Understanding acceptance of and adherence to a new formulation of paediatric antiretroviral treatment in the form of pellets (LPV/r)-A realist evaluation
Understanding acceptance of and adherence to a new formulation of paediatric antiretroviral treatment in the form of pellets (LPV/r)-A realist evaluation
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DOI：
10.1371/journal.pone.0220408
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发表时间：
2019-08-21
期刊：
影响因子：
3.7
通讯作者：
Marchal, Bruno
中科院分区：
文献类型：
--
作者：
Giralt, Ariadna Nebot;Nostlingerl, Christiana;Marchal, Bruno
改善儿科艾滋病毒治疗的可及性需要大规模的抗逆转录病毒治疗规划和适应婴儿和儿童需求的药物。世界卫生组织推荐洛匹那韦/利托那韦加两种核苷逆转录酶抑制剂作为所有三岁以下感染艾滋病毒的儿童的一线治疗，通常作为糖浆给予。为了克服糖浆制剂的苦味、毒性和冷藏等缺点，开发了丸剂制剂（即装入胶囊的压缩药物的小圆柱体）。本研究评估了影响护理人员接受和坚持洛匹那韦/利托那韦微丸的多层次因素及其潜在机制。方法在肯尼亚的三家医院进行临床试验，采用现实主义评估（一种考虑社会背景和变化机制的理论驱动评估方法）。通过文献回顾、家庭和诊所环境中的观察（n = 34）以及与护理人员和提供者的半结构化访谈（n = 44）收集数据。数据分析基于现实主义原则。结果观察到高水平的治疗起始和依从性。掩盖味道，中性包装和易于储存使新配方非常容易接受。护理人员制定了提供治疗的个人策略，特别是为了克服特定问题，例如，在刚刚断奶的婴儿或食物短缺的情况下。一个完善的程序理论从三角分析的结果中浮现出来，表明管理的便利性，自我效能和照顾者能力的提高，以及有效的提供者支持有助于高水平的坚持。结论与糖浆相比，以颗粒形式制定联合抗逆转录病毒治疗显然是婴儿和儿童及其护理人员更可接受的解决方案。在非试验环境下的进一步研究可能会揭示与提供者、服务和卫生系统有关的因素，这些因素有助于更好地遵守这些配方。
BackgroundImproving access to paediatric HIV treatment requires large-scale antiretroviral treatment programmes and medication adapted to infants and children's needs. The World Health Organisation recommends lopinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors as first-line treatment for all HIV-infected children younger than three years, usually given as a syrup. A pellet formulation (i.e. tiny cylinders of compressed medication put in capsules) was developed to overcome the syrup formulation's disadvantages such as bitterness, toxicity and cold storage. This study assessed multi-level factors influencing caregivers' acceptance of and adherence to lopinavir/ritonavir pellets as well as their underlying mechanisms.MethodsA realist evaluation (a theory-driven evaluation method considering the social context and mechanisms of change), embedded in a clinical trial was carried out in three hospital settings in Kenya. Data were collected through document review, observations (n = 34) in home and clinic settings and semi-structured interviews (n = 44) with caregivers and providers. Data analysis was based on realist principles.ResultsHigh levels of treatment initiation and adherence were observed. Taste masking, neutral packaging and easy storage made the new formulation highly acceptable. Caregivers developed individual strategies to deliver the treatment, particularly to overcome specific problems e.g. in case of just-weaned babies or food shortage. A refined program theory emerged from the triangulated findings showing that ease of administration combined with increased self-efficacy and competences of the caregivers, and effective provider support contributed to high levels of adherence.ConclusionsFormulating combined antiretroviral treatment in the form of pellets is clearly a more acceptable solution for infants and children and their caregivers compared to the syrup. Further research in non-trial settings may shed light on factors related to providers, services and the health system that contribute to better adherence of such formulations.