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).