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临床试验/NCT01068015
NCT01068015Unknown3 期

A COMMUNITY-BASED, RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF COMPREHENSIVE HIV/STIs INTERVENTION AMONG MEN WHO HAVE SEX WITH MEN IN 8 CITIES IN CHINA

National Center for AIDS/STD Control and Prevention, China CDC8 个研究点 分布在 1 个国家目标入组 3,214 人开始时间: 2009年6月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
发起方
入组人数
3,214
试验地点
8
主要终点
HIV incidence

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of the community based comprehensive HIV/STIs intervention among MSMs in China.

详细描述

National sentinel surveillance data show that HIV infections are increasing fast among men who have sex with men(MSM) in China. In some cities HIV prevalence among MSM is higher than 10%.It is urgent for China to explore innovative intervention to reduce HIV/AIDS transmission among this population.

The purposes of this study are:

  1. To evaluate the effectiveness of comprehensive interventions to decrease the HIV/STIs incidence among MSM population in China. The comprehensive intervention components include male circumcision, POL intervention, HIV testing and counseling and condom promotion.
  2. To determine the acceptability of male circumcision among MSM population in China.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 18 years or above
  • Male have oral sex or anal sex within 6 months with a man
  • Accept questionnaire survey and blood test
  • Can participate in three surveys in one year
  • HIV Negative
  • No mental disease and can understand informed consent

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

This arm receives free circumcision service, POL intervention, intensive HIV counseling and intensive condom promotion.

干预措施: behavior intervention and male circumcision (Other)

usual

No Intervention

This arm receives no extra HIV prevention services.

干预措施: behavior intervention and male circumcision (Other)

结局指标

主要结局

HIV incidence

时间窗: March 1,2010 to Dec,31,2010

次要结局

  • Syphilis, HSV-2 incidence(1,Mar.,2009 to 31,Dec,2010)
  • Frequency of condom uses, number of sexual partners(March, 1, 2010 to December, 31,2010)
  • The proportion of people who have intention to be circumcised(March, 1, 2010 to December, 31,2010)
  • The proportion of people who have been circumcised(March, 1, 2010 to December, 31, 2010)

研究者

发起方
National Center for AIDS/STD Control and Prevention, China CDC
申办方类型
Other Gov

研究点 (8)

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