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Completed

NCT Number: NCT01760720

Methadone Maintenance Treatment (MMT) Care for HIV Prevention

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.

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Key information

Conditions

Stigma Behavior Social Behavior Social Stigma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China CDC, NCAIDS

Beijing, China

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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
  • Anyone who does not meet the inclusion criteria

Service Providers

  • Inability to give informed consent
  • Anyone who does not meet the inclusion criteria.

Treatment and study plan

MMT CARE

Behavioral

Primary outcomes

  1. Client treatment retention

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

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

Secondary outcomes

  1. Client's mental health

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

    The Zung Depression Scale will be used to measure clients' depressive symptoms. Drug avoidance self-efficacy will be measured with selected questions from the Drug Avoidance Self-Efficacy Scale (DASES).

  2. Provider attitudes toward and interaction with clients

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

    Negative attitude toward drug users will be measured with questions adapted from the brief scale of attitude measurement developed by researchers at the National Centre for Education and Training on Addiction, Flinders University, Australia (2006). Provider-client interaction will be measured with 12 questions specifically developed for this study and tested in the pilot.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Methadone Maintenance Treatment (MMT) Care for HIV Prevention: A Randomized Controlled Trial (MMT2)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 4, 2013
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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