Clinical Trials

MainTitle

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

The recruitment status of this study is unknown.

Verified April 2010

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

Collaborator
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 (Responsible Party)
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
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
HIV
Syphilis
Herpesvirus 2, Human

Other : behavior intervention and male circumcision
Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by National Center for AIDS/STD Control and Prevention, China CDC:

Primary Outcome Measures

  • HIV incidence [ Time Frame: March 1,2010 to Dec,31,2010 ]
Secondary Outcome Measures:
  • Syphilis, HSV-2 incidence [ Time Frame: 1,Mar.,2009 to 31,Dec,2010 ]
  • Frequency of condom uses, number of sexual partners [ Time Frame: March, 1, 2010 to December, 31,2010 ]
  • The proportion of people who have intention to be circumcised [ Time Frame: March, 1, 2010 to December, 31,2010 ]
  • The proportion of people who have been circumcised [ Time Frame: March, 1, 2010 to December, 31, 2010 ]

Enrollment: 3214
Study Start Date: June 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

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.
ermine the acceptability of male circumcision among MSM population in China.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

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:

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068015

Locations

China
National Center for AIDS/STD Control and Provention
Beijing, Beijing, China, 100050
Center for Disease Control and Prevention, Chongqing City
Chongqing, Chongqing, China, 400042
Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region
Nanning, Guangxi Zhuang Autonomous Region, China, 530028
Center for Disease Control and Prevention, Guizhou Province
Guiyang, Guizhou, China, 550004
Center for Disease Control and Prevention, Shanghai City
Shanghai, Shanghai, China, 200336
Center for Disease Control and Prevention, Sichuan Province
Chengdu, Sichuan, China, 610041
Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region
Urumchi, Xingjiang Uyghur Autonomous Region, China, 830002
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
More Information

More Information

Additional Information:

National Science and Technology Major Project Web Site

Responsible Party: Professor Zunyou Wu, National Center for AIDS/STD Control and Prevention, China CDC  
ClinicalTrials.gov Identifier: NCT01068015   History of Changes  
Other Study ID Numbers: Intervention20100105  
Study First Received: February 11, 2010  
Last Updated: April 7, 2010  

Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:

MSM
Intervention
Popular Opinion Leader
Male Circumcision
HIV
Syphilis
HSV-2

Additional relevant MeSH terms:
Syphilis

ClinicalTrials.gov processed this data on October 19, 2018
This information is provided by ClinicalTrials.gov.