Rotsaert Anke, Ogara Collin, Mwanga-Amumpaire Juliet, Kekitiinwa Adeodata R, Musiime Victor, Najjingo Elizabeth, Kisitu Grace P, Nazzinda Rashidah, Nambi Esther, Lee Janice, Diallo Mariama, Kyomuhendo Flavia, Waweru Moses, Andrieux-Meyer Isabelle, Nöstlinger Christiana
Department of Public Health, Institute of Tropical Medicine, Nationalestraat 155, Antwerp 2000, Belgium.
Makerere University, Kampala, Uganda.
Ther Adv Infect Dis. 2023 Mar 21;10:20499361231159993. doi: 10.1177/20499361231159993. eCollection 2023 Jan-Dec.
Worldwide, 1.7 million children younger than 15 years were living with HIV in 2021. Only 52% of them had access to antiretrovirals (ARVs). Lack of age-appropriate ARV formulations (i.e. easy to swallow for young infants, acceptable taste) remains the main obstacle to the access to ARVs. Therefore, a strawberry-flavoured Abacavir/Lamivudine/Lopinavir/Ritonavir (30/15/40/10 mg) fixed-dose combination of granules in a capsule (4-in-1) for children living with HIV weighing 3-25 kg was developed.
We assessed caregivers' perceived acceptability of the 4-in-1 compared with previous paediatric ARV formulations and factors influencing acceptability.
This exploratory qualitative case study embedded in a phase I/II, open-label, randomized cross-over pharmacokinetic, safety and acceptability study (LOLIPOP) was conducted in three sites in Uganda (May 2019-October 2020). Thirty-six children weighing between 3 and 19.9 kg participated in the main study. We purposively sampled caregiver-child dyads according to weight bands, and conducted 20 semi-structured interviews with caregivers and 5 with healthcare providers. We triangulated these results with a quantitative acceptability questionnaire. We analysed interviews inductively using NVivo12 adopting a thematic analysis approach and acceptability questionnaires descriptively to assess concordance between them.
All caregivers found the 4-in-1 formulation highly acceptable and easier to use than previous formulations (i.e. pellets/tables/syrup). Appealing taste, ease of administration, easy storage and children's acceptance contributed to acceptability despite structural challenges of food shortage and HIV stigma. Visible improvements in children's health and comprehensive and tailored healthcare provider support to overcome initial difficulties such as vomiting increased caregivers' acceptance. Concordant results from questionnaire- and interview-data confirmed high acceptability.
Caregivers of children in all weight bands in this sample found the 4-in-1 granules highly acceptable compared with the pellets/tablets combination. Healthcare providers' support to caregivers allowed for individual tailoring of drug administration despite challenges such as food shortage. This enabled short-term adherence. These findings informed further practical recommendations.
Clinical trial number: NCT03836833.
2021年，全球有170万15岁以下儿童感染了艾滋病毒。其中只有52%的儿童能够获得抗逆转录病毒药物（ARV）。缺乏适合儿童年龄的抗逆转录病毒药物剂型（即便于幼儿吞咽、口味可接受）仍然是获取抗逆转录病毒药物的主要障碍。因此，研发了一种草莓口味的阿巴卡韦/拉米夫定/洛匹那韦/利托那韦（30/15/40/10毫克）固定剂量组合的胶囊颗粒剂（四合一剂型），用于体重3至25公斤的感染艾滋病毒儿童。
我们评估了与之前的儿科抗逆转录病毒药物剂型相比，护理人员对四合一剂型的可接受程度以及影响可接受性的因素。
这项探索性定性案例研究嵌入了一项I/II期、开放标签、随机交叉的药代动力学、安全性和可接受性研究（LOLIPOP），在乌干达的三个地点进行（2019年5月至2020年10月）。36名体重在3至19.9公斤之间的儿童参与了主要研究。我们根据体重范围有目的地抽取了护理人员与儿童的配对样本，对护理人员进行了20次半结构化访谈，对医疗服务提供者进行了5次访谈。我们用一份定量可接受性问卷对这些结果进行了三角验证。我们使用NVivo12采用主题分析方法对访谈进行归纳分析，并对可接受性问卷进行描述性分析，以评估两者之间的一致性。
所有护理人员都认为四合一剂型非常可接受，并且比之前使用的剂型（即小丸剂/片剂/糖浆剂）更易于使用。尽管存在食物短缺和艾滋病毒污名化等结构性挑战，但诱人的口味、易于给药、便于储存以及儿童的接受度都提高了可接受性。儿童健康状况的明显改善以及医疗服务提供者全面且量身定制的支持以克服如呕吐等初始困难，提高了护理人员的接受度。问卷数据和访谈数据的一致结果证实了该剂型的高可接受性。
与小丸剂/片剂组合相比，本样本中所有体重范围儿童的护理人员都认为四合一颗粒剂非常可接受。尽管存在食物短缺等挑战，但医疗服务提供者对护理人员的支持使得能够针对个体情况调整药物给药方式。这促进了短期的依从性。这些发现为进一步的实际建议提供了依据。
临床试验编号：NCT03836833。
