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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by National Center for AIDS/STD Control and Prevention, China CDC.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01068015
First Posted: February 12, 2010
Last Update Posted: April 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Anderson J, Wilson D, Templeton DJ, Grulich A, Carter R, Kaldor J. Cost-effectiveness of adult circumcision in a resource-rich setting for HIV prevention among men who have sex with men. J Infect Dis. 2009 Dec 15;200(12):1803-12. doi: 10.1086/648472.
NIMH Collaborative HIV/STD Prevention Trial Group. The community popular opinion leader HIV prevention programme: conceptual basis and intervention procedures. AIDS. 2007 Apr;21 Suppl 2:S59-68.
NIMH Collaborative HIV/STD Prevention Trial Group. Formative study conducted in five countries to adapt the community popular opinion leader intervention. AIDS. 2007 Apr;21 Suppl 2:S91-8.
Feng L, Ding X, Lu R, Liu J, Sy A, Ouyang L, Pan C, Yi H, Liu H, Xu J, Zhao J. High HIV prevalence detected in 2006 and 2007 among men who have sex with men in China's largest municipality: an alarming epidemic in Chongqing, China. J Acquir Immune Defic Syndr. 2009 Sep 1;52(1):79-85. doi: 10.1097/QAI.0b013e3181a4f53e.
Feng LG, Ding XB, Lu RR, Pan CB, Yi HR, Liu HH, Ou YL, Xu J. [HIV prevalence and its associated factors among men who have sex with men in Chongqing]. Zhonghua Yu Fang Yi Xue Za Zhi. 2008 Dec;42(12):870-4. Chinese.
Gao L, Zhang L, Jin Q. Meta-analysis: prevalence of HIV infection and syphilis among MSM in China. Sex Transm Infect. 2009 Sep;85(5):354-8. doi: 10.1136/sti.2008.034702. Epub 2009 Apr 6. Review.
Guo H, Wei JF, Yang H, Huan X, Tsui SK, Zhang C. Rapidly increasing prevalence of HIV and syphilis and HIV-1 subtype characterization among men who have sex with men in Jiangsu, China. Sex Transm Dis. 2009 Feb;36(2):120-5. doi: 10.1097/OLQ.0b013e31818d3fa0.
He Q, Wang Y, Lin P, Raymond HF, Li Y, Yang F, Zhao J, Li J, Ling L, McFarland W. High prevalence of risk behaviour concurrent with links to other high-risk populations: a potentially explosive HIV epidemic among men who have sex with men in Guangzhou, China. Sex Transm Infect. 2009 Sep;85(5):383-90. doi: 10.1136/sti.2009.035808. Epub 2009 Apr 8. Erratum in: Sex Transm Infect. 2009 Dec;85(7):562.
Hong FC, Zhou H, Cai YM, Pan P, Feng TJ, Liu XL, Chen XS. Prevalence of syphilis and HIV infections among men who have sex with men from different settings in Shenzhen, China: implications for HIV/STD surveillance. Sex Transm Infect. 2009 Feb;85(1):42-4. doi: 10.1136/sti.2008.031682. Epub 2008 Jul 24.
Lau JT, Wang M, Tse YK, Gu J, Tsui HY, Zhang Y, Wang N, Cheng F. HIV-related behaviors among men who have sex with men in China: 2005-2006. AIDS Educ Prev. 2009 Aug;21(4):325-39. doi: 10.1521/aeap.2009.21.4.325.
Li L, Cao H, Wu Z, Wu S, Xiao L. Diffusion of positive AIDS care messages among service providers in China. AIDS Educ Prev. 2007 Dec;19(6):511-8. doi: 10.1521/aeap.2007.19.6.511.
Li SW, Zhang XY, Li XX, Wang MJ, Li DL, Ruan YH, Zhang XX, Shao YM. Detection of recent HIV-1 infections among men who have sex with men in Beijing during 2005 - 2006. Chin Med J (Engl). 2008 Jun 20;121(12):1105-8.
Millett GA, Flores SA, Marks G, Reed JB, Herbst JH. Circumcision status and risk of HIV and sexually transmitted infections among men who have sex with men: a meta-analysis. JAMA. 2008 Oct 8;300(14):1674-84. doi: 10.1001/jama.300.14.1674. Review. Erratum in: JAMA. 2009 Mar 18;301(11):1126-9.
Reisen CA, Zea MC, Poppen PJ, Bianchi FT. Male circumcision and HIV status among Latino immigrant MSM in New York City. J LGBT Health Res. 2007;3(4):29-36. doi: 10.1080/15574090802263421.
Ruan S, Yang H, Zhu Y, Ma Y, Li J, Zhao J, McFarland W, Raymond HF. HIV prevalence and correlates of unprotected anal intercourse among men who have sex with men, Jinan, China. AIDS Behav. 2008 May;12(3):469-75. doi: 10.1007/s10461-008-9361-9. Epub 2008 Feb 8.
Ruan Y, Jia Y, Zhang X, Liang H, Li Q, Yang Y, Li D, Zhou Z, Luo F, Shi W, Shao Y. Incidence of HIV-1, syphilis, hepatitis B, and hepatitis C virus infections and predictors associated with retention in a 12-month follow-up study among men who have sex with men in Beijing, China. J Acquir Immune Defic Syndr. 2009 Dec;52(5):604-10. doi: 10.1097/QAI.0b013e3181b31f5c.
Ruan Y, Luo F, Jia Y, Li X, Li Q, Liang H, Zhang X, Li D, Shi W, Freeman JM, Vermund SH, Shao Y. Risk factors for syphilis and prevalence of HIV, hepatitis B and C among men who have sex with men in Beijing, China: implications for HIV prevention. AIDS Behav. 2009 Aug;13(4):663-70. doi: 10.1007/s10461-008-9503-0. Epub 2008 Dec 12.
Ruan Y, Qian HZ, Li D, Shi W, Li Q, Liang H, Yang Y, Luo F, Vermund SH, Shao Y. Willingness to be circumcised for preventing HIV among Chinese men who have sex with men. AIDS Patient Care STDS. 2009 May;23(5):315-21. doi: 10.1089/apc.2008.0199.
Templeton DJ, Millett GA, Grulich AE. Male circumcision to reduce the risk of HIV and sexually transmitted infections among men who have sex with men. Curr Opin Infect Dis. 2010 Feb;23(1):45-52. doi: 10.1097/QCO.0b013e328334e54d. Review.
Xiao Y, Ding X, Li C, Liu J, Sun J, Jia Y. Prevalence and correlates of HIV and syphilis infections among men who have sex with men in Chongqing Municipality, China. Sex Transm Dis. 2009 Oct;36(10):647-56. doi: 10.1097/OLQ.0b013e3181aac23d.
Zhong F, Lin P, Xu H, Wang Y, Wang M, He Q, Fan L, Li Y, Wen F, Liang Y, Raymond HF, Zhao J. Possible increase in HIV and syphilis prevalence among men who have sex with men in Guangzhou, China: results from a respondent-driven sampling survey. AIDS Behav. 2011 Jul;15(5):1058-66. doi: 10.1007/s10461-009-9619-x.

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
First Submitted: February 11, 2010
First Posted: February 12, 2010
Last Update Posted: April 8, 2010
Last Verified: April 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
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female


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