IMPLEMENTATION SCIENCE

Background
Men who have sex with men (MSM) accounted for a majority of new HIV diagnoses in the United States (U.S.) – 68% in 2020. Unfortunately, the lifetime risk for HIV infection among Black and Latino MSM and transgender men is even higher than that of the general male population. PrEP, an effective medication that prevents the acquisition of HIV, is available in the U.S. However, access to and use of PrEP remains very low, especially among Black and Latino MSM and transgender men. Barriers to use include but is not limited to, confidentiality concerns, stigma, or lack of geographic access to clinics providing PrEP. Cabotegravir long acting injectable for pre-exposure prophylaxis (CAB LA for PrEP), the first injectable HIV prevention option, may alleviate these barriers but implementation challenges of this new option must be rapidly addressed. CAB LA for PrEP has been developed to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals. The PILLAR study assessed innovative strategies that address challenges associated with feasibility of CAB LA for PrEP delivery.

Goals
The PILLAR study evaluated the process of integrating CAB LA for PrEP into standard of care at existing low and high PrEP sites from the perspective of staff and patients. The study assessed the feasibility of a set of enhanced toolkits and implementation strategies (dynamic implementation) relative to standard toolkits (routine implementation). The acceptability for CAB LA for PrEP by MSM and transgender men was also assessed.

Design
The PILLAR study is designed to evaluate the impact of two implementation strategy conditions – dynamic and routine implementation- in high and low volume PrEP sites over 12 months. Clinical sites were randomized 2:1 in the dynamic or routine implementation arms. 201 HIV negative individuals were enrolled once CAB LA for PrEP was prescribed to them; 58% were Black or Latino. 86 clinical staff also enrolled as Staff Study Participants (SSP) and completed questionnaires and interviews.

View PILLAR study congress posters

• Influencers and Decision-Making Factors for Choosing Injectable PrEP Among Men Who Have Sex With Men and Transgender Men in the United States
  Presented at AIDS 2024
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• Initial Clinical Care Experiences of Men Who Have Sex with Men and Transgender Men who Choose Injectable PrEP in the United States: Results from the PILLAR Study
  Presented at Continuum 2024
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• Healthcare Staff Acceptability and Feasibility of Telehealth Delivery of Cabotegravir for PrEP
  Presented at CROI 2024
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• Integrating long-acting PrEP into Care: PILLAR & EBONI Results
  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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• Healthcare staff perceptions of feasibility and acceptability on implementing injectable HIV pre-exposure prophylaxis into standard of care: baseline results from the PrEP implementation study for cabotegravir long acting for men in the real world (PILLAR)
  Presented at IDWeek 2023
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• Implementation Modifications to Support Injectable HIV Pre-exposure Prophylaxis Into Standard of Care in The United States: FRAME-IS Results From the PrEP Implementation Study For Cabotegravir Long Acting For Men in The Real World (PILLAR)
  Presented at SDIH, 2023
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