A Multicomponent Strategy to Improve HIV Pre-Exposure Prophylaxis in a Southern US Jail: Protocol for a Type 3 Hybrid Implementation-Effectiveness Trial (Preprint)

Abstract

BACKGROUND Pre-exposure prophylaxis (PrEP) is an effective approach to preventing HIV infection, but it is underutilized by populations who may benefit most, including people living in the Southern US and those involved in the criminal legal (CL) system. Improving access and use of PrEP for these groups could decrease HIV-related health disparities. Beyond individual outcomes, HIV prevention for CL-involved people can have a significant public health impact on HIV incidence due to high turnover between jail and the community. OBJECTIVE We will develop, implement, and evaluate a multicomponent PrEP implementation strategy for the Dallas County Jail (DCJ) to increase initiation of this HIV-preventive intervention for CL-involved individuals. METHODS This study is a type 3 hybrid implementation-effectiveness study, which takes a combined approach by assessing both the implementation of a strategy to identify candidates for PrEP at the DCJ and link them to PrEP providers upon community reentry, while also gathering information about clinical outcomes. The approach is guided by the EPIS (Exploration, Preparation, Implementation, Sustainment) implementation science framework. Initial formative work (Exploration) involves qualitative interviews of diverse key stakeholders, including CL-involved people, jail providers and community PrEP providers, to identify factors that may influence linkage to PrEP after jail release. These findings will be undergo rapid qualitative analysis (Preparation) to inform adaptation of a multicomponent jail PrEP implementation strategy protocol. We anticipate that innovative components of this strategy will include the development and incorporation of an electronic health record (EHR) prediction model to identify individuals who may be at high risk for HIV acquisition and integration of a PrEP patient navigator into the jail health team. This approach will allow medical providers and the navigator at the DCJ to engage individuals most likely to benefit in shared decision-making about PrEP and navigate them to community PrEP care (Implementation) in a process that begins before release from jail and ends with successful care linkage. Regular quantitative and qualitative evaluations of this approach will allow for ongoing stakeholder input, refinement of the implementation strategy, and maintenance of the program (Sustainment). Dissemination consultants with jail health expertise from other parts of the US will inform strategy adaptation for other jail settings. RESULTS The study was funded by the National Institute of Mental Health in April 2022. Findings from 26 qualitative interviews (9 formerly incarcerated individuals, 9 county jail staff, and 8 employees of community organizations), have been completed, analyzed and mapped to an implementation strategy formalized in a jail PrEP protocol. An HIV risk prediction model based on EHR data to identify individuals most likely to benefit from PrEP has been developed, internally validated and is ready to be deployed. We anticipate the availability of preliminary study findings in 2026. CONCLUSIONS This study will provide key insights on the feasibility and effectiveness of a PrEP implementation strategy among people at increased risk of HIV acquisition in an urban jail in the South. This practical and scalable strategy can then be used as a model for other urban jails to address HIV-related inequities. CLINICALTRIAL N/A