Injecting Drug Use Community Intervention Trial

NCT01108614 | Unknown Phase 3 DMC

• 2 other identifiers: Drug Users Intervention2008ZX10001-016
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• HIV incidence rate

  August 1,2009 to 31,Mar,2011

Secondary Outcomes (5)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Intervention

Usual

NO INTERVENTION

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

Interventions

Intervention BEHAVIORAL

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.

Also known as: Comprehensive intervention group

Intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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'
• 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
• 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

Sponsors & Collaborators

• National Center for AIDS/STD Control and Prevention, China CDC: lead
• Yunnan Center for Disease Control and Prevention: collaborator
• Xinjiang Center for Disease Control and Prevention: collaborator
• Sichuan Center for Disease Control and Prevention: collaborator
• Guangxi Center for Disease Control and Prevention: collaborator
• Guizhou Center for Disease Control and Prevention: collaborator

Study Sites (5)

Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530028, China

RECRUITING

Center for Disease Control and Prevention, Guizhou Province

Guiyang, Guizhou, 550004, China

RECRUITING

Center for Disease Control and Prevention, Sichuan Province

Chengdu, Sichuan, 610041, China

RECRUITING

Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region

Ürümqi, Xingjiang Uyghur Autonomous Region, 830002, China

RECRUITING

Center for Disease Control and Prevention, Yunnan Province

Kunming, Yunnan, 650022, China

RECRUITING

Related Publications (29)

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  BACKGROUND

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  BACKGROUND

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  PMID: 12466684 BACKGROUND

• Gogineni A, Stein MD, Friedmann PD. Social relationships and intravenous drug use among methadone maintenance patients. Drug Alcohol Depend. 2001 Sep 1;64(1):47-53. doi: 10.1016/s0376-8716(00)00230-1.

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  PMID: 9722816 BACKGROUND

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• Lansky A, Abdul-Quader AS, Cribbin M, Hall T, Finlayson TJ, Garfein RS, Lin LS, Sullivan PS. Developing an HIV behavioral surveillance system for injecting drug users: the National HIV Behavioral Surveillance System. Public Health Rep. 2007;122 Suppl 1(Suppl 1):48-55. doi: 10.1177/00333549071220S108.

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MeSH Terms

Conditions

Hepatitis C; Syphilis; HIV Infections; Drug Misuse

Interventions

Methods

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Genital Diseases; Urogenital Diseases; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Zunyou Wu, MD, PHD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zunyou Wu, MD, PHD

CONTACT

86-10-58900900; wuzy@chinacdc.cn

Wenyuan Yin, MD, MS

CONTACT

86-10-58900951; yinwy928@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 22, 2010
• Study Start: June 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: May 7, 2010

Record last verified: 2010-04

Locations

CN (5)