A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

HIV Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01315054
• Other study ID #: CDC-CGH-6014
• Secondary ID: CN_09_217
• Status: Active, not recruiting
• Phase: N/A
• First received: March 14, 2011
• Last updated: March 13, 2014
• Start date: May 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7700
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hepatitis C
• Herpes Simplex
• Herpes Simplex Type II
• HIV
• Syphilis

Intervention

Behavioral:
• MMT provider dosage training
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
• targeted counseling
targeted counseling provided to methadone maintenance clinic attendees

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

Locations

Country	Name	City	State
China	National Center for HIV/STD Prevention and Control, China CDC	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	National Center for AIDS/STD Control and Prevention, China CDC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMT retention rate		12 months	No
Primary	Illicit opioid use rate	by urinalysis and self-report	12 months	No
Secondary	HIV, HCV, syphilis and HSV-2 infection seroconversion rate		12 months	No
Secondary	High risk needle practice		12 months	No
Secondary	High risk sexual practice		12 months	No
Secondary	Quality of life(WHO Quality of Life -BREF)		12 months	No
Secondary	All-cause mortality		12 months	No