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A Methadone Maintenance Treatment Outcome Study in Three Provinces in China

A Methadone Maintenance Treatment Outcome Study in Three Provinces in China: Comparative Evaluation of the Impact of an Intensive Health Care Provider Training Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01315054
Enrollment
4258
Registered
2011-03-15
Start date
2011-05-31
Completion date
2018-12-31
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Herpes Simplex Type II, HIV, Syphilis

Keywords

IDUs, high risk behaviors, HIV, MMT dosage and retention, psychosocial services

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.

Interventions

BEHAVIORALMMT provider dosage training

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

BEHAVIORALtargeted counseling

targeted counseling provided to methadone maintenance clinic attendees

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

Sponsors

National Center for AIDS/STD Control and Prevention, China CDC
CollaboratorOTHER_GOV
Centers for Disease Control and Prevention
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Illicit opioid use rate12 monthsby urinalysis and self-report
MMT retention rate12 months% of patients retained at the end of the year after Methadone maintenance treatment

Secondary

MeasureTime frameDescription
All-cause mortality12 monthsPatients die by all causes during the program
High risk needle practice12 monthsShared needles used for drug injections without cleaning procedures involved
High risk sexual practice12 monthsSex without condoms and also with multiple partners
HIV, HCV, syphilis and HSV-2 infection seroconversion rate12 monthsPatients who were negative converted to being seropositive
Quality of life(WHO Quality of Life -BREF)12 monthsScale of quality of life by WHO

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026