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Methadone Maintenance Treatment (MMT) Care for HIV Prevention

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Li Li, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01760720
First received: January 2, 2013
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Stigma
Behavioral: MMT CARE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Methadone Maintenance Treatment (MMT) Care for HIV Prevention: A Randomized Controlled Trial (MMT2)

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Service Provider's prejudical attitude towards drug users [ Time Frame: Change from baseline to 3-, 6-, 12-, 18- and 24-month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • client's drug using behaviors [ Time Frame: Change from baseline to 3-, 6-, 12-, 18- and 24-month follow up ] [ Designated as safety issue: No ]
  • client's physical health [ Time Frame: Change from baseline to 3-, 6-, 12-, 18- and 24-month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 2856
Study Start Date: March 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: MMT CARE

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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760720

Contacts
Contact: Li Li, PhD 310-794-2446 lililili@ucla.edu

Locations
China
China CDC, NCAIDS Recruiting
Beijing, China
Contact: Zunyou Wu, PhD       wuzy@263.net   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Study Director: Zunyou Wu, PhD China CDC
  More Information

No publications provided

Responsible Party: Li Li, Professor in Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01760720     History of Changes
Other Study ID Numbers: R01DA033130
Study First Received: January 2, 2013
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 19, 2014