Due to concerns about privacy breaches and fear of social stigma, some individuals engaging in high-risk behaviors—particularly men who have sex with men (MSM)—may avoid in-person HIV testing services and instead choose to purchase HIV self-test kits online for self-testing. Unlike traditional e-commerce platforms that directly provide self-test kits without conducting risk assessments, the “Easy Test Know” platform integrates a structured behavioral risk assessment prior to HIVST kit purchase, allowing users to be categorized into different HIV risk groups. This study aimed to evaluate the performance of a digital HIV behavioral risk stratification tool integrated with online self-testing among MSM, and to determine whether incorporating multi-dimensional behavioral indicators—particularly high-risk venue diversity score—could improve the prediction of HIV positivity compared with the platform’s existing rule-based risk scoring algorithm. This retrospective observational study utilized data from the “Easy Test Know” platform between November 2023 and February 2025. The study included MSM classified as medium or high risk by the platform algorithm. Firth logistic regression models were developed to predict HIV positivity using behavioral variables, including high-risk venue diversity score. Model performance was evaluated using area under the receiver operating characteristic curve (AUC) and calibration analyses. A total of 9,961 participants were included, of whom 90.8% were classified as high risk by the platform. The overall HIV positivity rate was 0.59%, with a higher rate in the high-risk group. The platform’s baseline risk score demonstrated moderate discriminatory power for predicting HIV positivity (AUC = 0.646). High-risk venue diversity score showed a dose–response association with HIV positivity. The data-driven model incorporating the platform’s existing variables together with the newly derived high-risk venue diversity score improved discrimination compared with the rule-based platform algorithm (ΔAUC = +0.082). The fully adjusted model achieved the highest predictive performance (AUC = 0.752). Digital behavioral risk stratification demonstrated moderate ability to differentiate HIV risk among MSM using online HIV self-testing services. Compared with the platform’s original rule-based scoring system, data-driven behavioral models incorporating high-risk venue diversity score showed improved predictive performance. These findings support the potential value of data-driven approaches for optimizing digital HIV risk assessment tools.

BACKGROUND: Since the UNAIDS introduced HIV self-testing in 2014, its application has been widely adopted globally. Developed in China approximately 2015, HIV self-testing (HIVST), which involves the online purchase of testing kits via e-commerce platforms, has emerged as the most significant distribution method. This approach offers numerous benefits, including user-friendliness, speed, and enhanced privacy protection. OBJECTIVE: To understand the spatiotemporal heterogeneity of online HIVST purchasing behavior and its potential driving factors in China. METHODS: The online retail sales data of HIVST kits from the two largest e-commerce platforms in China from 2015 to 2020 were collected for this study. The Bayesian spatiotemporal hierarchical model (BSTHM) was used to investigate the spatiotemporal characteristics and identify the rapidly growing high-demand regions of online HIVST kit sales. Furthermore, the BSTHM was used to identify potential driving factors associated with online sales, including college students per 10,000 persons, GDP per capita, net per person, phone per person, population density, road density and HIV screening cases per 10,000 persons. RESULTS: From 2015 to 2020, the sales of online HIVST kits experienced a dramatic surge, increasing from 837,061 kits to reaching 7,827,411 kits annually, with a total of 23,987,155 kits sold, with annual peak sales in December. Four economically superior regions in China, the Pearl River Delta, Yangtze River Delta, Beijing-Tianjin areas, and Shandong Peninsula, presented relatively high spatial preferences for online purchased HIVST kits. Thirty-eight rapidly growing high-demand regions were identified, which were located mainly in northeastern China (28.9%, 11/38), the Pearl River Delta (28.9%, 11/38) and the Beijing-Tianjin areas (15.8%, 6/38). The number of college students per 10,000 persons, GDP per capita, net per person, population density and number of HIV screening cases per 10,000 persons were identified as the driving factors that were positively associated with the online purchase rate of HIVST kits. CONCLUSIONS: Our study illuminates the spatiotemporal dynamics and driving factors behind online HIVST kit sales across mainland China, offering pivotal insights for crafting detailed HIVST guidelines. We pinpointed regions with significant sales demand, guiding policymakers in resource reallocation and HIV care continuum optimization, particularly in identified critical ' rapidly growing high-demand’ regions.

