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

Phase 3

• Conditions: HIV; Syphilis; Herpesvirus 2, Human
• Interventions: Other: behavior intervention and male circumcision

• Registration Number: NCT01068015
• Lead Sponsor: National Center for AIDS/STD Control and Prevention, China CDC

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:

1. 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.

2. To determine the acceptability of male circumcision among MSM population in China.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-02-11
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-07
• Last Update Posted: 2010-04-08
• Primary Completion: 2010-11
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 3214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	behavior intervention and male circumcision	This arm receives free circumcision service, POL intervention, intensive HIV counseling and intensive condom promotion.
usual	behavior intervention and male circumcision	This arm receives no extra HIV prevention services.

Primary Outcome Measures

Name	Time	Method
HIV incidence	March 1,2010 to Dec,31,2010

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Center for Disease Control and Prevention, Guizhou Province; 🇨🇳 Guiyang, Guizhou, China

Center for Disease Control and Prevention, Sichuan Province; 🇨🇳 Chengdu, Sichuan, China

National Center for AIDS/STD Control and Provention; 🇨🇳 Beijing, Beijing, China

Center for Disease Control and Prevention, Chongqing City; 🇨🇳 Chongqing, Chongqing, China

Center for Disease Control and Prevention, Shanghai City; 🇨🇳 Shanghai, Shanghai, China

Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guangxi Zhuang Autonomous Region, China

Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region; 🇨🇳 Urumchi, Xingjiang Uyghur Autonomous Region, China

Center for Disease Control and Prevention, Yunnan Province; 🇨🇳 Kunming, Yunnan, China