Wang Yajie, Zhang Wei, Bao Dongping, Ong Jason J, Tucker Joseph D, Ye Rouxuan, Zheng Heping, Yang Bin, Wang Cheng
Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.
Southern Medical University Institute for Global Health and Sexually Transmitted Diseases, Guangzhou, Guangdong, China.
BMC Infect Dis. 2021 May 27;21(1):491. doi: 10.1186/s12879-021-06137-0.
Syphilis is a common sexually transmitted infection (STI) among men who have sex with men (MSM). Increasing syphilis testing is important to syphilis control. However, in low- and middle-income countries like China, syphilis testing rates remain low among MSM. We describe a randomized controlled trial protocol to examine the effectiveness of social network distribution approaches of syphilis self-testing among MSM in China.
We will recruit index and alter MSM. Indexes will be eligible if they: are born biologically male; aged 18 years or above; ever had sex with another man; are willing to distribute syphilis testing packages or referral links to their alters; and willing to provide personal contact information for future follow-up. Three hundred MSM will be recruited and randomly assigned in a 1:1:1 ratio into three arms: standard of care (control arm); standard syphilis self-testing (SST) delivery arm; and referral link SST delivery arm. Indexes will distribute SST packages or referral links to encourage alters to receive syphilis testing. All indexes will complete a baseline survey and a 3-month follow-up survey. Syphilis self-test results will be determined by photo verification via a digital platform. The primary outcome is the mean number of alters who returned verified syphilis testing results per index in each arm.
The trial findings will provide practical implications in strengthening syphilis self-testing distribution and increasing syphilis testing uptake among MSM in China. This study also empowers MSM community in expanding syphilis testing by using their own social network.
Chinese Clinical Trial Registry, ChiCTR2000036988 . Registered 26 August 2020 - Retrospectively registered.
梅毒是男男性行为者（MSM）中常见的性传播感染（STI）。增加梅毒检测对梅毒控制至关重要。然而，在中国等低收入和中等收入国家，MSM中的梅毒检测率仍然很低。我们描述了一项随机对照试验方案，以检验在中国MSM中梅毒自我检测的社交网络传播方法的有效性。
我们将招募索引MSM和受其影响的MSM。索引MSM符合以下条件即具备资格：生物学上为男性；年龄在18岁及以上；曾与另一名男性发生性行为；愿意向受其影响的人分发梅毒检测包或转诊链接；并愿意提供个人联系信息以便未来随访。将招募300名MSM，并按1:1:1的比例随机分为三组：标准护理组（对照组）；标准梅毒自我检测（SST）发放组；以及转诊链接SST发放组。索引MSM将分发SST包或转诊链接，以鼓励受其影响的人接受梅毒检测。所有索引MSM都将完成基线调查和为期3个月的随访调查。梅毒自我检测结果将通过数字平台的照片验证来确定。主要结局是每组中每个索引MSM收到经核实的梅毒检测结果的受其影响者的平均数量。
试验结果将为加强梅毒自我检测分发以及提高中国MSM中的梅毒检测接受率提供实际意义。本研究还通过利用MSM自身的社交网络，增强了他们在扩大梅毒检测方面的能力。
中国临床试验注册中心，ChiCTR2000036988。2020年8月26日注册——追溯注册。
