Clinical Trials For Genital Herpes Injecting Drug Use Community Intervention Trial

Injecting Drug Use Community Intervention Trial

This study is currently recruiting participants.

Verified by National Center for AIDS/STD Control and Prevention, China CDC, April 2010

First Received: April 20, 2010   Last Updated: May 6, 2010   History of Changes

Sponsor:

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

Collaborators:

Yunnan Center for Disease Control and Prevention

Xinjiang Center for Disease Control and Prevention

Sichuan Center for Disease Control and Prevention

Guangxi Center for Disease Control and Prevention

Guizhou Center for Disease Control and Prevention

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT01108614

Purpose

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.


Condition

Intervention

Phase

HIV

Hepatitis C

Syphilis

HSV-2

HIV Infections

Behavioral: Intervention

Phase III


Study Type:

Interventional

Study Design:

Allocation: Randomized

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Open Label

Primary Purpose: Prevention

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


Resource links provided by NLM:


MedlinePlus related topics: AIDS Hepatitis Hepatitis C Syphilis

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources


Further study details as provided by National Center for AIDS/STD Control and Prevention, China CDC:


Primary Outcome Measures:

HIV incidence rate [ Time Frame: August 1,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

HCV, Syphilis, HSV-2 incidence [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]

MMT Retention Rate and Lapse/Relapse Rate [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]

Frequency of condom uses [ Time Frame: 1,Aug.,2009 to 31, Mar,2011 ] [ Designated as safety issue: No ]

The awareness of HIV-related Information among the clients [ [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]

The proportion of discordant couple/partners receiving HIV testing [ Time Frame: 1,Aug.,2009 to 31,Dec,2010 ] [ Designated as safety issue: No ]


Estimated Enrollment:

12000

Study Start Date:

June 2009

Estimated Study Completion Date:

March 2011

Estimated Primary Completion Date:

December 2010 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

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

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.

Usual: No Intervention

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



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:

To evaluate the effectiveness of comprehensive interventions to decrease the HIV/STIs incidence among MMT clients.

To prevent the sexual transmission between those HIV+ clients and their spouse/partners with intensified intervention.

Eligibility


Ages Eligible for Study:

20 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108614


Contacts

Contact: Zunyou Wu, MD, PHD

86-10-58900900

wuzy@chinacdc.cn

Contact: Wenyuan Yin, MD, MS

86-10-58900951

yinwy928@yahoo.com.cn


Locations

China, Guangxi Zhuang Autonomous Region

Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region

Recruiting

Nanning, Guangxi Zhuang Autonomous Region, China, 530028

Contact: Wei Liu, MD     0771-2518838     lw_gx@126.com

Contact: Li Rongjian, MD     0771-2528838     gxlrj@126.com

Principal Investigator: Wei Liu, MD

China, Guizhou Province

Center for Disease Control and Prevention, Guizhou Province

Recruiting

Guiyang, Guizhou Province, China, 550004

Contact: Limei Shen, MD     0851-6823903     shenlm999@tom.com

Contact: Yongming Yao, MD     0851-6820035     yaoyongming667@163.com

Principal Investigator: Limei Shen, MD

China, Sichuan

Center for Disease Control and Prevention, Sichuan Province

Recruiting

Chengdu, Sichuan, China, 610041

Contact: Linglin Zhang, MD     028-85589207     weirzhang@vip.163.com

Contact: Lai Wenhong, MD,MS     028-85581160     sclwh66@163.com

Principal Investigator: Linglin Zhang, MD

China, Xingjiang Uyghur Autonomous Region

Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region

Recruiting

Urumchi, Xingjiang Uyghur Autonomous Region, China, 830002

Contact: Fan Li, MD     0991-3822696     xjfanli@126.com

Contact: Feng Zhang, MD,MS     0991-8569907     xjabzf@126.com

Principal Investigator: Fan Li, MD

China, Yunnan province

Center for Disease Control and Prevention, Yunnan Province

Recruiting

Kunming, Yunnan province, China, 650022

Contact: Manhong Jia, MD     0871-3626304     jmanhong@yahoo.com.cn

Contact: Wanyue Zhang, MD     0871-3630775

Principal Investigator: Manhong Jia, MD

Sponsors and Collaborators

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

Yunnan Center for Disease Control and Prevention

Xinjiang Center for Disease Control and Prevention

Sichuan Center for Disease Control and Prevention

Guangxi Center for Disease Control and Prevention

Guizhou Center for Disease Control and Prevention

Investigators

Principal Investigator:

