Injecting Drug Use Community Intervention Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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:
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To evaluate the effectiveness of comprehensive interventions to decrease the HIV/STIs incidence among MMT clients.
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To prevent the sexual transmission between those HIV+ clients and their spouse/partners with intensified intervention.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
| No Intervention: Usual Routine HIV prevention, including health education, counseling and testing, condom promotion. |
Outcome Measures
Primary Outcome Measures
- HIV incidence rate [August 1,2009 to 31,Mar,2011]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
(1) For MMT clients:
Inclusion Criteria:
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20 years or above and have independent capacity of civil conduct.
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Those have enrolled in MMT clinics more than one month, and progressed to the phase of maintenance treatment.
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No mental and other physical diseases
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More than 6-month stay at local places and registered at the designated clinics.
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Complete Informed consent
Exclusion Criteria:
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Fail to complete Informed consent
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Temporarily transit in or out of the designated clinic.
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Those have enrolled in MMT clinics less than one month, and haven't progressed to the phase of maintenance treatment.
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With serious mental or other physical diseases
For the spouse or sex partners of MMT HIV+ clients'
Inclusion Criteria:
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20 years or above and have independent capacity of civil conduct.
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Keep fixed sexual contact with HIV+ clients in the recent 6 month
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No mental and other physical diseases
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More than 6-month stay at local places and be able to participate the 1 year follow up.
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Complete Informed consent
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The recent HIV test is negative
Exclusion Criteria:
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Fail to complete Informed consent
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Temporarily transit in or out of the designated clinic.
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With serious mental or other physical diseases
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The recent HIV test is positive
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region | Nanning | Guangxi Zhuang Autonomous Region | China | 530028 |
| 2 | Center for Disease Control and Prevention, Guizhou Province | Guiyang | Guizhou | China | 550004 |
| 3 | Center for Disease Control and Prevention, Sichuan Province | Chengdu | Sichuan | China | 610041 |
| 4 | Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region | Urumchi | Xingjiang Uyghur Autonomous Region | China | 830002 |
| 5 | Center for Disease Control and Prevention, Yunnan Province | Kunming | Yunnan | China | 650022 |
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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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- Drug Users Intervention
- 2008ZX10001-016