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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Center for AIDS/STD Control and Prevention, China CDC.
Recruitment status was  Active, not recruiting
Sponsor:
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
Information provided by:
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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Syphilis, HSV-2 incidence [ Time Frame: 1,Mar.,2009 to 31,Dec,2010 ] [ Designated as safety issue: No ]
  • Frequency of condom uses, number of sexual partners [ Time Frame: March, 1, 2010 to December, 31,2010 ] [ Designated as safety issue: No ]
  • The proportion of people who have intention to be circumcised [ Time Frame: March, 1, 2010 to December, 31,2010 ] [ Designated as safety issue: No ]
  • The proportion of people who have been circumcised [ Time Frame: March, 1, 2010 to December, 31, 2010 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068015

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

Additional Information:
Publications:

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
Health Authority: China: Ministry of Health

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
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014