Scaling up for impact: HIV testing counselor-led pathway to accelerate PrEP delivery at scale

University Of Washington, Seattle WA

Investigators

Abstract

ABSTRACT We have entered an exciting era for PrEP with two additional non-oral products, a monthly dapivirine vaginal ring and a bi-monthly injectable cabotegravir, with several more options in various stages of clinical development. While the effectiveness of these interventions is now well established, uptake and persistence on PrEP depend not only on client-level factors but also on how well opportunity costs and health system barriers can be navigated by potential PrEP clients. Thus, taking these novel PrEP interventions to full scale will require simplifying and diversifying models for delivery, to achieve options that are accessible, scalable, and meet the needs of clients and health systems. Since 2020, in collaboration with the Kenyan Ministry of Health we have demonstrated PrEP can be delivered in African family planning clinics (FP) using existing staff and infrastructure in a programmatic stepped-wedge cluster-randomized trial (FP-Plus project), significantly increasing the proportion of general population women screened for PrEP from 3% to 93% and PrEP initiations among eligible women from <3% to 46%. We have also learned that there are several key health system barriers, such as heavy workload and lengthy clinic visits that burden the health system and limit expanded delivery at scale up. Within the FP-Plus project, we piloted model that allows HIV testing (HTS) counselors to screen and determine PrEP eligibility and that it both reduced clinic time by 60% and resulted in higher PrEP initiations and early PrEP continuation versus comparable control clinics maintaining usual care. We hypothesize that PrEP care can be done by HTS providers, in a single HIV testing encounter with clinician oversight as needed, in a way that will be more time- efficient and client-centered and will be acceptable, scalable, and readily transferable to other African settings. With an interdisciplinary team and our deep knowledge of the Kenya health system, we will use a participatory research approach with key stakeholders to co-develop and refine the core components of a ‘scalable unit’ composed of a simplified HTS counselor-led PrEP care intervention and an MOH feasible technical advisory and provider training support delivery at scale (Aim 1). We will then road test the effectiveness and impact of HTS counselor-led PrEP care to catalyze expansion of PrEP delivery at scale in 20 Kenyan health facilities representing a spectrum of clinical contexts likely to occur at full scale implementation (Aim 2). Lastly, we will use mixed methods to triangulate multilevel determinants of delivery at scale, including behavior science studies to understand and incorporate women perspectives, explore partner and community influence, and barriers to PrEP access and use; clinic and provider capacity to deliver multiple PrEP products; and key stakeholders’ power, interests, and perspectives (Aim 3). We have already demonstrated that PrEP can be delivered in African health facilities; this work will boldly extend that further, aiming for simplified facility-based PrEP delivery with greater clinic efficiency, diminished client burden, and greater public health impact of PrEP at population level.