Injecting Drug Use Community Intervention Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Center for AIDS/STD Control and Prevention, China CDC.
Recruitment status was  Recruiting
Sponsor:
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
Information provided by:
National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier:
NCT01108614
First received: April 20, 2010
Last updated: May 6, 2010
Last verified: April 2010
  Purpose

The purpose of this study is to reduce the HIV/HCV incidence among the clients attending community-based methadone maintenance treatment (MMT) , and to prevent the secondary sexual transmission from HIV+ clients to their spouse and sex partners, through intensified comprehensive intervention.


Condition Intervention Phase
HIV
Hepatitis C
Syphilis
HSV-2
HIV Infections
Behavioral: Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Center for AIDS/STD Control and Prevention, China CDC:

Primary Outcome Measures:
  • HIV incidence rate [ Time Frame: August 1,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HCV, Syphilis, HSV-2 incidence [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]
  • MMT Retention Rate and Lapse/Relapse Rate [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]
  • Frequency of condom uses [ Time Frame: 1,Aug.,2009 to 31, Mar,2011 ] [ Designated as safety issue: No ]
  • The awareness of HIV-related Information among the clients [ [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]
  • The proportion of discordant couple/partners receiving HIV testing [ Time Frame: 1,Aug.,2009 to 31,Dec,2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12000
Study Start Date: June 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Usual
Routine HIV prevention, including health education, counseling and testing, condom promotion.

Detailed Description:

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:

  1. To evaluate the effectiveness of comprehensive interventions to decrease the HIV/STIs incidence among MMT clients.
  2. To prevent the sexual transmission between those HIV+ clients and their spouse/partners with intensified intervention.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

(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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108614

Contacts
Contact: Zunyou Wu, MD, PHD 86-10-58900900 wuzy@chinacdc.cn
Contact: Wenyuan Yin, MD, MS 86-10-58900951 yinwy928@yahoo.com.cn

Locations
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         
Sponsors and Collaborators
National Center for AIDS/STD Control and Prevention, China CDC
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
Investigators
Principal Investigator: Zunyou Wu, MD, PHD National Center for AIDS/STD Control and Prevention, China CDC
  More Information

Additional Information:
Publications:
Ball A, Beg M, Doupe A, Weiler G. World Health Organization, Evidence for Action for HIV Prevention, Treatment and Care among Injecting Drug Users. The International Journal of Drug Policy. 2005;16.

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
Study First Received: April 20, 2010
Last Updated: May 6, 2010
Health Authority: China: Ministry of Health

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:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis C
Syphilis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Infection
Genital Diseases, Male
Genital Diseases, Female
Methadone

ClinicalTrials.gov processed this record on July 09, 2014