IMPLEMENTATION SCIENCE

Background
Cabotegravir (CAB) for PrEP has provided people, who for varying reasons, are more likely to acquire HIV with a new prevention option. The long-acting (LA) injectable modality can contribute to reducing disparities in HIV infections and PrEP utilization. In 2019, of the approximately 37,000 new cases of HIV infection in the United States (U.S.), 19% were among cisgender women and 1% were among transgender women.^[1] In 2022, among all cisgender women, 55% of diagnoses were among African American/Black women. Among all transgender women, 46% of diagnoses were among African American/Black TGW.^[2] The Southern U.S. accounted for the highest number of diagnoses of HIV infection among women, with the largest being among African American/Black (22%) women.

Goals
The EBONI study is evaluating the appropriateness of CAB LA for PrEP as assessed by various clinic staff, also known as Study Staff Participants (SPPs). The study will compare each of three study arms that have different strategies to support the implementation of CAB LA for PrEP the clinical setting: Standard Implementation (SI), Enhanced Implementation (EI) and Enhanced Collaborative Implementation (ECI). Additionally, the study is evaluating the acceptability of CAB LA for PrEP while also evaluating the fidelity to injection and dosing window across traditional and non-traditional settings.

Design
Approximately 21 clinical sites were randomized 1:1:1 in the three implementation conditions. Randomization occured at the level of study sites (which may vary in size and type) and the study also enrolled various clinical staff at each study site. Approximately 160 HIV-negative individuals will be enrolled once CAB LA for PrEP is prescribed to them; a minimum of 20% and no more than 30% will be transwomen. Sites randomized to SI have access to standard CAB LA for PrEP resources for providers and patients to use as needed along with implementation monitoring. Sites randomized to the EI arm and the ECI arm received enhanced resources for providers and patients and provider education. Quantitative and qualitative measures will be used to assess the outcomes from the perspectives of SSPs and Patient Study Participants (PSPs), to determine effective implementation strategies and to identify barriers and facilitators (including solutions).

View EBONI congress posters

• Designing the EBONI Study: Role of Providers and Black Women
  Presented at XULA 2024
  

• Integrating long-acting injectable cabotegravir for PrEP into standard of care for cisgender women, transgender women, transgender men, and men who have sex with men: results from the PILLAR & EBONI studies
  Presented at IDWeek 2023
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• Engaging black women on cabotegravir LA for prep by optimizing novel implementation strategies (EBONI) study: provider perceptions of appropriateness cabotegravir la for prep for cis- and- trans black women
  Presented at IDWeek 2023
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• Addressing Inequities in Awareness and Uptake of HIV Biomedical Prevention for US Black Women: The Role of Providers and Black Women in Designing the EBONI Study
  Presented at SDIH 2023
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