Injecting Drug Use Community Intervention Trial - Full Text View

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 3


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: HIV/AIDS Hepatitis Syphilis

Drug Information available for: Methadone Methadone hydrochloride

Genetic and Rare Diseases Information Center resources: Treponema Infection

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
Experimental: 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.	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. Other Name: Comprehensive intervention group
No Intervention: Usual 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Center for Disease Control and Prevention, Guizhou Province	Recruiting
Guiyang, Guizhou, 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
Center for Disease Control and Prevention, Yunnan Province	Recruiting
Kunming, Yunnan, 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 This link exits the ClinicalTrials.gov site

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.

International Harm Reduction Development Program of the Open Society Institute. Saving lives by reducing harm: HIV prevention and treatment for injecting drug users. New York City, USA; 2006.

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. doi: 10.1007/s11524-007-9248-5. 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. doi: 10.1097/PSY.0b013e3181772157. 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. doi: 10.1002/14651858.CD004145.pub3. Review. Update in: Cochrane Database Syst Rev. 2011;(8):CD004145.

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


Acquired Immunodeficiency Syndrome Communicable Diseases HIV Infections Hepatitis C Infection Syphilis Bacterial Infections Digestive System Diseases Flaviviridae Infections Genital Diseases, Female Genital Diseases, Male Gram-Negative Bacterial Infections Hepatitis Hepatitis, Viral, Human Immune System Diseases	Immunologic Deficiency Syndromes Lentivirus Infections Liver Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases, Viral Slow Virus Diseases Spirochaetales Infections Treponemal Infections Virus Diseases Methadone Analgesics Analgesics, Opioid

ClinicalTrials.gov processed this record on February 26, 2015