Feasibility, Fidelity, and Effectiveness of Administering Long-Acting Cabotegravir + Rilpivirine in Infusion Centers in the United States: Findings From the Phase 4 GLACIER Implementation Study.

BackgroundGLACIER (Giving Long-Acting Cabotegravir plus rilpivirine [CAB + RPV LA] in an Infusion Center [IC]) is a Phase 4 implementation study evaluating the perspective of people living with HIV-1 (participants) and IC staff on CAB + RPV LA delivery at ICs over 8 months.MethodsParticipants and IC staff completed quantitative questionnaires on feasibility (Feasibility of Intervention Measure [FIM]) and acceptability (Acceptability of Intervention Measure [AIM]) at Month (M) 1, M3, and M8; both scales comprised four items, rated on a 1 to 5 Likert scale (1 "completely disagree" to 5 "completely agree"). Semistructured qualitative interviews and clinical outcomes data were also collected.ResultsAmong 44 enrolled participants (mean age 46 years), 51% were CAB + RPV LA-naive; 113 IC staff were enrolled. At M1, mean FIM scores (standard deviation [SD]) indicated that both groups found IC administration highly feasible (participants: 4.44 [0.80]; IC staff: 3.71 [0.97]), with scores remaining high at M3 (participants: 4.53 [0.69]; IC staff: 3.86 [0.72]) through to M8 (participants: 4.41 [0.80]; IC staff: 4.00 [0.81]). Similar findings were observed for mean AIM scores (SD), indicating high acceptance at M1 (participants: 4.51 [0.66]; IC staff: 3.65 [0.89]) to M3 (participants: 4.60 [0.67]; IC staff: 3.60 [0.97]) through to M8 (participants: 4.51 [0.55]; IC staff: 3.96 [0.84]). Qualitative data supported these observations. Of 194 injections, 96.4% were within the treatment window; virological suppression was maintained with no confirmed virological failures or adverse event-related discontinuations.ConclusionsCAB + RPV LA administration at ICs was feasible, acceptable, well-tolerated, and effective.ClinicalTrials.gov numberNCT04982445 (https://clinicaltrials.gov/study/NCT04982445).