A Pilot Study of Daily TDF/FTC-based PrEP Among High-risk Toronto MSM:The PREPARATORY-5 Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Participants' self-reported overall acceptability of PrEP
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tenofovir/emtricitabine
MSM receiving once daily TDF/FTC-based (Truvada®) pre-exposure prophylaxis
干预措施: Tenofovir/emtricitabine (Drug)
结局指标
主要结局
Participants' self-reported overall acceptability of PrEP
时间窗: 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
时间窗: 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
次要结局
- Sexually transmitted infections(12 months)
- Adherence to daily TDF/FTC-based PrEP(12 months)
- Time required by the patient, physician and research coordinator for each type of study visit.(12 months)
- Percentage change in bone mineral density at the lumbar spine and total hip(12 months)
- HIV infection(12 months)
- Burden of syndemic health problems(12 months)
- Pilot testing study instruments(12 months)
- Change in estimated glomerular filtration rate(12 months)
- Adverse events(12 months)