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)


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.