A differentiated care model to improve the efficiency of PrEP delivery in Kenya

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PROJECT SUMMARY AND ABSTRACT The overall goal of the proposed K99/R00 Award is to support Dr. Kenneth Mugwanya’s research training to develop into an independent global health HIV researcher, focusing on application of rigorous implementation science research methods to translate effective HIV interventions to practice. Dr. Mugwanya is a physician- epidemiologist and a postdoctoral fellow at the University of Washington. This proposal outlines a 4-year career development and training plan to bolster his capacity with new skills in implementation science research. Training plan: To expand his skills and ensure transition to independence, the candidate has assembled a multidisciplinary mentoring team from the U.S. and Kenya with expertise in implementation science, clinical trials, HIV prevention, PrEP, qualitative research, and impact evaluation. Together, they have crafted a robust training and mentoring plan that includes relevant advanced coursework, seminars, scientific conferences, and regular meetings with the mentors. The training goals for the K-phase are: 1) Gain strong proficiency in the fundamentals of implementation science research methods, including operations research, monitoring and evaluation, qualitative methods, and impact evaluation; 2) Learn how to integrate qualitative research methods in the design, conduct, and implementation of HIV prevention interventions, and 3) Transition to independence with a focus on implementation science research. The proposed work builds on his research experience, prior training, and long- term career goal of contributing to scalable solutions to reduce HIV incidence globally. Research plan: PrEP is a potent HIV prevention strategy but maximizing access and minimizing costs of delivery are key challenges for optimizing the public health impact. In Kenya, the country with 4th largest epidemic, HIV serodiscordant couples and at-risk women account for >50% of new infections. We are conducting a national scale-up of PrEP for couples and other at-risk persons in routine clinics in Kenya (R01MH095507). We have found PrEP is highly desired but inefficiencies in the PrEP cascade pose a challenge to optimal efficiency. The overall goal of our four integrated aims is to define a scalable model for time-efficient and cost-saving PrEP provision. The Specific Aims are: 1) Develop a scalable differentiated care model for efficient PrEP delivery with core strategies including rapid risk assessment, HIV self-testing (HIVST), direct-to-pharmacy visits, and point – of-care (POC) creatinine; 2) Conduct a pilot randomized trial to test whether a differentiated care model promotes efficient PrEP provision; 3) Conduct a mixed methods study to explore acceptability and how HIVST, pharmacy visits, and POC creatinine fit into PrEP provision; and 4) Assess the cost and cost-effectiveness of differentiated delivery of PrEP. These research aims correspond with Dr. Mugwanya’s training goals; he will emerge as an independent scientist able to make substantial contributions to high priority public health problems.