A Cohort for Evaluation of Open-label PrEP Delivery and PrEP Preferences Among African Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,087
- 试验地点
- 20
- 主要终点
- A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women
研究概览
简要总结
INSIGHT is a Prospective, Observational, open-label cohort study on women in Sub-Saharan Africa on PrEP screening, informed choice, and compliance.
There are no specific intervention arms or comparative treatment plans. We will follow and observe participants taking PrEP, not taking PrEP, as well as those who begin or end PrEP during the course of the observational period.
详细描述
Primary goals:
- Estimate HIV incidence using recency testing on samples from women who screen out due to HIV infection, as well as assess HIV incidence prospectively in the cohort.
- Assess the characteristics of women who initiate PrEP compared to those who do not initiate PrEP.
- Evaluate young women's preferences for attributes of long-acting formulations of PrEP, using a discrete choice experiment.
- Assess the acceptability of a patient-facing PrEP decision support tool to provide young women more informed choice about PrEP options.
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
- 16 Years 至 31 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •16-30 years of age
排除标准
- •not sexually active
- •over 31 years of age at consent
结局指标
主要结局
A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women
时间窗: 1 year
We will collect data on STI prevalence, contraception use, sexual behavior, risk perception as correlates for PrEP uptake, persistence and adherence. Adherence will be measured by the timing of PrEP refills, self-reported PrEP use, and drug level testing for tenofovir (TFV) levels .PrEP adherence will be assessed during periods of risk, based on behavioral data and self-perceived risk. Participants in this cohort will be informed of other HIV prevention efficacy trials. A discrete choice experiment will be used to assess women's preferences around PrEP delivery form (pill and injection), dosing frequency, and relative dose forgiveness for different PrEP formulations. A patient-facing decision support tool about PrEP options will be evaluated with respect to its utility in assisting young women to consider their HIV prevention needs and PrEP preferences.
次要结局
未报告次要终点
研究者
Connie Celum
Professor: School of Medicine
University of Washington