Next Generation Real-time Monitoring for PrEP Adherence in Young Kenyan Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 2
- 主要终点
- Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
研究概览
简要总结
Next generation real-time monitoring for PrEP adherence in young Kenyan women
详细描述
This protocol describes a longitudinal study of young Kenyan women at high risk for HIV who will be offered HIV pre-exposure prophylaxis (PrEP) for up to two years. Adherence will be monitored in all women with the next generation Wisepill; half will be randomized to receive short message service (SMS) reminders. The technical function, acceptability, cost, and validity of the next generation Wisepill device coupled to SMS reminders will be determined among this cohort of young Kenyan women. Additionally, SMS will be used for longitudinal assessment of risk perception and its alignment with PrEP adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HIV-uninfected (as determined by Kenya national testing algorithms)
- •Wanting to start PrEP with an initial recommendation of 6 months of use
- •Clinically safe to receive PrEP, in accordance with Centers for Disease Control and Prevention (CDC) guidelines:
- •Creatinine clearance >60 mL/min
- •Not infected with hepatitis B
- •No other medical condition that in the discretion of the site investigator would make participation unsafe or complicate the goals of the study
- •Sexually active (defined as vaginal or anal sex) within the last 3 months
- •At high risk for HIV infection based on a validated risk score of >5 or being in an HIV serodiscordant relationship
- •Not pregnant
- •Owns a personal cell phone (not shared) compatible with study protocols and the ability to charge it
- •Ability to send a text message
- •Intending to stay in the area for at least the next year
- •Willing to use study criteria
排除标准
- •Unable to provide consent
- •Breast-feeding (PrEPis not currently approved for use during breast-feeding)
- •Concurrent participation in another research study that may influence adherence to PrEP and/or interfere with the procedures of this study.
结局指标
主要结局
Enacted Adherence as Measured by Electronic Monitoring at 6 and 24 Months
时间窗: up to 2 years follow-up
Comparison of average percent adherence (doses taken/doses prescribed) by study arm at each time point among participants choosing to pick up PrEP.
次要结局
- Number of Participants Reporting High Acceptability of Wisepill Devices for PrEP Adherence Monitoring(Month 1)
- USD Per Month(two years)
研究者
Jessica Haberer, MD
Research Scientist
Massachusetts General Hospital