Methadone Maintenance Treatment (MMT) Care for HIV Prevention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01760720|
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stigma||Behavioral: MMT CARE||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2866 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Methadone Maintenance Treatment (MMT) Care for HIV Prevention: A Randomized Controlled Trial (MMT2)|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
No Intervention: control
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
- 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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760720
|China CDC, NCAIDS|
|Study Director:||Zunyou Wu, PhD||China CDC|