目的 通过对不同病毒载量的同一研究对象同时进行血浆HIV-1 RNA与干血斑HIV-1 DNA的基因型耐药检测并对结果进行比较,探讨HIV-1 DNA用于耐药检测的可行性和用途.方法 2021年12月采集云南省、广西壮族自治区及新疆维吾尔自治区接受ART后1年以上的HIV/AIDS患者静脉血5 mL,EDTA抗凝,分离血浆和制备成干血斑样本,分别提取病毒DNA和RNA进行pol区扩增,比较两种方法的扩增效率;并对同时扩增成功的序列利用MEGA7构建系统进化树并分析序列一致性.利用斯坦福大学HIV耐药数据库进行耐药位点分析,比较耐药性结果.结果 209例样本中,来自云南82份(39.2％),来自广西壮族自治区69份(33.0％),来自新疆维吾尔自治区58份(27.8％).105 例 VL＜20 拷贝/mL,25 例 20 拷贝/mL≤VL＜200 拷贝/mL,42 例 200 拷贝/mL≤VL＜1 000 拷贝/mL,37 例 VL≥1 000拷贝/mL.不同病毒载量的样本分类中,使用血浆中HIV-RNA pol区扩增成功率分别为12.4％、28.0％、69.0％、89.2％;使用干血斑中HIV-DNA pol区扩增成功率分别为39.0％、52.0％、59.5％、73.0％;血浆结合干血斑各组的扩增成功率为41.0％、56.0％、76.2％、89.2％.两种耐药检测方法同时扩增成功66例,耐药结果完全一致为98.5％,序列一致性99.7％.其中有58例(58/66,87.9％)配对样本耐药位点完全一致,8例配对样本耐药位点不完全一致.耐药位点不完全一致的配对样本中仅1例导致耐药结果不同,其他主要由混合碱基导致但未对耐药结果产生影响.结论 应用干血斑HIV-1 DNA进行基因型耐药检测可以弥补目前血浆HIV-1 RNA耐药检测不足,特别是对病毒载量＜1 000拷贝/mL的样本,能够提高耐药检测效率.同时二者检测结果基因序列与耐药位点的一致性很好.结合干血斑样本容易制备、保存与运输的优点,提高了在偏远欠发达地区进行耐药监测的可及性.

实验室检测是艾滋病临床诊断、病程进展监测、抗病毒治疗启动、治疗效果监测、耐药性检测及调整治疗方案等诊疗工作不可或缺的技术支撑.为满足不断增加的艾滋病诊断和治疗相关的防治需求,全国艾滋病实验室网络不断发展壮大.特别是实施"四免一关怀"政策以来,实验室网络建设快速持续发展,检测技术和检测策略也适时进行完善、更新,为艾滋病诊断和治疗提供了有力的技术支持和质量保证,助力我国艾滋病防治工作取得显著成效.

Background: Identifying young individuals living with human immunodeficiency virus (HIV) who are unaware of their status is a major challenge for HIV control in China. To address this, an innovative, anonymous vending machine-based urine self-collection for HIV testing (USCT) program was implemented in 2016 in colleges across China. Methods: From June 2016 to December 2019, 146 vending machines stocked with urine self-collection kits were distributed on 73 college campuses across 11 provinces of China. Urine samples were collected, delivered, and tested in an anonymous manner. We analyzed the returned rate, reactive rate (likelihood of HIV screening positive), testing effectiveness (the annual number of college students living with HIV screened by USCT or other testing methods), and the spatiotemporal relationship between USCT usage and student activity per college generated from the usage of a social networking application. Results: Among the 5178 kits sold, 3109 (60%) samples were returned; of these, 2933 (94%) were eligible for testing. The HIV reactive rate was 2.3% (66 of 2933). The average effectiveness ratio among the 34 participating Beijing colleges was 0.39 (12:31) between USCT and conventional testing methods. A strong spatiotemporal correlation between USCT numbers and online student activity was observed during school semesters in Beijing. Conclusions: USCT is a powerful complement to current interventions that target at-risk students and promote HIV testing. The social networking-based evaluation framework can be a guide in prioritizing at-risk target populations.

