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Intervention study for reducing HIV/STD infection of low-grade commercial sex workers

注册号:

Registration number:

ChiCTR-TRC-12002655 

注册号获得时间:

Date of releasing the registration number:

2012/11/09 

注册号状态:

预注册 

Registration Status:

Prospective registration 

注册题目:

减少低档暗娼HIV/STD感染干预研究 

Public title:

Intervention study for reducing HIV/STD infection of low-grade commercial sex workers 

研究课题的正式科学名称:

强化综合干预措施对减少低档暗娼HIV/STD感染率的效果研究 

Scientific title:

The effect study of strengthening integrated intervention measures for reducing HIV/STD infective rate of low-grade commercial sex workers 

研究课题代号(代码):

Study subject ID:

2012ZX10001-007 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

董薇 

研究负责人:

柔克明 

Applicant:

Wei Dong 

Study leader:

Keming Rou 

申请注册联系人电话:

Applicant telephone:

+86 010 58900946 

研究负责人电话:

Study leader's telephone:

+86 010 58900948 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

dongwei98@tom.com 

研究负责人电子邮件:

Study leader's E-mail:

kemingrou@gmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

北京市昌平区昌百路155号中国疾病预防控制中心性艾中心401 

研究负责人通讯地址:

北京市昌平区昌百路155号中国疾病预防控制中心性艾中心402 

Applicant address:

401 room, NCAIDS/STD, China CDC, 155 Changbai Road Changping District, Beijing City 

Study leader's address:

402 room, NCAIDS/STD, China CDC, 155 Changbai Road Changping District, Beijing City 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

中国疾病预防控制中心性病艾滋病预防控制中心 

Applicant's institution:

National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

X120717225 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View 

批准本研究的伦理委员会名称:

中国疾病预防控制中心性病艾滋病预防控制中心伦理委员会 

Name of the ethic committee:

Institution Review Board, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention 

伦理委员会批准日期:

Date of approved by ethic committee:

2012/08/23 

研究实施负责(组长)单位:

中国疾病预防控制中心性病艾滋病预防控制中心 

Primary sponsor:

National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention 

研究实施负责(组长)单位地址:

北京市昌平区昌百路155号 

Primary sponsor's address:

155 Changbai Road Changping District, Beijing City 

试验主办单位(项目批准或申办者):

Secondary sponsor:

未填写任何试验主办单位。

No data added。

经费或物资来源:

国家“十二五”科技重大专项——艾滋病高危人群的综合干预技术研究 (2012ZX10001-007) 

Source(s) of funding:

National Scientific and Technological Key Project for "Integrated intervention technoloy study of HIV High-Risk People" during the Twelfth Five-year Plan Period,(2012ZX10001-007) 

研究疾病:

艾滋病 

Target disease:

Acquired immune deficiency syndrome,AIDS 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

以降低低档暗娼中HIV和梅毒感染率为目的,探索针对该人群有效的行为干预策略和措施,控制性病艾滋病在低档暗娼人群中的传播。 

Objectives of Study:

For the purpose of reducing HIV and syphilis infective rate of low-grade commercial sex workers, we hope to explore some effective behavior intervention strategies and measures to control the spread of STD and AIDS in low-grade FSWs. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

18周岁及以上;每次发生商业性行为平均价格≤80元;同意接受问卷调查和血清学检测;无精神疾病和智力缺陷,能够充分理解知情同意过程;综合考虑场所因素,依存于条件比较简陋的出租屋、小旅舍、小发廊、以及没有场所的站街者等。 

Inclusion criteria

18 and older than 18 years female; The average price of each commercial sex occurrence is lower than 80 RMB; The objects agreed to accept the survey and serological testing; The ones no mental illness and mental retardation, can fully understand the process of informed consent; When selecting the objects, we should consider workplace factors that the FSWs dependent on the houses where the conditions were rather simple and crude, such as rented houses,boarding houses, small salon or just standing on the Street. 

排除标准:

每次发生商业性行为平均价格≥80元的中高档暗娼;在本地停留时间小于1年;不同意接受问卷调查和血清学检测;聋哑人及智力缺陷者。 

Exclusion criteria:

The average price of each commercial sex occurrence is higher than 80 RMB; Duration of stay in local is less than 1 year; The ones do not agree to accept the survey and serological testing; deaf and dumb or mental retardation women. 

