跳至主要内容
临床试验/NCT01532609
NCT01532609已完成不适用

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

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
1
主要终点
Service provider's job satisfaction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Service provider's job satisfaction

时间窗: Changes from baseline to 3-, 6- and 9-month follow-up

Service provider's prejudical attitude towards drug users

时间窗: Changes from baseline to 3-, 6- and 9-month follow-up

Provide-client interaction

时间窗: Changes from baseline to 3-, 6- and 9-month follow-up

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

时间窗: Changes from baseline to 3-, 6- and 9-month follow-up

Service provider's perceived risk at work

时间窗: Changes from baseline to 3-, 6- and 9-month follow-up

Service provider's perceived institutional support

时间窗: Changes from baseline to 3-, 6- and 9-month follow-up

Service providers' MMT knowledge

时间窗: Changes from baseline to 3-, 6- and 9-month follow-up

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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