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

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ClinicalTrials.gov Identifier: NCT01068015

Recruitment Status : Unknown

Verified April 2010 by National Center for AIDS/STD Control and Prevention, China CDC.
Recruitment status was: Active, not recruiting

First Posted : February 12, 2010

Last Update Posted : April 8, 2010

View this study on Beta.ClinicalTrials.gov

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

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

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Study Type :	Interventional (Clinical Trial)
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 :	June 2009
Estimated Primary Completion Date :	November 2010
Estimated Study Completion Date :	December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Genetic and Rare Diseases Information Center resources: Treponema Infection

U.S. FDA Resources

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.

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

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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

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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

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. doi: 10.1097/01.aids.0000266458.49138.fa.

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. doi: 10.1097/01.aids.0000266461.33891.d0.

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.

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. 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.

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.

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Responsible Party:	Professor Zunyou Wu, National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier:	NCT01068015
Other Study ID Numbers:	Intervention20100105
First Posted:	February 12, 2010 Key Record Dates
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:

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Syphilis Treponemal Infections Spirochaetales Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses	Infections Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases Communicable Diseases Genital Diseases Urogenital Diseases

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