Methadone Maintenance Treatment (MMT) Care for HIV Prevention
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ClinicalTrials.gov Identifier: NCT01760720 |
Recruitment Status
:
Completed
First Posted
: January 4, 2013
Last Update Posted
: July 26, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | January 2, 2013 | |||
First Posted Date ICMJE | January 4, 2013 | |||
Last Update Posted Date | July 26, 2017 | |||
Study Start Date ICMJE | March 2012 | |||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Client treatment retention [ Time Frame: Change from baseline to 6-, 12-, 18- and 24-month follow up ] MMT retention will be measured by the treatment status (in treatment vs. drop out) at each follow-up point.
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Original Primary Outcome Measures ICMJE |
Service Provider's prejudical attitude towards drug users [ Time Frame: Change from baseline to 3-, 6-, 12-, 18- and 24-month follow up ] | |||
Change History | Complete list of historical versions of study NCT01760720 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Methadone Maintenance Treatment (MMT) Care for HIV Prevention | |||
Official Title ICMJE | Methadone Maintenance Treatment (MMT) Care for HIV Prevention: A Randomized Controlled Trial (MMT2) | |||
Brief Summary | Based on our previous success with the intervention pilot (R34MH083512), we conducted this randomized controlled trial (MMT CARE), which will integrate behavioral intervention components with a primarily pharmacological model of MMT. The intervention focuses on treatment adherence and effective outcomes by reducing stigmatizing attitudes and behaviors among service providers, enhancing their communication skills, and improving their interactions with and support of their clients' behavior changes. Our goal is to bring a contextual change to support a protective environment for clients' motivation and capacity in order to reduce their HIV risk. The findings could benefit not only China but also the global community by effectively combining interventions for controlling the HIV epidemic. | |||
Detailed Description | Injecting drug use is the major mode of HIV transmission for 740,000 people living with HIV (PLH) in China. In response to this situation, China introduced methadone maintenance treatment (MMT) in 2004, which is now dispensed by 701 clinics serving 295,000 clients. Despite this impressive scale-up, China's MMT programs still face serious challenges, including high drop-out rates, a large number of clients who continue to use heroin during MMT, a gap between clients' needs and services availability, providers' lack of skills in counseling and education, and stigma linked to resistance to harm reduction. This study aims to address these challenges. Based on our previous success with the intervention pilot (R34MH083512), we conducted this randomized controlled trial (MMT CARE), which will integrate behavioral intervention components with a primarily pharmacological model of MMT. The intervention focuses on treatment adherence and effective outcomes by reducing stigmatizing attitudes and behaviors among service providers, enhancing their communication skills, and improving their interactions with and support of their clients' behavior changes. Our goal is to bring a contextual change to support a protective environment for clients' motivation and capacity in order to reduce their HIV risk. The findings could benefit not only China but also the global community by effectively combining interventions for controlling the HIV epidemic. The study will be implemented in Sichuan, Guangdong, Hunan, Shaanxi and Jiangsu provinces. A total of 68 MMT clinics will be randomly selected from the five provinces and randomized to either the intervention condition (MMT CARE group) or the control condition. From each selected clinic, we will recruit 6 service providers and 36 clients, totaling 408 service providers and 2,448 clients (204 service provider and 1,224 clients in each condition, respectively). The Specific Aims of the study are as follows:
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Stigma | |||
Intervention ICMJE | Behavioral: MMT CARE | |||
Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
2866 | |||
Original Estimated Enrollment ICMJE |
2856 | |||
Actual Study Completion Date | December 2015 | |||
Actual Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: MMT clients
Exclusion Criteria: MMT Clients
Service Providers
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01760720 | |||
Other Study ID Numbers ICMJE | R01DA033130( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Li Li, PhD, University of California, Los Angeles | |||
Study Sponsor ICMJE | University of California, Los Angeles | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University of California, Los Angeles | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |