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Injecting Drug Use Community Intervention Trial

Primary Purpose

HIV, Hepatitis C, Syphilis

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

About this trial

This is an interventional prevention trial for HIV focused on measuring Methadone maintenance treatment, drug users, heroin, HIV, HCV, Syphilis, HSV-2

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

(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

Sites / Locations

Center for Disease Control and Prevention,Guangxi Zhuang Autonomous RegionRecruiting
Center for Disease Control and Prevention, Guizhou ProvinceRecruiting
Center for Disease Control and Prevention, Sichuan ProvinceRecruiting
Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous RegionRecruiting
Center for Disease Control and Prevention, Yunnan ProvinceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual

Arm Description

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.

Routine HIV prevention, including health education, counseling and testing, condom promotion.

Outcomes

Primary Outcome Measures

HIV incidence rate

Secondary Outcome Measures

HCV, Syphilis, HSV-2 incidence

MMT Retention Rate and Lapse/Relapse Rate

Frequency of condom uses

The awareness of HIV-related Information among the clients [

The proportion of discordant couple/partners receiving HIV testing

Full Information

NCT ID

NCT01108614

First Posted

April 20, 2010

Last Updated

May 6, 2010

Sponsor

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

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

1. Study Identification

Unique Protocol Identification Number

NCT01108614

Brief Title

Injecting Drug Use Community Intervention Trial

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 Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2009 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

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

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV, Hepatitis C, Syphilis, HSV-2, HIV Infections

Keywords

Methadone maintenance treatment, drug users, heroin, HIV, HCV, Syphilis, HSV-2

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Usual

Arm Type

No Intervention

Arm Description

Routine HIV prevention, including health education, counseling and testing, condom promotion.

Intervention Type

Behavioral

Intervention Name(s)

Intervention

Other Intervention Name(s)

Comprehensive intervention group

Intervention Description

Primary Outcome Measure Information:

Title

HIV incidence rate

Time Frame

August 1,2009 to 31,Mar,2011

Secondary Outcome Measure Information:

Title

HCV, Syphilis, HSV-2 incidence

Time Frame

1,Aug.,2009 to 31,Mar,2011

Title

MMT Retention Rate and Lapse/Relapse Rate

Time Frame

1,Aug.,2009 to 31,Mar,2011

Title

Frequency of condom uses

Time Frame

1,Aug.,2009 to 31, Mar,2011

Title

The awareness of HIV-related Information among the clients [

Time Frame

1,Aug.,2009 to 31,Mar,2011

Title

The proportion of discordant couple/partners receiving HIV testing

Time Frame

1,Aug.,2009 to 31,Dec,2010

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zunyou Wu, MD, PHD

Phone

86-10-58900900

wuzy@chinacdc.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Wenyuan Yin, MD, MS

Phone

86-10-58900951

yinwy928@yahoo.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zunyou Wu, MD, PHD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region

City

Nanning

State/Province

Guangxi Zhuang Autonomous Region

ZIP/Postal Code

530028

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Liu, MD

Phone

0771-2518838

lw_gx@126.com

First Name & Middle Initial & Last Name & Degree

Li Rongjian, MD

Phone

0771-2528838

gxlrj@126.com

First Name & Middle Initial & Last Name & Degree

Wei Liu, MD

Facility Name

Center for Disease Control and Prevention, Guizhou Province

City

Guiyang

State/Province

Guizhou

ZIP/Postal Code

550004

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Limei Shen, MD

Phone

0851-6823903

shenlm999@tom.com

First Name & Middle Initial & Last Name & Degree

Yongming Yao, MD

Phone

0851-6820035

yaoyongming667@163.com

First Name & Middle Initial & Last Name & Degree

Limei Shen, MD

Facility Name

Center for Disease Control and Prevention, Sichuan Province

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linglin Zhang, MD

Phone

028-85589207

weirzhang@vip.163.com

First Name & Middle Initial & Last Name & Degree

Lai Wenhong, MD,MS

Phone

028-85581160

sclwh66@163.com

First Name & Middle Initial & Last Name & Degree

Linglin Zhang, MD

Facility Name

Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region

City

Urumchi

State/Province

Xingjiang Uyghur Autonomous Region

ZIP/Postal Code

830002

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fan Li, MD

Phone

0991-3822696

xjfanli@126.com

First Name & Middle Initial & Last Name & Degree

Feng Zhang, MD,MS

Phone

0991-8569907

xjabzf@126.com

First Name & Middle Initial & Last Name & Degree

Fan Li, MD

Facility Name

Center for Disease Control and Prevention, Yunnan Province

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

650022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manhong Jia, MD

Phone

0871-3626304

jmanhong@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Wanyue Zhang, MD

Phone

0871-3630775

First Name & Middle Initial & Last Name & Degree

Manhong Jia, MD

12. IPD Sharing Statement

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Injecting Drug Use Community Intervention Trial

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