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

HIV/AIDS Clinical Trial

— MMT1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532609
• Other study ID #: R34MH083512
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Capacity Building
• Drug Use
• HIV Infections
• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
China	Sichuan Provincial Center for Disease Control and Prevention	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Centers for Disease Control and Prevention, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Service providers' MMT knowledge		Changes from baseline to 3-, 6- and 9-month follow-up
Primary	Service provider's prejudical attitude towards drug users		Changes from baseline to 3-, 6- and 9-month follow-up
Primary	Provide-client interaction		Changes from baseline to 3-, 6- and 9-month follow-up
Primary	Provider's perceived stigma due to work with drug using population		Changes from baseline to 3-, 6- and 9-month follow-up
Primary	Service provider's perceived risk at work		Changes from baseline to 3-, 6- and 9-month follow-up
Primary	Service provider's perceived institutional support		Changes from baseline to 3-, 6- and 9-month follow-up
Primary	Service provider's job satisfaction		Changes from baseline to 3-, 6- and 9-month follow-up
Secondary	Client's drug using behavior		Changes from baseline to 3-, 6- and 9-month follow-up
Secondary	Client's physical health		Changes from baseline to 3-, 6- and 9-month follow-up
Secondary	MMT client's mental health		Changes from baseline to 3-, 6- and 9-month follow-up
Secondary	Client's perceived stigma from MMT clients		Changes from baseline to 3-, 6- and 9-month follow-up
Secondary	Client's readiness to change		Changes from baseline to 3-, 6- and 9-month follow-up
Secondary	Client's drug avoidance self-efficacy		Changes from baseline to 3-, 6- and 9-month follow-up
Secondary	Client's social support		Changes from baseline to 3-, 6- and 9-month follow-up