Clinical trial NCT01108614: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV
Hepatitis C
Syphilis
HSV-2
HIV Infections
Keywords: Methadone maintenance treatment
drug users
heroin
HIV
HCV
Syphilis
HSV-2
Lead sponsor: National Center for AIDS/STD Control and Prevention, China CDC
Sponsor class: OTHER_GOV
Collaborators: name: Yunnan Center for Disease Control and Prevention
name: Xinjiang Center for Disease Control and Prevention
name: Sichuan Center for Disease Control and Prevention
name: Guangxi Center for Disease Control and Prevention
name: Guizhou Center for Disease Control and Prevention
First posted: 2010-04-22
Enrollment: 12000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: HIV incidence rate
timeFrame: August 1,2009 to 31,Mar,2011
Secondary outcomes:
measure: HCV, Syphilis, HSV-2 incidence
timeFrame: 1,Aug.,2009 to 31,Mar,2011
measure: MMT Retention Rate and Lapse/Relapse Rate
timeFrame: 1,Aug.,2009 to 31,Mar,2011
measure: Frequency of condom uses
timeFrame: 1,Aug.,2009 to 31, Mar,2011
measure: The awareness of HIV-related Information among the clients [
timeFrame: 1,Aug.,2009 to 31,Mar,2011
measure: The proportion of discordant couple/partners receiving HIV testing
timeFrame: 1,Aug.,2009 to 31,Dec,2010
Other outcomes:
Locations:
city: Nanning
country: China
facility: Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region
state: Guangxi Zhuang Autonomous Region
city: Guiyang
country: China
facility: Center for Disease Control and Prevention, Guizhou Province
state: Guizhou
city: Chengdu
country: China
facility: Center for Disease Control and Prevention, Sichuan Province
state: Sichuan
city: Urumchi
country: China
facility: Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region
state: Xingjiang Uyghur Autonomous Region
city: Kunming
country: China
facility: Center for Disease Control and Prevention, Yunnan Province
state: Yunnan
Study officials:
affiliation: National Center for AIDS/STD Control and Prevention, China CDC
name: Zunyou Wu, MD, PHD
role: PRINCIPAL_INVESTIGATOR
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