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

Primary Purpose

HIV, Syphilis, Herpesvirus 2, Human

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
behavior intervention and male circumcision
Sponsored by
National Center for AIDS/STD Control and Prevention, China CDC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring MSM, Intervention, Popular Opinion Leader, Male Circumcision, HIV, Syphilis, HSV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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:

-

Sites / Locations

  • National Center for AIDS/STD Control and Provention
  • Center for Disease Control and Prevention, Chongqing City
  • Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region
  • Center for Disease Control and Prevention, Guizhou Province
  • Center for Disease Control and Prevention, Shanghai City
  • Center for Disease Control and Prevention, Sichuan Province
  • Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region
  • Center for Disease Control and Prevention, Yunnan Province

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

usual

Arm Description

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

This arm receives no extra HIV prevention services.

Outcomes

Primary Outcome Measures

HIV incidence

Secondary Outcome Measures

Syphilis, HSV-2 incidence
Frequency of condom uses, number of sexual partners
The proportion of people who have intention to be circumcised
The proportion of people who have been circumcised

Full Information

First Posted
February 11, 2010
Last Updated
April 7, 2010
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
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1. Study Identification

Unique Protocol Identification Number
NCT01068015
Brief Title
(Men Who Have Sex With Men) MSM Community Intervention Trial
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Syphilis, Herpesvirus 2, Human
Keywords
MSM, Intervention, Popular Opinion Leader, Male Circumcision, HIV, Syphilis, HSV-2

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
This arm receives free circumcision service, POL intervention, intensive HIV counseling and intensive condom promotion.
Arm Title
usual
Arm Type
No Intervention
Arm Description
This arm receives no extra HIV prevention services.
Intervention Type
Other
Intervention Name(s)
behavior intervention and male circumcision
Intervention Description
MSM in intervention arm can receive circumcision service for free, POL intervention, intensive HIV counseling and intensive condom promotion.
Primary Outcome Measure Information:
Title
HIV incidence
Time Frame
March 1,2010 to Dec,31,2010
Secondary Outcome Measure Information:
Title
Syphilis, HSV-2 incidence
Time Frame
1,Mar.,2009 to 31,Dec,2010
Title
Frequency of condom uses, number of sexual partners
Time Frame
March, 1, 2010 to December, 31,2010
Title
The proportion of people who have intention to be circumcised
Time Frame
March, 1, 2010 to December, 31,2010
Title
The proportion of people who have been circumcised
Time Frame
March, 1, 2010 to December, 31, 2010

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zunyou Wu, MD, PHD
Organizational Affiliation
National Center for AIDS/STD Control and Prevention, China CDC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jie Xu, MD, MS, MPH
Organizational Affiliation
National Center for AIDS/STD Control and Prevention, China CDC
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for AIDS/STD Control and Provention
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Center for Disease Control and Prevention, Chongqing City
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi Zhuang Autonomous Region
ZIP/Postal Code
530028
Country
China
Facility Name
Center for Disease Control and Prevention, Guizhou Province
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Facility Name
Center for Disease Control and Prevention, Shanghai City
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200336
Country
China
Facility Name
Center for Disease Control and Prevention, Sichuan Province
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region
City
Urumchi
State/Province
Xingjiang Uyghur Autonomous Region
ZIP/Postal Code
830002
Country
China
Facility Name
Center for Disease Control and Prevention, Yunnan Province
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650022
Country
China

12. IPD Sharing Statement

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PubMed Identifier
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Citation
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(Men Who Have Sex With Men) MSM Community Intervention Trial

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