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

摘要 这项实施科学K01研究和培训补助金旨在优化预曝光的交付 孕妇和产后妇女的预防(PrEP)。怀孕是感染艾滋病毒的高危时期。AS 预防母婴传播(母婴传播)方案变得更加有效，更大比例的 新的婴儿感染将是由于怀孕期间的意外感染。Prep是一个有效的，由女性控制的， 在两个世界卫生组织的高危地区推荐的妊娠期循证干预 组织和肯尼亚的指导方针。需要一种实施科学的方法来改进 妊娠期PrEP分娩的手术化和扩大。正在进行的20个站点的R01试验(MPI：John- 和最近完成的一个16个站点的项目(MPI：John-Stewart，Baeten)是第一个也是最大的 在产前保健诊所(ANC)内实施孕期孕期孕前预防接种的项目。拟议的K01将利用 医护人员(HCW)的经验和站点之间的异质性，以识别和测试方法 改善PrEP的交付。本项目的研究目标(R1-3)是确定成功的决定因素 在ANC期间使用混合方法进行准备交付，R2)选择和测试特定的实施策略，以 使用中断的时间序列分析提高PrEP交付的保真度和渗透率，以及R3)量化 在非国大期间修改PrEP交付的预算影响，并了解决策者的决策。这个 这项研究的研究目标将使瓦格纳博士有机会实现她的培训目标(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)了解决策者的决策流程，t5)了解负责任的研究 孕妇，和T6)建立了她的科学记录，并过渡到独立。这些研究和 培训目标将为瓦格纳博士过渡到独立做好准备；她将计划提交一份R01集群 随机试验，以测试一揽子实施战略，以改善PrEP在 非国大。瓦格纳博士将在华盛顿大学完成K01职业发展培训，这是 实施科学和卫生经济学培训的极佳环境，有25年的强劲表现 与肯尼亚机构合作的历史，以及在实施过程中提供的杰出指导 科学家、PrEP专家、孕期艾滋病毒预防领导人和政策制定者。

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.