Choice-Based PrEP Delivery for Transgender People in Uganda - PROJECT SUMMARY/ABSTRACT Transgender people (TGP) are at high risk for HIV infection, and are an important, under-researched key population in sub-Saharan Africa. Globally, HIV acquisition risk among TGP is 13 times higher than other adults aged 15-49 years. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention tool that could change the trajectory of the HIV epidemic among TGP, yet its population-level impact has been suboptimal due to lack of access to PrEP, and poor adherence to a daily pill. Long-acting formulations that overcome some of the limitations of a daily pill herald a new era of choice in PrEP options. Current PrEP choices for TGP include: 1) daily oral PrEP with emtricitabine co-formulated with tenofovir disoproxil fumarate (FTC/TDF) or tenofovir alafenamide (FTC/TAF), and 2) injectable long acting cabotegravir (CAB LA). CAB LA is an emergent and effective HIV prevention intervention for TGP who may not be able to consistently adhere to a daily pill, and oral PrEP is an effective prevention option for users who may not tolerate CAB LA. Choice-based PrEP delivery is a promising “next step” in HIV prevention. Choice of PrEP formulation (oral or injectable PrEP) and choice of delivery approach (community or facility delivery) could bring a major advance in HIV prevention, but neither has been implemented for TGP in Africa. Outstanding questions for choice-based PrEP delivery to TGP include end- user preferences, how to deliver injectable PrEP, understanding the science of choice, and trajectories of PrEP choice in the context of sub-Saharan Africa. To address these questions, we will use the PRECEDE-PROCEED intervention development model that is widely used for public health interventions, to design, implement, and evaluate choice-based PrEP delivery for TGP. Leveraging the multi-disciplinary expertise of our research team, and working at three sites experienced in prevention delivery for TGP in Uganda, we propose the following specific aims: PRECEDE - 1) identify factors that influence PrEP implementation for transgender people by using qualitative methods to identify predisposing, enabling, and reinforcing factors that impact PrEP implementation (intervention design); PROCEED - 2) use differentiated service delivery principles to offer choice of CAB-LA or oral PrEP, and choice of facility or community delivery (with option to switch or stop), to 300 HIV-negative TGP with follow-up for 24 months and evaluate implementation and effect on PrEP use (intervention implementation); 3) use mixed methods to evaluate “how” and “why” choice influences PrEP use among TGP (intervention evaluation); and 4) estimate cost implications associated with integrating CAB LA into HIV programs (budget impact analysis). The primary outcomes are PrEP formulation choice, adherence and persistence and choice of delivery approach. Our community engaged approach to choice-based PrEP delivery and implementation among TGP will reveal key programmatic design elements to achieve optimal adherence and persistence among a population with the highest HIV risk on a continent with the highest HIV burden.
