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CAB+RPV LA implementation outcomes and acceptability of monthly clinic visits improved during COVID-19 pandemic across US healthcare clinics (CUSTOMIZE: hybrid III implementation-effectiveness study)

Title
CAB+RPV LA implementation outcomes and acceptability of monthly clinic visits improved during COVID-19 pandemic across US healthcare clinics (CUSTOMIZE: hybrid III implementation-effectiveness study)
Presenter
Maggie Czarnogorski
Authors
M. Czarnogorski * (1), C. Garris (1), L. Stassek (2), S. Mansukhani (3), R. D'Amico (1), M. Dalessandro (4), W. Williams (5), S. Wu (5), M. Wohlfeiler (6), J. Flamm (7), P. Benson (8), C. Zurawski (9), M. Bosse (1)
Institutions
(1) ViiV Healthcare, Research Triangle Park, United States, (2) Evidera, Seattle, United States, (3) Evidera, Waltham, United States, (4) ViiV Healthcare, Collegeville, United States, (5) GlaxoSmithKline, Collegeville, United States, (6) AIDS Healthcare Foundation, Miami Beach, United States, (7) Kaiser Permanente, Sacramento, United States, (8) Be Well Medical Center, Berkley, United States, (9) Atlanta I.D. Group, Atlanta, United States

BACKGROUND: COVID-19 has disrupted healthcare service delivery globally. CUSTOMIZE was a 12-month implementation science study evaluating monthly provider-administered cabotegravir+rilpivirine long-acting (CAB+RPV LA), started before and continued during the COVID pandemic. This analysis summarizes COVID-19 impact on CAB+RPV LA implementation outcomes.
METHODS: Implementation outcomes from staff and patients were descriptively compared at Months 4 (M4) (~Nov-Dec 2019, pre-COVID) and 12 (M12) (~Oct 2020, during COVID). 19 patients (19%) had COVID-impacted visits (missed/rescheduled visit, quarantine, clinic closure, etc) related to the pandemic vs. 82 (81%) without COVID-impacted visits.
RESULTS: All implementation outcomes scores among staff and patients improved during COVID (M12) vs pre-COVID (Table). At M4, staff were most concerned about awareness of missed injection visits (45.8%), which decreased to 21.7% at M12. At M12, more staff disagreed that the following were barriers to LA implementation: patient failing LA due to missed doses/injection appointments (78.3% vs. M4: 41.6%), management of other care needs (73.9% vs. 41.6%), and patient transitioning from oral to injectable treatment (91.3% vs. 79.1%). Five patients received temporary OT to cover impacted injection visits. All five restarted LA; no viral failures occurred. No COVID-impacted patients withdrew from the study. Overall patient acceptability of monthly clinic visits slightly improved during COVID (M12: 87.2% vs. M4: 83.3%). At M12, COVID-impacted patients were more likely than non-COVID-impacted patients to indicate that monthly clinic visits were extremely/very acceptable (94.7% vs. 85.5%); to be positive/extremely positive about receiving CAB+RPV LA (100% vs. 97.6%); and to prefer LA over daily oral tablets (94.7% vs. 91.6%).

CONCLUSIONS: During the pandemic, CAB+RPV LA remained highly acceptable and appropriate to staff and patients. Some patients were given OT for missed injection visits and maintained uninterrupted ART; all patients restarted LA with no virologic failures. Acceptability of coming to clinic monthly and preference for LA ART remained extremely high during the COVID pandemic.