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Clinical Trials/NCT01532609
NCT01532609
Completed
Not Applicable

Methadone Maintenance and HIV Prevention: A Window of Opportunity in China Version

University of California, Los Angeles1 site in 1 country220 target enrollmentMarch 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Capacity Building
Sponsor
University of California, Los Angeles
Enrollment
220
Locations
1
Primary Endpoint
Service provider's job satisfaction
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study is an intervention pilot that integrates the current methadone maintenance treatment (MMT) program in China with psychosocial and behavioral components in order to address the critical link between drug use and HIV/AIDS.

The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the intervention manuals and supporting materials, and finalized assessment measures and implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT clinics involving 41 service providers and 179 clients, and followed up at three, six, and nine months.

Detailed Description

The implementation of the MMT program in China is one of the most significant measures ever taken by the Chinese government to address drug use and HIV prevention challenges. In 2004, China launched a series of MMT programs at eight pilot clinics in five provinces. By December 2007, 503 MMT clinics had been established nationwide across 23 provinces. Several studies have found that positive outcomes in drug use, criminality, and employment were associated with participation in MMT. However, special challenges are facing the current MMT programs are facing: 1) clients' drop-out rates are high; and 2) providers at MMT clinics do not have sufficient training, and some of them hesitate to serve the population. We have recognized the urgent need and conducted the study to address these challenges. The intervention pilot proceeds in two phases in Sichuan, China. In Phase 1, we developed the intervention manuals and supporting materials, and finalized assessment measures and implementation procedures. In Phase 2, we conducted an intervention pilot across 6 MMT clinics involving 41 service providers and 179 clients, and followed up at three, six, and nine months. The specific aims of the proposed study are: Specific Aim 1: To assess the feasibility and acceptability of the MMT PLUS intervention with process evaluation and participant feedback. Specific Aim 2: To examine primary outcomes on whether service providers in the intervention group, compared to providers in the standard care, will demonstrate improved adherence to MMT protocol, decrease in prejudicial attitudes, increase in comfort working with MMT clients, increase in motivating clients and making personalized risk management plan. Specific Aim 3: To explore secondary outcomes on whether MMT clients in the intervention group, compared to clients in the standard care, will report increased motivation to change, improved psychological and physical health, increased positive support network, and reduced HIV risk behavior. Specific Aim 4: To investigate exploratory outcomes on whether MMT clients in the intervention group, compared to clients in the standard care, will report improved MMT treatment retention and decreased drug use.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
March 2011
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Service providers
  • Age 18 and above
  • Currently working in MMT clinic
  • Informed consent
  • MMT clients
  • Age 18 or over
  • Currently enrolled in MMT
  • Informed consent

Exclusion Criteria

  • Service providers
  • Anyone who does not meet the inclusion criteria.
  • MMT clients:
  • Psychosis, neurological damage, as judged by an interviewer in consultation with a clinical supervisor inability to give informed consent

Outcomes

Primary Outcomes

Service provider's job satisfaction

Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up

Service provider's prejudical attitude towards drug users

Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up

Provide-client interaction

Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up

Provider's perceived stigma due to work with drug using population

Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up

Service provider's perceived risk at work

Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up

Service provider's perceived institutional support

Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up

Service providers' MMT knowledge

Time Frame: Changes from baseline to 3-, 6- and 9-month follow-up

Secondary Outcomes

  • Client's perceived stigma from MMT clients(Changes from baseline to 3-, 6- and 9-month follow-up)
  • Client's drug avoidance self-efficacy(Changes from baseline to 3-, 6- and 9-month follow-up)
  • Client's physical health(Changes from baseline to 3-, 6- and 9-month follow-up)
  • Client's social support(Changes from baseline to 3-, 6- and 9-month follow-up)
  • Client's readiness to change(Changes from baseline to 3-, 6- and 9-month follow-up)
  • Client's drug using behavior(Changes from baseline to 3-, 6- and 9-month follow-up)
  • MMT client's mental health(Changes from baseline to 3-, 6- and 9-month follow-up)

Study Sites (1)

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