Orkin Chloe, Hayes Rosalie, Haviland Joanne, Wong Yuk Lam, Ring Kyle, Apea Vanessa, Kasadha Bakita, Clarke Emily, Byrne Ruth, Fox Julie, Barber Tristan J, Clarke Amanda, Paparini Sara
SHARE Collaborative, Blizard Institute, Queen Mary University of London, London, United Kingdom.
HIV/GUM Directorate, Barts Health NHS Trust, London, United Kingdom.
Clin Infect Dis. 2025 Jun 4;80(5):1103-1113. doi: 10.1093/cid/ciae523.
The equity-focused Implementing Long-Acting Novel Antiretrovirals study evaluated feasibility, acceptability, appropriateness of delivering on-label 2-monthly cabotegravir and rilpivirine (CAB + RPV) injections for human immunodeficiency virus (HIV)-1 therapy in clinics and community settings.
The study, which mandated inclusive recruitment, was conducted May-December 2022 at 6 UK sites. Injections were delivered in clinic (month [M] 1-6) and in clinic or community setting according to patient choice (M6-12). Surveys were completed at baseline, M4, and M12 using validated measures for feasibility (FIM), acceptability (AIM), and appropriateness (IAM). Primary endpoint: proportion of participants agreeing that the injection and community setting were feasible (FIM ≥4) at M12. Fourteen participants completed interviews at baseline and M12.
Community settings offered by sites included: home visits (n = 3), HIV support organizations (n = 2), and community clinic (n = 1). Of 114 participants, 54% were female, 70% racially minoritized, and 40% aged ≥50 years. A total of 27/114 chose to receive injections in community settings. FIM/AIM/IAM scores at M12 were high for the injection (79.0-87.4%) and lower for the community setting (44.2-47.4%) overall. Subgroup analyses indicated differences in scores by gender and ethnicity. Among those who attended the community, FIM/AIM/IAM scores for the community setting at M12 were high (73.1-80.8%). Concerns about stigma, inconvenience, and losing access to trusted clinicians negatively influenced perceptions of receiving injections at community settings, amongst other factors.
CAB + RPV injections were considered highly feasible, acceptable, and appropriate; however, few chose community delivery. Those that chose community delivery found it highly acceptable and feasible. Further exploration of CAB + RPV delivery in alternative community sites not offered (eg, primary care, pharmacies) is warranted.
CLINICALTRIALS.GOV: NCT05294159.
以公平为重点的长效新型抗逆转录病毒药物实施研究评估了在诊所和社区环境中,每两个月进行一次卡博特韦和利匹韦林(CAB + RPV)注射用于人类免疫缺陷病毒(HIV)-1治疗的可行性、可接受性和适宜性。
该研究要求进行包容性招募,于2022年5月至12月在英国的6个地点开展。在诊所进行注射(第1 - 6个月),并根据患者选择在诊所或社区环境中进行注射(第6 - 12个月)。在基线、第4个月和第12个月完成使用可行性(FIM)、可接受性(AIM)和适宜性(IAM)的有效测量方法的调查。主要终点:在第12个月时,同意注射和社区环境可行(FIM≥4)的参与者比例。14名参与者在基线和第12个月完成了访谈。
各地点提供的社区环境包括:家访(n = 3)、HIV支持组织(n = 2)和社区诊所(n = 1)。114名参与者中,54%为女性,70%为少数族裔,40%年龄≥50岁。共有27/114的参与者选择在社区环境中接受注射。总体而言,第12个月时注射的FIM/AIM/IAM评分较高(79.0 - 87.4%),而社区环境的评分较低(44.2 - 47.4%)。亚组分析表明,评分在性别和种族方面存在差异。在参与社区注射的人群中,第12个月时社区环境的FIM/AIM/IAM评分较高(73.1 - 80.8%)。除其他因素外,对耻辱感、不便以及无法接触到信任的临床医生的担忧对在社区环境中接受注射的认知产生了负面影响。
CAB + RPV注射被认为具有高度可行性、可接受性和适宜性;然而,很少有人选择在社区进行注射。那些选择在社区进行注射的人认为其具有高度可接受性和可行性。有必要进一步探索在未提供的替代社区地点(如初级保健机构、药房)进行CAB + RPV注射。
NCT05294159。