Expanding syphilis test uptake using rapid dual self-testing for syphilis and HIV among men who have sex with men in China: A multiarm randomized controlled trial.
Expanding syphilis test uptake using rapid dual self-testing for syphilis and HIV among men who have sex with men in China: A multiarm randomized controlled trial.
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DOI：
10.1371/journal.pmed.1003930
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发表时间：
2022-03
期刊：
影响因子：
15.8
通讯作者：
Yang B
中科院分区：
文献类型：
--
作者：
Wang C;Ong JJ;Zhao P;Weideman AM;Tang W;Smith MK;Marks M;Fu H;Cheng W;Terris-Prestholt F;Zheng H;Tucker JD;Yang B
梅毒检测率低是许多低收入和中等收入国家男男性行为者（MSM）的一个主要公共卫生问题。系统自检（SST）可以补充和扩展基于设施的测试。我们的目的是评估提供SST在中国MSM人群中提高梅毒检测率的有效性和成本。于2020年1月7日至2020年7月17日进行了一项开放标签、平行3组随机对照试验（RCT）。在中国26个省的124个城市招募了至少18岁的男性，在过去的一年中与男性进行了无避孕套肛交，在过去的6个月内没有进行梅毒检测，并且有稳定的住所和邮寄地址。使用大小为12的区组随机化，将入组受试者随机分配（1：1：1）至3个组：标准治疗组、标准SST组和彩票激励SST组（如果进行梅毒检测，则有1/10的机会赢得15美元）。主要结局是在试验期间进行梅毒检测并通过照片验证确认的参与者比例，并使用风险差异（RD）估计组间比较。分析是在改良的意向治疗基础上进行的：如果参与者至少启动了1次随访调查，则将其纳入完整的病例分析。使用Sycidol/HIV Duo快速检测试剂盒。共有451名男子参加。标准治疗组共有136例（90.7%，136/150）、标准SST组共有142例（94.0%，142/151）和彩票激励SST组共有137例（91.3%，137/150）被纳入最终分析。在试验期间至少进行1次梅毒检测的男性比例为63.4%（95%置信区间[CI]：55.5%-71.3%，p = 0.001），标准SST组中，65.7%（95% CI：57.7%至73.6%，p = 0.0002），14.7%（95% CI：8.8%至20.7%，p < 0.001），标准SST与标准护理组之间的估计RD为48.7%（95%CI：37.8%至58.4%，p < 0.001）。大多数（78.5%，95% CI：72.7%至84.4%，p < 0.001）梅毒自我检测者报告从未进行过梅毒检测。标准SST的人均测试成本为26.55美元，彩票激励SST为28.09美元，标准护理为66.19美元。研究期间未报告研究相关不良事件。局限性在于2019冠状病毒病（COVID-19）限制的影响可能加剧了对分散检测的需求。与标准治疗相比，提供SST显著增加了中国MSM梅毒检测的比例，并且更便宜（每个人检测）。中国临床试验注册中心：ChiCTR 1900022409。在一项多组随机对照试验中，Cheng Wang及其同事确定了在中国男男性行为者中扩大梅毒自我检测的有效性和成本。男男性行为者（MSM）的梅毒负担很高，而检测覆盖率仍然很低。梅毒自我检测（SST）可能有助于在MSM中扩大梅毒检测。本研究是第一个随机对照试验（RCT），以评估SST的有效性和成本。我们在2020年1月7日至2020年7月17日期间从中国26个省的124个城市招募了451名MSM参与者。我们的研究表明，与标准护理相比，在MSM中推广SST大大增加了梅毒检测的吸收。与标准治疗组相比，SST组的人均测试成本更便宜。我们的RCT和经济评估加强了SST计划在MSM中的证据。对我们研究结果的解释可能会受到2019冠状病毒病（COVID-19）限制的影响，这可能会加剧对分散检测的需求。未来的研究需要在个人使用自我检测试剂盒后加强与临床和公共卫生服务的联系。
Low syphilis testing uptake is a major public health issue among men who have sex with men (MSM) in many low- and middle-income countries. Syphilis self-testing (SST) may complement and extend facility-based testing. We aimed to evaluate the effectiveness and costs of providing SST on increasing syphilis testing uptake among MSM in China. An open-label, parallel 3-arm randomized controlled trial (RCT) was conducted between January 7, 2020 and July 17, 2020. Men who were at least 18 years of age, had condomless anal sex with men in the past year, reported not testing for syphilis in the last 6 months, and had a stable residence with mailing addresses were recruited from 124 cities in 26 Chinese provinces. Using block randomization with blocks of size 12, enrolled participants were randomly assigned (1:1:1) into 3 arms: standard of care arm, standard SST arm, and lottery incentivized SST arm (1 in 10 chance to win US$15 if they had a syphilis test). The primary outcome was the proportion of participants who tested for syphilis during the trial period and confirmed with photo verification and between arm comparisons were estimated with risk differences (RDs). Analyses were performed on a modified intention-to-treat basis: Participants were included in the complete case analysis if they had initiated at least 1 follow-up survey. The Syphilis/HIV Duo rapid test kit was used. A total of 451 men were enrolled. In total, 136 (90·7%, 136/150) in the standard of care arm, 142 (94·0%, 142/151) in the standard of SST arm, and 137 (91·3%, 137/150) in the lottery incentivized SST arm were included in the final analysis. The proportion of men who had at least 1 syphilis test during the trial period was 63.4% (95% confidence interval [CI]: 55.5% to 71.3%, p = 0.001) in the standard SST arm, 65.7% (95% CI: 57.7% to 73.6%, p = 0.0002) in the lottery incentivized SST arm, and 14.7% (95% CI: 8.8% to 20.7%, p < 0.001) in the standard of care arm. The estimated RD between the standard SST and standard of care arm was 48.7% (95% CI: 37.8% to 58.4%, p < 0.001). The majority (78.5%, 95% CI: 72.7% to 84.4%, p < 0.001) of syphilis self-testers reported never testing for syphilis. The cost per person tested was US$26.55 for standard SST, US$28.09 for the lottery incentivized SST, and US$66.19 for the standard of care. No study-related adverse events were reported during the study duration. Limitation was that the impact of the Coronavirus Disease 2019 (COVID-19) restrictions may have accentuated demand for decentralized testing. Compared to standard of care, providing SST significantly increased the proportion of MSM testing for syphilis in China and was cheaper (per person tested). Chinese Clinical Trial Registry: ChiCTR1900022409. In a multi-arm randomized controlled trial, Cheng Wang and colleagues determine the effectiveness and cost of expanding syphilis self testing among men who have sex with men in China. Men who have sex with men (MSM) have a high burden of syphilis, while testing coverage remains low. Syphilis self-testing (SST) could be useful to help expand syphilis testing among MSM. This study is the first randomized controlled trial (RCT) to evaluate the effectiveness and cost of SST. We recruited 451 MSM participants in a 3-arm RCT from 124 cities in 26 Chinese provinces between January 7, 2020 and July 17, 2020. Our study showed that promoting SST among MSM substantially increased syphilis test uptake compared with the standard of care. The cost per person tested is cheaper for the SST arm compared to the standard of care arm. Our RCT and economic evaluation strengthens the evidence for SST programs among MSM. The interpretation of our study’s findings might be affected by the Coronavirus Disease 2019 (COVID-19) restrictions, which may have accentuated demand for decentralized testing. Future studies are needed to enhance linkage to clinical and public health services after an individual uses a self-test kit.
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