目的 构建1型艾滋病病毒(HIV-1)脱氧核糖核酸(DNA)全血和干血斑评价盘,并对两种国产HIV-1 DNA 检测试剂(试剂A和试剂B)性能进行实验室评价.方法 从中国疾病预防控制中心性病艾滋病预防控制中心参比实验室样本库中筛选全血和干血斑样本,构建HIV-1 DNA全血和干血斑评价盘,评价盘包含阳性参考品20份,阴性参考品20份,最低检测限参考品5份,精密度参考品2份;并从云南省德宏州收集临床样本,通过评价盘和临床样本对两种试剂的敏感性、特异性、最低检测限和精密度进行评价.结果 从云南省德宏州疾病预防控制中心和佑安医院共收集临床样本278份(全血和对应干血斑各278份),包含207份阳性样本和71份阴性样本.阳性样本中,106份未接受抗病毒治疗(ART),101份已接受ART.全血评价盘结果显示,两种试剂的阴、阳性样本符合率20/20,最低检测限均为4/5,A试剂精密度为1.2％(CV1)和1.4％(CV2),B试剂精密度为2.8％(CV1)和1.3％ (CV2).干血斑评价盘结果显示,两种试剂阴、阳性样本符合率均为20/20,最低检测限均为3/5,A试剂精密度为2.5％(CV1)和3.4％(CV2),B试剂精密度为3.1％ (CV1)和2.8％(CV2).177份未进行ART临床样本评价结果显示,对于全血样本,两种试剂特异性和敏感性均为100％ (71/71,106/106);对于干血斑样本,两种试剂特异性均为100％ (71/71),试剂A敏感性为98.1％ (104/106),试剂B敏感性为99.1％ (105/106).101份已接受ART样本评价结果显示,对于全血样本,试剂A和试剂B敏感性均为100％(101/101);对于干血斑样本,试剂A敏感性为91.1％(92/101),试剂B敏感性为90.1％ (91/101).结论 两种HIV DNA检测试剂均能符合全血和干血斑评价盘要求;在检测未进行ART全血和干血斑临床样本时均表现良好,且试剂A与B之间无显著差异,两种国产HIV-1 DNA检测试剂均能满足HIV-1核酸检测要求.

BACKGROUND Identifying young HIV-infected individuals who are unaware of their status is a major challenge for HIV control in China. To address this, an innovative, anonymous vending machine-based urine self-collection for HIV testing (USCT) program was implemented in 2016 in colleges across China. METHODS From June 2016 to December 2019, 146 vending machines stocked with urine self-collection kits were distributed on 73 college campuses across 11 provinces of China. Urine samples were collected, delivered, and tested in an anonymous manner. We analyzed the returned rate, reactive rate (likelihood of HIV screening positive), testing effectiveness (the annual number of HIV-infected college students screened by USCT or other testing methods), and the spatiotemporal relationship between USCT usage and student activity per college generated from the usage of a social networking application. RESULTS Among the total of 5178 kits sold, 3109 (60%) samples were returned and of these 2933 (94%) were eligible for testing. The HIV-reactive rate was 2.3% (66/2933). The average effectiveness ratio among the 34 participating Beijing colleges was 0.39 (12:31) between USCT and conventional testing methods. A strong spatiotemporal correlation between USCT numbers and online student activity was observed during school semesters in Beijing. CONCLUSIONS USCT is a powerful complement to current interventions that target at-risk students and promote HIV testing. The social networking-based evaluation framework can guide us in prioritizing at-risk target populations.

