Capacity BuildingMMT1NCT01532609
Methadone Maintenance and HIV Prevention: A Window of Opportunity in China
A study testing MMT CARE in people with Capacity Building and Drug Use, run by University of California, Los Angeles at 1 site in China.
Trial summary
This study is an intervention pilot that integrates the current methadone maintenance treatment (MMT) program in China with psychosocial and behavioral components in order to address the critical link between drug use and HIV/AIDS. The intervention pilot proceeds in two phases in Sichuan, China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Capacity Building, Drug Use, HIV/AIDS
- 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
- 220 participants
- Where
- 1 siteChina
- Study dates
- Mar 2009to Mar 2011
- 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
- Service providers
- Age 18 and above
- Currently working in MMT clinic
- Informed consent
- MMT clients
- Age 18 or over
- Currently enrolled in MMT
- Informed consent
Who cannot join
- Service providers
- Anyone who does not meet the inclusion criteria.
- MMT clients:
- Psychosis, neurological damage, as judged by an interviewer in consultation with a clinical supervisor inability to give informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Sichuan Provincial Center for Disease Control and Prevention
Chengdu, Sichuan
About this study
Official title: Methadone Maintenance and HIV Prevention: A Window of Opportunity in China Version
This study is an intervention pilot that integrates the current methadone maintenance treatment (MMT) program in China with psychosocial and behavioral components in order to address the critical link between drug use and HIV/AIDS.
The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the intervention manuals and supporting materials, and finalized assessment measures and implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT clinics involving 41 service providers and 179 clients, and followed up at three, six, and nine months.
Read the detailed description
The implementation of the MMT program in China is one of the most significant measures ever taken by the Chinese government to address drug use and HIV prevention challenges. In 2004, China launched a series of MMT programs at eight pilot clinics in five provinces. By December 2007, 503 MMT clinics had been established nationwide across 23 provinces. Several studies have found that positive outcomes in drug use, criminality, and employment were associated with participation in MMT. However, special challenges are facing the current MMT programs are facing: 1) clients' drop-out rates are high; and 2) providers at MMT clinics do not have sufficient training, and some of them hesitate to serve the population. We have recognized the urgent need and conducted the study to address these challenges.
The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the intervention manuals and supporting materials, and finalized assessment measures and implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT clinics involving 41 service providers and 179 clients, and followed up at three, six, and nine months.
The specific aims of the proposed study are:
Specific Aim 1: To assess the feasibility and acceptability of the MMT PLUS intervention with process evaluation and participant feedback.
Specific Aim 2: To examine primary outcomes on whether service providers in the intervention group, compared to providers in the standard care, will demonstrate improved adherence to MMT protocol, decrease in prejudicial attitudes, increase in comfort working with MMT clients, increase in motivating clients and making personalized risk management plan.
Specific Aim 3: To explore secondary outcomes on whether MMT clients in the intervention group, compared to clients in the standard care, will report increased motivation to change, improved psychological and physical health, increased positive support network, and reduced HIV risk behavior.
Specific Aim 4: To investigate exploratory outcomes on whether MMT clients in the intervention group, compared to clients in the standard care, will report improved MMT treatment retention and decreased drug use.
- Conditions
- Capacity Building, Drug Use, HIV/AIDS
- Being tested
- MMT CARE
- Keywords
- Methadone maintenance therapy, Behavioral intervention, Service provider, Drug use
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMT CAREBehavioural
Intervention group service providers received four training sessions (plus reunion sessions) on MMT protocol, reducing stigma and its impact, maintaining positive interactions with clients, and motivational interviewing skills. The participating providers are required to conduct three individual motivational sessions with their clients upon completion of the intervention sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group service providers received four training sessions (plus reunion sessions) on MMT protocol, reducing stigma and its impact, maintaining positive interactions with clients, and motivational interviewing skills. The participating providers are required to conduct three individual motivational sessions with their clients upon completion of the intervention sessions. Receives: Behavioral: MMT CARE |
| Standard care | No intervention | No additional training or service is provided for standard care group service providers or clients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Service providers' MMT knowledge
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's prejudical attitude towards drug users
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Provide-client interaction
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Provider's perceived stigma due to work with drug using population
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's perceived risk at work
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's perceived institutional support
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's job satisfaction
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Secondary outcomes (7)
Client's drug using behavior
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Client's physical health
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
MMT client's mental health
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Client's perceived stigma from MMT clients
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Client's readiness to change
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Client's drug avoidance self-efficacy
Measured: Changes from baseline to 3-, 6- and 9-month follow-up
Client's social support
Measured: Changes from baseline to 3-, 6- and 9-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 posted14 Feb 2012 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionMar 2011
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 Capacity BuildingStudies 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China
- Responsible party
- Sponsor
- Investigators
- Li Li, PhD, Principal investigator, NPI-Center for Community Health, UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532609
- Sponsor's protocol ID
- R34MH083512
- Acronym
- MMT1
- Status last verified
- Sep 2023
- First submitted
- 8 Feb 2012
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li L, Wu Z, Liang LJ, Lin C, Zhang L, Guo S, Rou K, Li J. An intervention targeting service providers and clients for methadone maintenance treatment in China: a cluster-randomized trial. Addiction. 2013 Feb;108(2):356-66. doi: 10.1111/j.1360-0443.2012.04020.x. Epub 2012 Oct 5.
