Injecting Drug Use Community Intervention Trial

National Center for AIDS/STD Control and Prevention, China CDC

Status and phase: Unknown; Phase 3

Conditions: HSV-2; Syphilis; Hepatitis C; HIV; HIV Infections

Treatments: Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01108614

Drug Users Intervention

2008ZX10001-016 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12,000 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention

Usual

No Intervention group

Description:

Routine HIV prevention, including health education, counseling and testing, condom promotion.