HIVNCT01315054
A Methadone Maintenance Treatment Outcome Study in Three Provinces in China
A study testing MMT provider dosage training, targeted counseling and national guidelines in people with HIV and Hepatitis C, run by Centers for Disease Control and Prevention at 1 site in China.
Trial summary
The primary goal of this PHE is to determine the effectiveness of a tailored education program for MMT service providers. It was to be evaluated through methadone dose levels prescribed to new patients after training completion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hepatitis C, Syphilis
- What is being tested?
- MMT provider dosage training, targeted counseling and national guidelines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,258 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Dec 2018
- 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
- client participants will include both men and women who are opiate-dependent drug users who started MMT not more than one month prior to enrollment in the study
- 18 years of age or older
- residing in the study areas
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
National Center for HIV/STD Prevention and Control, China CDC
Beijing, 100050
About this study
Official title: A Methadone Maintenance Treatment Outcome Study in Three Provinces in China: Comparative Evaluation of the Impact of an Intensive Health Care Provider Training Program
The primary goal of this PHE is to determine the effectiveness of a tailored education program for MMT service providers. It was to be evaluated through methadone dose levels prescribed to new patients after training completion. The effects of methadone dose, with and without the inclusion of additional counseling services, would be measured through MMT retention and illicit opioid use.
Read the detailed description
Methadone treatment has became one of main actions taken in China to control the spread of HIV among drug users. However，the average methadone dose used is relatively low. An intensive methadone maintenance treatment (MMT) provider training on methadone dosage may be effective in increasing the methadone dose levels prescribed to new patients. The study will evaluate the effectiveness of a tailored education program for MMT service providers using subsequent methadone dose prescribed to new patients. The effects of methadone dose, with and without the inclusion of additional psychosocial services, will then be measured through MMT retention and illicit opioid use.
- Conditions
- HIV, Hepatitis C, Syphilis, Herpes Simplex Type II
- Being tested
- MMT provider dosage training, targeted counseling, national guidelines
- Keywords
- IDUs, high risk behaviors, HIV, MMT dosage and retention, psychosocial services
- Medical subject headings
- Hepatitis C, Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMT provider dosage trainingBehavioural
Also called training
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
targeted counselingBehavioural
Also called counseling
targeted counseling provided to methadone maintenance clinic attendees
national guidelinesOther
Also called dosing guidelines
Provided a hard copy of the existing national guidelines for methadone dosing
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Other | Using currently practiced methadone dosage prescription methods Receives: Other: national guidelines |
| MMT provider dosage training | Experimental | Intensive health care provider training on prescribing methadone dosage based on national guidelines Receives: Behavioral: MMT provider dosage training; Other: national guidelines |
| MMT provider dosage training/counseling | Experimental | Intensive health care provider training on prescribing methadone dosage, plus providing on-site psychosocial counseling services and peer support to clients . Receives: Behavioral: MMT provider dosage training; Behavioral: targeted counseling; Other: national guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMT retention rate
% of patients retained at the end of the year after Methadone maintenance treatment
Measured: 12 months
Illicit opioid use rate
by urinalysis and self-report
Measured: 12 months
Secondary outcomes (5)
HIV, HCV, syphilis and HSV-2 infection seroconversion rate
Patients who were negative converted to being seropositive
Measured: 12 months
High risk needle practice
Shared needles used for drug injections without cleaning procedures involved
Measured: 12 months
High risk sexual practice
Sex without condoms and also with multiple partners
Measured: 12 months
Quality of life（WHO Quality of Life -BREF）
Scale of quality of life by WHO
Measured: 12 months
All-cause mortality
Patients die by all causes during the program
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2015
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- National Center for AIDS/STD Control and Prevention, China CDC
- Responsible party
- Sponsor
- Investigators
- Marc Bulterys, MD, PhD, Principal investigator, US CDC GAP China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315054
- Sponsor's protocol ID
- CDC-CGH-6014
- Other IDs
- CN_09_217
- Status last verified
- Aug 2024
- First submitted
- 14 Mar 2011
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Methadone Maintenance Treatment Outcome Study in Three Provinces in China: Comparative Evaluation of the Impact of an Intensive Health Care Provider Training Program
- ClinicalTrials.gov ID
- NCT01315054
- Acronym / sponsor ID
- CDC-CGH-6014
- Conditions
- HIV, Hepatitis C, Syphilis, Herpes Simplex Type II
- Keywords
- IDUs, high risk behaviors, HIV, MMT dosage and retention, psychosocial services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,258 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- National Center for AIDS/STD Control and Prevention, China CDC
- Study start
- May 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Mar 2011 (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.
The primary goal of this PHE is to determine the effectiveness of a tailored education program for MMT service providers. It was to be evaluated through methadone dose levels prescribed to new patients after training completion. The effects of methadone dose, with and without the inclusion of additional counseling services, would be measured through MMT retention and illicit opioid use.
Detailed description
Methadone treatment has became one of main actions taken in China to control the spread of HIV among drug users. However，the average methadone dose used is relatively low. An intensive methadone maintenance treatment (MMT) provider training on methadone dosage may be effective in increasing the methadone dose levels prescribed to new patients. The study will evaluate the effectiveness of a tailored education program for MMT service providers using subsequent methadone dose prescribed to new patients. The effects of methadone dose, with and without the inclusion of additional psychosocial services, will then be measured through MMT retention and illicit opioid use.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control arm | Other | Other: national guidelinesUsing currently practiced methadone dosage prescription methods |
| MMT provider dosage training | Experimental | Behavioral: MMT provider dosage training, Other: national guidelinesIntensive health care provider training on prescribing methadone dosage based on national guidelines |
| MMT provider dosage training/counseling | Experimental | Behavioral: MMT provider dosage training, Behavioral: targeted counseling, Other: national guidelinesIntensive health care provider training on prescribing methadone dosage, plus providing on-site psychosocial counseling services and peer support to clients . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- client participants will include both men and women who are opiate-dependent drug users who started MMT not more than one month prior to enrollment in the study
- 18 years of age or older
- residing in the study areas
Key exclusion criteria (0 listed)
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 provider dosage trainingAlso: trainingTraining on methadone dosing provided to health care providers working in methadone maintenance clinics | Behavioural | MMT provider dosage training, MMT provider dosage training/counseling |
| targeted counselingAlso: counselingtargeted counseling provided to methadone maintenance clinic attendees | Behavioural | MMT provider dosage training/counseling |
| national guidelinesAlso: dosing guidelinesProvided a hard copy of the existing national guidelines for methadone dosing | Other | Control arm, MMT provider dosage training, MMT provider dosage training/counseling |
Primary outcome
MMT retention rate
Time frame: 12 months
% of patients retained at the end of the year after Methadone maintenance treatment
Illicit opioid use rate
Time frame: 12 months
by urinalysis and self-report
5 secondary outcomes
HIV, HCV, syphilis and HSV-2 infection seroconversion rate
Time frame: 12 months
High risk needle practice
Time frame: 12 months
High risk sexual practice
Time frame: 12 months
Quality of life（WHO Quality of Life -BREF）
Time frame: 12 months
All-cause mortality
Time frame: 12 months
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 22 Aug 2024.
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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.
Marc Bulterys, MD, PhD principal investigator
US CDC GAP China
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 provider dosage training, targeted counseling and national guidelines in people with HIV and Hepatitis C, run by Centers for Disease Control and Prevention 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 3 inclusion and 0 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 22 Aug 2024. 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?
MMT retention rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2024.