目的 了解基于互联网的“1+1”艾滋病病毒(HIV)自助检测(含指尖血快速检测及尿液传递检测)在伊犁州男男性行为者(MSM)中的可接受性和有效性.方法 为满足伊犁州MSM在匿名状态下既快速获得检测结果,又得到专业准确检测及服务的要求,开发了基于互联网的“1+1”HIV自助检测,与伊犁州当地社区组织合作,免费发放160份“1+1”HIV自助检测服务包.MSM拿到服务包后,阅读知情同意书,按照操作说明书进行血液自检,并自行采集尿液,填写调查问卷.将尿液样本和调查问卷邮寄至伊犁州疾病预防控制中心艾滋病检测实验室.结果 共收到133份尿液样本及调查问卷,回收率83.1％;91.7％(122例)的年龄≤40岁,汉族占54.1％(72人),维吾尔族占35.3％(47人),本科以上学历者占29.3％(39人).男男同性恋者占79.7％(106人),双性恋者占20.3％(27人).17.0％(18/106)的男男同性恋者及33.3％(9/27)的双性恋者在最近6个月内发生过无保护性行为.133人指尖血快检阳性率为10.5％(14人),尿液抗体检测阳性率为14.3％(19人).19位HIV尿液抗体检测阳性者中,有15随访成功并进行了复检和确证,其中12人为新诊断HIV感染者;此外,17位HIV尿液抗体检测阳性者,86位HIV抗体检测阴性者匿名查询了检测结果.结论 通过消除传统医务人员主动提供咨询检测和自愿咨询检测的实名制障碍,“1+1”HIV自助检测服务可帮助专业医疗机构人员与MSM建立起相应的衔接,有效发现潜在的HIV感染者,并对初筛阳性者进行及时的随访和确证.

目的 了解高校大学生对艾滋病尿液传递检测的认知、态度及可接受度,为进一步在高校开展艾滋病尿液传递检测提供依据和参考.方法 1)采取整群随机抽样方法选取试点及非试点高校学生,利用网络平台,设计、录入网络版“HIV尿液传递检测调查问卷”,并通过QQ,微信在电脑或手机端完成调查问卷;2)通过与高校工作人员、社团骨干面对面定性访谈.结果 参与问卷调查的试点高校及非试点高校学生分别是683人及695人,其中,试点高校学生的知晓率是87.6％(598/683),支持率是89.6％ (612/683).非试点高校学生的知晓率是44.5％(309/695),支持率是76.8％(534/695).大学生知晓“HIV尿液传递检测”的途径呈现多元化趋势,首推互联网媒体.此外,87.4％(597/683)的试点高校学生知晓学校有自助检测服务机出售“匿名尿液HIV筛查服务包”,且62.2％(425/683)的学生购买过.83.5％(570/683)的试点高校学生知晓学校有相关机构免费发放“匿名尿液HIV筛查服务包”,且73.5％(502/683)的学生免费领取过.结论 “HIV尿液传递检测”在大学生人群中有着很高的认知度和可接受性,对促进HIV检测进校园起到了很好的宣传动员效果,应进一步在更多高校推广.

目的 了解网络购买艾滋病病毒(HIV)快速检测试剂用于自我检测人群的特征,为进一步扩大基于互联网的HIV检测服务,促进人群主动检测提供依据和参考.方法 随机选取网络购买HIV快速检测试剂的1 000人作为调查对象,在邮寄给其的快递盒内放入项目简介卡发布问卷调查信息.利用网络平台,设计、录入网络版“网络购买HIV快速检测试剂用于自我检测调查问卷”,调查对象通过QQ,微信在电脑或手机端完成调查问卷.结果 共有591人完成网络问卷调查,其中男性512人,女性79人;年龄中位数25岁(15～50岁);未婚占78.7％(465人);大专或本科以上文化占66.2％(391人);自由职业者及大学生人群是主要购买人群,分别占36.0％ (213人)及26.2％(155人);月收入在2 000～5 000元之间的占53.0％(313人).异性恋人群占57.5％(340人),男男同性恋人群占27.2％(161人),双性恋人群占15.2％(90人).此外,64.7％(220/340)的异性恋人群、69.6％(112/161)的男男同性恋人群及72.2％(65/90)的双性恋人群在最近6个月内发生过无保护性行为.50.9％(301/591)的调查对象在自我检测后会和客服人员联系进行咨询.28.8％(170人)的调查对象在自我检测后,选择去疾病预防控制中心或医院寻求进一步确证及咨询服务.结论 网络购买HIV快速检测试剂用于自我检测的人群大部分是未婚年轻男性,他们受教育程度较高,多数为异性恋,且收入属中上等,在最近6个月内发生过无保护性行为,对该人群提供检测后的专业咨询服务非常重要.

