皮毛前沿资讯|mLab+移动健康App辅助HIV与梅毒自检的可行性与可用性:试点随机对照研究

*仅供医学专业人士阅读参考

小编按：

今天小编带给大家的是来自Mayada M. Mahmoud团队于2025年12月发表在《MIR formative research》杂志上的Feasibility and Usability of an mHealth App (mLab+) to Guide Users Through HIV and Syphilis Self-Testing: Pilot Randomized Controlled Trial.（mLab+移动健康App辅助HIV与梅毒自检的可行性与可用性：试点随机对照研究）

作者团队介绍

Rebecca Schnall，博士，任职于美国哥伦比亚大学护理学院与梅尔曼公共卫生学院，主要研究方向为移动健康技术在HIV预防、自检与性传播感染防控中的应用，是mLab与mLab+系列App的主要研发者。

研究背景

HIV自检是美国“终结HIV流行”计划的核心策略，既往mLab App已证实可有效提升HIV自检率。美国梅毒发病率持续上升，男男性行为人群（MSM）是HIV与梅毒共感染高危群体，两类感染风险高度重叠。居家自检可解决隐私顾虑、可及性不足等问题，但缺乏同时支持HIV+梅毒双联自检的移动辅助工具。现有快速自检存在结果判读困难、操作步骤复杂、缺乏专业引导等问题，亟需配套移动应用提升自检准确性与完成度。

研究目的

评估mLab+移动健康App（见图1）辅助用户完成HIV+梅毒双联即时检测（POC）的可行性与可用性，为该工具的居家推广与大规模应用提供依据。

研究方法

（1）研究设计：3个月试点随机对照试验（RCT），仅报告干预组数据；2023年10月—2024年6月开展（见图2）。

（2）研究对象：出生性别为男性、有男男性行为、18–39岁、HIV/梅毒阴性/状态未知、近3个月未检测、拥有智能手机、能理解英文（见Textbox 1）。

（3）干预措施：使用mLab+App，配合DPPHIV-梅毒双联检测试剂，由App提供分步图文指导、自动计时、拍照上传、AI图像判读、结果记录。

（4）评估指标

主要结局：独立完成自检的人数比例

可行性：招募速度、3个月留存率、App使用行为数据（日志）

可用性：Health-ITUES量表、PSSUQ量表评分

（5）实施场景：临床机构内，在医护监督下完成操作。

研究结果

（1）基线特征：干预组20人，19名男性、1名非二元性别；平均年龄28岁；种族以白人与黑人为主。

（2）自检完成情况：80%（16/20）参与者可独立完成双联自检，无需医护协助（见表1）。

（3）App使用行为

平均单次使用时长：30分33秒，除27%（13/48）的5分钟及以下疗程外，疗程时长分布大致正常（见图3）；

77%会话进入检测页面，71%启动检测，62.5%完成检测并获得结果；用户主要耗时在检测指导、计时、结果上传页面（见图4）。

（4）留存与转介

3个月留存率80%（16/20）（见表3）；阳性参与者均获得转介，但仅40%成功衔接后续医疗服务。

（5）可用性评分

PSSUQ总分2.65（1–7分，分数越低可用性越高）；Health-ITUES总分3.62（1–5分，分数越高可用性越高）；整体为中高水平可用性（见表4、图5）。

（6）检测结果：基线25%呈阳性反应，随访15%呈阳性反应，均为梅毒或HIV单阳/共阳（见表2）。

结果解读

1.结果解读：(1)mLab+App可有效引导高危人群独立完成HIV+梅毒双联自检，操作流程顺畅、用户接受度高。(2)App的分步指导、自动计时、图像判读功能显著降低自检难度，解决居家自检的核心痛点。(3)中高可用性评分证明界面友好、实用性强，适合真实场景推广。(4)临床环境内完成率高，提示脱离临床监督的居家场景仍需优化支持。

2.研究局限性：样本量小（仅20人），为单中心预试验；仅在临床机构内开展，未验证真实居家使用效果；受FDA限制，无法开展居家自检，外部效度有限；阳性结果转介率偏低，缺乏App内直接就医衔接功能；未纳入跨性别女性等其他高危群体。

3.研究创新性：全球首个同时支持HIV+梅毒双联自检的移动健康App，集成图像算法自动判读；以用户为中心设计，提供全流程可视化指导、自动计时、结果管理；填补MSM人群HIV+梅毒同步居家自检工具的空白，契合“终结HIV流行”与性病防控需求；结合使用日志（paradata）客观评估用户行为，比单纯问卷更精准。

4. 研究结论：mLab+App辅助HIV与梅毒自检具备良好可行性与中高可用性，可作为高危人群居家自检的有效工具。未来需在非临床居家场景开展更大样本研究，优化转介与就医衔接功能，进一步验证其提升检测率与健康结局的效果。

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文字编辑：周倩扬

南医大二附院皮肤科检验师

指导审核：张瑞丽

南医大二附院皮肤科主任、主任医师

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