A Hybrid Effectiveness-Implementation Trial of a Urine Point-of-Care Assay to Increase PrEP Adherence Among Women in Kenya
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 主要终点
- Urine TFV assay
研究概览
简要总结
The goal of this randomized trial study is to learn if drug-level feedback counseling works to improve oral PrEP adherence in adolescent girls and young women.
Researchers will compare urine TFV assay positivity between arms. All participants will attend visits on the same schedule, and receive the same SOC counseling for PrEP adherence. Participants in the intervention arm will additionally take POC urine TFV tests and receive drug-level feedback as part of that counseling.
详细描述
This will be a randomized trial conducted in four public clinic facilities in Kiambu County. We will enroll 400 AGYW ages 15-29 who have been using oral PrEP for one month and will randomize them 1:1 to our DLFB intervention or standard-of-care (SOC). Enrolled AGYW will return for follow-up two months after enrollment and quarterly thereafter through 12 months. Intervention participants will receive DLFB counseling using our urine TFV assay at all visits. SOC arm participants will receive standard counseling; urine will be collected longitudinally but will be tested at study end. We will collect behavioral data via computer assisted self-interviewing (CASI) surveys. Our primary outcome will be the proportion of positive urine assays at each visit. We will compare urine TFV assay positivity between arms using a repeated measures mixed effects logistic regression model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HIV uninfected
- •Received daily oral PrEP one month prior, with a negative result on a urine assay one-month post PrEP initiation
- •Currently attending or willing to attend one of the study clinics for PrEP refills
- •Interest in continuing on oral PrEP despite adherence challenges
- •No known sero-discordant relationships
- •Living in Kiambu County and not planning to relocate for the next year
排除标准
- •Inadequate capacity to consent or complete planned study procedures
- •Do not speak English or Kiswahili
- •Test positive for HIV at screening
- •Concomitant participation in another PrEP adherence support study
结局指标
主要结局
Urine TFV assay
时间窗: Month 6 post-PrEP initiation
To determine the short-term adherence to PrEP between arms, we will look at the difference in the population proportions via a positive result on urine TFV assay over follow-up.
次要结局
未报告次要终点
研究者
Jennifer Velloza
Affiliate Assistant Professor: School of Medicine, Global Health
University of Washington