HIVPhase 3NCT01068015
(Men Who Have Sex With Men) MSM Community Intervention Trial
A Phase 3 study testing behavior intervention and male circumcision in people with HIV and Syphilis, run by National Center for AIDS/STD Control and Prevention, China CDC at 8 sites in China.
Trial summary
The purpose of this study is to evaluate the effectiveness of the community based comprehensive HIV/STIs intervention among MSMs in China. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV, Syphilis, Herpesvirus 2, Human
- What is being tested?
- behavior intervention and male circumcision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,214 participants
- Where
- 8 sitesChina
- Study dates
- Jun 2009to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
National Center for AIDS/STD Control and Provention
Beijing, Beijing Municipality, 100050
Center for Disease Control and Prevention, Sichuan Province
Chengdu, Sichuan, 610041
Center for Disease Control and Prevention, Chongqing City
Chongqing, Chongqing Municipality, 400042
Center for Disease Control and Prevention, Guizhou Province
Guiyang, Guizhou, 550004
Center for Disease Control and Prevention, Yunnan Province
Kunming, Yunnan, 650022
Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530028
Center for Disease Control and Prevention, Shanghai City
Shanghai, Shanghai Municipality, 200336
Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region
Ürümqi, Xingjiang Uyghur Autonomous Region, 830002
About this study
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
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:
- 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.
- Conditions
- HIV, Syphilis, Herpesvirus 2, Human
- Being tested
- behavior intervention and male circumcision
- Keywords
- MSM, Intervention, Popular Opinion Leader, Male Circumcision, HIV, Syphilis, HSV-2
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavior intervention and male circumcisionOther
MSM in intervention arm can receive circumcision service for free, POL intervention, intensive HIV counseling and intensive condom promotion.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm receives free circumcision service, POL intervention, intensive HIV counseling and intensive condom promotion. Receives: Other: behavior intervention and male circumcision |
| usual | No intervention | This arm receives no extra HIV prevention services. Receives: Other: behavior intervention and male circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV incidence
Measured: March 1,2010 to Dec,31,2010
Secondary outcomes (4)
Syphilis, HSV-2 incidence
Measured: 1,Mar.,2009 to 31,Dec,2010
Frequency of condom uses, number of sexual partners
Measured: March, 1, 2010 to December, 31,2010
The proportion of people who have intention to be circumcised
Measured: March, 1, 2010 to December, 31,2010
The proportion of people who have been circumcised
Measured: March, 1, 2010 to December, 31, 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startJun 2009
- Primary completionNov 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,214 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDC
- Sponsor type
- Other government
- 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
- Investigators
- Zunyou Wu, MD, PHD, Principal investigator, National Center for AIDS/STD Control and Prevention, China CDCJie Xu, MD, MS, MPH, Principal investigator, National Center for AIDS/STD Control and Prevention, China CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068015
- Sponsor's protocol ID
- Intervention20100105
- Status last verified
- Apr 2010
- First submitted
- 11 Feb 2010
- Last updated
- 8 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
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 19909084NIMH 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 17413265NIMH 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 17413268Feng 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 19448559Feng 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 19141218Gao 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 19351623Guo 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 19125142He 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 19357129Hong 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 18653567Lau 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 19670968Li 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 18190275Li 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 18706227Millett 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 18840841Reisen 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 19002268Ruan 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01068015
- Acronym / sponsor ID
- Intervention20100105
- Conditions
- HIV, Syphilis, Herpesvirus 2, Human
- Keywords
- MSM, Intervention, Popular Opinion Leader, Male Circumcision, HIV, Syphilis, HSV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,214 participants (actual)
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDCOther government
- 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
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of the community based comprehensive HIV/STIs intervention among MSMs in China.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: behavior intervention and male circumcisionThis arm receives free circumcision service, POL intervention, intensive HIV counseling and intensive condom promotion. |
| usual | No intervention | Other: behavior intervention and male circumcisionThis arm receives no extra HIV prevention services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavior intervention and male circumcisionMSM in intervention arm can receive circumcision service for free, POL intervention, intensive HIV counseling and intensive condom promotion. | Other | Intervention, usual |
Primary outcome
HIV incidence
Time frame: March 1,2010 to Dec,31,2010
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2010.
- Background: PubMed 19909084Anderson 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.
- Background: PubMed 17413265NIMH 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.
- Background: PubMed 17413268NIMH 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.
- Background: PubMed 19448559Feng 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.
- Background: PubMed 19141218Feng 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.
- Background: PubMed 19351623Gao 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.
- Background: PubMed 19125142Guo 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.
- Background: PubMed 19357129He 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.
- Background: PubMed 18653567Hong 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.
- Background: PubMed 19670968Lau 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.
- Background: PubMed 18190275Li 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.
- Background: PubMed 18706227Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing behavior intervention and male circumcision in people with HIV and Syphilis, run by National Center for AIDS/STD Control and Prevention, China CDC at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV incidence (time frame: March 1,2010 to Dec,31,2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01068015, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2010.