Zunyou Wu, MD, PHD

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

More Information


Additional Information:

National Science and Technology Project


Publications:

Costenbader EC, Astone NM, Latkin CA. The dynamics of injection drug users’ personal networks and HIV risk behaviors. Addiction. 2006 Jul;101(7):1003-13.

Booth RE, Corsi KF, Mikulich-Gilbertson SK. Factors associated with methadone maintenance treatment retention among street-recruited injection drug users. Drug Alcohol Depend. 2004 May 10;74(2):177-85.

Gifford E, Humphreys K. The psychological science of addiction. Addiction. 2007 Mar;102(3):352-61.

Gyarmathy VA, Neaigus A. Marginalized and socially integrated groups of IDUs in Hungary: potential bridges of HIV infection. J Urban Health. 2005 Sep;82(3 Suppl 4):iv101-12.

Latkin CA, Sherman S, Knowlton A. HIV prevention among drug users: outcome of a network-oriented peer outreach intervention. Health Psychol. 2003 Jul;22(4):332-9.

Lloyd JJ, Ricketts EP, Strathdee SA, Cornelius LJ, Bishai D, Huettner S, Havens JR, Latkin C. Social contextual factors associated with entry into opiate agonist treatment among injection drug users. Am J Drug Alcohol Abuse. 2005;31(4):555-70.

Termorshuizen F, Krol A, Prins M, Geskus R, van den Brink W, van Ameijden EJ. Prediction of relapse to frequent heroin use and the role of methadone prescription: an analysis of the Amsterdam Cohort Study among drug users. Drug Alcohol Depend. 2005 Aug 1;79(2):231-40. Epub 2005 Feb 24.

Ball A, Beg M, Doupe A, Weiler G. World Health Organization, Evidence for Action for HIV Prevention, Treatment and Care among Injecting Drug Users. The International Journal of Drug Policy. 2005;16.

de la Fuente L, Bravo MJ, Lew C, Barrio G, Soriano V, Royuela L. [The prevalence of human immunodeficiency virus infection and the risk behaviors in the heroin addicts of Barcelona, Madrid and Seville: an example of the advantages of centering studies on addicts and not just on intravenous users] Med Clin (Barc). 1999 Nov 20;113(17):646-51. Spanish.

Welp EA, Lodder AC, Langendam MW, Coutinho RA, van Ameijden EJ. HIV prevalence and risk behaviour in young drug users in Amsterdam. AIDS. 2002 Jun 14;16(9):1279-84.

Garfein RS, Monterroso ER, Tong TC, Vlahov D, Des Jarlais DC, Selwyn P, Kerndt PR, Word C, Fernando MD, Ouellet LJ, Holmberg SD. Comparison of HIV infection risk behaviors among injection drug users from East and West Coast US cities. J Urban Health. 2004 Jun;81(2):260-7.

Gilman SM, Galanter M, Dermatis H. Methadone Anonymous: A 12-Step Program for Methadone Maintained Heroin Addicts. Subst Abus. 2001 Dec;22(4):247-256.

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.

Hartel DM, Schoenbaum EE. Methadone treatment protects against HIV infection: two decades of experience in the Bronx, New York City. Public Health Rep. 1998 Jun;113 Suppl 1:107-15.

Langendam MW, van Brussel GH, Coutinho RA, van Ameijden EJ. Methadone maintenance and cessation of injecting drug use: results from the Amsterdam Cohort Study. Addiction. 2000 Apr;95(4):591-600.

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 1:48-55.

