Overview

This trial is active, not recruiting.

Conditions hiv, hepatitis c, syphilis, herpes simplex type ii
Treatments mmt provider dosage training, targeted counseling, national guidelines
Sponsor Centers for Disease Control and Prevention
Collaborator National Center for AIDS/STD Control and Prevention, China CDC
Start date May 2011
End date December 2014
Trial size 7700 participants
Trial identifier NCT01315054, CDC-CGH-6014, CN_09_217

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Other)
Using currently practiced methadone dosage prescription methods
national guidelines dosing guidelines
Provided a hard copy of the existing national guidelines for methadone dosing
(Experimental)
Intensive health care provider training on prescribing methadone dosage based on national guidelines
mmt provider dosage training training
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
national guidelines dosing guidelines
Provided a hard copy of the existing national guidelines for methadone dosing
(Experimental)
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 training
Training on methadone dosing provided to health care providers working in methadone maintenance clinics
targeted counseling counseling
targeted counseling provided to methadone maintenance clinic attendees
national guidelines dosing guidelines
Provided a hard copy of the existing national guidelines for methadone dosing

Primary Outcomes

Measure
MMT retention rate
time frame: 12 months
Illicit opioid use rate
time frame: 12 months

Secondary Outcomes

Measure
HIV, HCV, syphilis and HSV-2 infection seroconversion rate
time frame: 12 months
High risk needle practice
time frame: 12 months
High risk sexual practice
time frame: 12 months
Quality of life(WHO Quality of Life -BREF)
time frame: 12 months
All-cause mortality
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Marc Bulterys, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Centers for Disease Control and Prevention.