Isoniazid preventive therapy completion in children under 5 years old who are contacts of tuberculosis cases in Lima, Peru: study protocol for an open-label, cluster-randomized superiority trial.
Isoniazid preventive therapy completion in children under 5 years old who are contacts of tuberculosis cases in Lima, Peru: study protocol for an open-label, cluster-randomized superiority trial.
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接触结核病病例的 5 岁以下儿童患严重和致命结核病的风险很高。接触者调查、卡介苗接种和异烟肼预防治疗（IPT）是预防儿童结核病的最有效策略。然而，IPT 的实施在儿童（尤其是 5 岁以下）结核感染护理的多个阶段面临挑战。在秘鲁，很大一部分儿童没有完成 IPT，这凸显了设计有效干预措施的必要性，以提高预防性治疗的依从性和完成率。尽管此类干预措施的证据不断增加，但在中等结核病发病率环境中的干预措施仍然缺乏。本研究旨在测试干预方案的有效性、可接受性和可行性，以增加已接受 IPT 治疗的 < 5 儿童完成 IPT 的信息和动力。一项开放标签、整群随机优势试验将在秘鲁南利马的两个地区进行。 30 个卫生机构将被随机分组，其中 10 个用于干预，20 个用于控制（标准护理）。我们的目标是在每个集群中招募来自不同家庭的 10 名儿童。参与者将是发起 IPT 的 5 岁以下儿童的看护人。干预措施包括教育材料、短信服务 (SMS) 提醒和激励。主要结果将是接受 24 周 IPT 的儿童比例（22 次）以及接受 24 周 IPT 的儿童比例。护理标准是每周到医疗机构接诊，每月进行检查。干预措施的可行性和可接受性将通过与看护人的面谈进行评估。幼儿结核病的不良后果、IPT 的高有效性以及 IPT 完成率低，凸显了提高 5 岁以下儿童 IPT 依从性和完成率的必要性。需要对适应环境的干预措施进行测试，以提高 IPT 完成率，从而提高幼儿结核病的预防。 ClinicalTrials.gov NCT03881228。注册于 2019 年 3 月 19 日。在线版本包含可在 10.1186/s13063-022-07062-6 获取的补充材料。
Children < 5 years old in contact with TB cases are at high risk for developing severe and fatal forms of TB. Contact investigation, BCG vaccination, and isoniazid preventive therapy (IPT) are the most effective strategies to prevent TB among children. However, the implementation of IPT faces challenges at several stages of the cascade of care of TB infection among children, particularly those less than 5 years old. In Peru, a large proportion of children do not complete IPT, which highlights the need to design effective interventions that enhance preventive therapy adherence and completion. Although the body of evidence for such interventions has grown, interventions in medium TB incidence settings are lacking. This study aims to test the effectiveness, acceptability, and feasibility of an intervention package to increase information and motivation to complete IPT among children < 5 who have been prescribed IPT. An open-label, cluster-randomized superiority trial will be conducted in two districts in South Lima, Peru. Thirty health facilities will be randomized as clusters, 10 to the intervention and 20 to control (standard of care). We aim to recruit 10 children from different households in each cluster. Participants will be caretakers of children aged < 5 years old who initiated IPT. The intervention consists of educational material, and short message services (SMS) reminders and motivators. The primary outcomes will be the proportion of children who picked up > 90% of the 24 weeks of IPT (22 pick-ups) and the proportion of children who picked up the 24 weeks of IPT. The standard of care is a weekly pick-up with monthly check-ups in a health facility. Feasibility and acceptability of the intervention will be assessed through an interview with the caretaker. Unfavorable outcomes of TB in young children, high effectiveness of IPT, and low rates of IPT completion highlight the need to enhance adherence and completion of IPT among children < 5 years old. Testing of a context-adapted intervention is needed to improve IPT completion rates and therefore TB prevention in young children. ClinicalTrials.gov NCT03881228. Registered on March 19, 2019. The online version contains supplementary material available at 10.1186/s13063-022-07062-6.
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影响因子：
3.3
作者：
Otero, Larissa;Battaglioli, Tullia;Van der Stuyft, Patrick
通讯作者：
Van der Stuyft, Patrick
影响因子：
168.9
作者：
Reuter, Anja;Hughes, Jennifer;Furin, Jennifer
通讯作者：
Furin, Jennifer
影响因子：
4.2
作者：
Fisher, JD;Fisher, WA;Misovich, SJ
通讯作者：
Misovich, SJ
影响因子：
10
作者：
Mandalakas, Anna M.;Hesseling, Anneke C.;Sinanovic, Edina
通讯作者：
Sinanovic, Edina
DOI：
10.1002/14651858.cd007952.pub3
发表时间：
2015-09-03
期刊：
The Cochrane database of systematic reviews
影响因子：
--
作者：
Lutge EE;Wiysonge CS;Knight SE;Sinclair D;Volmink J
通讯作者：
Volmink J