for each type of study visit.
Percentage change in bone mineral density at the lumbar spine and total hip	12 months
HIV infection	12 months	HIV infection will be detected using point-of-care tests, standard serology and HIV RNA testing.
Burden of syndemic health problems	12 months	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.
Pilot testing study instruments	12 months	Outcomes related to pilot testing study instruments will include numbers of minutes required and participant-reported acceptability for each procedure
Change in estimated glomerular filtration rate	12 months	Estimated by the Modified Diet in Renal Disease (MDRD) formula
Adverse events	12 months	Adverse events will be assessed at each visit via clinical assessment and laboratory monitoring (CBC, phosphate, urinalysis).

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada