StigmaNCT01760720
Methadone Maintenance Treatment (MMT) Care for HIV Prevention
A study testing MMT CARE in people with Stigma, run by University of California, Los Angeles at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stigma
- What is being tested?
- MMT CARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,866 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methadone Maintenance Treatment (MMT) Care for HIV Prevention: A Randomized Controlled Trial (MMT2)
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.
Read the 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:
- 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.
- Conditions
- Stigma
- Being tested
- MMT CARE
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMT CAREBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MMT CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client treatment retention
MMT retention will be measured by the treatment status (in treatment vs. drop out) at each follow-up point.
Measured: Change from baseline to 6-, 12-, 18- and 24-month follow up
Secondary outcomes (2)
Client's mental health
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).
Measured: Change from baseline to 6-, 12-, 18- and 24-month follow up
Provider attitudes toward and interaction with clients
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.
Measured: Change from baseline to 6-, 12-, 18- and 24-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StigmaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,866 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, PhD, University of California, Los Angeles
- Investigators
- Zunyou Wu, PhD, Study director, China CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760720
- Sponsor's protocol ID
- R01DA033130
- Status last verified
- Jul 2017
- First submitted
- 2 Jan 2013
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30797387
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone Maintenance Treatment (MMT) Care for HIV Prevention: A Randomized Controlled Trial (MMT2)
- ClinicalTrials.gov ID
- NCT01760720
- Acronym / sponsor ID
- R01DA033130
- Conditions
- Stigma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,866 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Standard care |
| intervention | Experimental | Behavioral: MMT CAREThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- MMT clients
- Age 20 and above
- Currently enrolled in MMT at the participating clinics
- Informed consent Service providers
- Age 18 and above
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMT CARE | Behavioural | intervention |
Primary outcome
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.
2 secondary outcomes
Client's mental health
Time frame: Change from baseline to 6-, 12-, 18- and 24-month follow up
Provider attitudes toward and interaction with clients
Time frame: Change from baseline to 6-, 12-, 18- and 24-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Derived from this study: PubMed 30797387Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zunyou Wu, PhD study director
China CDC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMT CARE in people with Stigma, run by University of California, Los Angeles at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client treatment retention (time frame: Change from baseline to 6-, 12-, 18- and 24-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01760720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.