Injecting Drug Use Community Intervention Trial

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01108614
• Other study ID #: Drug Users Intervention
• Secondary ID: 2008ZX10001-016
• Status: Recruiting
• Phase: Phase 3
• First received: April 20, 2010
• Last updated: May 6, 2010
• Start date: June 2009
• Est. completion date: March 2011

Study information

• Verified date: April 2010
• Source: National Center for AIDS/STD Control and Prevention, China CDC
• Contact: Zunyou Wu, MD, PHD
• Phone: 86-10-58900900
• Email: wuzy[@]chinacdc.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

(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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis C
• HIV
• HIV Infections
• HSV-2
• Syphilis

Intervention

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.

Locations

Country	Name	City	State
China	Center for Disease Control and Prevention, Sichuan Province	Chengdu	Sichuan
China	Center for Disease Control and Prevention, Guizhou Province	Guiyang	Guizhou
China	Center for Disease Control and Prevention, Yunnan Province	Kunming	Yunnan
China	Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region	Nanning	Guangxi Zhuang Autonomous Region
China	Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region	Urumchi	Xingjiang Uyghur Autonomous Region

Sponsors (6)

Lead Sponsor	Collaborator
National Center for AIDS/STD Control and Prevention, China CDC	Guangxi Center for Disease Control and Prevention, Guizhou Center for Disease Control and Prevention, Sichuan Center for Disease Control and Prevention, Xinjiang Center for Disease Control and Prevention, Yunnan Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

References & Publications (29)

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV incidence rate		August 1,2009 to 31,Mar,2011	No
Secondary	HCV, Syphilis, HSV-2 incidence		1,Aug.,2009 to 31,Mar,2011	No
Secondary	MMT Retention Rate and Lapse/Relapse Rate		1,Aug.,2009 to 31,Mar,2011	No
Secondary	Frequency of condom uses		1,Aug.,2009 to 31, Mar,2011	No
Secondary	The awareness of HIV-related Information among the clients [		1,Aug.,2009 to 31,Mar,2011	No
Secondary	The proportion of discordant couple/partners receiving HIV testing		1,Aug.,2009 to 31,Dec,2010	No

External Links

•   National Science and Technology Project