Methadone Maintenance Treatment (MMT) Care for HIV Prevention

NCT01760720 | Completed DMC

• 1 other identifier: R01DA033130
• Study Type: interventional
• Target: 2,866
• Locations: 1 country
• Sites: 1

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.

Conditions

Stigma

Outcome Measures

Primary Outcomes (1)

• Client treatment retention

  MMT retention will be measured by the treatment status (in treatment vs. drop out) at each follow-up point.

  Change from baseline to 6-, 12-, 18- and 24-month follow up

Secondary Outcomes (2)

• Client's mental health

  Change from baseline to 6-, 12-, 18- and 24-month follow up

• Provider attitudes toward and interaction with clients

  Change from baseline to 6-, 12-, 18- and 24-month follow up

Study Arms (2)

control

NO INTERVENTION

Standard care

intervention

EXPERIMENTAL

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.

Behavioral: MMT CARE

Interventions

MMT CARE BEHAVIORAL

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Service Providers
• Inability to give informed consent

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

China CDC, NCAIDS

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 30797387 DERIVED

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Zunyou Wu, PhD

  China CDC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 4, 2013
• Study Start: March 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 26, 2017

Record last verified: 2017-07

Locations

CN (1)