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
  Purpose

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.


Condition Intervention
Capacity Building
Drug Use
HIV/AIDS
Behavioral: MMT CARE

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Methadone Maintenance and HIV Prevention: A Window of Opportunity in China Version

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 220
Study Start Date: March 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Standard care
No additional training or service is provided for standard care group service providers or clients.

Detailed Description:

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.

  Eligibility

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

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
  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: NCT01532609

Locations
China, Sichuan
Sichuan Provincial Center for Disease Control and Prevention
Chengdu, Sichuan, China
Sponsors and Collaborators
University of California, Los Angeles
Chinese Center for Disease Control and Prevention
Investigators
Principal Investigator: Li Li, PhD NPI-Center for Community Health, UCLA
  More Information

No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Li Li, Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01532609     History of Changes
Other Study ID Numbers: R34 MH083512
Study First Received: February 8, 2012
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Methadone maintenance therapy
Behavioral intervention
Service provider
Drug use

Additional relevant MeSH terms:
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014