Abstract：
BACKGROUND: HIV self-testing (HIVST) provides a key measure for the early detection of HIV infection in men who have sex with men (MSM). However, dual HIV/syphilis self-testing in the MSM population has not been studied. We describe a randomised controlled trial to evaluate the effect of dual HIV/syphilis self-testing on the testing frequency among MSM in China.
METHODS: This randomised controlled trial will be implemented in Guangxi, China. 330 MSM, including 255 frequent testers and 75 less frequent testers, will be recruited and randomly assigned in a 1:1:1 ratio into one of three arms: a site-based testing arm, a single HIVST arm and a dual HIV/syphilis self-testing arm. Participants in the single HIVST arm and dual HIV/syphilis self-testing arm will receive two free finger-prick-based HIVST or HIV/syphilis self-testing kits at enrolment. The data will be collected at five separate times: baseline, 3 months, 6 months, 9 months and 12 months. The primary outcome is the mean frequency of HIV testing used by MSM after intervention comparing each group during the study period. The secondary outcome includes changes in sex behaviours (eg, number of male sex partners and the proportion of consistent condom use) and the mean number of HIV tests used by the social network members over the study period.
BACKGROUND: The study protocol was reviewed and approved by the Medical Ethics Committee of Guangxi Medical University, China (20210173). The study results will be disseminated through conferences and academic journals.
BACKGROUND: ChiCTR2100050898.
METHODS: This randomised controlled trial will be implemented in Guangxi, China. 330 MSM, including 255 frequent testers and 75 less frequent testers, will be recruited and randomly assigned in a 1:1:1 ratio into one of three arms: a site-based testing arm, a single HIVST arm and a dual HIV/syphilis self-testing arm. Participants in the single HIVST arm and dual HIV/syphilis self-testing arm will receive two free finger-prick-based HIVST or HIV/syphilis self-testing kits at enrolment. The data will be collected at five separate times: baseline, 3 months, 6 months, 9 months and 12 months. The primary outcome is the mean frequency of HIV testing used by MSM after intervention comparing each group during the study period. The secondary outcome includes changes in sex behaviours (eg, number of male sex partners and the proportion of consistent condom use) and the mean number of HIV tests used by the social network members over the study period.
BACKGROUND: The study protocol was reviewed and approved by the Medical Ethics Committee of Guangxi Medical University, China (20210173). The study results will be disseminated through conferences and academic journals.
BACKGROUND: ChiCTR2100050898.
摘要：
背景：HIV自我检测（HIVST）为早期发现男男性行为者（MSM）的HIV感染提供了关键措施。然而,尚未研究MSM人群中的双重HIV/梅毒自检。我们描述了一项随机对照试验，以评估双重HIV/梅毒自检对中国MSM检测频率的影响。
方法：这项随机对照试验将在广西实施，中国。330MSM,包括255名频繁测试人员和75名频率较低的测试人员，将被招募并以1:1:1的比例随机分配到三个手臂之一：基于现场的测试手臂，单一的HIVST臂和双重艾滋病毒/梅毒自检臂。单一HIVST臂和双重HIV/梅毒自检臂的参与者将在注册时获得两个免费的基于手指刺破的HIVST或HIV/梅毒自检试剂盒。数据将在五个不同的时间收集：基线，3个月,6个月,9个月和12个月。主要结果是在研究期间比较各组干预后MSM使用的HIV检测的平均频率。次要结果包括性行为的变化(例如，男性性伴侣的数量和持续使用避孕套的比例）以及社交网络成员在研究期间使用的HIV检测的平均数量。
背景：研究方案经广西医科大学医学伦理委员会审核通过，中国(20210173)。研究结果将通过会议和学术期刊传播。
背景：ChiCTR2100050898。
方法：这项随机对照试验将在广西实施，中国。330MSM,包括255名频繁测试人员和75名频率较低的测试人员，将被招募并以1:1:1的比例随机分配到三个手臂之一：基于现场的测试手臂，单一的HIVST臂和双重艾滋病毒/梅毒自检臂。单一HIVST臂和双重HIV/梅毒自检臂的参与者将在注册时获得两个免费的基于手指刺破的HIVST或HIV/梅毒自检试剂盒。数据将在五个不同的时间收集：基线，3个月,6个月,9个月和12个月。主要结果是在研究期间比较各组干预后MSM使用的HIV检测的平均频率。次要结果包括性行为的变化(例如，男性性伴侣的数量和持续使用避孕套的比例）以及社交网络成员在研究期间使用的HIV检测的平均数量。
背景：研究方案经广西医科大学医学伦理委员会审核通过，中国(20210173)。研究结果将通过会议和学术期刊传播。
背景：ChiCTR2100050898。
