Perspectives of people living with HIV‐1 on implementation of long‐acting cabotegravir plus rilpivirine in US healthcare settings: results from the CUSTOMIZE hybrid III implementation‐effectiveness study

作者：Cindy Garris, Maggie Czarnogorski, Marybeth Dalessandro, Ronald D’Amico, Toyin Nwafor, Will Williams, Deanna Merrill, Yuanyuan Wang, Larissa Stassek, Michael Wohlfeiler, Gary Sinclair, Leandro Mena, Blair Thedinger, Jason Flamm, Paul Benson, William Spreen · 发表于：Journal of the International AIDS Society · 年份：2022 · DOI：10.1002/jia2.26006 · 被引用次数：45 · 研究领域：HIV-related health complications and treatments、HIV/AIDS drug development and treatment、HIV, Drug Use, Sexual Risk

INTRODUCTION: The CUSTOMIZE hybrid III implementation-effectiveness study evaluated implementation of once-monthly long-acting (LA) cabotegravir + rilpivirine in diverse US healthcare settings. Here, we report patient participant perspectives after 12 months in CUSTOMIZE. METHODS: CUSTOMIZE was a phase IIIb, 12-month study conducted from July 2019 to October 2020 at eight diverse US HIV clinics that enrolled virologically suppressed people living with HIV-1 (PLHIV) on a stable oral regimen to receive monthly cabotegravir + rilpivirine LA injections after a 1-month oral lead-in. Participants were administered quantitative surveys before injections at months 1 (baseline), 4 and 12. A randomly selected subset of participants was interviewed at baseline and month 12. Data collection at month 12 was completed by October 2020 (during the COVID-19 pandemic). RESULTS: At baseline, 109 and 34 participants completed surveys and interviews, respectively; 87% were male; 35% were Black or African American. All participants who remained in the study at month 12 (n = 102) maintained HIV-1 RNA <50 copies/ml; two participants withdrew due to injection-related reasons. Mean total scores measuring acceptability and appropriateness of cabotegravir + rilpivirine LA were high at baseline (4.5-4.6 out of 5) and month 12 (4.7-4.9). At month 12, 74% of participants reported nothing interfered with receiving LA injections; injection pain or soreness was the most common concern (15%). Time spent in the...