一项基于社区的多中心混合方法评估，旨在评估消除淋巴丝虫病的三联药物方案的可接受性。
A multicenter, community-based, mixed methods assessment of the acceptability of a triple drug regimen for elimination of lymphatic filariasis.
机构信息
Bruyère Research Institute, Ottawa, Canada.
School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
出版信息
PLoS Negl Trop Dis. 2021 Mar 3;15(3):e0009002. doi: 10.1371/journal.pntd.0009002. eCollection 2021 Mar.
BACKGROUND
Many countries will not reach elimination targets for lymphatic filariasis in 2020 using the two-drug treatment regimen (diethylcarbamazine citrate [DEC] and albendazole [DA]). A cluster-randomized, community-based safety study performed in Fiji, Haiti, India, Indonesia and Papua New Guinea tested the safety and efficacy of a new regimen of ivermectin, DEC and albendazole (IDA).
METHODOLOGY/PRINCIPAL FINDINGS: To assess acceptability of IDA and DA, a mixed methods study was embedded within this community-based safety study. The study objective was to assess the acceptability of IDA versus DA. Community surveys were performed in each country with randomly selected participants (>14 years) from the safety study participant list in both DA and IDA arms. In depth interviews (IDI) and focus group discussions (FGD) assessed acceptability-related themes. In 1919 individuals, distribution of sex, microfilariae (Mf) presence and circulating filarial antigenemia (CFA), adverse events (AE) and age were similar across arms. A composite acceptability score summed the values from nine indicators (range 9-36). The median (22.5) score indicated threshold of acceptability. There was no difference in scores for IDA and DA regimens. Mean acceptability scores across both treatment arms were: Fiji 33.7 (95% CI: 33.1-34.3); Papua New Guinea 32.9 (95% CI: 31.9-33.8); Indonesia 30.6 (95% CI: 29.8-31.3); Haiti 28.6 (95% CI: 27.8-29.4); India 26.8 (95% CI: 25.6-28) (P<0.001). AE, Mf or CFA were not associated with acceptability. Qualitative research (27 FGD; 42 IDI) highlighted professionalism and appreciation for AE support. No major concerns were detected about number of tablets. Increased uptake of LF treatment by individuals who had never complied with MDA was observed.
CONCLUSIONS/SIGNIFICANCE: IDA and DA regimens for LF elimination were highly and equally acceptable in individuals participating in the community-based safety study in Fiji, Haiti, India, Indonesia, and Papua New Guinea. Country variation in acceptability was significant. Acceptability of the professionalism of the treatment delivery was highlighted.
背景
许多国家使用双药治疗方案（柠檬酸二乙胺嗪[DEC]和阿苯达唑[DA]）无法在 2020 年达到消灭淋巴丝虫病的目标。在斐济、海地、印度、印度尼西亚和巴布亚新几内亚进行的一项基于社区的安全性研究中，采用了伊维菌素、DEC 和阿苯达唑（IDA）的新方案进行了一项随机分组、基于社区的安全性研究，以测试其安全性和疗效。
方法/主要发现：为了评估 IDA 和 DA 的可接受性，在这项基于社区的安全性研究中嵌入了一项混合方法研究。研究目的是评估 IDA 与 DA 的可接受性。在每个国家，从 DA 和 IDA 臂的安全性研究参与者名单中随机选择参与者（>14 岁）进行社区调查。深入访谈（IDI）和焦点小组讨论（FGD）评估了与可接受性相关的主题。在 1919 名参与者中，手臂间的性别分布、微丝蚴（Mf）存在和循环丝状抗原血症（CFA）、不良事件（AE）和年龄相似。综合可接受性评分将九个指标的值相加（范围 9-36）。中位数（22.5）得分表示可接受性的阈值。IDA 和 DA 方案的评分无差异。两个治疗组的平均可接受性评分分别为：斐济 33.7（95%CI：33.1-34.3）；巴布亚新几内亚 32.9（95%CI：31.9-33.8）；印度尼西亚 30.6（95%CI：29.8-31.3）；海地 28.6（95%CI：27.8-29.4）；印度 26.8（95%CI：25.6-28）（P<0.001）。AE、Mf 或 CFA 与可接受性无关。定性研究（27 个 FGD；42 个 IDI）突出了 AE 支持的专业性和赞赏。对片剂数量没有明显的担忧。从未遵守 MDA 的个人中观察到 LF 治疗的接受度增加。
结论/意义：在参与斐济、海地、印度、印度尼西亚和巴布亚新几内亚的基于社区的安全性研究的个体中，IDA 和 DA 方案用于消灭淋巴丝虫病非常高且同样可接受。国家间的可接受性差异具有统计学意义。突出了对治疗提供专业性的认可。
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