Clinical trial NCT01760720: Methadone Maintenance Treatment (MMT) Care for HIV Prevention
Official title: Methadone Maintenance Treatment (MMT) Care for HIV Prevention: A Randomized Controlled Trial (MMT2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stigma
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 2866
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

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.

Primary outcomes:
measure: Client treatment retention
timeFrame: Change from baseline to 6-, 12-, 18- and 24-month follow up
Secondary outcomes:
measure: Client's mental health
timeFrame: Change from baseline to 6-, 12-, 18- and 24-month follow up
measure: Provider attitudes toward and interaction with clients
timeFrame: Change from baseline to 6-, 12-, 18- and 24-month follow up
Other outcomes:
Locations:
city: Beijing
country: China
facility: China CDC, NCAIDS
Study officials:
affiliation: China CDC
name: Zunyou Wu, PhD
role: STUDY_DIRECTOR
References:
citation: 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.