研究实施时间:

Study execute time:

From2012-10-15To 2014-12-31 

干预措施:

Interventions:

组别:

干预组

样本量:

600

Group:

intervention group

Sample size:

干预措施:

男用/女用安全套强化推广

干预措施代码:

Intervention:

male/female condom strengthening popularization

Intervention code:

组别:

干预组

样本量:

100

Group:

Intervention group

Sample size:

干预措施:

梅毒免费转介治疗

干预措施代码:

Intervention:

Syphilis Free treatment referral

Intervention code:

组别:

干预组

样本量:

150

Group:

Intervention group

Sample size:

干预措施:

HIV阴性者暴露前预防用药

干预措施代码:

Intervention:

Pre-exposure prophylaxis for HIV-negative

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

张家界市 

Country:

China 

Province:

Hunan 

City:

Zhangjiajie city 

单位(医院):

张家界市疾病预防控制中心 

单位级别:

市级 

Institution
hospital:

CDC of Zhangjiajie City 

Level of the institution:

municipal 

国家:

中国 

省(直辖市):

湖南 

市(区县):

江华县 

Country:

China 

Province:

Hunan 

City:

Jianghua county 

单位(医院):

江华县疾控中心 

单位级别:

县级 

Institution
hospital:

CDC of Jianghua county 

Level of the institution:

county 

国家:

中国 

省(直辖市):

湖南 

市(区县):

宁远县 

Country:

China 

Province:

Hunan 

City:

Ningyuan county 

单位(医院):

宁远县疾控中心 

单位级别:

县级 

Institution
hospital:

CDC of Ningyuan county 

Level of the institution:

County  

国家:

中国 

省(直辖市):

湖南 

市(区县):

吉首县 

Country:

China 

Province:

Hunan 

City:

Jishou county 

单位(医院):

吉首县疾控中心 

单位级别:

县级 

Institution
hospital:

CDC of Jishou county 

Level of the institution:

County  

国家:

中国 

省(直辖市):

广西 

市(区县):

柳州市 

Country:

China 

Province:

Guangxi 

City:

Liuzhou city 

单位(医院):

柳州市疾控中心 

单位级别:

市级 

Institution
hospital:

CDC of Liuzhou City 

Level of the institution:

municipal 

国家:

中国 

省(直辖市):

广西 

市(区县):

平南县 

Country:

China 

Province:

Guangxi 

City:

Pingnan county 

单位(医院):

平南县疾控中心 

单位级别:

县级 

Institution
hospital:

CDC of Pingnan county 

Level of the institution:

county 

国家:

中国 

省(直辖市):

广西 

市(区县):

贵港市 

Country:

China 

Province:

Guangxi 

City:

Guigang city 

单位(医院):

贵港市疾控中心 

单位级别:

市级 

Institution
hospital:

CDC of Guigang City 

Level of the institution:

municipal 

国家:

中国 

省(直辖市):

广西 

市(区县):

都安县 

Country:

China 

Province:

Guangxi 

City:

Du'an county 

单位(医院):

都安县疾控中心 

单位级别:

县级 

Institution
hospital:

CDC of Du'an county 

Level of the institution:

county 

国家:

中国 

省(直辖市):

云南 

市(区县):

大理市 

Country:

China 

Province:

Yunnan 

City:

Dali city 

单位(医院):

大理市疾控中心 

单位级别:

市级 

Institution
hospital:

CDC of Dali City 

Level of the institution:

municipal 

国家:

中国 

省(直辖市):

云南 

市(区县):

开远市 

Country:

China 

Province:

Yunnan 

City:

Kaiyuan city 

单位(医院):

开远市疾控中心 

单位级别:

市级 

Institution
hospital:

CDC of Kaiyuan City 

Level of the institution:

municipal 

国家:

中国 

省(直辖市):

云南 

市(区县):

景洪市 

Country:

China 

Province:

Yunnan 

City:

Jinghong city 

单位(医院):

景洪市疾控中心 

单位级别:

市级 

Institution
hospital:

CDC of Jinghong City 

Level of the institution:

municipal 

国家:

中国 

省(直辖市):

云南 

市(区县):

勐腊县 

Country:

China 

Province:

Yunnan 

City:

Mengla county 

单位(医院):

勐腊县疾控中心 

单位级别:

县级 

Institution
hospital:

CDC of Mengla county 

Level of the institution:

county 

测量指标:

Outcomes:

指标中文名:

HIV感染率

Outcome:

HIV infective rate

指标中文名:

梅毒感染率

Outcome:

Syphilis infective rate

指标中文名:

男用安全套使用率

Outcome:

Utilization rate of male condom

指标中文名:

女用安全套的使用率和可接受性

Outcome:

Utilization rate and acceptabilityof female condom

指标中文名:

暴露前预防用药的可接受性和依从性

Outcome:

Acceptability and compliance of Pre-exposure prophylaxis

指标中文名:

梅毒转介治疗率

Outcome:

Treatment rate of syphilis free treatment referral

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

上臂静脉

Sample Name:

Blood

Tissue:

Upper arm vein

人体标本去向

使用后保存

说明

保存至本研究结束后1年

Fate of sample:

Preservation after use

Note:

Save to 1 years after the end of the study

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

随机方法(请说明由何人用什么方法产生随机序列):

研究人员根据研究对象以市(县)为单位的HIV/STD感染率基线数据可比的原则,以省为层,以市(县)为单位将研究对象按照分层区组随机化的方法分组。干预组6个市(县),对照组6个市(县)。

性别:

女性

Randomization Procedure (please state who generates the random number sequence and by what method):

Cluster randomization based on county

Gender:

Female

盲法:

Blinding:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

Data collection Institution:

资料管理单位:

Data management Institution:

资料分析单位:

Data analysis Institution:

创建人:

Creater Name:

董薇 2012/11/8 13:10:53
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