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

April 20, 2010
May 6, 2010
June 2009
December 2010   (final data collection date for primary outcome measure)
HIV incidence rate [ Time Frame: August 1,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01108614 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Injecting Drug Use Community Intervention Trial
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV
  • Hepatitis C
  • Syphilis
  • HSV-2
  • HIV Infections
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
  • 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.
    Intervention: Behavioral: Intervention
  • No Intervention: Usual
    Routine HIV prevention, including health education, counseling and testing, condom promotion.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12000
March 2011
December 2010   (final data collection date for primary outcome measure)

(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
Both
20 Years and older
No
Contact: Zunyou Wu, MD, PHD 86-10-58900900 wuzy@chinacdc.cn
Contact: Wenyuan Yin, MD, MS 86-10-58900951 yinwy928@yahoo.com.cn
China
 
NCT01108614
Drug Users Intervention, 2008ZX10001-016
Yes
Professor Zunyou Wu, National Center for AIDS/STD Control and Prevention, China CDC
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
Principal Investigator: Zunyou Wu, MD, PHD National Center for AIDS/STD Control and Prevention, China CDC
National Center for AIDS/STD Control and Prevention, China CDC
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP