Langa José C, Sidat Mohsin, Sacarlal Jahit, Moon Troy D
Department of Microbiology, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique.
Department of Community Health, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique.
PLoS One. 2025 May 23;20(5):e0324792. doi: 10.1371/journal.pone.0324792. eCollection 2025.
Laboratory diagnosis for cryptococcal disease among HIV-infected patients remains a challenge in most low- and middle-income countries (LMIC). Difficulties with sustained access to cryptococcal rapid tests is cited as a major barrier to the routine screening for cryptococcus in many LMIC. Thus, clinicians in these countries often resort to empirical treatment based solely on clinical suspicion of cryptococcosis. To address this challenge, we aim to evaluate the re-introduction of India ink testing for diagnosis of cryptococcosis among HIV-infected patients in southern Mozambique. India ink testing was historically a common first choice, low-cost, laboratory diagnostic tool for cryptococcal infection. This study uses implementation science methods framed by the Dynamic Adaption Process (DAP) and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) conceptual frameworks to develop a multi-phase, stepped-wedged trial using mixed-methods approaches. The study will be conducted in six hospitals from southern Mozambique over a period of 15 months and will include the following phases: pre-implementation (baseline assessment), Adaptation-implementation (gradual introduction of the intervention), and post-implementation (post-intervention assessment). This study aims to promote the use of India Ink staining as a cheap and readily available tool for cryptococcosis diagnosis in southern Mozambique. Lessons learned in this study may be important to inform approaches to overcome the existing challenges in diagnosis of cryptococcosis in many LMICs due unavailability of readily diagnostic tools. Trial registration: ISRCTN11882960, Registered 06 August 2024.
在大多数低收入和中等收入国家（LMIC），对感染艾滋病毒患者的隐球菌病进行实验室诊断仍是一项挑战。在许多低收入和中等收入国家，持续获得隐球菌快速检测存在困难被认为是对隐球菌进行常规筛查的主要障碍。因此，这些国家的临床医生常常仅基于对隐球菌病的临床怀疑就采取经验性治疗。为应对这一挑战，我们旨在评估重新引入印度墨汁染色法用于莫桑比克南部感染艾滋病毒患者隐球菌病的诊断。印度墨汁染色法在历史上是用于隐球菌感染诊断的常见首选、低成本实验室诊断工具。本研究采用由动态适应过程（DAP）以及覆盖、效果、采用、实施和维持（RE-AIM）概念框架构建的实施科学方法，运用混合方法开展一项多阶段、阶梯楔形试验。该研究将在莫桑比克南部的六家医院进行，为期15个月，包括以下阶段：实施前（基线评估）、适应-实施（逐步引入干预措施）和实施后（干预后评估）。本研究旨在推广将印度墨汁染色作为一种廉价且易于获得的工具，用于莫桑比克南部隐球菌病的诊断。鉴于缺乏现成的诊断工具，本研究中吸取的经验教训对于为许多低收入和中等收入国家克服隐球菌病诊断方面的现有挑战提供方法可能具有重要意义。试验注册号：ISRCTN11882960，于2024年8月6日注册。
