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Injecting Drug Use Community Intervention Trial

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01108614
Enrollment
12000
Registered
2010-04-22
Start date
2009-06-30
Completion date
2011-03-31
Last updated
2010-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALIntervention

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.

Sponsors

Yunnan Center for Disease Control and Prevention
CollaboratorOTHER
Xinjiang Center for Disease Control and Prevention
CollaboratorOTHER
Sichuan Center for Disease Control and Prevention
CollaboratorOTHER_GOV
Guangxi Center for Disease Control and Prevention
CollaboratorOTHER_GOV
Guizhou Center for Disease Control and Prevention
CollaboratorOTHER
National Center for AIDS/STD Control and Prevention, China CDC
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
HIV incidence rateAugust 1,2009 to 31,Mar,2011

Secondary

MeasureTime frame
HCV, Syphilis, HSV-2 incidence1,Aug.,2009 to 31,Mar,2011
MMT Retention Rate and Lapse/Relapse Rate1,Aug.,2009 to 31,Mar,2011
Frequency of condom uses1,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 testing1,Aug.,2009 to 31,Dec,2010

Countries

China

Contacts

Primary ContactZunyou Wu, MD, PHD
wuzy@chinacdc.cn86-10-58900900
Backup ContactWenyuan Yin, MD, MS
yinwy928@yahoo.com.cn86-10-58900951

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026