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

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Drug Use; Capacity Building
• Intervention / Treatment: Behavioral: MMT CARE

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Provincial Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Service providers' MMT knowledge	Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's prejudical attitude towards drug users	Changes from baseline to 3-, 6- and 9-month follow-up
Provide-client interaction	Changes from baseline to 3-, 6- and 9-month follow-up
Provider's perceived stigma due to work with drug using population	Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's perceived risk at work	Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's perceived institutional support	Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's job satisfaction	Changes from baseline to 3-, 6- and 9-month follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Client's drug using behavior	Changes from baseline to 3-, 6- and 9-month follow-up
Client's physical health	Changes from baseline to 3-, 6- and 9-month follow-up
MMT client's mental health	Changes from baseline to 3-, 6- and 9-month follow-up
Client's perceived stigma from MMT clients	Changes from baseline to 3-, 6- and 9-month follow-up
Client's readiness to change	Changes from baseline to 3-, 6- and 9-month follow-up
Client's drug avoidance self-efficacy	Changes from baseline to 3-, 6- and 9-month follow-up
Client's social support	Changes from baseline to 3-, 6- and 9-month follow-up

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Centers for Disease Control and Prevention, China
• Investigators: Principal Investigator: Li Li, PhD, NPI-Center for Community Health, UCLA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: February 8, 2012
• First Submitted That Met QC Criteria: February 9, 2012
• First Posted (Estimated): February 14, 2012

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Behavioral intervention; Drug use; Methadone maintenance therapy; Service provider
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R34MH083512 (U.S. NIH Grant/Contract)