A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

Not Applicable

Completed

• Conditions: Hepatitis C; Herpes Simplex Type II; HIV; Syphilis
• Interventions: Other: national guidelines; Behavioral: MMT provider dosage training; Behavioral: targeted counseling

• Registration Number: NCT01315054
• Lead Sponsor: Centers for Disease Control and Prevention

Brief 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. 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 Timeline

• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Study Start: 2011-05
• Primary Completion: 2015-12
• Study Completion: 2018-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4258

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	national guidelines	Using currently practiced methadone dosage prescription methods
MMT provider dosage training	MMT provider dosage training	Intensive health care provider training on prescribing methadone dosage based on national guidelines
MMT provider dosage training/counseling	MMT provider dosage training	Intensive health care provider training on prescribing methadone dosage, plus providing on-site psychosocial counseling services and peer support to clients .
MMT provider dosage training/counseling	targeted counseling	Intensive health care provider training on prescribing methadone dosage, plus providing on-site psychosocial counseling services and peer support to clients .
MMT provider dosage training	national guidelines	Intensive health care provider training on prescribing methadone dosage based on national guidelines
MMT provider dosage training/counseling	national guidelines	Intensive health care provider training on prescribing methadone dosage, plus providing on-site psychosocial counseling services and peer support to clients .

Primary Outcome Measures

Name	Time	Method
Illicit opioid use rate	12 months	by urinalysis and self-report
MMT retention rate	12 months	% of patients retained at the end of the year after Methadone maintenance treatment

Secondary Outcome Measures

Name	Time	Method
HIV, HCV, syphilis and HSV-2 infection seroconversion rate	12 months	Patients who were negative converted to being seropositive
High risk needle practice	12 months	Shared needles used for drug injections without cleaning procedures involved
Quality of life（WHO Quality of Life -BREF）	12 months	Scale of quality of life by WHO
High risk sexual practice	12 months	Sex without condoms and also with multiple partners
All-cause mortality	12 months	Patients die by all causes during the program

Trial Locations

Locations (1)

National Center for HIV/STD Prevention and Control, China CDC; 🇨🇳 Beijing, China