Trial reportJournal of the International Association of Providers of AIDS Care
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.
Trial report in Journal of the International Association of Providers of AIDS Care. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04982445 (A Phase 4, Open-label, Single Arm Study to Optimize Implementation of CABENUVA for the Treatment of HIV-1, for Administration in U.S. Community-based Infusion Centers or Other Alternate Sites of Administration), which is not on this map. Not yet cited in PubMed.
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A Phase 4, Open-label, Single Arm Study to Optimize Implementation of CABENUVA for the Treatment of HIV-1, for Administration in U.S. Community-based Infusion Centers or Other Alternate Sites of Administration
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Authors and funding
17 authors.
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Abstract
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).
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