ENGAGING BLACK WOMEN ON CAB LA FOR PREP BY OPTIMIZING NOVEL IMPLEMENTATION STRATEGIES (EBONI) STUDY
Background
Cabotegravir (CAB) for PrEP will provide 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. Of the approximately 37K new cases of HIV infection in the United States (U.S.), 19% were among cisgender women and 1% were among transgender women. 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. 1,2 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
This study aims to evaluate the appropriateness of CAB LA for PrEP as assessed by Study Staff Participants (SPPs). EBONI compares 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 the Enhanced Collaborative Implementation (ECI) compared to the SI arm. Additionally, the study aims to evaluate 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 will be randomized 1:1:1 in the three implementation conditions. Randomization will occur at the level of study sites (which may vary in size and type) and the study will enroll the staff at the study site. Approximately 250 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 will have access to standard CAB PrEP resources for providers and patients to use as needed along with implementation monitoring. Sites randomized to the EI arm and the ECI arm will both receive 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 PSPs, to determine effective implementation strategies and to identify barriers and facilitators (including solutions).
ViiV Study Lead and Contact
Tammeka Evans, Senior Director of Global Public Health and Innovation
References
- Centers for Disease Control and Prevention. (2021) Monitoring selected national HIV prevention and care objectives by using HIV surveillance data—United States and 6 dependent areas, 2019. HIV Surveillance Supplemental Report 26(No. 2). http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html. Published May 2021. Accessed September 12, 2021.
- Centers for Disease Control and Prevention. (2019, April) HIV and Transgender Communities. Issue Brief. Retrieved from HIV and Transgender Communities (cdc.gov)
Collaborators
Syneos Health
RTI International
Clinical sites in the Ending
the Epidemic Territories
Setting
Clinical Settings
Location
United States
Duration
Aug 2022 – Aug 2024
Study ID
Collaboration Study – IMP 217711
Category
Health Related Quality of Life/Long-acting Prevention and Treatment Implementation
Study focus areas
Our implementation research projects have a global reach and focus on improving the HIV prevention and care continuum.
NP-GBL-HVX-WCNT-220049 October 2023
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