HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics: The HIV Testing Services PrEP Integration (HTS PrEP) Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30,000
- 试验地点
- 2
- 主要终点
- PrEP screening
研究概览
简要总结
This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥15 years of age
- •Accessing health services at participating public health facilities.
- •Not known to be living with HIV prior to the visit when their clinical data is first abstracted
排除标准
- 未提供
研究组 & 干预措施
Control (Usual care)
The control period (usual care) will be when the clinics are still implementing the usual care model, prior to implementing the intervention. Prior to launching the intervention, all facilities will have a baseline phase of 3 months. That time, in conjunction with other periods when the clinics are implementing usual care will serve as the control period.
HTS counselor-led PrEP care model
During the intervention period, all core components of PrEP delivery - including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills will be conducted by existing facility HTS counselor as part of standard of care.
干预措施: HTS counselor-led PrEP care model (Other)
结局指标
主要结局
PrEP screening
时间窗: Up to 42 months
Using individual client-level data at clinics, compare proportion of clients completing PrEP eligibility screening in usual care (control) versus intervention time points
PrEP initiation
时间窗: Up to 42 months
Using individual client-level data at clinics, compare PrEP initiation in usual care (control) versus intervention time points. PrEP initiation will be measured as the proportion of eligible clients starting PrEP use documented on ministry of health (MOH) tools.
PrEP continuation
时间窗: Up to 42 months
Using individual client-level data at clinics, compare PrEP continuation in usual care (control) versus intervention time points. PrEP continuation among clients initiating PrEP will be determined by clinic visit attendance and pharmacy PrEP refill records obtained by abstraction of MOH clinic records.
次要结局
未报告次要终点
研究者
Kenneth K Mugwanya
Associate Professor: School of Medicine, Global Health
University of Washington