比较 HIV 自我检测与标准 HIV 检测对关键人群的影响：系统评价和荟萃分析。

BACKGROUND: We update a previous systematic review to inform new World Health Organization HIV self-testing (HIVST) recommendations. We compared the effects of HIVST to standard HIV testing services to understand which service delivery models are effective for key populations. METHODS: We did a systematic review of randomised controlled trials (RCTs) which compared HIVST to standard HIV testing in key populations, published from 1 January 2006 to 4 June 2019 in PubMed, Embase, Global Index Medicus, Social Policy and Practice, PsycINFO, Health Management Information Consortium, EBSCO CINAHL Plus, Cochrane Library and Web of Science. We extracted study characteristic and outcome data and conducted risk of bias assessments using the Cochrane ROB tool version 1. Random effects meta-analyses were conducted, and pooled effect estimates were assessed along with other evidence characteristics to determine the overall strength of the evidence using GRADE methodology. RESULTS: After screening 5909 titles and abstracts, we identified 10 RCTs which reported on testing outcomes. These included 9679 participants, of whom 5486 were men who have sex with men (MSM), 72 were trans people and 4121 were female sex workers. Service delivery models included facility-based, online/mail and peer distribution. Support components were highly diverse and ranged from helplines to training and supervision. HIVST increased testing uptake by 1.45 times (RR=1.45 95% CI 1.20, 1.75). For MSM and small numbers of trans people, HIVST increased the mean number of HIV tests by 2.56 over follow-up (mean difference = 2.56; 95% CI 1.24, 3.88). There was no difference between HIVST and SoC in regard to positivity among tested overall (RR = 0.91; 95% CI 0.73, 1.15); in sensitivity analysis of positivity among randomised HIVST identified significantly more HIV infections among MSM and trans people (RR = 2.21; 95% CI 1.20, 4.08) and in online/mail distribution systems (RR = 2.21; 95% CI 1.14, 4.32). Yield of positive results in FSW was not significantly different between HIVST and SoC. HIVST reduced linkage to care by 17% compared to SoC overall (RR = 0.83; 95% CI 0.74, 0.92). Impacts on STI testing were mixed; two RCTs showed no decreases in STI testing while one showed significantly lower STI testing in the intervention arm. There were no negative impacts on condom use (RR = 0.95; 95% CI 0.83, 1.08), and social harm was very rare. CONCLUSIONS: HIVST is safe and increases testing uptake and frequency as well as yield of positive results for MSM and trans people without negative effects on linkage to HIV care, STI testing, condom use or social harm. Testing uptake was increased for FSW, yield of positive results were not and linkage to HIV care was worse. Strategies to improve linkage to care outcomes for both groups are crucial for effective roll-out.

背景：我们更新了之前的系统评价，以告知世界卫生组织新的 HIV 自我检测（HIVST）建议。我们比较了 HIVST 与标准 HIV 检测服务的效果，以了解哪些服务提供模式对重点人群有效。

方法：我们对 2006 年 1 月 1 日至 2019 年 6 月 4 日期间在 PubMed、Embase、全球索引医学、社会政策与实践、PsycINFO、健康管理信息联盟、EBSCO CINAHL Plus、考克兰图书馆和 Web of Science 中发表的比较 HIVST 与标准 HIV 检测在关键人群中的随机对照试验（RCT）进行了系统评价。我们提取了研究特征和结局数据，并使用 Cochrane ROB 工具版本 1 进行了偏倚风险评估。进行了随机效应荟萃分析，并结合其他证据特征评估了汇总效应估计值，以使用 GRADE 方法确定证据的总体强度。

结果：在筛选了 5909 篇标题和摘要后，我们确定了 10 项报告检测结果的 RCT。这些研究包括 9679 名参与者，其中 5486 名是男男性行为者（MSM），72 名是跨性别者，4121 名是女性性工作者。服务提供模式包括基于机构、在线/邮件和同伴分发。支持组件高度多样化，范围从热线到培训和监督。HIVST 将检测率提高了 1.45 倍（RR=1.45，95%CI 1.20，1.75）。对于 MSM 和少数跨性别者，HIVST 在随访期间使 HIV 检测次数平均增加了 2.56 次（平均差异=2.56；95%CI 1.24，3.88）。HIVST 与 SoC 在总体检测阳性率方面没有差异（RR=0.91；95%CI 0.73，1.15）；在随机分配的 HIVST 中，HIV 感染的阳性率明显更高，包括 MSM 和跨性别者（RR=2.21；95%CI 1.20，4.08）和在线/邮件分发系统（RR=2.21；95%CI 1.14，4.32）。在 FSW 中，HIVST 与 SoC 的阳性结果检出率没有显著差异。与 SoC 相比，HIVST 将 HIV 检测率降低了 17%（RR=0.83；95%CI 0.74，0.92）。STI 检测的影响混杂；两项 RCT 显示 STI 检测没有减少，而一项 RCT 显示干预组的 STI 检测明显减少。HIVST 对 condom 使用（RR=0.95；95%CI 0.83，1.08）没有负面影响，并且社会危害非常罕见。

结论：HIVST 是安全的，它增加了 MSM 和跨性别者的检测率和检测频率，提高了阳性检测结果的检出率，而不会对 HIV 护理、STI 检测、避孕套使用或社会危害产生负面影响。HIVST 增加了 FSW 的检测率，但阳性结果的检出率并没有增加，而 HIV 护理的连接情况更差。为了有效推广，针对这两个群体的改善连接结果的策略至关重要。