Brady JE, Friedman SR, Cooper HL, Flom PL, Tempalski B, Gostnell K. Estimating the prevalence of injection drug users in the U.S. and in large U.S. metropolitan areas from 1992 to 2002. J Urban Health. 2008 May;85(3):323-51. Epub 2008 Mar 15.

Des Jarlais DC, Braine N, Yi H, Turner C. Residual injection risk behavior, HIV infection, and the evaluation of syringe exchange programs. AIDS Educ Prev. 2007 Apr;19(2):111-23.

Des Jarlais DC, Semaan S. HIV prevention for injecting drug users: the first 25 years and counting. Psychosom Med. 2008 Jun;70(5):606-11. Epub 2008 Jun 2. Review.

Gowing L, Farrell M, Bornemann R, Sullivan L, Ali R. Substitution treatment of injecting opioid users for prevention of HIV infection. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004145. Review.

Gossop M, Marsden J, Stewart D, Rolfe A. Patterns of improvement after methadone treatment: 1 year follow-up results from the National Treatment Outcome Research Study. Drug Alcohol Depend. 2000 Nov 1;60(3):275-86.

King VL, Kidorf MS, Stoller KB, Brooner RK. Influence of psychiatric comorbidity on HIV risk behaviors: changes during drug abuse treatment. J Addict Dis. 2000;19(4):65-83.

Strang J, Marsden J, Cummins M, Farrell M, Finch E, Gossop M, Stewart D, Welch S. Randomized trial of supervised injectable versus oral methadone maintenance: report of feasibility and 6-month outcome. Addiction. 2000 Nov;95(11):1631-45.

Margolin A, Avants SK, Warburton LA, Hawkins KA, Shi J. A randomized clinical trial of a manual-guided risk reduction intervention for HIV-positive injection drug users. Health Psychol. 2003 Mar;22(2):223-8.

Zaric GS, Barnett PG, Brandeau ML. HIV transmission and the cost-effectiveness of methadone maintenance. Am J Public Health. 2000 Jul;90(7):1100-11.

Beckett M, Burnam A, Collins RL, Kanouse DE, Beckman R. Substance use and high-risk sex among people with HIV: a comparison across exposure groups. AIDS Behav. 2003 Jun;7(2):209-19.

Preston KL, Umbricht A, Epstein DH. Methadone dose increase and abstinence reinforcement for treatment of continued heroin use during methadone maintenance. Arch Gen Psychiatry. 2000 Apr;57(4):395-404.

Sees KL, Delucchi KL, Masson C, Rosen A, Clark HW, Robillard H, Banys P, Hall SM. Methadone maintenance vs 180-day psychosocially enriched detoxification for treatment of opioid dependence: a randomized controlled trial. JAMA. 2000 Mar 8;283(10):1303-10.


Responsible Party:

National Center for AIDS/STD Control and Prevention, China CDC ( Professor Zunyou Wu )

ClinicalTrials.gov Identifier:

NCT01108614 History of Changes

Other Study ID Numbers:

Drug Users Intervention, 2008ZX10001-016

Study First Received:

April 20, 2010

Last Updated:

May 6, 2010

Health Authority:

China: Ministry of Health


Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:

Methadone maintenance treatment

drug users

heroin

HIV

HCV

Syphilis

HSV-2


Additional relevant MeSH terms:

Bacterial Infections

Respiratory System Agents

Sexually Transmitted Diseases, Bacterial

Sexually Transmitted Diseases, Viral

Liver Diseases

Slow Virus Diseases

Flaviviridae Infections

Physiological Effects of Drugs

Hepatitis, Viral, Human

Infection

Gram-Negative Bacterial Infections

Genital Diseases, Female

Treponemal Infections

Sensory System Agents

Therapeutic Uses

Analgesics

Hepatitis C

Retroviridae Infections

Syphilis

Analgesics, Opioid

RNA Virus Infections

Immune System Diseases

Acquired Immunodeficiency Syndrome

Central Nervous System Depressants

Narcotics

Genital Diseases, Male

Pharmacologic Actions

Immunologic Deficiency Syndromes

Virus Diseases

Hepatitis


ClinicalTrials.gov processed this record on June 15, 2010

Injecting Drug Use Community Intervention Trial

This study is currently recruiting participants.

