PRe-Exposure Prophylaxis Acceptability & Readiness Assessments for Toronto gaY, Bisexual and Other Men Who Have Sex With Men-5 (PREP-5)
A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM:The PREPARATORY-5 Study
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5B 1W8
- St. Michael's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Tenofovir/emtricitabine
MSM receiving once daily TDF/FTC-based (Truvada®) pre-exposure prophylaxis
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Once daily Tenofovir/emtricitabine (Truvada®)
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Participants' self-reported overall acceptability of PrEP
大体时间:12 months
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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.
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12 months
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The level of community interest in PrEP
大体时间:12 months
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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
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Adherence to daily TDF/FTC-based PrEP
大体时间:12 months
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Adherence will be measured by self-report, pill count, and intra-RBC tenofovir diphosphate levels.
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12 months
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Time required by the patient, physician and research coordinator for each type of study visit.
大体时间:12 months
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The time required by the patient, physician and research coordinator will be measured for each type of study visit.
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12 months
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HIV infection
大体时间:12 months
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HIV infection will be detected using point-of-care tests, standard serology and HIV RNA testing.
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12 months
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Sexually transmitted infections
大体时间:12 months
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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.
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12 months
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Burden of syndemic health problems
大体时间:12 months
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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.
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12 months
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Change in estimated glomerular filtration rate
大体时间:12 months
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Estimated by the Modified Diet in Renal Disease (MDRD) formula
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12 months
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Percentage change in bone mineral density at the lumbar spine and total hip
大体时间:12 months
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12 months
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Adverse events
大体时间:12 months
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Adverse events will be assessed at each visit via clinical assessment and laboratory monitoring (CBC, phosphate, urinalysis).
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12 months
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Pilot testing study instruments
大体时间:12 months
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Outcomes related to pilot testing study instruments will include numbers of minutes required and participant-reported acceptability for each procedure
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12 months
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合作者和调查者
出版物和有用的链接
一般刊物
- Tan DHS, Schnubb A, Lawless J, Szadkowski L, Grennan T, Wilton J, Fowler S, Hart TA, Maxwell J, Raboud JM. Acceptability and tolerability of and adherence to HIV preexposure prophylaxis among Toronto gay and bisexual men: a pilot study. CMAJ Open. 2018 Dec 10;6(4):E611-E617. doi: 10.9778/cmajo.20180068. Print 2018 Oct-Dec.
- Wilton J, Noor SW, Schnubb A, Lawless J, Hart TA, Grennan T, Fowler S, Maxwell J, Tan DHS. High HIV risk and syndemic burden regardless of referral source among MSM screening for a PrEP demonstration project in Toronto, Canada. BMC Public Health. 2018 Feb 27;18(1):292. doi: 10.1186/s12889-018-5180-8.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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