Testing implementation strategies to improve delivery of PrEP for pregnant and postpartum women in Kenya

摘要 此实施科学K 01研究和培训补助金旨在优化预曝光的交付 预防（PrEP）用于孕妇和产后妇女。怀孕是感染艾滋病毒的高危时期。作为 预防母婴传播方案更加有效， 新的婴儿感染将是由于怀孕期间发生的感染。PrEP是一种有效的，女性控制的， 世界卫生组织和联合国儿童基金会建议在高风险地区的怀孕期间进行循证干预， 组织和肯尼亚准则。将需要一种科学的实施方法来改善 在怀孕期间实施和扩大PrEP分娩。一项正在进行的20家研究中心R 01试验（MPI：John- Stewart，Baeten）和最近完成的16个站点项目（MPI：John-Stewart，Baeten）是第一个也是最大的 在产前护理诊所（ANC）内提供怀孕期间的PrEP项目。拟议的K 01将利用 卫生保健工作者（HCW）的经验和站点之间的异质性，以确定和测试方法 改善PrEP提供。本项目的研究目标（R1-3）是R1）确定成功的决定因素 使用混合方法在ANC期间提供PrEP，R2）选择并测试特定实施策略， 使用中断的时间序列分析提高PrEP输送保真度和渗透率，以及R3）量化 在ANC期间修改PrEP交付的预算影响，并了解决策者的决定。的 本研究的研究目标将使瓦格纳博士有机会实现其培训目标（T1-6），包括： T1）学习实施科学框架、成果衡量和实施战略 识别和测试，T2）学习准实验研究设计，T3）进行预算影响分析， T4）了解决策者的决策过程，T5）学习负责任的研究行为， 孕妇和T6）建立她的科学记录和过渡到独立。这些研究和 培训目标将使瓦格纳博士为过渡到独立做好准备;她将计划提交R 01群集 随机试验，以测试一套实施策略，以改善PrEP的成功交付期间 ANC。瓦格纳博士将在华盛顿大学完成她的K 01职业发展培训， 在实施科学和卫生经济学培训的绝佳环境，具有强大的>25年 与肯尼亚机构的合作历史，以及实施过程中的出色指导 科学家、PrEP专家、孕期艾滋病预防领导者和政策制定者。

ABSTRACT This implementation science K01 research and training grant aims to optimize the delivery of pre-exposure prophylaxis (PrEP) for pregnant and postpartum women. Pregnancy is a high-risk time for HIV acquisition. As prevention of mother-to-child transmission (PMTCT) programs become more effective, a greater proportion of new infant infections will be due to incident infection during pregnancy. PrEP is an effective, female-controlled, evidence-based intervention that is recommended during pregnancy in high-risk regions in both World Health Organization and Kenyan guidelines. An implementation science approach will be needed to improve operationalization and scale-up of PrEP delivery during pregnancy. An ongoing 20-site R01 trial (MPI: John- Stewart, Baeten) and a recently completed 16-site project (MPI: John-Stewart, Baeten) are the first and largest projects to deliver PrEP during pregnancy within antenatal care clinics (ANC). The proposed K01 will leverage the experiences of health care workers (HCW) and the heterogeneity between sites, to identify and test ways of improving PrEP delivery. This project’s research aims (R1-3) are to R1) identify determinants of successful PrEP delivery during ANC using mixed-methods, R2) select and test specific implementation strategies to improve PrEP delivery fidelity and penetration using interrupted time series analyses, and R3) quantify the budget impact of modifications to PrEP delivery during ANC and understand policymaker decisions. The research aims of this study will allow Dr. Wagner the opportunity to meet her training aims (T1-6), including: T1) learning implementation science frameworks, outcome measurement, and implementation strategy identification and testing, T2) learn quasi-experimental research designs, T3) conduct budget impact analyses, T4) understand policymaker decision-making processes, T5) learn about responsible conduct of research with pregnant women, and T6) build her scientific record and transition to independence. These research and training goals will prepare Dr. Wagner to transition to independence; she will plan to submit an R01 cluster randomized trial to test a package of implementation strategies to improve successful delivery of PrEP during ANC. Dr. Wagner will complete her K01 career development training at the University of Washington, which is a superb environment for training in implementation science and health economics, with a strong >25 year history of collaboration with Kenyan institutions, and with outstanding mentorship from implementation scientists, PrEP experts, leaders in HIV prevention during pregnancy, and policymakers.