目的 了解广西高校新生对HIV尿液自助采样包的使用意愿及关注因素,为进一步在高校开展HIV尿液自我采样传递检测提供依据和参考. 方法 采取整群随机抽样方法,分别选取广西A、B两所高校新生进行匿名问卷调查,其中,A校在健康教育讲座前问卷调查,B校在健康教育讲座后问卷调查. 结果 本次调查中,共发放问卷500份,A、B两所高校新生的问卷回收率分别是88.0％(132/150),96.9％ (339/350),差异有统计学意义(P＜0.001).A、B两所高校新生艾滋病基本知识平均知晓率分别为73.7％,87.7％,差异有统计学意义(P＜0.001).受访的大学新生中有2.3％(11/471)曾接受过HIV检测.A、B两所高校新生对HIV尿液自助采样包的使用意愿率分别是63.6％ (84/132),88.5％(300/339),差异有统计学意义(P＜0.001).男生对HIV尿液自助采样包的使用意愿率均要稍高于女生,但差异无统计学意义(P＞0.05).在阻碍HIV尿液自助采样包的使用因素调查中,54.0％(47/87)认为操作流程不方便,37.9％ (33/87)怀疑结果的准确性,8.1％(7/87)认为容易污染.此外,在大学新生对HIV尿液自助采样包的关注因素调查中,首要关注的是保密性(85.4％,402/471),其次是准确性(72.4％,341/471).超过一半的新生认为100～150元是HIV尿液自助采样包的可接受价格范围,高达97％的新生认为检测结果的反馈时长应小于7d. 结论 广西高校新生对HIV尿液自助采样包的态度积极,使用意愿较高,对HIV尿液自我采样传递检测持相对开放态度.HIV尿液自助采样包的保密性和准确性是大学新生最为关注的两个因素.举办健康教育讲座对HIV尿液自助采样包进行适当的介绍和宣传,可有效提高使用意愿.

历经数十载,我国艾滋病流行形势及防治工作需求发生了深刻变化,全国艾滋病实验室网络也从无到有、从小到大,为全国不断增长的艾滋病监测、临床诊断、血液安全筛查等提供着不可或缺的技术支撑.国家参比实验室紧密结合防治工作需求,不断探索、适时创新,为我国艾滋病防治工作做出了杰出贡献,主要技术贡献如下.

目的 研究建立干血斑(DBS)样本用于艾滋病病毒(HIV)抗体筛查(免疫层析法)的方法,为扩大HIV检测提供一个简便可行的筛查方法 .方法 制备系列稀释20～210干血斑与配对血浆样本,对DBS进行洗脱后,研究来自两家不同生产商的人类免疫缺陷病毒(HIV1/2)抗体检测试剂盒(胶体金法)的检测限,并以最低检出限为依据优化选择用于该两种试剂的最适DBS洗脱液体积和加样体积,通过310份已知样本与1 304份临床样本对该方法 进行验证与应用.结果 来自两个不同生产商的试剂检测限一致,但同一试剂下配对血浆样本与DBS样本检测限不同(血浆为20～27,DBS为20～23);两种试剂优化选择出的最适DBS洗脱液体积(200μL)和加样体积(150μL)一致,可将最低检测限降低至24;两种试剂进行方法验证的结果一致,阳性一致率均为95.45％ (105/110),阴性一致率均为100％(200/200),总一致率均为98.39％(305/310),Kappa值0.964(P＜0.001);两种试剂进行临床应用结果完全一致,来自北京市男男性行为者(MSM)1 304份临床DBS样本中(以随访确认结果为金标准),免疫层析法的敏感性为92.31％(120/130),特异性为100％(1 174/1 174),检测准确率为99.23％(1 294/1 304);与酶联免疫吸附试验检测结果 相比,免疫层析法存在7.69％(10/130)弱阳性漏检,无假阳性出现.结论 DBS样本的HIV快速筛查方法简便可行,无假阳性,但存在弱阳性漏检,其应用存在地区与人群差异,更适用于落后偏远、弱阳性率低的地区与人群筛查.

