Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.
Guangdong Center for Skin Diseases and STI Control, Guangzhou, Guangdong, China.
BMC Infect Dis. 2020 Jun 29;20(1):455. doi: 10.1186/s12879-020-05188-z.
Men who have sex with men (MSM) bear a high burden of syphilis infection. Expanding syphilis testing to improve timely diagnosis and treatment is critical to improve syphilis control. However, syphilis testing rates remain low among MSM, particularly in low- and middle-income countries. We describe the protocol for a randomised controlled trial (RCT) to assess whether provision of syphilis self-testing services can increase the uptake of syphilis testing among MSM in China.
Four hundred forty-four high-risk MSM will be recruited online and randomized in a 1:1:1 ratio to (1) standard syphilis self-testing arm; (2) a self-testing arm program enhanced with crowdsourcing and a lottery-based incentive, and (3) a standard of care (control). Self-testing services include a free syphilis self-test kit through the mail at monthly intervals. Participants in the lottery incentive arm will additionally receive health promotion materials generated from an open crowdsourcing contest and be given a lottery draw with a 10% chance to win 100 RMB (approximately 15 US Dollars) upon confirmed completion of syphilis testing. Syphilis self-test kits have step-by-step instructions and an instructional video. This is a non-blinded, open-label, parallel RCT. Participants in each arm will be followed-up at three and 6 months through WeChat (a social media app like Facebook messenger). Confirmation of syphilis self-test use will be determined by requiring participants to submit a photo of the used test kit to study staff via secure data messaging. Both self-testing and facility-based testing will be ascertained by sending a secure photographic image of the completed kit through an existing digital platform. The primary outcome is the proportion of participants who tested for syphilis in the past 3 months.
Findings from this study will provide much needed insight on the impact of syphilis self-testing on promoting routine syphilis screening among MSM. The findings will also contribute to our understanding of the safety, effectiveness and acceptability of syphilis self-testing. These findings will have important implications for self-testing policy, both in China and internationally.
ChiCTR1900022409 (10 April, 2019).
男男性行为者（MSM）感染梅毒的负担沉重。扩大梅毒检测以改善及时诊断和治疗对于改善梅毒控制至关重要。然而，在 MSM 中，梅毒检测率仍然很低，特别是在中低收入国家。我们描述了一项随机对照试验（RCT）的方案，以评估提供梅毒自检服务是否可以提高中国 MSM 中梅毒检测率。
将招募 444 名高危 MSM 进行在线随机分组，以 1:1:1 的比例分为（1）标准梅毒自检组；（2）增强众包和彩票激励的自检组；（3）标准护理（对照组）。自检服务包括每月通过邮件免费提供梅毒自检试剂盒。彩票激励组的参与者还将收到来自公开众包竞赛的健康促进材料，并在确认完成梅毒检测后有 10%的机会赢得 100 元人民币（约合 15 美元）的彩票奖金。梅毒自检试剂盒附有详细的使用说明和教学视频。这是一项非盲、开放标签、平行 RCT。每个组的参与者将通过微信（类似于 Facebook 信使的社交媒体应用程序）在 3 个月和 6 个月时进行随访。通过要求参与者通过安全数据消息将使用过的测试套件照片提交给研究人员来确认梅毒自检的使用情况。自检和机构检测都将通过发送已完成试剂盒的安全照片图像来确定，这是通过现有的数字平台进行的。主要结局是过去 3 个月内接受梅毒检测的参与者比例。
这项研究的结果将为梅毒自检对促进 MSM 常规梅毒筛查的影响提供急需的见解。研究结果还将有助于我们了解梅毒自检的安全性、有效性和可接受性。这些发现将对中国和国际上的自检政策产生重要影响。
ChiCTR1900022409（2019 年 4 月 10 日）。
