NCT01068015

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,214

participants targeted

Target at P75+ for phase_3 hiv

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_3 hiv

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 8, 2010

Status Verified

April 1, 2010

Enrollment Period

1.4 years

First QC Date

February 11, 2010

Last Update Submit

April 7, 2010

Conditions

HIVSyphilisHerpesvirus 2, Human

Keywords

MSMInterventionPopular Opinion LeaderMale CircumcisionHIVSyphilisHSV-2

Outcome Measures

Primary Outcomes (1)

  • HIV incidence

    March 1,2010 to Dec,31,2010

Secondary Outcomes (4)

  • Syphilis, HSV-2 incidence

    1,Mar.,2009 to 31,Dec,2010

  • Frequency of condom uses, number of sexual partners

    March, 1, 2010 to December, 31,2010

  • The proportion of people who have intention to be circumcised

    March, 1, 2010 to December, 31,2010

  • The proportion of people who have been circumcised

    March, 1, 2010 to December, 31, 2010

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: behavior intervention and male circumcision

usual

NO INTERVENTION

This arm receives no extra HIV prevention services.

Other: behavior intervention and male circumcision

Interventions

behavior intervention and male circumcisionOTHER

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

Interventionusual

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

National Center for AIDS/STD Control and Provention

Beijing, Beijing Municipality, 100050, China

Location

Center for Disease Control and Prevention, Chongqing City

Chongqing, Chongqing Municipality, 400042, China

Location

Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530028, China

Location

Center for Disease Control and Prevention, Guizhou Province

Guiyang, Guizhou, 550004, China

Location

Center for Disease Control and Prevention, Shanghai City

Shanghai, Shanghai Municipality, 200336, China

Location

Center for Disease Control and Prevention, Sichuan Province

Chengdu, Sichuan, 610041, China

Location

Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region

Ürümqi, Xingjiang Uyghur Autonomous Region, 830002, China

Location

Center for Disease Control and Prevention, Yunnan Province

Kunming, Yunnan, 650022, China

Location

Related 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.

    PMID: 19909084BACKGROUND

  • 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.

    PMID: 17413265BACKGROUND

  • 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.

    PMID: 17413268BACKGROUND

  • 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.

    PMID: 19448559BACKGROUND

  • 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.

    PMID: 19141218BACKGROUND

  • 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.

    PMID: 19351623BACKGROUND

  • 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.

    PMID: 19125142BACKGROUND

  • 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.

    PMID: 19357129BACKGROUND

  • 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.

    PMID: 18653567BACKGROUND

  • 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.

    PMID: 19670968BACKGROUND

  • 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.

    PMID: 18190275BACKGROUND

  • 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.

    PMID: 18706227BACKGROUND

  • 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.

    PMID: 18840841BACKGROUND

  • 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.

    PMID: 19002268BACKGROUND

  • 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.

    PMID: 18259850BACKGROUND

  • 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.

    PMID: 19710617BACKGROUND

  • 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.

    PMID: 19082879BACKGROUND

  • 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.

    PMID: 19335172BACKGROUND

  • 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.

    PMID: 19935420BACKGROUND

  • 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.

    PMID: 19955876BACKGROUND

  • 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.

    PMID: 19826942BACKGROUND

MeSH Terms

Conditions

Syphilis

Interventions

Circumcision, Male

Condition Hierarchy (Ancestors)

Treponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesCommunicable DiseasesGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Body Modification, Non-TherapeuticCosmetic TechniquesTherapeuticsSurgical Procedures, OperativeUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 12, 2010

Study Start

June 1, 2009

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

April 8, 2010

Record last verified: 2010-04

Locations

CN(8)