Verified by National Center for AIDS/STD Control and Prevention, China CDC, April 2010

First Received: April 20, 2010   Last Updated: May 6, 2010   History of Changes

Sponsor:

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

Collaborators:

Yunnan Center for Disease Control and Prevention

Xinjiang Center for Disease Control and Prevention

Sichuan Center for Disease Control and Prevention

Guangxi Center for Disease Control and Prevention

Guizhou Center for Disease Control and Prevention

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT01108614

Purpose

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.


Condition

Intervention

Phase

HIV

Hepatitis C

Syphilis

HSV-2

HIV Infections

Behavioral: Intervention

Phase III


Study Type:

Interventional

Study Design:

Allocation: Randomized

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Open Label

Primary Purpose: Prevention

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


Resource links provided by NLM:


MedlinePlus related topics: AIDS Hepatitis Hepatitis C Syphilis

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources


Further study details as provided by National Center for AIDS/STD Control and Prevention, China CDC:


Primary Outcome Measures:

HIV incidence rate [ Time Frame: August 1,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

HCV, Syphilis, HSV-2 incidence [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]

MMT Retention Rate and Lapse/Relapse Rate [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]

Frequency of condom uses [ Time Frame: 1,Aug.,2009 to 31, Mar,2011 ] [ Designated as safety issue: No ]

The awareness of HIV-related Information among the clients [ [ Time Frame: 1,Aug.,2009 to 31,Mar,2011 ] [ Designated as safety issue: No ]

The proportion of discordant couple/partners receiving HIV testing [ Time Frame: 1,Aug.,2009 to 31,Dec,2010 ] [ Designated as safety issue: No ]


Estimated Enrollment:

12000

Study Start Date:

June 2009

Estimated Study Completion Date:

March 2011

Estimated Primary Completion Date:

December 2010 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

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

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.

Usual: No Intervention

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



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:

To evaluate the effectiveness of comprehensive interventions to decrease the HIV/STIs incidence among MMT clients.

To prevent the sexual transmission between those HIV+ clients and their spouse/partners with intensified intervention.

Eligibility


Ages Eligible for Study:

