A Randomized Community Intervention Trial on Reducing HIV Infection Among Drug Users Attending Methadone Maintenance Treatment(MMT) and Preventing Secondary Transmission From HIV Positive Clients to Their Sexual Partners in China
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 12,000
- 试验地点
- 5
- 主要终点
- HIV incidence rate
研究概览
简要总结
The purpose of this study is to reduce the HIV/HCV incidence among the clients attending community-based methadone maintenance treatment (MMT) , and to prevent the secondary sexual transmission from HIV+ clients to their spouse and sex partners, through intensified comprehensive intervention.
详细描述
Even though National sentinel surveillance data show that the increase rate of HIV new infections among IDUs in China has become stabilized and slowed down, the new HIV infection is still on the rise, especially in the Yunnan, Guizhou, Guangxi, Xinjiang and Sichuan. This study attempts to further reduce the new infection among MMT clients, and particularly to prevent the transmission from HIV infected clients to their sexual partners with comprehensive intervention.
The purposes of this study are:
- To evaluate the effectiveness of comprehensive interventions to decrease the HIV/STIs incidence among MMT clients.
- To prevent the sexual transmission between those HIV+ clients and their spouse/partners with intensified intervention.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) For MMT clients:
- •Inclusion Criteria:
- •20 years or above and have independent capacity of civil conduct.
- •Those have enrolled in MMT clinics more than one month, and progressed to the phase of maintenance treatment.
- •No mental and other physical diseases
- •More than 6-month stay at local places and registered at the designated clinics.
- •Complete Informed consent
排除标准
- •Fail to complete Informed consent
- •Temporarily transit in or out of the designated clinic.
- •Those have enrolled in MMT clinics less than one month, and haven't progressed to the phase of maintenance treatment.
- •With serious mental or other physical diseases
- •For the spouse or sex partners of MMT HIV+ clients'
- •Inclusion Criteria:
- •20 years or above and have independent capacity of civil conduct.
- •Keep fixed sexual contact with HIV+ clients in the recent 6 month
- •No mental and other physical diseases
- •More than 6-month stay at local places and be able to participate the 1 year follow up.
- •Complete Informed consent
- •The recent HIV test is negative
- •Exclusion Criteria:
- •Fail to complete Informed consent
- •Temporarily transit in or out of the designated clinic.
- •With serious mental or other physical diseases
- •The recent HIV test is positive
结局指标
主要结局
HIV incidence rate
时间窗: August 1,2009 to 31,Mar,2011
次要结局
- HCV, Syphilis, HSV-2 incidence(1,Aug.,2009 to 31,Mar,2011)
- MMT Retention Rate and Lapse/Relapse Rate(1,Aug.,2009 to 31,Mar,2011)
- Frequency of condom uses(1,Aug.,2009 to 31, Mar,2011)
- The awareness of HIV-related Information among the clients [(1,Aug.,2009 to 31,Mar,2011)
- The proportion of discordant couple/partners receiving HIV testing(1,Aug.,2009 to 31,Dec,2010)