A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

Sponsor

Centers for Disease Control and Prevention (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT01315054

Collaborator

National Center for AIDS/STD Control and Prevention, China CDC (Other)

7,700

Enrollment

Location

Arms

Duration (Months)

178.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Hepatitis C Syphilis Herpes Simplex Type II	Behavioral: MMT provider dosage training Behavioral: targeted counseling Other: national guidelines	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

7700 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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 Start Date :

May 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Control arm Using currently practiced methadone dosage prescription methods	Other: national guidelines Provided a hard copy of the existing national guidelines for methadone dosing Other Names: dosing guidelines
Experimental: MMT provider dosage training Intensive health care provider training on prescribing methadone dosage based on national guidelines	Behavioral: MMT provider dosage training Training on methadone dosing provided to health care providers working in methadone maintenance clinics Other Names: training Other: national guidelines Provided a hard copy of the existing national guidelines for methadone dosing Other Names: dosing guidelines
Experimental: MMT provider dosage training/counseling 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 Training on methadone dosing provided to health care providers working in methadone maintenance clinics Other Names: training Behavioral: targeted counseling targeted counseling provided to methadone maintenance clinic attendees Other Names: counseling Other: national guidelines Provided a hard copy of the existing national guidelines for methadone dosing Other Names: dosing guidelines

Arm

Intervention/Treatment

Other: Control arm

Using currently practiced methadone dosage prescription methods

Other: national guidelines

Provided a hard copy of the existing national guidelines for methadone dosing

Other Names:

dosing guidelines

Experimental: MMT provider dosage training

Intensive health care provider training on prescribing methadone dosage based on national guidelines

Behavioral: MMT provider dosage training

Training on methadone dosing provided to health care providers working in methadone maintenance clinics

Other Names:

training

Other: national guidelines

Provided a hard copy of the existing national guidelines for methadone dosing

Other Names:

dosing guidelines

Experimental: MMT provider dosage training/counseling

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

Training on methadone dosing provided to health care providers working in methadone maintenance clinics

Other Names:

training

Behavioral: targeted counseling

targeted counseling provided to methadone maintenance clinic attendees

Other Names:

counseling

Other: national guidelines

Provided a hard copy of the existing national guidelines for methadone dosing

Other Names:

dosing guidelines

Outcome Measures

Primary Outcome Measures

MMT retention rate [12 months]
Illicit opioid use rate [12 months]
by urinalysis and self-report

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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