Zhao Peizhen, Xu Wenqian, Tucker Joseph D, Tang Weiming, Weideman Ann Marie, Enders Kimberly, Liang Peng, Huang Shujie, Fitzpatrick Thomas, Wang Cheng
Dermatology Hospital of Southern Medical University, Guangzhou, China.
Southern Medical University Institute for Global Health, Guangzhou, China.
BMJ Open. 2025 Aug 12;15(8):e093944. doi: 10.1136/bmjopen-2024-093944.
Doxycycline postexposure prophylaxis (doxy-PEP) can prevent sexually transmitted infections (STIs) among men who have sex with men (MSM) and transgender women (TGW). STI rates are high among MSM and TGW in China, and implementation strategies are needed to optimise doxy-PEP services. Pay-it-forward and social network distribution approaches may increase uptake of STI services and could increase the uptake of doxy-PEP. We present the protocol for a randomised controlled trial evaluating the effectiveness of pay-it-forward strategies with and without adjunctive social network distribution among MSM and TGW in China.
A total of 399 MSM and TGW will be recruited at seven sites in China and randomly allocated in a 1:1:1 ratio to (1) self-pay, (2) pay-it-forward alone or (3) pay-it-forward with adjunctive social network distribution of doxy-PEP. Participants assigned to the self-pay arm can purchase a doxy-PEP packet out-of-pocket. Participants in the pay-it-forward arm will be offered a free doxy-PEP packet and the opportunity to donate to support doxy-PEP for future participants. Participants in the pay-it-forward arm with social network distribution will receive the pay-it-forward intervention as well as additional free doxy-PEP packets to distribute to peers. Those randomised to the self-pay and the pay-it-forward with social network distribution arms (ie, index participants) will receive and distribute referral cards to recruit additional peers (ie, alter participants). Alter participants recruited through the control arm will be referred to the clinic to purchase doxy-PEP. Alter participants recruited through the pay-it-forward with adjunctive social network distribution arm will receive doxy-PEP directly from referring index participants. Both index and alter participants in each arm will be asked to complete a follow-up survey 3 and 6 months after enrolment. The primary outcome will be the proportion of participants who report using doxy-PEP within 72-hours of condomless anal or oral sex on one or more occasions during follow-up.
Ethical approval was obtained from the ethics review committee of the Dermatology Hospital of Southern Medical University (Approval number: 2023109). The findings will be disseminated in peer-reviewed publications.
The study has been registered with the Chinese Clinical Trial Registry (trial ID ChiCTR2300074903). Date of registration: 18 August 2023.
多西环素暴露后预防（多西环素-PEP）可预防男男性行为者（MSM）和跨性别女性（TGW）中的性传播感染（STI）。中国MSM和TGW中的性传播感染率很高，需要实施策略来优化多西环素-PEP服务。“传递爱心”和社交网络分发方法可能会增加性传播感染服务的使用率，并可能提高多西环素-PEP的使用率。我们展示了一项随机对照试验的方案，该试验评估在中国MSM和TGW中采用和不采用辅助社交网络分发的“传递爱心”策略的有效性。
在中国的七个地点共招募399名MSM和TGW，并按1:1:1的比例随机分配至（1）自费组，（2）仅“传递爱心”组或（3）“传递爱心”并辅助多西环素-PEP社交网络分发组。分配到自费组的参与者可以自掏腰包购买一包多西环素-PEP。“传递爱心”组的参与者将获得一包免费的多西环素-PEP，并获得捐赠机会，以支持为未来参与者提供多西环素-PEP。采用社交网络分发的“传递爱心”组的参与者将接受“传递爱心”干预，并额外获得免费的多西环素-PEP包分发给同伴。随机分配到自费组和采用社交网络分发的“传递爱心”组（即索引参与者）的人将接收并分发转诊卡，以招募更多同伴（即改变参与者）。通过对照组招募的改变参与者将被转介到诊所购买多西环素-PEP。通过“传递爱心”并辅助社交网络分发组招募的改变参与者将直接从转诊的索引参与者那里获得多西环素-PEP。每组的索引参与者和改变参与者都将被要求在入组后3个月和6个月完成一次随访调查。主要结局将是在随访期间报告在一次或多次无保护肛交或口交后72小时内使用多西环素-PEP的参与者比例。
获得了南方医科大学皮肤病医院伦理审查委员会的伦理批准（批准号：2023109）。研究结果将在同行评审的出版物中发表。
该研究已在中国临床试验注册中心注册（试验编号ChiCTR2300074903）。注册日期：2023年8月18日。
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