HIVPhase 3NCT01108614
Injecting Drug Use Community Intervention Trial
A Phase 3 study testing Intervention in people with HIV and Hepatitis C, run by National Center for AIDS/STD Control and Prevention, China CDC at 5 sites in China.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- HIV, Hepatitis C, Syphilis
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 5 sitesChina
- Study dates
- Jun 2009to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 20 years or above and have independent capacity of civil conduct.
Show all 11Show fewer
- 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
Who cannot join
- 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'
- Fail to complete Informed consent
Show all 9Show fewer
- Temporarily transit in or out of the designated clinic.
- With serious mental or other physical diseases
- The recent HIV test is positive
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Center for Disease Control and Prevention, Sichuan Province
Chengdu, Sichuan, 610041
Linglin Zhang, MD, 028-85589207, weirzhang@vip.163.com
Lai Wenhong, MD,MS, 028-85581160, sclwh66@163.com
- Recruiting
Center for Disease Control and Prevention, Guizhou Province
Guiyang, Guizhou, 550004
Limei Shen, MD, 0851-6823903, shenlm999@tom.com
Yongming Yao, MD, 0851-6820035, yaoyongming667@163.com
- Recruiting
Center for Disease Control and Prevention, Yunnan Province
Kunming, Yunnan, 650022
Manhong Jia, MD, 0871-3626304, jmanhong@yahoo.com.cn
Wanyue Zhang, MD, 0871-3630775
- Recruiting
Center for Disease Control and Prevention,Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530028
Wei Liu, MD, 0771-2518838, lw_gx@126.com
Li Rongjian, MD, 0771-2528838, gxlrj@126.com
- Recruiting
Center for Disease Control and Prevention, Xingjiang Uyghur Autonomous Region
Ürümqi, Xingjiang Uyghur Autonomous Region, 830002
Fan Li, MD, 0991-3822696, xjfanli@126.com
Feng Zhang, MD,MS, 0991-8569907, xjabzf@126.com
About this study
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
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.
Read the 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.
- Conditions
- HIV, Hepatitis C, Syphilis, HSV-2, HIV Infections
- Being tested
- Intervention
- Keywords
- Methadone maintenance treatment, drug users, heroin, HIV, HCV, Syphilis, HSV-2
- Medical subject headings
- Hepatitis C, Syphilis, HIV Infections, Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Also called Comprehensive intervention group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention |
| Usual | No intervention | Routine HIV prevention, including health education, counseling and testing, condom promotion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV incidence rate
Measured: August 1,2009 to 31,Mar,2011
Secondary outcomes (5)
HCV, Syphilis, HSV-2 incidence
Measured: 1,Aug.,2009 to 31,Mar,2011
MMT Retention Rate and Lapse/Relapse Rate
Measured: 1,Aug.,2009 to 31,Mar,2011
Frequency of condom uses
Measured: 1,Aug.,2009 to 31, Mar,2011
The awareness of HIV-related Information among the clients [
Measured: 1,Aug.,2009 to 31,Mar,2011
The proportion of discordant couple/partners receiving HIV testing
Measured: 1,Aug.,2009 to 31,Dec,2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDC
- Sponsor type
- Other government
- 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
- Investigators
- Zunyou Wu, MD, PHD, Principal investigator, National Center for AIDS/STD Control and Prevention, China CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108614
- Sponsor's protocol ID
- Drug Users Intervention
- Other IDs
- 2008ZX10001-016
- Status last verified
- Apr 2010
- First submitted
- 20 Apr 2010
- Last updated
- 7 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1111/j.1360-0443.2006.01431.x.
PubMed 16771892Booth 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. doi: 10.1016/j.drugalcdep.2003.12.009.
PubMed 15099661Gifford E, Humphreys K. The psychological science of addiction. Addiction. 2007 Mar;102(3):352-61. doi: 10.1111/j.1360-0443.2006.01706.x.
