Cassidy A. Gutner, Laurent Hocqueloux, Celia Jonsson-Oldenbüttel, Linos Vandekerckhove, Berend J. van Welzen, Laurence Slama, María Crusells-Canales, Julián Olalla Sierra, Rebecca DeMoor, Jenny Scherzer, Mounir Ait-Khaled, Gilda Bontempo, Martin Gill, Natasha Patel, Ronald D'Amico, Kai Hove, Bryan Baugh, Nicola Barnes, Monica Hadi, Emma L. Low, Savita Bakhshi Anand, Alison Hamilton, Harmony P. Garges, Maggie Czarnogorski
{"title":"长效卡博特拉韦和利匹韦林的实施:从欧洲各地卡博特拉韦和利匹韦林实施研究的工作人员研究参与者角度得出的主要结果。","authors":"Cassidy A. Gutner, Laurent Hocqueloux, Celia Jonsson-Oldenbüttel, Linos Vandekerckhove, Berend J. van Welzen, Laurence Slama, María Crusells-Canales, Julián Olalla Sierra, Rebecca DeMoor, Jenny Scherzer, Mounir Ait-Khaled, Gilda Bontempo, Martin Gill, Natasha Patel, Ronald D'Amico, Kai Hove, Bryan Baugh, Nicola Barnes, Monica Hadi, Emma L. Low, Savita Bakhshi Anand, Alison Hamilton, Harmony P. Garges, Maggie Czarnogorski","doi":"10.1002/jia2.26243","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Introduction</h3>\n \n <p>Cabotegravir plus rilpivirine (CAB + RPV) is the first complete long-acting (LA) regimen recommended for maintaining HIV-1 virological suppression. Cabotegravir And Rilpivirine Implementation Study in European Locations (CARISEL) is an implementation–effectiveness study examining the implementation of CAB+RPV LA administered every 2 months (Q2M) in European HIV centres. We present staff study participant (SSP) perspectives on the administration of CAB+RPV LA over 12 months.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>Eighteen clinics were randomized to one of two implementation support packages: standard arm (Arm-S) or enhanced arm (Arm-E). Arm-S included video injection training and provider/patient toolkits. Additionally, Arm-E included skilled wrap-around team meetings, face-to-face injection training and continuous quality improvement (CQI) calls. SSPs completed surveys on the acceptability, appropriateness and feasibility of CAB+RPV LA as an intervention and its implementation into their clinics, as well as barriers and facilitators to implementation. All surveys were completed at Month (M)1 (baseline), M5 and M12; data collection was completed by February 2022. Qualitative data were obtained from semi-structured interviews at M1, M5 and M12. The primary objective was assessed via formal statistical comparisons between study arms of the Acceptability of Implementation Measure, Implementation Appropriateness Measure and Feasibility of Implementation Measure surveys (1–5 Likert scale ranging from 1 = “completely disagree” to 5 = “completely agree”). Equivalent measures anchored to CAB+RPV LA as a therapy were also assessed.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Seventy SSPs completed surveys and interviews at M1, 68 at M5 and 62 at M12. Mean acceptability/appropriateness/feasibility scores were ≥3.8 (out of 5) at M12 for implementation- and intervention-based measures. An analysis of covariance showed no significant differences between study arms for these outcomes. Although barriers were noted, most SSPs were not overly concerned that these would impact implementation; concern about these anticipated barriers also decreased over time. At M12, 90.3% (<i>n</i> = 56/62) of SSPs held a positive opinion about CAB+RPV LA implementation. Qualitative interviews and CQI calls highlighted three top practices that supported implementation: implementation planning; education about CAB+RPV LA clinical efficacy; and education around administering injections and managing pain/discomfort after injections.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>CARISEL demonstrated that CAB+RPV LA dosed Q2M was successfully implemented across a range of European locations, with SSPs finding implementation highly acceptable, appropriate and feasible.</p>\n </section>\n \n <section>\n \n <h3> ClinicalTrials.gov number</h3>\n \n <p>NCT04399551</p>\n </section>\n </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":null,"pages":null},"PeriodicalIF":4.6000,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11231444/pdf/","citationCount":"0","resultStr":"{\"title\":\"Implementation of long-acting cabotegravir and rilpivirine: primary results from the perspective of staff study participants in the Cabotegravir And Rilpivirine Implementation Study in European Locations\",\"authors\":\"Cassidy A. 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Implementation of long-acting cabotegravir and rilpivirine: primary results from the perspective of staff study participants in the Cabotegravir And Rilpivirine Implementation Study in European Locations
Introduction
Cabotegravir plus rilpivirine (CAB + RPV) is the first complete long-acting (LA) regimen recommended for maintaining HIV-1 virological suppression. Cabotegravir And Rilpivirine Implementation Study in European Locations (CARISEL) is an implementation–effectiveness study examining the implementation of CAB+RPV LA administered every 2 months (Q2M) in European HIV centres. We present staff study participant (SSP) perspectives on the administration of CAB+RPV LA over 12 months.
Methods
Eighteen clinics were randomized to one of two implementation support packages: standard arm (Arm-S) or enhanced arm (Arm-E). Arm-S included video injection training and provider/patient toolkits. Additionally, Arm-E included skilled wrap-around team meetings, face-to-face injection training and continuous quality improvement (CQI) calls. SSPs completed surveys on the acceptability, appropriateness and feasibility of CAB+RPV LA as an intervention and its implementation into their clinics, as well as barriers and facilitators to implementation. All surveys were completed at Month (M)1 (baseline), M5 and M12; data collection was completed by February 2022. Qualitative data were obtained from semi-structured interviews at M1, M5 and M12. The primary objective was assessed via formal statistical comparisons between study arms of the Acceptability of Implementation Measure, Implementation Appropriateness Measure and Feasibility of Implementation Measure surveys (1–5 Likert scale ranging from 1 = “completely disagree” to 5 = “completely agree”). Equivalent measures anchored to CAB+RPV LA as a therapy were also assessed.
Results
Seventy SSPs completed surveys and interviews at M1, 68 at M5 and 62 at M12. Mean acceptability/appropriateness/feasibility scores were ≥3.8 (out of 5) at M12 for implementation- and intervention-based measures. An analysis of covariance showed no significant differences between study arms for these outcomes. Although barriers were noted, most SSPs were not overly concerned that these would impact implementation; concern about these anticipated barriers also decreased over time. At M12, 90.3% (n = 56/62) of SSPs held a positive opinion about CAB+RPV LA implementation. Qualitative interviews and CQI calls highlighted three top practices that supported implementation: implementation planning; education about CAB+RPV LA clinical efficacy; and education around administering injections and managing pain/discomfort after injections.
Conclusions
CARISEL demonstrated that CAB+RPV LA dosed Q2M was successfully implemented across a range of European locations, with SSPs finding implementation highly acceptable, appropriate and feasible.
期刊介绍:
The Journal of the International AIDS Society (JIAS) is a peer-reviewed and Open Access journal for the generation and dissemination of evidence from a wide range of disciplines: basic and biomedical sciences; behavioural sciences; epidemiology; clinical sciences; health economics and health policy; operations research and implementation sciences; and social sciences and humanities. Submission of HIV research carried out in low- and middle-income countries is strongly encouraged.