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

NCT ID: NCT01532609

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-03-31

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.

Conditions

Capacity Building; Drug Use; HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MMT CARE

Intervention Type: BEHAVIORAL

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.

Standard care

No additional training or service is provided for standard care group service providers or clients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

MMT clients:

• Psychosis, neurological damage, as judged by an interviewer in consultation with a clinical supervisor inability to give informed consent

Exclusion Criteria

Service providers

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention, China

OTHER_GOV

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Li, PhD

Role: PRINCIPAL_INVESTIGATOR

NPI-Center for Community Health, UCLA

Locations

Sichuan Provincial Center for Disease Control and Prevention

Chengdu, Sichuan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 22788780 (View on PubMed)

Other Identifiers

R34MH083512

Identifier Type: NIH

Identifier Source: org_study_id

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