search
Back to results

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

Primary Purpose

Capacity Building, Drug Use, HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MMT CARE
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Capacity Building focused on measuring Methadone maintenance therapy, Behavioral intervention, Service provider, Drug use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sichuan Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Standard care

Arm Description

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 additional training or service is provided for standard care group service providers or clients.

Outcomes

Primary Outcome Measures

Service providers' MMT knowledge
Service provider's prejudical attitude towards drug users
Provide-client interaction
Provider's perceived stigma due to work with drug using population
Service provider's perceived risk at work
Service provider's perceived institutional support
Service provider's job satisfaction

Secondary Outcome Measures

Client's drug using behavior
Client's physical health
MMT client's mental health
Client's perceived stigma from MMT clients
Client's readiness to change
Client's drug avoidance self-efficacy
Client's social support

Full Information

First Posted
February 8, 2012
Last Updated
September 28, 2023
Sponsor
University of California, Los Angeles
Collaborators
Centers for Disease Control and Prevention, China
search

1. Study Identification

Unique Protocol Identification Number
NCT01532609
Brief Title
Methadone Maintenance and HIV Prevention: A Window of Opportunity in China
Acronym
MMT1
Official Title
Methadone Maintenance and HIV Prevention: A Window of Opportunity in China Version
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
Centers for Disease Control and Prevention, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Capacity Building, Drug Use, HIV/AIDS
Keywords
Methadone maintenance therapy, Behavioral intervention, Service provider, Drug use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
No additional training or service is provided for standard care group service providers or clients.
Intervention Type
Behavioral
Intervention Name(s)
MMT CARE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Service providers' MMT knowledge
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
Service provider's prejudical attitude towards drug users
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
Provide-client interaction
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
Provider's perceived stigma due to work with drug using population
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
Service provider's perceived risk at work
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
Service provider's perceived institutional support
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
Service provider's job satisfaction
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Secondary Outcome Measure Information:
Title
Client's drug using behavior
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
Client's physical health
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
MMT client's mental health
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
Client's perceived stigma from MMT clients
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
Client's readiness to change
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
Client's drug avoidance self-efficacy
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up
Title
Client's social support
Time Frame
Changes from baseline to 3-, 6- and 9-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Li, PhD
Organizational Affiliation
NPI-Center for Community Health, UCLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sichuan Provincial Center for Disease Control and Prevention
City
Chengdu
State/Province
Sichuan
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22788780
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs