PrEPARE-SCALE: Scaling up Integrated PrEP Delivery in Kenyan Maternal and Child Health Clinics for Pregnant and Postpartum Women
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 17,000
- 试验地点
- 5
- 主要终点
- Service penetration
研究概览
简要总结
This project aims to develop a community of practice; then test a combination of community of practice, quality improvement, and a training toolkit, to enhance implementation and clinical outcomes; and identify patterns attributes associated with successful implementation.
详细描述
Aim 1: To develop and determine the impact of a Community of Practice (CoP) on stakeholder and healthcare worker engagement and knowledge of integrated pre-exposure prophylaxis (PrEP) delivery.
Aim 2: To determine the impact of a 3-component scale-up package on implementation outcomes and PrEP patient outcomes among pregnant and postpartum populations.
Aim 2a: To determine the impact of the scale-up package on PrEP implementation outcomes, including reach, service penetration, adoption (primary outcomes), and PrEP fidelity and maintenance (secondary outcomes).
Aim 2b: To determine the impact of the scale-up package on PrEP patient outcomes, including PrEP initiation and continuation.
Aim 3: To identify difference-making bundles of facility- and regional-level attributes and implementation processes that influence reach, fidelity implementation, and maintenance.
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
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Health Care Workers:
- •work at a facility involved in study
- •involved in PrEP service delivery
- •>=18 years
- •female clients seeking health services at study facilities
- •pregnant or postpartum
- •>15 years (includes emancipated minors)
排除标准
- 未提供
研究组 & 干预措施
Implementation strategy package
Package includes a Community of Practice, a quality improvement (QI) practice, and a training & delivery toolkit.
干预措施: Implementation strategy package (Other)
Comparison
结局指标
主要结局
Service penetration
时间窗: 1 year
Number and proportion of pregnant and postpartum maternal child health clinic (MCH) clients who are screened for PrEP
Adoption (facility)
时间窗: 1 year
Proportion of facilities per county that have begun offering PrEP in MCH
Reach
时间窗: 1 year
Number of pregnant and postpartum MCH clients initiated on PrEP each month
Adoption (provider)
时间窗: 1 year
Number, proportion, and representativeness of nurses and HIV testing services (HTS) providers who have begun offering or counseling on PrEP in MCH
次要结局
未报告次要终点
研究者
Anjuli Wagner
Assistant Professor, Global Health
University of Washington