Sustainable Healthcenter Implementation PrEP Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,420
- 试验地点
- 5
- 主要终点
- Medication adherence
研究概览
简要总结
A health services implementation pilot study, conducted with an observational cohort of HIV-uninfected persons including men who have sex with men, heterosexual women and men, and injection drug users receiving daily oral antiretroviral preexposure prophylaxis (PrEP) at four federally qualified health centers that provide sexual health and primary care services to communities with high HIV incidence/prevalence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •documented without HIV infection (acute or established)
- •report sexual behaviors that indicate substantial risk of HIV acquisition
- •report injection-related behaviors that indicate substantial risk of HIV acquisition
排除标准
- •<18 years of age
- •documented HIV infection (acute or established)
研究组 & 干预措施
Persons prescribed PrEP
adults prescribed daily oral antiretroviral preexposure prophylaxis (PrEP) with the coformulated TDF/FTC to reduce HIV acquisition.
干预措施: coformulated TDF/FTC (Drug)
结局指标
主要结局
Medication adherence
时间窗: Every 3 months up to 36 months
Self-reported medication adherence and detection of tenofovir in dried blood spots at each clinical visit while prescribed PrEP
Behavioral Responses
时间窗: Every 3 months up to 36 months
Trends in sexual and injection HIV acquisition risk behaviors among patients measured at each clinic visit while prescribed PrEP
Clinical safety
时间窗: Every 3 months up to 36 months
Side effects, rates of renal adverse events, rates of atraumatic bone fractures, HIV infections with/without virus with mutations associated with TDF or FTC resistance, documented at clinical visits while prescribed PrEP
次要结局
- Clinical practice variation(Every 3 months up to 36 months)
- Costs(Up to 3 years)
研究者
Karen Hoover
Lead, Prevention Research Team
Centers for Disease Control and Prevention