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

HIV Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01068015
• Other study ID #: Intervention20100105
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 11, 2010
• Last updated: April 7, 2010
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: National Center for AIDS/STD Control and Prevention, China CDC
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3214
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpesvirus 2, Human
• HIV
• Syphilis

Intervention

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.

Locations

Country	Name	City	State
China	National Center for AIDS/STD Control and Provention	Beijing	Beijing
China	Center for Disease Control and Prevention, Sichuan Province	Chengdu	Sichuan
China	Center for Disease Control and Prevention, Chongqing City	Chongqing	Chongqing
China	Center for Disease Control and Prevention, Guizhou Province	Guiyang	Guizhou
China	Center for Disease Control and Prevention, Yunnan Province	Kunming	Yunnan
China	Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region	Nanning	Guangxi Zhuang Autonomous Region
China	Center for Disease Control and Prevention, Shanghai City	Shanghai	Shanghai
China	Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region	Urumchi	Xingjiang Uyghur Autonomous Region

Sponsors (9)

Lead Sponsor

Collaborator

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

Beijing Center for Disease Control and Prevention, Chongqing 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, Sichuan Center for Disease Control and Prevention, Xinjiang Center for Disease Control and Prevention, Yunnan Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

References & Publications (21)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV incidence		March 1,2010 to Dec,31,2010	No
Secondary	Syphilis, HSV-2 incidence		1,Mar.,2009 to 31,Dec,2010	No
Secondary	Frequency of condom uses, number of sexual partners		March, 1, 2010 to December, 31,2010	No
Secondary	The proportion of people who have intention to be circumcised		March, 1, 2010 to December, 31,2010	No
Secondary	The proportion of people who have been circumcised		March, 1, 2010 to December, 31, 2010	No

External Links

•   National Science and Technology Major Project Web Site