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Methadone Maintenance Treatment (MMT) Care for HIV Prevention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Li Li, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01760720
First received: January 2, 2013
Last updated: February 16, 2016
Last verified: February 2016
History of Changes
January 2, 2013
February 16, 2016
March 2012
December 2015   (Final data collection date for primary outcome measure)
Service Provider's prejudical attitude towards drug users [ Time Frame: Change from baseline to 3-, 6-, 12-, 18- and 24-month follow up ]
Same as current
Complete list of historical versions of study NCT01760720 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Methadone Maintenance Treatment (MMT) Care for HIV Prevention
Methadone Maintenance Treatment (MMT) Care for HIV Prevention: A Randomized Controlled Trial (MMT2)
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.

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:

  1. 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.
  2. 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.
  3. To explore whether providers' improved outcomes are associated with improved client outcomes.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Stigma
Behavioral: MMT CARE
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2866
December 2015
December 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01760720
R01DA033130
Yes
Not Provided
Not Provided
Not Provided
Li Li, University of California, Los Angeles
University of California, Los Angeles
Not Provided
Study Director: Zunyou Wu, PhD China CDC
University of California, Los Angeles
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP