(Men Who Have Sex With Men) MSM Community Intervention Trial
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Center for AIDS/STD Control and Prevention, China CDC.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
National Center for AIDS/STD Control and Prevention, China CDC
Collaborators:
Yunnan Center for Disease Control and Prevention
Xinjiang Center for Disease Control and Prevention
Sichuan Center for Disease Control and Prevention
Guangxi Center for Disease Control and Prevention
Guizhou Center for Disease Control and Prevention
Shanghai Center for Disease Control and Prevention
Beijing Center for Disease Control and Prevention
Chongqing Center for Disease Control and Prevention
Information provided by:
National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier:
NCT01068015
First received: February 11, 2010
Last updated: April 7, 2010
Last verified: April 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 11, 2010 | ||||||||
| Last Updated Date | April 7, 2010 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
HIV incidence [ Time Frame: March 1,2010 to Dec,31,2010 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01068015 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | (Men Who Have Sex With Men) MSM Community Intervention Trial | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief Summary | The purpose of this study is to evaluate the effectiveness of the community based comprehensive HIV/STIs intervention among MSMs in China. |
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| Detailed Description | 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:
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Other: behavior intervention and male circumcision
MSM in intervention arm can receive circumcision service for free, POL intervention, intensive HIV counseling and intensive condom promotion. |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | 3214 | ||||||||
| Estimated Completion Date | December 2010 | ||||||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - |
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01068015 | ||||||||
| Other Study ID Numbers ICMJE | Intervention20100105 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Professor Zunyou Wu, National Center for AIDS/STD Control and Prevention, China CDC | ||||||||
| Study Sponsor ICMJE | National Center for AIDS/STD Control and Prevention, China CDC | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Center for AIDS/STD Control and Prevention, China CDC | ||||||||
| Verification Date | April 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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