Injecting Drug Use Community Intervention Trial

May 6, 2010 updated by: National Center for AIDS/STD Control and Prevention, China CDC

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

12000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi Zhuang Autonomous Region, China, 530028
        • Recruiting
        • Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region
        • Principal Investigator:
          • Wei Liu, MD
        • Contact:
        • Contact:
          • Li Rongjian, MD
          • Phone Number: 0771-2528838
          • Email: gxlrj@126.com
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • Recruiting
        • Center for Disease Control and Prevention, Guizhou Province
        • Contact:
        • Contact:
        • Principal Investigator:
          • Limei Shen, MD
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Center for Disease Control and Prevention, Sichuan Province
        • Contact:
        • Contact:
        • Principal Investigator:
          • Linglin Zhang, MD
    • Xingjiang Uyghur Autonomous Region
      • Urumchi, Xingjiang Uyghur Autonomous Region, China, 830002
        • Recruiting
        • Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fan Li, MD
    • Yunnan
      • Kunming, Yunnan, China, 650022
        • Recruiting
        • Center for Disease Control and Prevention, Yunnan Province
        • Contact:
        • Contact:
          • Wanyue Zhang, MD
          • Phone Number: 0871-3630775
        • Principal Investigator:
          • Manhong Jia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

(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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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 Names:
  • Comprehensive intervention group
No Intervention: Usual
Routine HIV prevention, including health education, counseling and testing, condom promotion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV incidence rate
Time Frame: August 1,2009 to 31,Mar,2011
August 1,2009 to 31,Mar,2011

Secondary Outcome Measures

Outcome Measure
Time Frame
HCV, Syphilis, HSV-2 incidence
Time Frame: 1,Aug.,2009 to 31,Mar,2011
1,Aug.,2009 to 31,Mar,2011
MMT Retention Rate and Lapse/Relapse Rate
Time Frame: 1,Aug.,2009 to 31,Mar,2011
1,Aug.,2009 to 31,Mar,2011
Frequency of condom uses
Time Frame: 1,Aug.,2009 to 31, Mar,2011
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
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
1,Aug.,2009 to 31,Dec,2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for AIDS/STD Control and Prevention, China CDC

Collaborators

Sichuan Center for Disease Control and Prevention
Guizhou Center for Disease Control and Prevention
Guangxi Center for Disease Control and Prevention
Yunnan Center for Disease Control and Prevention
Xinjiang Center for Disease Control and Prevention

Investigators

  • Principal Investigator: Zunyou Wu, MD, PHD, National Center for AIDS/STD Control and Prevention, China CDC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

May 7, 2010

Last Update Submitted That Met QC Criteria

May 6, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Drug Users Intervention
  • 2008ZX10001-016 (Other Grant/Funding Number: Ministry of Health, the People's Republic of China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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