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

Sponsor

National Center for AIDS/STD Control and Prevention, China CDC (Other)

Overall Status

Unknown status

CT.gov ID

NCT01068015

Collaborator

Yunnan Center for Disease Control and Prevention (Other), Xinjiang Center for Disease Control and Prevention (Other), Sichuan Center for Disease Control and Prevention (Other), Guangxi Center for Disease Control and Prevention (Other), Guizhou Center for Disease Control and Prevention (Other), Shanghai Center for Disease Control and Prevention (Other), Beijing Center for Disease Control and Prevention (Other), Chongqing Center for Disease Control and Prevention (Other)

3,214

Enrollment

Locations

Arms

Duration (Months)

401.8

Patients Per Site

22.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Syphilis Herpesvirus 2, Human	Other: behavior intervention and male circumcision	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3214 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 Start Date :

Jun 1, 2009

Anticipated Primary Completion Date :

Nov 1, 2010

Anticipated Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention This arm receives free circumcision service, POL intervention, intensive HIV counseling and intensive condom promotion.	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.
No Intervention: usual This arm receives no extra HIV prevention services.	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.

Arm

Intervention/Treatment

Experimental: Intervention

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

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.

No Intervention: usual

This arm receives no extra HIV prevention services.

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.

Outcome Measures

Primary Outcome Measures

HIV incidence [March 1,2010 to Dec,31,2010]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Center for AIDS/STD Control and Provention	Beijing	Beijing	China	100050
2	Center for Disease Control and Prevention, Chongqing City	Chongqing	Chongqing	China	400042
3	Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region	Nanning	Guangxi Zhuang Autonomous Region	China	530028
4	Center for Disease Control and Prevention, Guizhou Province	Guiyang	Guizhou	China	550004
5	Center for Disease Control and Prevention, Shanghai City	Shanghai	Shanghai	China	200336
6	Center for Disease Control and Prevention, Sichuan Province	Chengdu	Sichuan	China	610041
7	Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region	Urumchi	Xingjiang Uyghur Autonomous Region	China	830002
8	Center for Disease Control and Prevention, Yunnan Province	Kunming	Yunnan	China	650022

Sponsors and Collaborators

National Center for AIDS/STD Control and Prevention, China CDC
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

Investigators

Principal Investigator: Zunyou Wu, MD, PHD, National Center for AIDS/STD Control and Prevention, China CDC
Principal Investigator: Jie Xu, MD, MS, MPH, National Center for AIDS/STD Control and Prevention, China CDC