Injecting Drug Use Community Intervention Trial

Phase 3

• Conditions: HIV; Hepatitis C; Syphilis; HSV-2; HIV Infections
• Interventions: Behavioral: Intervention

• Registration Number: NCT01108614
• Lead Sponsor: National Center for AIDS/STD Control and Prevention, China CDC

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:

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 Timeline

• Study Start: 2009-06
• Status Verified: 2010-04
• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-20
• Study First Posted: 2010-04-22
• Last Update Submitted: 2010-05-06
• Last Update Posted: 2010-05-07
• Primary Completion: 2010-12
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	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.

Primary Outcome Measures

Name	Time	Method
HIV incidence rate	August 1,2009 to 31,Mar,2011

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guangxi Zhuang Autonomous Region, China

Center for Disease Control and Prevention, Sichuan Province; 🇨🇳 Chengdu, Sichuan, China

Center for Disease Control and Prevention, Yunnan Province; 🇨🇳 Kunming, Yunnan, China

Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region; 🇨🇳 Urumchi, Xingjiang Uyghur Autonomous Region, China

Center for Disease Control and Prevention, Guizhou Province; 🇨🇳 Guiyang, Guizhou, China