Injecting Drug Use Community Intervention Trial
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ClinicalTrials.gov Identifier: NCT01108614 |
Recruitment Status
: Unknown
Verified April 2010 by National Center for AIDS/STD Control and Prevention, China CDC.
Recruitment status was: Recruiting
First Posted
: April 22, 2010
Last Update Posted
: May 7, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Hepatitis C Syphilis HSV-2 HIV Infections | Behavioral: Intervention | Phase 3 |
Even though National sentinel surveillance data show that the increase rate of HIV new infections among IDUs in China has become stabilized and slowed down, the new HIV infection is still on the rise, especially in the Yunnan, Guizhou, Guangxi, Xinjiang and Sichuan. This study attempts to further reduce the new infection among MMT clients, and particularly to prevent the transmission from HIV infected clients to their sexual partners with comprehensive intervention.
The purposes of this study are:
- To evaluate the effectiveness of comprehensive interventions to decrease the HIV/STIs incidence among MMT clients.
- To prevent the sexual transmission between those HIV+ clients and their spouse/partners with intensified intervention.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 12000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Randomized Community Intervention Trial on Reducing HIV Infection Among Drug Users Attending Methadone Maintenance Treatment(MMT) and Preventing Secondary Transmission From HIV Positive Clients to Their Sexual Partners in China |
Study Start Date : | June 2009 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | March 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Intervention
Intensive HIV psychological counseling ,Increased methadone dosage under individualized treatment principle, enhance randomized urine test, strengthen family and social support , partner notification and routine HIV testing, condom promotion, STD referral services.
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Behavioral: Intervention
Intensive HIV psychological counseling ,Increased methadone dosage under individualized treatment principle, enhance randomized urine test, strengthen family and social support , partner notification and routine HIV testing, condom promotion, STD referral services.
Other Name: Comprehensive intervention group
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No Intervention: Usual
Routine HIV prevention, including health education, counseling and testing, condom promotion.
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- HIV incidence rate [ Time Frame: August 1,2009 to 31,Mar,2011 ]
- HCV, Syphilis, HSV-2 incidence [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ]
- MMT Retention Rate and Lapse/Relapse Rate [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ]
- Frequency of condom uses [ Time Frame: 1,Aug.,2009 to 31, Mar,2011 ]
- The awareness of HIV-related Information among the clients [ [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ]
- The proportion of discordant couple/partners receiving HIV testing [ Time Frame: 1,Aug.,2009 to 31,Dec,2010 ]

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
(1) For MMT clients:
Inclusion Criteria:
- 20 years or above and have independent capacity of civil conduct.
- Those have enrolled in MMT clinics more than one month, and progressed to the phase of maintenance treatment.
- No mental and other physical diseases
- More than 6-month stay at local places and registered at the designated clinics.
- Complete Informed consent
Exclusion Criteria:
- Fail to complete Informed consent
- Temporarily transit in or out of the designated clinic.
- Those have enrolled in MMT clinics less than one month, and haven't progressed to the phase of maintenance treatment.
- With serious mental or other physical diseases
For the spouse or sex partners of MMT HIV+ clients'
Inclusion Criteria:
- 20 years or above and have independent capacity of civil conduct.
- Keep fixed sexual contact with HIV+ clients in the recent 6 month
- No mental and other physical diseases
- More than 6-month stay at local places and be able to participate the 1 year follow up.
- Complete Informed consent
- The recent HIV test is negative
Exclusion Criteria:
- Fail to complete Informed consent
- Temporarily transit in or out of the designated clinic.
- With serious mental or other physical diseases
- The recent HIV test is positive

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): NCT01108614
Contact: Zunyou Wu, MD, PHD | 86-10-58900900 | wuzy@chinacdc.cn | |
Contact: Wenyuan Yin, MD, MS | 86-10-58900951 | yinwy928@yahoo.com.cn |
China, Guangxi Zhuang Autonomous Region | |
Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region | Recruiting |
Nanning, Guangxi Zhuang Autonomous Region, China, 530028 | |
Contact: Wei Liu, MD 0771-2518838 lw_gx@126.com | |
Contact: Li Rongjian, MD 0771-2528838 gxlrj@126.com | |
Principal Investigator: Wei Liu, MD | |
China, Guizhou | |
Center for Disease Control and Prevention, Guizhou Province | Recruiting |
Guiyang, Guizhou, China, 550004 | |
Contact: Limei Shen, MD 0851-6823903 shenlm999@tom.com | |
Contact: Yongming Yao, MD 0851-6820035 yaoyongming667@163.com | |
Principal Investigator: Limei Shen, MD | |
China, Sichuan | |
Center for Disease Control and Prevention, Sichuan Province | Recruiting |
Chengdu, Sichuan, China, 610041 | |
Contact: Linglin Zhang, MD 028-85589207 weirzhang@vip.163.com | |
Contact: Lai Wenhong, MD,MS 028-85581160 sclwh66@163.com | |
Principal Investigator: Linglin Zhang, MD | |
China, Xingjiang Uyghur Autonomous Region | |
Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region | Recruiting |
Urumchi, Xingjiang Uyghur Autonomous Region, China, 830002 | |
Contact: Fan Li, MD 0991-3822696 xjfanli@126.com | |
Contact: Feng Zhang, MD,MS 0991-8569907 xjabzf@126.com | |
Principal Investigator: Fan Li, MD | |
China, Yunnan | |
Center for Disease Control and Prevention, Yunnan Province | Recruiting |
Kunming, Yunnan, China, 650022 | |
Contact: Manhong Jia, MD 0871-3626304 jmanhong@yahoo.com.cn | |
Contact: Wanyue Zhang, MD 0871-3630775 | |
Principal Investigator: Manhong Jia, MD |
Principal Investigator: | Zunyou Wu, MD, PHD | National Center for AIDS/STD Control and Prevention, China CDC |
Additional Information:
Publications:
Responsible Party: | Professor Zunyou Wu, National Center for AIDS/STD Control and Prevention, China CDC |
ClinicalTrials.gov Identifier: | NCT01108614 History of Changes |
Other Study ID Numbers: |
Drug Users Intervention 2008ZX10001-016 ( Other Grant/Funding Number: Ministry of Health, the People's Republic of China ) |
First Posted: | April 22, 2010 Key Record Dates |
Last Update Posted: | May 7, 2010 |
Last Verified: | April 2010 |
Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:
Methadone maintenance treatment drug users heroin HIV |
HCV Syphilis HSV-2 |
Additional relevant MeSH terms:
Infection Hepatitis C HIV Infections Acquired Immunodeficiency Syndrome Syphilis Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Treponemal Infections Gram-Negative Bacterial Infections Bacterial Infections Sexually Transmitted Diseases, Bacterial Spirochaetales Infections Genital Diseases, Male Genital Diseases, Female Methadone Analgesics, Opioid Narcotics Central Nervous System Depressants |