Scaling up and out: Exploring options for differentiated delivery of pre-exposure prophylaxis in Kenya

Thesis (Ph.D.)--University of Washington, 2021In Kenya, daily oral pre-exposure prophylaxis (PrEP) for HIV prevention is a key component of the country’s national HIV/AIDS response. Since its approval by the Kenya national drug regulatory authority in 2015, PrEP has been rolled out predominantly in HIV clinics; however, the country’s 5-year plan for implementing PrEP at scale calls for integration of PrEP into other service delivery models and more efficient use of available resources. Currently, there is limited implementation science research to inform PrEP scale-up (i.e., expansion to additional HIV clinics) and scale-out (i.e., expansion to new service delivery models and populations) in Kenya. Our objective was to identify barriers and facilitators of PrEP integration and/or optimization in three healthcare settings: HIV clinics, family planning (FP) clinics, and retail pharmacies. In Aim 1, we analyzed data from a prospective cohort study delivering integrated PrEP-FP services to adolescent girls and young women (AGYW) at two FP clinics in Kisumu, Kenya. Using the Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC) compilation, we identified supply-side implementation strategies for integrating PrEP into routine FP services and contextual factors influencing strategy choice and outcome, as captured in routine monitoring and evaluation documents (n=213) and key informant interviews (n=15). We found that, overall, implementing PrEP was more labor intensive at a public FP clinic compared to a private, youth-friendly clinic because it required a series of implementation strategies to make the physical and social environment conductive to offering AGYW-centered care. Nevertheless, provider adoption of PrEP delivery was low at both clinics, likely due to the widespread perception that PrEP was not within their scope of work. We recommend that PrEP implementers approach PrEP implementation, in part, as a behavioral intervention for FP providers and specifically assess the need for implementation strategies that support providers’ clinical decision-making, address workload constraints, and establish clear worker expectations. In Aim 2, we conducted a pilot study of a one-stop shop (OSS) model for PrEP delivery at four public clinics in Western Province, Kenya and evaluated whether this model could improve care efficiency and acceptability without negatively impacting PrEP uptake or continuation. Interviews with clients (n=15) and providers (n=14), technical assistance reports (n=69), and clinic flow maps indicate that the OSS achieved efficiency gains by redirecting PrEP clients away from bottlenecks, moving steps closer together (e.g., relocating supplies; cross-training and task-shifting), and differentiating clients based on the subset of services needed. Analysis of time-and-motion observations (n=47) revealed that, following OSS implementation, median client wait time dropped significantly from 31 minutes to 6 minutes (p=0.02) while median time spent with a provider remained around 23 minutes (p=0.4). Clients and providers expressed a strong preference for the OSS model and additionally identified increased privacy, reduced stigma, and higher quality client-provider interactions as benefits of the OSS model. Controlled interrupted time series analysis of PrEP initiations (n=1227) and follow-up visits (n=2696) revealed no significant difference between intervention and control clinics in terms of trends in PrEP initiation and on-time returns (all p>0.05). We conclude that the OSS model is a promising option for reducing variability in service time and increasing client and provider satisfaction without adding additional human resources. In Aim 3, we conducted a formative research study to understand the acceptability and feasibility of retail pharmacy-based PrEP delivery. Using the CFIR, we conducted and analyzed in-depth interviews with 40 pharmacy clients, 16 pharmacy providers, 16 PrEP clients, and 10 PrEP providers from Kisumu and Kiambu Counties, Kenya. Most participants expressed strong support for expanding PrEP to retail pharmacies, though conditioned their acceptance on assurances that care would be private, respectful, safe, and affordable. Participant-reported determinants of feasibility centered primarily on ensuring that the intervention is compatible with retail pharmacy operations (e.g., adequate staffing; use of documentation systems that meet PrEP reporting requirements). Our findings may inform the development of a tailored package of implementation strategies for integrating PrEP into routine pharmacy practice