Methadone Maintenance Treatment (MMT) Care for HIV Prevention

Tracking Information
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; (submitted: July 24, 2017)	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.
Original Primary Outcome Measures ICMJE; (submitted: January 3, 2013)	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; (submitted: July 24, 2017)	Client's mental health [ Time Frame: Change from baseline to 6-, 12-, 18- and 24-month follow up ]The Zung Depression Scale will be used to measure clients' depressive symptoms. Drug avoidance self-efficacy will be measured with selected questions from the Drug Avoidance Self-Efficacy Scale (DASES).; Provider attitudes toward and interaction with clients [ Time Frame: Change from baseline to 6-, 12-, 18- and 24-month follow up ]Negative attitude toward drug users will be measured with questions adapted from the brief scale of attitude measurement developed by researchers at the National Centre for Education and Training on Addiction, Flinders University, Australia (2006). Provider-client interaction will be measured with 12 questions specifically developed for this study and tested in the pilot.
Original Secondary Outcome Measures ICMJE; (submitted: January 3, 2013)	client's drug using behaviors [ Time Frame: Change from baseline to 3-, 6-, 12-, 18- and 24-month follow up ]; client's physical health [ Time Frame: Change from baseline to 3-, 6-, 12-, 18- and 24-month follow up ]
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: To examine whether providers in the intervention group, compared to providers in the control group, demonstrate improved adherence to MMT protocols, decreased prejudicial attitudes, increased interactions with clients, and increased communications with clients on risk reduction.; To examine whether MMT clients in the intervention group, compared to clients in the control group, demonstrate improved treatment adherence/retention, decreased concurrent drug use, increased motivation for behavior change, improved mental health, increased positive support, and reduced HIV risk behaviors.; To explore whether providers' improved outcomes are associated with improved client outcomes.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Stigma
Intervention ICMJE	Behavioral: MMT CARE
Study Arms	No Intervention: control Standard care; Experimental: intervention The MMT CARE intervention has 3 session/modules: 1) MMT protocol and procedures, understanding stigma and its impact; 2) effective communication with clients, introducing motivational interviewing; 3) application of motivational interviewing, motivating clients for behavior change. The intervention contents reflect challenges faced by service providers working at MMT clinics and the impact of these challenges on their clients. Sessions will occur once a week for three weeks, with each session featuring a different set of themes and relevant activities. Each session will be 90-100 minutes long and will be conducted with a group of 5 to 7 providers. Intervention: Behavioral: MMT CARE
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 16, 2016)	2866
Original Estimated Enrollment ICMJE; (submitted: January 3, 2013)	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; Age 20 and above; Currently enrolled in MMT at the participating clinics; Informed consent Service providers; Age 18 and above; Currently working in the participating MMT clinics; Informed consent Exclusion Criteria: MMT Clients; Psychosis, neurological damage, as judged by an interviewer in consultation with a clinical supervisor; Currently under criminal or civil charges; Inability to give informed consent; Anyone who does not meet the inclusion criteria Service Providers; Inability to give informed consent; Anyone who does not meet the inclusion criteria.
Sex/Gender	Sexes Eligible for Study: All
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	Study Director: Zunyou Wu, PhD China CDC
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