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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- National Center for AIDS/STD Control and Prevention, China CDC
- Enrollment
- 12000
- Locations
- 5
- Primary Endpoint
- HIV incidence rate
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
HIV incidence rate
Time Frame: August 1,2009 to 31,Mar,2011
Secondary Outcomes
- 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)