20 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108614


Contacts

Contact: Zunyou Wu, MD, PHD

86-10-58900900

wuzy@chinacdc.cn

Contact: Wenyuan Yin, MD, MS

86-10-58900951

yinwy928@yahoo.com.cn


Locations

China, Guangxi Zhuang Autonomous Region

Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region

Recruiting

Nanning, Guangxi Zhuang Autonomous Region, China, 530028

Contact: Wei Liu, MD     0771-2518838     lw_gx@126.com

Contact: Li Rongjian, MD     0771-2528838     gxlrj@126.com

Principal Investigator: Wei Liu, MD

China, Guizhou Province

Center for Disease Control and Prevention, Guizhou Province

Recruiting

Guiyang, Guizhou Province, China, 550004

Contact: Limei Shen, MD     0851-6823903     shenlm999@tom.com

Contact: Yongming Yao, MD     0851-6820035     yaoyongming667@163.com

Principal Investigator: Limei Shen, MD

China, Sichuan

Center for Disease Control and Prevention, Sichuan Province

Recruiting

Chengdu, Sichuan, China, 610041

Contact: Linglin Zhang, MD     028-85589207     weirzhang@vip.163.com

Contact: Lai Wenhong, MD,MS     028-85581160     sclwh66@163.com

Principal Investigator: Linglin Zhang, MD

China, Xingjiang Uyghur Autonomous Region

Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region

Recruiting

Urumchi, Xingjiang Uyghur Autonomous Region, China, 830002

Contact: Fan Li, MD     0991-3822696     xjfanli@126.com

Contact: Feng Zhang, MD,MS     0991-8569907     xjabzf@126.com

Principal Investigator: Fan Li, MD

China, Yunnan province

Center for Disease Control and Prevention, Yunnan Province

Recruiting

Kunming, Yunnan province, China, 650022

Contact: Manhong Jia, MD     0871-3626304     jmanhong@yahoo.com.cn

Contact: Wanyue Zhang, MD     0871-3630775

Principal Investigator: Manhong Jia, MD

Sponsors and Collaborators

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

Yunnan Center for Disease Control and Prevention

Xinjiang Center for Disease Control and Prevention

Sichuan Center for Disease Control and Prevention

Guangxi Center for Disease Control and Prevention

Guizhou Center for Disease Control and Prevention

Investigators

Principal Investigator:

Zunyou Wu, MD, PHD

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

More Information


Additional Information:

National Science and Technology Project


Publications:

Costenbader EC, Astone NM, Latkin CA. The dynamics of injection drug users’ personal networks and HIV risk behaviors. Addiction. 2006 Jul;101(7):1003-13.

Booth RE, Corsi KF, Mikulich-Gilbertson SK. Factors associated with methadone maintenance treatment retention among street-recruited injection drug users. Drug Alcohol Depend. 2004 May 10;74(2):177-85.

Gifford E, Humphreys K. The psychological science of addiction. Addiction. 2007 Mar;102(3):352-61.

Gyarmathy VA, Neaigus A. Marginalized and socially integrated groups of IDUs in Hungary: potential bridges of HIV infection. J Urban Health. 2005 Sep;82(3 Suppl 4):iv101-12.

Latkin CA, Sherman S, Knowlton A. HIV prevention among drug users: outcome of a network-oriented peer outreach intervention. Health Psychol. 2003 Jul;22(4):332-9.

Lloyd JJ, Ricketts EP, Strathdee SA, Cornelius LJ, Bishai D, Huettner S, Havens JR, Latkin C. Social contextual factors associated with entry into opiate agonist treatment among injection drug users. Am J Drug Alcohol Abuse. 2005;31(4):555-70.

Termorshuizen F, Krol A, Prins M, Geskus R, van den Brink W, van Ameijden EJ. Prediction of relapse to frequent heroin use and the role of methadone prescription: an analysis of the Amsterdam Cohort Study among drug users. Drug Alcohol Depend. 2005 Aug 1;79(2):231-40. Epub 2005 Feb 24.

Ball A, Beg M, Doupe A, Weiler G. World Health Organization, Evidence for Action for HIV Prevention, Treatment and Care among Injecting Drug Users. The International Journal of Drug Policy. 2005;16.

de la Fuente L, Bravo MJ, Lew C, Barrio G, Soriano V, Royuela L. [The prevalence of human immunodeficiency virus infection and the risk behaviors in the heroin addicts of Barcelona, Madrid and Seville: an example of the advantages of centering studies on addicts and not just on intravenous users] Med Clin (Barc). 1999 Nov 20;113(17):646-51. Spanish.

Welp EA, Lodder AC, Langendam MW, Coutinho RA, van Ameijden EJ. HIV prevalence and risk behaviour in young drug users in Amsterdam. AIDS. 2002 Jun 14;16(9):1279-84.

Garfein RS, Monterroso ER, Tong TC, Vlahov D, Des Jarlais DC, Selwyn P, Kerndt PR, Word C, Fernando MD, Ouellet LJ, Holmberg SD. Comparison of HIV infection risk behaviors among injection drug users from East and West Coast US cities. J Urban Health. 2004 Jun;81(2):260-7.

Gilman SM, Galanter M, Dermatis H. Methadone Anonymous: A 12-Step Program for Methadone Maintained Heroin Addicts. Subst Abus. 2001 Dec;22(4):247-256.

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.

Hartel DM, Schoenbaum EE. Methadone treatment protects against HIV infection: two decades of experience in the Bronx, New York City. Public Health Rep. 1998 Jun;113 Suppl 1:107-15.

Langendam MW, van Brussel GH, Coutinho RA, van Ameijden EJ. Methadone maintenance and cessation of injecting drug use: results from the Amsterdam Cohort Study. Addiction. 2000 Apr;95(4):591-600.

