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Status unknownNCT01068015Updated Apr 8, 2010

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

A Phase 3 interventional study of behavior intervention and male circumcision in HIV, Syphilis and Herpesvirus 2, Human, sponsored by National Center for AIDS/STD Control and Prevention, China CDC. Status unknown at 8 sites in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-08.

Sponsored by National Center for AIDS/STD Control and Prevention, China CDC · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
3,214
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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

Read the 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.
02

Conditions studied

  • HIV
  • Syphilis
  • Herpesvirus 2, Human

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Keywords

  • MSM
  • Intervention
  • Popular Opinion Leader
  • Male Circumcision
  • HIV
  • Syphilis
  • HSV-2
03

In context

Syphilis

122 studies on the registry are indexed under Syphilis; 33 are open to participants now.

This study's enrollment of 3,214 is above the median of 400 across 84 interventional studies indexed under Syphilis.

Browse Syphilis studies →

Lead sponsor

National Center for AIDS/STD Control and Prevention, China CDC is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

-

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,214 participants (actual)

Study arms

  • Experimental
    Intervention

    This arm receives free circumcision service, POL intervention, intensive HIV counseling and intensive condom promotion.

    Other: behavior intervention and male circumcision

  • No intervention
    usual

    This arm receives no extra HIV prevention services.

    Other: behavior intervention and male circumcision

Interventions

  • Otherbehavior intervention and male circumcision

    MSM in intervention arm can receive circumcision service for free, POL intervention, intensive HIV counseling and intensive condom promotion.

06

What researchers measure

Primary outcomes

  1. HIV incidence

    Time frame: March 1,2010 to Dec,31,2010

Secondary outcomes

  1. Syphilis, HSV-2 incidence

    Time frame: 1,Mar.,2009 to 31,Dec,2010

  2. Frequency of condom uses, number of sexual partners

    Time frame: March, 1, 2010 to December, 31,2010

  3. The proportion of people who have intention to be circumcised

    Time frame: March, 1, 2010 to December, 31,2010

  4. The proportion of people who have been circumcised

    Time frame: March, 1, 2010 to December, 31, 2010

07

Study locations

8 sites
  • National Center for AIDS/STD Control and Provention
    Beijing, Beijing Municipality 100050, China
  • Center for Disease Control and Prevention, Chongqing City
    Chongqing, Chongqing Municipality 400042, China
  • Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region
    Nanning, Guangxi 530028, China
  • Center for Disease Control and Prevention, Guizhou Province
    Guiyang, Guizhou 550004, China
  • Center for Disease Control and Prevention, Shanghai City
    Shanghai, Shanghai Municipality 200336, China
  • Center for Disease Control and Prevention, Sichuan Province
    Chengdu, Sichuan 610041, China
  • Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region
    Ürümqi, Xingjiang Uyghur Autonomous Region 830002, China
  • Center for Disease Control and Prevention, Yunnan Province
    Kunming, Yunnan 650022, China
08

References and documents

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. PubMed 19909084 ↗
  • 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. PubMed 17413265 ↗
  • 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. PubMed 17413268 ↗
  • 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. PubMed 19448559 ↗
  • 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. PubMed 19141218 ↗
  • 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. PubMed 19351623 ↗
  • 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. PubMed 19125142 ↗
  • 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. PubMed 19357129 ↗
  • 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. PubMed 18653567 ↗
  • 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. PubMed 19670968 ↗
  • 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. PubMed 18190275 ↗
  • 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. PubMed 18706227 ↗
  • 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. PubMed 18840841 ↗
  • 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. PubMed 19002268 ↗
  • 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. PubMed 18259850 ↗
  • 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. PubMed 19710617 ↗
  • 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. PubMed 19082879 ↗
  • 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. PubMed 19335172 ↗
  • 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. PubMed 19935420 ↗
  • 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. PubMed 19955876 ↗
  • 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. PubMed 19826942 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01068015
Lead sponsor
National Center for AIDS/STD Control and Prevention, China CDC
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
First posted
Feb 12, 2010
Start date
Jun 2009
Primary completion
Nov 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Apr 8, 2010

Study contacts

Zunyou Wu, MD, PHD
principal investigator · National Center for AIDS/STD Control and Prevention, China CDC
Jie Xu, MD, MS, MPH
principal investigator · National Center for AIDS/STD Control and Prevention, China CDC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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