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在中国与男性发生性关系的男性中,自愿医疗男性割礼和事件艾滋病毒感染 (COM研究):随机对照试验的协议

Yanxiao Gao¹, Weiran Zheng¹, Yinghui Sun¹

¹School of Public Health, Sun Yat-sen University, Shenzhen, China.

JMIR research protocols

|May 29, 2023

概括

这项随机对照试验调查了自愿医疗男性割礼 (VMMC) 以预防与男性发生性关系的男性 (MSM) 感染艾滋病毒. 这项研究旨在提供证据,证明VMMC在减少这一群体中艾滋病毒感染的有效性.

科学领域:

公共卫生公共卫生
预防传染病预防传染病
临床试验临床试验

背景情况:

观察性研究表明,自愿医疗男性割礼 (VMMC) 可能会降低与男性发生性关系的男性 (MSM) 的艾滋病毒风险.
缺乏随机对照试验 (RCT) 数据存在关于VMMC在MSM中预防HIV的有效性.
这项研究解决了在这个特定人群中需要强有力的RCT证据的需求.

研究的目的:

评估VMMC在预防MSM中艾滋病毒感染方面的有效性.
评估VMMC的有效性,特别是在主要从事插入性交的男性中.
提供第一个基于RCT的证据,用于MSM中预防HIV的VMMC.

主要方法:

一个多中心的RCT涉及8个中国城市18-49岁的MSM.
参与者随机选择接受VMMC (干预) 或没有割礼 (控制).
主要终点:HIV血清转化;次要终点:VMMC安全性,满意度和行为变化. 使用治疗意图分析的数据.

主要成果:

招聘发生在2020年8月至2022年7月期间.
数据收集预计将于2023年7月结束.
计划在2023年9月之前完成完整的数据分析.

结论:

这项试验是第一个评估VMMC在MSM中预防HIV的疗效的RCT.
预计结果将提供初步证据,支持VMMC在减少MSM中发生的HIV感染中的潜在作用.
这些发现将为针对MSM的艾滋病毒预防的公共卫生战略提供关键数据.

关键词:

中国中国中国中国.艾滋病病毒艾滋病病毒艾滋病病毒与男性发生性关系的男性.随机对照试验是随机对照试验.自愿的医疗男性割礼.

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