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 1:48-55.

Brady JE, Friedman SR, Cooper HL, Flom PL, Tempalski B, Gostnell K. Estimating the prevalence of injection drug users in the U.S. and in large U.S. metropolitan areas from 1992 to 2002. J Urban Health. 2008 May;85(3):323-51. Epub 2008 Mar 15.

Des Jarlais DC, Braine N, Yi H, Turner C. Residual injection risk behavior, HIV infection, and the evaluation of syringe exchange programs. AIDS Educ Prev. 2007 Apr;19(2):111-23.

Des Jarlais DC, Semaan S. HIV prevention for injecting drug users: the first 25 years and counting. Psychosom Med. 2008 Jun;70(5):606-11. Epub 2008 Jun 2. Review.

Gowing L, Farrell M, Bornemann R, Sullivan L, Ali R. Substitution treatment of injecting opioid users for prevention of HIV infection. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004145. Review.

Gossop M, Marsden J, Stewart D, Rolfe A. Patterns of improvement after methadone treatment: 1 year follow-up results from the National Treatment Outcome Research Study. Drug Alcohol Depend. 2000 Nov 1;60(3):275-86.

King VL, Kidorf MS, Stoller KB, Brooner RK. Influence of psychiatric comorbidity on HIV risk behaviors: changes during drug abuse treatment. J Addict Dis. 2000;19(4):65-83.

Strang J, Marsden J, Cummins M, Farrell M, Finch E, Gossop M, Stewart D, Welch S. Randomized trial of supervised injectable versus oral methadone maintenance: report of feasibility and 6-month outcome. Addiction. 2000 Nov;95(11):1631-45.

Margolin A, Avants SK, Warburton LA, Hawkins KA, Shi J. A randomized clinical trial of a manual-guided risk reduction intervention for HIV-positive injection drug users. Health Psychol. 2003 Mar;22(2):223-8.

Zaric GS, Barnett PG, Brandeau ML. HIV transmission and the cost-effectiveness of methadone maintenance. Am J Public Health. 2000 Jul;90(7):1100-11.

Beckett M, Burnam A, Collins RL, Kanouse DE, Beckman R. Substance use and high-risk sex among people with HIV: a comparison across exposure groups. AIDS Behav. 2003 Jun;7(2):209-19.

Preston KL, Umbricht A, Epstein DH. Methadone dose increase and abstinence reinforcement for treatment of continued heroin use during methadone maintenance. Arch Gen Psychiatry. 2000 Apr;57(4):395-404.

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Responsible Party:

National Center for AIDS/STD Control and Prevention, China CDC ( Professor Zunyou Wu )

ClinicalTrials.gov Identifier:

NCT01108614 History of Changes

Other Study ID Numbers:

Drug Users Intervention, 2008ZX10001-016

Study First Received:

April 20, 2010

Last Updated:

May 6, 2010

Health Authority:

China: Ministry of Health


Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:

Methadone maintenance treatment

drug users

heroin

HIV

HCV

Syphilis

HSV-2


Additional relevant MeSH terms:

Bacterial Infections

Respiratory System Agents

Sexually Transmitted Diseases, Bacterial

Sexually Transmitted Diseases, Viral

Liver Diseases

Slow Virus Diseases

Flaviviridae Infections

Physiological Effects of Drugs

Hepatitis, Viral, Human

Infection

Gram-Negative Bacterial Infections

Genital Diseases, Female

Treponemal Infections

Sensory System Agents

Therapeutic Uses

Analgesics

Hepatitis C

Retroviridae Infections

Syphilis

Analgesics, Opioid

RNA Virus Infections

Immune System Diseases

Acquired Immunodeficiency Syndrome

Central Nervous System Depressants

Narcotics

Genital Diseases, Male

Pharmacologic Actions

Immunologic Deficiency Syndromes

Virus Diseases

Hepatitis


ClinicalTrials.gov processed this record on June 15, 2010