(Men Who Have Sex With Men) MSM Community Intervention Trial

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

Detailed Description
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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: 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. To determine the acceptability of male circumcision among MSM population in China.

Official Title
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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

Conditions
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HIV, Syphilis, Herpesvirus 2, Human

Intervention / Treatment
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* Other: behavior intervention and male circumcision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This arm receives free circumcision service, POL intervention, intensive HIV counseling and intensive condom promotion. | Other: behavior intervention and male circumcision<br>* MSM in intervention arm can receive circumcision service for free, POL intervention, intensive HIV counseling and intensive condom promotion.<br>|
| No Intervention: usual<br>This arm receives no extra HIV prevention services. | Other: behavior intervention and male circumcision<br>* MSM in intervention arm can receive circumcision service for free, POL intervention, intensive HIV counseling and intensive condom promotion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV incidence |  | March 1,2010 to Dec,31,2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSM, Intervention, Popular Opinion Leader, Male Circumcision, HIV, Syphilis, HSV-2