Methadone Maintenance Treatment (MMT) Care for HIV Prevention

NCT ID: NCT01760720

Last Updated: 2017-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2866 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-12-31

Brief Summary

Based on our previous success with the intervention pilot (R34MH083512), we conducted this randomized controlled trial (MMT CARE), which will integrate behavioral intervention components with a primarily pharmacological model of MMT. The intervention focuses on treatment adherence and effective outcomes by reducing stigmatizing attitudes and behaviors among service providers, enhancing their communication skills, and improving their interactions with and support of their clients' behavior changes. Our goal is to bring a contextual change to support a protective environment for clients' motivation and capacity in order to reduce their HIV risk. The findings could benefit not only China but also the global community by effectively combining interventions for controlling the HIV epidemic.

Detailed Description

Injecting drug use is the major mode of HIV transmission for 740,000 people living with HIV (PLH) in China. In response to this situation, China introduced methadone maintenance treatment (MMT) in 2004, which is now dispensed by 701 clinics serving 295,000 clients. Despite this impressive scale-up, China's MMT programs still face serious challenges, including high drop-out rates, a large number of clients who continue to use heroin during MMT, a gap between clients' needs and services availability, providers' lack of skills in counseling and education, and stigma linked to resistance to harm reduction. This study aims to address these challenges.

Based on our previous success with the intervention pilot (R34MH083512), we conducted this randomized controlled trial (MMT CARE), which will integrate behavioral intervention components with a primarily pharmacological model of MMT. The intervention focuses on treatment adherence and effective outcomes by reducing stigmatizing attitudes and behaviors among service providers, enhancing their communication skills, and improving their interactions with and support of their clients' behavior changes. Our goal is to bring a contextual change to support a protective environment for clients' motivation and capacity in order to reduce their HIV risk. The findings could benefit not only China but also the global community by effectively combining interventions for controlling the HIV epidemic.

The study will be implemented in Sichuan, Guangdong, Hunan, Shaanxi and Jiangsu provinces. A total of 68 MMT clinics will be randomly selected from the five provinces and randomized to either the intervention condition (MMT CARE group) or the control condition. From each selected clinic, we will recruit 6 service providers and 36 clients, totaling 408 service providers and 2,448 clients (204 service provider and 1,224 clients in each condition, respectively).

The Specific Aims of the study are as follows:

1. To examine whether providers in the intervention group, compared to providers in the control group, demonstrate improved adherence to MMT protocols, decreased prejudicial attitudes, increased interactions with clients, and increased communications with clients on risk reduction.

2. To examine whether MMT clients in the intervention group, compared to clients in the control group, demonstrate improved treatment adherence/retention, decreased concurrent drug use, increased motivation for behavior change, improved mental health, increased positive support, and reduced HIV risk behaviors.

3. To explore whether providers' improved outcomes are associated with improved client outcomes.

Conditions

Stigma

Study Design

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

Study Groups

control

Standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention

The MMT CARE intervention has 3 session/modules: 1) MMT protocol and procedures, understanding stigma and its impact; 2) effective communication with clients, introducing motivational interviewing; 3) application of motivational interviewing, motivating clients for behavior change. The intervention contents reflect challenges faced by service providers working at MMT clinics and the impact of these challenges on their clients. Sessions will occur once a week for three weeks, with each session featuring a different set of themes and relevant activities. Each session will be 90-100 minutes long and will be conducted with a group of 5 to 7 providers.

Group Type: EXPERIMENTAL

MMT CARE

Intervention Type: BEHAVIORAL

Interventions

MMT CARE

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

MMT clients

• Age 20 and above
• Currently enrolled in MMT at the participating clinics
• Informed consent Service providers
• Age 18 and above
• Currently working in the participating MMT clinics
• Informed consent

Service Providers

• Inability to give informed consent

Exclusion Criteria

MMT Clients

• Psychosis, neurological damage, as judged by an interviewer in consultation with a clinical supervisor
• Currently under criminal or civil charges
• Inability to give informed consent

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

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Li Li, PhD

Professor in Residence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zunyou Wu, PhD

Role: STUDY_DIRECTOR

China CDC

Locations

China CDC, NCAIDS

Beijing, , China

Countries

China

References

Li L, Liang LJ, Lin C, Feng N, Cao W, Wu Z. An intervention to improve provider-patient interaction at methadone maintenance treatment in China. J Subst Abuse Treat. 2019 Apr;99:149-155. doi: 10.1016/j.jsat.2019.01.022. Epub 2019 Feb 3.

Reference Type: DERIVED

PMID: 30797387 (View on PubMed)

Other Identifiers

R01DA033130

Identifier Type: NIH

Identifier Source: org_study_id

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