A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV, Hepatitis C, Syphilis, Herpes Simplex Type II

Intervention / Treatment
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* Behavioral: MMT provider dosage training
* Behavioral: targeted counseling
* Other: national guidelines


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control arm<br>Using currently practiced methadone dosage prescription methods | Other: national guidelines<br>* Provided a hard copy of the existing national guidelines for methadone dosing<br>* Other names: dosing guidelines;|
| Experimental: MMT provider dosage training<br>Intensive health care provider training on prescribing methadone dosage based on national guidelines | Behavioral: MMT provider dosage training<br>* Training on methadone dosing provided to health care providers working in methadone maintenance clinics<br>* Other names: training;Other: national guidelines<br>* Provided a hard copy of the existing national guidelines for methadone dosing<br>* Other names: dosing guidelines;|
| Experimental: MMT provider dosage training/counseling<br>Intensive health care provider training on prescribing methadone dosage, plus providing on-site psychosocial counseling services and peer support to clients . | Behavioral: MMT provider dosage training<br>* Training on methadone dosing provided to health care providers working in methadone maintenance clinics<br>* Other names: training;Behavioral: targeted counseling<br>* targeted counseling provided to methadone maintenance clinic attendees<br>* Other names: counseling;Other: national guidelines<br>* Provided a hard copy of the existing national guidelines for methadone dosing<br>* Other names: dosing guidelines;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMT retention rate |  | 12 months | 
| Illicit opioid use rate | by urinalysis and self-report | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV, HCV, syphilis and HSV-2 infection seroconversion rate |  | 12 months | 
| High risk needle practice |  | 12 months | 
| High risk sexual practice |  | 12 months | 
| Quality of life（WHO Quality of Life -BREF） |  | 12 months | 
| All-cause mortality |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IDUs, high risk behaviors, HIV, MMT dosage and retention, psychosocial services