ABSTRACT This implementation science R01 study aims to test a scale-up package to expand the delivery of pre-exposure prophylaxis (PrEP) for pregnant and postpartum women in Kenya. The pregnancy and postpartum periods are high risk for HIV acquisition. PrEP is an effective, woman-controlled, evidence-based intervention that is recommended during pregnancy in high risk regions in both World Health Organization and Kenyan guidelines. Delivery of PrEP integrated into maternal and child health (MCH) clinics is feasible, acceptable, and preferable to pregnant and postpartum women. Our team has led 3 implementation science (PIs: John-Stewart, Baeten, Kinuthia, Wagner) studies with >55 facilities focused on delivering PrEP integrated into MCH, testing implementation strategies to optimize delivery in western Kenyan counties. These represented the first and largest projects to deliver PrEP integrated into MCH. Integrated PrEP delivery is now ready for scale up more broadly, which will require new implementation strategies to target scale up. The proposed R01 will leverage the experiences of health care workers (HCW), expertise from research team members, and heterogeneity between sites and counties, to develop and test a package of scale-up strategies for improving PrEP delivery. This project’s aims are to: 1) develop and determine the impact of a Community of Practice (CoP) on stakeholder and health care worker engagement and knowledge, 2) determine the impact of a 3 component scale up package – CoP, quality improvement, and training & delivery toolkit – on implementation outcomes and PrEP clinical outcomes, and 3) identify combinations of facility- and regional-level attributes and processes that explain patterns of implementation. These research aims follow directly from Dr. Wagner’s K01 on which Dr. Kinuthia is a mentorship member. The joint leadership between the University of Washington and Kenyatta National Hospital provide a superb research environment for implementation science projects, with a strong >35 year history of collaboration between the institutions. The established investigative team includes expertise in implementation science, PrEP, HIV prevention during pregnancy and postpartum, engagement with Ministry of Health, mixed-methods, configurational analyses, and strong expertise in delivery of PrEP in MCH.

PROJECT NARRATIVE Pregnancy is a high-risk time for acquiring HIV; pre-exposure prophylaxis (PrEP) is an effective, woman- controlled, evidence-based intervention that is recommended during pregnancy in high-risk settings. In Kenya, PrEP is being delivered in some regions during pregnancy and postpartum integrated into maternal and child health services, but scale-up has been sub-optimal. 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.