PubMed 17298641Gyarmathy 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. doi: 10.1093/jurban/jti112.
PubMed 16107433Latkin 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. doi: 10.1037/0278-6133.22.4.332.
PubMed 12940388Lloyd 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. doi: 10.1081/ada-200068114.
PubMed 16320434Termorshuizen 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. doi: 10.1016/j.drugalcdep.2005.01.013. Epub 2005 Feb 24.
PubMed 16002032International 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.
PubMed 10618778Welp 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. doi: 10.1097/00002030-200206140-00011.
PubMed 12045494Garfein 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. doi: 10.1093/jurban/jth112.
PubMed 15136659Gilman SM, Galanter M, Dermatis H. Methadone Anonymous: A 12-Step Program for Methadone Maintained Heroin Addicts. Subst Abus. 2001 Dec;22(4):247-256. doi: 10.1080/08897070109511466.
PubMed 12466684Gogineni 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.
PubMed 11470340Hartel 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(Suppl 1):107-15.
PubMed 9722816
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01108614
- Acronym / sponsor ID
- Drug Users Intervention
- Conditions
- HIV, Hepatitis C, Syphilis, HSV-2, HIV Infections
- Keywords
- Methadone maintenance treatment, drug users, heroin, HIV, HCV, Syphilis, HSV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- National Center for AIDS/STD Control and Prevention, China CDCOther government
- 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
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionIntensive 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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'
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: Comprehensive intervention groupIntensive 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. | Behavioural | Intervention |
Primary outcome
HIV incidence rate
Time frame: August 1,2009 to 31,Mar,2011
5 secondary outcomes
HCV, Syphilis, HSV-2 incidence
Time frame: 1,Aug.,2009 to 31,Mar,2011
MMT Retention Rate and Lapse/Relapse Rate
Time frame: 1,Aug.,2009 to 31,Mar,2011
Frequency of condom uses
Time frame: 1,Aug.,2009 to 31, Mar,2011
The awareness of HIV-related Information among the clients [
Time frame: 1,Aug.,2009 to 31,Mar,2011
The proportion of discordant couple/partners receiving HIV testing
Time frame: 1,Aug.,2009 to 31,Dec,2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2010.
- Background: PubMed 16771892Costenbader EC, Astone NM, Latkin CA. The dynamics of injection drug users' personal networks and HIV risk behaviors. Addiction. 2006 Jul;101(7):1003-13. doi: 10.1111/j.1360-0443.2006.01431.x.
- Background: PubMed 15099661Booth 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. doi: 10.1016/j.drugalcdep.2003.12.009.
- Background: PubMed 17298641Gifford E, Humphreys K. The psychological science of addiction. Addiction. 2007 Mar;102(3):352-61. doi: 10.1111/j.1360-0443.2006.01706.x.
- Background: PubMed 16107433Gyarmathy 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. doi: 10.1093/jurban/jti112.
- Background: PubMed 12940388Latkin 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. doi: 10.1037/0278-6133.22.4.332.
- Background: PubMed 16320434Lloyd 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. doi: 10.1081/ada-200068114.
- Background: PubMed 16002032Termorshuizen 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. doi: 10.1016/j.drugalcdep.2005.01.013. Epub 2005 Feb 24.
- BackgroundInternational 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.
- BackgroundBall 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.
- Background: PubMed 10618778de 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.
- Background: PubMed 12045494Welp 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. doi: 10.1097/00002030-200206140-00011.
- Background: PubMed 15136659Garfein 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. doi: 10.1093/jurban/jth112.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zunyou Wu, MD, PHD principal investigator
National Center for AIDS/STD Control and Prevention, China CDC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intervention in people with HIV and Hepatitis C, run by National Center for AIDS/STD Control and Prevention, China CDC at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zunyou Wu, MD, PHD (86-10-58900900, wuzy@chinacdc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV incidence rate (time frame: August 1,2009 to 31,Mar,2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01108614, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2010.