Methadone Maintenance and HIV Prevention: A Window of Opportunity in China (MMT1)

This study has been completed.
Sponsor:
Collaborator:
Chinese Center for Disease Control and Prevention
Information provided by (Responsible Party):
Li Li, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01532609
First received: February 8, 2012
Last updated: February 9, 2012
Last verified: March 2009

February 8, 2012
February 9, 2012
March 2009
December 2010   (final data collection date for primary outcome measure)
  • Service providers' MMT knowledge [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • Service provider's prejudical attitude towards drug users [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • Provide-client interaction [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • Provider's perceived stigma due to work with drug using population [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • Service provider's perceived risk at work [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • Service provider's perceived institutional support [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • Service provider's job satisfaction [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01532609 on ClinicalTrials.gov Archive Site
  • Client's drug using behavior [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • Client's physical health [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • MMT client's mental health [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • Client's perceived stigma from MMT clients [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • Client's readiness to change [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • Client's drug avoidance self-efficacy [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
  • Client's social support [ Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Methadone Maintenance and HIV Prevention: A Window of Opportunity in China
Methadone Maintenance and HIV Prevention: A Window of Opportunity in China Version

This study is an intervention pilot that integrates the current methadone maintenance treatment (MMT) program in China with psychosocial and behavioral components in order to address the critical link between drug use and HIV/AIDS.

The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the intervention manuals and supporting materials, and finalized assessment measures and implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT clinics involving 41 service providers and 179 clients, and followed up at three, six, and nine months.

The implementation of the MMT program in China is one of the most significant measures ever taken by the Chinese government to address drug use and HIV prevention challenges. In 2004, China launched a series of MMT programs at eight pilot clinics in five provinces. By December 2007, 503 MMT clinics had been established nationwide across 23 provinces. Several studies have found that positive outcomes in drug use, criminality, and employment were associated with participation in MMT. However, special challenges are facing the current MMT programs are facing: 1) clients' drop-out rates are high; and 2) providers at MMT clinics do not have sufficient training, and some of them hesitate to serve the population. We have recognized the urgent need and conducted the study to address these challenges.

The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the intervention manuals and supporting materials, and finalized assessment measures and implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT clinics involving 41 service providers and 179 clients, and followed up at three, six, and nine months.

The specific aims of the proposed study are:

Specific Aim 1: To assess the feasibility and acceptability of the MMT PLUS intervention with process evaluation and participant feedback.

Specific Aim 2: To examine primary outcomes on whether service providers in the intervention group, compared to providers in the standard care, will demonstrate improved adherence to MMT protocol, decrease in prejudicial attitudes, increase in comfort working with MMT clients, increase in motivating clients and making personalized risk management plan.

Specific Aim 3: To explore secondary outcomes on whether MMT clients in the intervention group, compared to clients in the standard care, will report increased motivation to change, improved psychological and physical health, increased positive support network, and reduced HIV risk behavior.

Specific Aim 4: To investigate exploratory outcomes on whether MMT clients in the intervention group, compared to clients in the standard care, will report improved MMT treatment retention and decreased drug use.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Capacity Building
  • Drug Use
  • HIV/AIDS
Behavioral: MMT CARE
Intervention group service providers received four training sessions (plus reunion sessions) on MMT protocol, reducing stigma and its impact, maintaining positive interactions with clients, and motivational interviewing skills. The participating providers are required to conduct three individual motivational sessions with their clients upon completion of the intervention sessions.
  • Experimental: Intervention
    Intervention group service providers received four training sessions (plus reunion sessions) on MMT protocol, reducing stigma and its impact, maintaining positive interactions with clients, and motivational interviewing skills. The participating providers are required to conduct three individual motivational sessions with their clients upon completion of the intervention sessions.
    Intervention: Behavioral: MMT CARE
  • No Intervention: Standard care
    No additional training or service is provided for standard care group service providers or clients.
Li L, Wu Z, Liang LJ, Lin C, Zhang L, Guo S, Rou K, Li J. An intervention targeting service providers and clients for methadone maintenance treatment in China: a cluster-randomized trial. Addiction. 2013 Feb;108(2):356-66. doi: 10.1111/j.1360-0443.2012.04020.x. Epub 2012 Oct 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
March 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Service providers

  • Age 18 and above
  • Currently working in MMT clinic
  • Informed consent

MMT clients

  • Age 18 or over
  • Currently enrolled in MMT
  • Informed consent

Exclusion Criteria:

Service providers

  • Anyone who does not meet the inclusion criteria.

MMT clients:

  • Psychosis, neurological damage, as judged by an interviewer in consultation with a clinical supervisor inability to give informed consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01532609
R34 MH083512
Yes
Li Li, University of California, Los Angeles
University of California, Los Angeles
Chinese Center for Disease Control and Prevention
Principal Investigator: Li Li, PhD NPI-Center for Community Health, UCLA
University of California, Los Angeles
March 2009

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