Innovative human immunodeficiency virus (HIV) testing services will be needed to achieve the first 90 (90% of HIV-positive persons aware of their infection status) of the 90-90-90 target in China. Here, we describe an internet-based urine delivery testing service delivered through three pilot drugstores in Beijing that send specimens to a designated laboratory for HIV. From May 2016 to January 2017, we provided 500 HIV urine-testing service packs for display at the drugstores, and a total of 430 (86.0%) urine specimens were mailed back. All of the 430 urine specimens were of good quality and were tested. 70 urine specimens were HIV positive, showing a 16.3% (70/430) positivity rate. A total of 94.3% (66/70) of the HIV-positive participants obtained their test results through the internet, and 69.7% (46/66) of these participants received follow-up care. A total of 40 out of 46 (87.0%) participants agreed to have their results confirmed by a blood test, and 39 out of 40 (97.5%) participants were confirmed as HIV-1 positive, including two individuals that were previously diagnosed. Lastly, 28 out of 37 (75.7%) of the study participants were referred to the hospital and provided free antiviral treatment. Our data indicate that this innovative HIV testing service is effective and play an important role in HIV testing and surveillance.

Objective To investigate the feasibility of clinical application by self-help sampling urine and dried blood-spot(DBS) specimens for HIV detection.Methods Self-sampling packages of human immunodeficiency virus (HIV) were distributed and recovered by health professionals among men having sex with men (MSM),injecting drug users (IDUs),and healthy population with their infection status known,including female sex workers(FSW) with their infection status unknown.Enzyme linked immunosorbent assay(ELISA) was used to detect the urine and dried blood spots of 807 samples of known infection status and 283 samples of unknown infection.283 cases of female sex workers also got nucleic acid qualitative detection.Results The coincidence rates of the results of antibody detection of urine compared with the known infection status were 96.55％,98.99％,and 95.20％ respectively,among the healthy people,MSM and IDUs with 97.03％ coincidence rate of the total samples.The coincidence rates of the results of antibody detection of DBS compared with the known infection status were 98.47％,100％ and 98.80％ respectively among the healthy people,MSM and IDUs,with 99.13％ coincidence rate of the total samples.The comparison between the results of the antibody test and that of DBS nucleic acid qualitative detection among the female sex workers showed the coincidence rates of 96.82％ and 97.88％ respectively for DBS and the urine sample.Conclusion It is found that the self-sampling package can lead to a high detection efficiency.It is not only suitable for the high-risk behavior population but also has a practical value for the general population as well.

目的 制备用于艾滋病病毒1型(HIV-1) DNA检测的干血斑能力验证质控品,并对其均一性和稳定性进行评估.方法 培养仅含单拷贝的缺陷型HIV-1基因的8E5细胞,使用HIV-1阴性全血进行倍比稀释后,滴加到滤纸片上,制备成含有不同拷贝数8E5细胞的滤纸片干血斑.在不同温度条件下放置不同时间,然后使用雅培Real-time HIV-1定性检测试剂盒对其进行检测、整理并分析检测结果,评价滤纸片干血斑能力验证质控品的均一性和稳定性.结果 滤纸片干血斑随机抽样平行检测结果完全一致;-20℃或4℃放置1年,室温放置3个月或在37℃放置4天,检测结果均一致.在应用性评价中,参加能力验证项目的15家实验室检测结果全部正确,制备的滤纸片干血斑作为质控品效果良好.结论 使用8E5细胞制备的HIV-1 DNA定性检测能力验证质控品的均一性、稳定性良好,是一种可用于目前中国HIV-1 DNA定性检测能力验证质控品制备方法.