Centro Internacional de Entrenamiento e Investigaciones Médicas, CIDEIM, Cali, Colombia.
Universidad Icesi, Cali, Colombia.
PLoS Negl Trop Dis. 2023 Mar 27;17(3):e0011180. doi: 10.1371/journal.pntd.0011180. eCollection 2023 Mar.
In Latin America, cutaneous leishmaniasis primarily affects dispersed rural communities, that have limited access to the public health system and medical attention. Mobile health (mHealth) strategies have shown potential to improve clinical management and epidemiological surveillance of neglected tropical diseases, particularly those of the skin.
The Guaral +ST app for Android was designed to monitor cutaneous leishmaniasis treatment and assess therapeutic response. We carried out a randomized trial in the coastal municipality of Tumaco in southwestern Colombia, with parallel arms comparing a) follow-up aided by the app to b) standard institution-based follow-up. Treatment was prescribed according to national guidelines. Follow-up of therapeutic response was scheduled at the end of treatment and at 7, 13 and 26 weeks after the start of treatment. The primary endpoint was the proportion of participants who were monitored at or around week 26, allowing outcome and effectiveness of treatment to be determined.
Follow-up of treatment and outcome assessment was achieved in significantly more patients in the intervention arm than the controls, Of the 75 participants in the two randomized arms, 74 had information on whether or not treatment was followed and outcome determined at or around week 26. Among these, 26/49 (53.1%) were evaluated in the intervention arm, and none (0/25, 0%) in the control arm (difference = 53.1%, 95% confidence interval 39.1-67.0%, p<0.001). Of the 26 participants evaluated at or around week 26 in the intervention arm, 22 (84.6%) had cured. There were no serious adverse events, nor events of severe intensity among patients monitored by CHW using the app.
This study provides proof of concept for mHealth to monitor treatment of CL in remote and complex settings, deliver improved care and to provide information to the health system on the effectiveness of treatment as it is delivered to affected populations.
ISRCTN54865992.
在拉丁美洲，皮肤利什曼病主要影响分散的农村社区，这些社区获得公共卫生系统和医疗服务的机会有限。移动医疗（mHealth）策略已显示出改善被忽视热带病（尤其是皮肤疾病）临床管理和流行病学监测的潜力。
为了监测皮肤利什曼病的治疗并评估治疗反应，我们为安卓系统设计了“Guaral+ST”应用程序。我们在哥伦比亚西南部沿海城市图马科进行了一项随机试验，平行组比较了 a）应用程序辅助随访与 b）基于机构的标准随访。治疗方案根据国家指南制定。治疗结束时以及治疗开始后 7、13 和 26 周时安排了治疗反应的随访。主要终点是在 26 周左右接受监测的参与者比例，以确定治疗结局和效果。
干预组接受治疗和结局评估的患者明显多于对照组。在两个随机组的 75 名参与者中，有 74 名提供了关于是否按照规定接受治疗以及在 26 周左右是否确定结局的信息。其中，在干预组有 26/49（53.1%）接受了评估，而对照组无一例（0/25，0%）（差异=53.1%，95%置信区间 39.1-67.0%，p<0.001）。在干预组中，在 26 周左右接受评估的 26 名参与者中，有 22 名（84.6%）治愈。使用应用程序由 CHW 监测的患者均无严重不良事件，也无严重强度事件。
这项研究为 mHealth 在偏远和复杂环境中监测 CL 治疗、提供更好的护理以及向卫生系统提供关于治疗效果的信息提供了概念验证，因为这些信息是在为受影响人群提供治疗时获得的。
ISRCTN54865992。
