NCT01315054

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,258

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

4.6 years

First QC Date

March 14, 2011

Last Update Submit

August 20, 2024

Conditions

HIVHepatitis CSyphilisHerpes Simplex Type II

Keywords

IDUshigh risk behaviorsHIVMMT dosage and retentionpsychosocial services

Outcome Measures

Primary Outcomes (2)

  • MMT retention rate

    % of patients retained at the end of the year after Methadone maintenance treatment

    12 months

  • Illicit opioid use rate

    by urinalysis and self-report

    12 months

Secondary Outcomes (5)

  • 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

Study Arms (3)

Control arm

OTHER

Using currently practiced methadone dosage prescription methods

Other: national guidelines

MMT provider dosage training

EXPERIMENTAL

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

Behavioral: MMT provider dosage trainingOther: national guidelines

MMT provider dosage training/counseling

EXPERIMENTAL

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 trainingBehavioral: targeted counselingOther: national guidelines

Interventions

MMT provider dosage trainingBEHAVIORAL

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

Also known as: training
MMT provider dosage trainingMMT provider dosage training/counseling
targeted counselingBEHAVIORAL

targeted counseling provided to methadone maintenance clinic attendees

Also known as: counseling
MMT provider dosage training/counseling
national guidelinesOTHER

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

Also known as: dosing guidelines
Control armMMT provider dosage trainingMMT provider dosage training/counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older
  • residing in the study areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for HIV/STD Prevention and Control, China CDC

Beijing, 100050, China

Location

MeSH Terms

Conditions

Hepatitis CSyphilis

Interventions

Counseling

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesTreponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialSexually Transmitted DiseasesGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Marc Bulterys, MD, PhD

    US CDC GAP China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2018

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations

CN(1)