Injecting Drug Use Community Intervention Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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(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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>* Other names: Comprehensive intervention group;|
| No Intervention: Usual<br>Routine HIV prevention, including health education, counseling and testing, condom promotion. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV incidence rate |  | August 1,2009 to 31,Mar,2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV, Syphilis, HSV-2 incidence |  | 1,Aug.,2009 to 31,Mar,2011 | 
| MMT Retention Rate and Lapse/Relapse Rate |  | 1,Aug.,2009 to 31,Mar,2011 | 
| Frequency of condom uses |  | 1,Aug.,2009 to 31, Mar,2011 | 
| The awareness of HIV-related Information among the clients [ |  | 1,Aug.,2009 to 31,Mar,2011 | 
| The proportion of discordant couple/partners receiving HIV testing |  | 1,Aug.,2009 to 31,Dec,2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Methadone maintenance treatment, drug users, heroin, HCV, Syphilis, HSV-2