PubMed 22788780
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone Maintenance and HIV Prevention: A Window of Opportunity in China Version
- ClinicalTrials.gov ID
- NCT01532609
- Acronym / sponsor ID
- MMT1 / R34MH083512
- Conditions
- Capacity Building, Drug Use, HIV/AIDS
- Keywords
- Methadone maintenance therapy, Behavioral intervention, Service provider, Drug use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Feb 2012 (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.
This study is an intervention pilot that integrates the current methadone maintenance treatment (MMT) program in China with psychosocial and behavioral components in order to address the critical link between drug use and HIV/AIDS.
The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the intervention manuals and supporting materials, and finalized assessment measures and implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT clinics involving 41 service providers and 179 clients, and followed up at three, six, and nine months.
Detailed description
The implementation of the MMT program in China is one of the most significant measures ever taken by the Chinese government to address drug use and HIV prevention challenges. In 2004, China launched a series of MMT programs at eight pilot clinics in five provinces. By December 2007, 503 MMT clinics had been established nationwide across 23 provinces. Several studies have found that positive outcomes in drug use, criminality, and employment were associated with participation in MMT. However, special challenges are facing the current MMT programs are facing: 1) clients' drop-out rates are high; and 2) providers at MMT clinics do not have sufficient training, and some of them hesitate to serve the population. We have recognized the urgent need and conducted the study to address these challenges.
The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the intervention manuals and supporting materials, and finalized assessment measures and implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT clinics involving 41 service providers and 179 clients, and followed up at three, six, and nine months.
The specific aims of the proposed study are:
Specific Aim 1: To assess the feasibility and acceptability of the MMT PLUS intervention with process evaluation and participant feedback.
Specific Aim 2: To examine primary outcomes on whether service providers in the intervention group, compared to providers in the standard care, will demonstrate improved adherence to MMT protocol, decrease in prejudicial attitudes, increase in comfort working with MMT clients, increase in motivating clients and making personalized risk management plan.
Specific Aim 3: To explore secondary outcomes on whether MMT clients in the intervention group, compared to clients in the standard care, will report increased motivation to change, improved psychological and physical health, increased positive support network, and reduced HIV risk behavior.
Specific Aim 4: To investigate exploratory outcomes on whether MMT clients in the intervention group, compared to clients in the standard care, will report improved MMT treatment retention and decreased drug use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MMT CAREIntervention group service providers received four training sessions (plus reunion sessions) on MMT protocol, reducing stigma and its impact, maintaining positive interactions with clients, and motivational interviewing skills. The participating providers are required to conduct three individual motivational sessions with their clients upon completion of the intervention sessions. |
| Standard care | No intervention | –No additional training or service is provided for standard care group service providers or clients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Service providers
- Age 18 and above
- Currently working in MMT clinic
- Informed consent
- MMT clients
Key exclusion criteria (4 listed)
- Service providers
- Anyone who does not meet the inclusion criteria.
- Psychosis, neurological damage, as judged by an interviewer in consultation with a clinical supervisor inability to give informed consent
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 CAREIntervention group service providers received four training sessions (plus reunion sessions) on MMT protocol, reducing stigma and its impact, maintaining positive interactions with clients, and motivational interviewing skills. The participating providers are required to conduct three individual motivational sessions with their clients upon completion of the intervention sessions. | Behavioural | Intervention |
Primary outcome
Service providers' MMT knowledge
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's prejudical attitude towards drug users
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Provide-client interaction
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Provider's perceived stigma due to work with drug using population
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's perceived risk at work
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's perceived institutional support
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Service provider's job satisfaction
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
7 secondary outcomes
Client's drug using behavior
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Client's physical health
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
MMT client's mental health
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Client's perceived stigma from MMT clients
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Client's readiness to change
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Client's drug avoidance self-efficacy
Time frame: Changes from baseline to 3-, 6- and 9-month follow-up
Client's social support
Time frame: Changes from baseline to 3-, 6- and 9-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 2 Oct 2023.
- Derived from this study: PubMed 22788780Li L, Wu Z, Liang LJ, Lin C, Zhang L, Guo S, Rou K, Li J. An intervention targeting service providers and clients for methadone maintenance treatment in China: a cluster-randomized trial. Addiction. 2013 Feb;108(2):356-66. doi: 10.1111/j.1360-0443.2012.04020.x. Epub 2012 Oct 5.
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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.
Li Li, PhD principal investigator
NPI-Center for Community Health, UCLA
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 Capacity Building and Drug Use, 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 8 inclusion and 4 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 2 Oct 2023. 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?
Service providers' MMT knowledge (time frame: Changes from baseline to 3-, 6- and 9-month follow-up). The study lists 7 primary outcomes in all. 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 NCT01532609, 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 2 Oct 2023.