Back to resultsA Methadone Maintenance Treatment Outcome Study in Three Provinces in China
Primary Purpose
HIV, Hepatitis C, Syphilis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MMT provider dosage training
targeted counseling
national guidelines
Sponsored by
About this trial
This is an interventional health services research trial for HIV focused on measuring IDUs, high risk behaviors, HIV, MMT dosage and retention, psychosocial services
Eligibility Criteria
Inclusion Criteria:
- 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
Sites / Locations
- National Center for HIV/STD Prevention and Control, China CDC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Control arm
MMT provider dosage training
MMT provider dosage training/counseling
Arm Description
Using currently practiced methadone dosage prescription methods
Intensive health care provider training on prescribing methadone dosage based on national guidelines
Intensive health care provider training on prescribing methadone dosage, plus providing on-site psychosocial counseling services and peer support to clients .
Outcomes
Primary Outcome Measures
MMT retention rate
Illicit opioid use rate
by urinalysis and self-report
Secondary Outcome Measures
HIV, HCV, syphilis and HSV-2 infection seroconversion rate
High risk needle practice
High risk sexual practice
Quality of life（WHO Quality of Life -BREF）
All-cause mortality
Full Information
NCT ID
NCT01315054
First Posted
March 14, 2011
Last Updated
March 13, 2014
Sponsor
Centers for Disease Control and Prevention
Collaborators
National Center for AIDS/STD Control and Prevention, China CDC
1. Study Identification
Unique Protocol Identification Number
NCT01315054
Brief Title
A Methadone Maintenance Treatment Outcome Study in Three Provinces in China
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 Combined With Expanded Services on Treatment Retention, Heroin Use, Methadone Dosing and HIV Risk Practices
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
National Center for AIDS/STD Control and Prevention, China CDC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Hepatitis C, Syphilis, Herpes Simplex Type II
Keywords
IDUs, high risk behaviors, HIV, MMT dosage and retention, psychosocial services
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
Other
Arm Description
Using currently practiced methadone dosage prescription methods
Arm Title
MMT provider dosage training
Arm Type
Experimental
Arm Description
Intensive health care provider training on prescribing methadone dosage based on national guidelines
Arm Title
MMT provider dosage training/counseling
Arm Type
Experimental
Arm Description
Intensive health care provider training on prescribing methadone dosage, plus providing on-site psychosocial counseling services and peer support to clients .
Intervention Type
Behavioral
Intervention Name(s)
MMT provider dosage training
Other Intervention Name(s)
training
Intervention Description
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
Intervention Type
Behavioral
Intervention Name(s)
targeted counseling
Other Intervention Name(s)
counseling
Intervention Description
targeted counseling provided to methadone maintenance clinic attendees
Intervention Type
Other
Intervention Name(s)
national guidelines
Other Intervention Name(s)
dosing guidelines
Intervention Description
Provided a hard copy of the existing national guidelines for methadone dosing
Primary Outcome Measure Information:
Title
MMT retention rate
Time Frame
12 months
Title
Illicit opioid use rate
Description
by urinalysis and self-report
Time Frame
12 months
Secondary Outcome Measure Information:
Title
HIV, HCV, syphilis and HSV-2 infection seroconversion rate
Time Frame
12 months
Title
High risk needle practice
Time Frame
12 months
Title
High risk sexual practice
Time Frame
12 months
Title
Quality of life（WHO Quality of Life -BREF）
Time Frame
12 months
Title
All-cause mortality
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Bulterys, MD, PhD
Organizational Affiliation
US CDC GAP China
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for HIV/STD Prevention and Control, China CDC
City
Beijing
ZIP/Postal Code
100050
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Methadone Maintenance Treatment Outcome Study in Three Provinces in China
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