Funding has been awarded to principal investigator Dr. Kenneth Mugwanya by the National Institute of Mental Health for "A differentiated care model to improve the efficiency of PrEP delivery in Kenya".
Abstract:
PrEP is a potent HIV prevention strategy but maximizing access and minimizing costs of delivery are key challenges for optimizing the public health impact. Kenya, with the 4th largest HIV epidemic in the world, officially launched PrEP in May 2017, making it the first African national PrEP program. In collaboration with the Kenyan Ministry of Health, since 2017 we have been conducting a large step-wedge randomized roll-out of PrEP in 24 high-volume (the Partners Scale- Up Project, R01MH095507).The project uses implementation science methods to document the process of PrEP delivery at scale in a national public health model. Our preliminary data show high enthusiasm and uptake for PrEP delivered in HIV clinics, with good continuation and high adherence – but also highlighted inefficiencies including frequent and lengthy visits that burden the health system. For PrEP clients, long waiting times and frequent clinic visits endanger PrEP continuation because of opportunity costs.
In African HIV treatment programs, differentiated care services – i.e., patient-centered strategies that simplify care for most patients, through task shifting or refill-only visits – have been successfully implemented, with improved adherence and viral suppression. For PrEP, similar approaches to streamline patient flow to promote access to and continuation on PrEP need to be clearly defined. We propose to evaluate the feasibility and acceptability of a facility pharmacy-based PrEP refill care pathway (a differentiated care intervention). The core components are: 1) 3-monthly refills, 2) direct-topharmacy refill visits, and 3) HIV self-testing (HIVST) while waiting for refills. We hypothesize that the intervention could streamline client flow in busy HIV care clinics, freeing providers to concentrate on urgent services, reducing client waiting time, minimizing stigma, and improving retention.
In this pilot implementation study, four clinics of comparable patient volume will be randomly allocated to implement either current PrEP patient flow or intervention; primary outcome assessments will at the patient-level. The Specific Aims are: 1) To evaluate whether a differentiated care intervention improves the efficiency of PrEP delivery while resulting in equivalent or better, patient waiting time, PrEP continuation, and adherence; 2) Conduct a mixed methods study to explore acceptability and how HIVST and pharmacy refill visits fit into PrEP provision; and 3) Assess the cost and cost-effectiveness of differentiated delivery of PrEP. We will conduct novel process flow mapping and time and motion studies to define optimal client flow. Relevant constructs of the Consolidated Framework for Implementation
Science Research will be used to explore contextual information on factors important for acceptability, adoption, and maintenance, as well as quality and fidelity of the proposed intervention. Key outcomes will be patient visit time (measure of efficiency), patient satisfaction, PrEP continuation, and PrEP adherence.
The proposed work will advance PrEP delivery in innovative ways, aiming for greater efficiency, reduced workload, diminished client burden, and better outcomes – allowing human and financial resources to be directed to those in most need.
Sponsor Award Number: 4R00MH118134-02