跳至主要内容
临床试验/NCT04927091
NCT04927091已完成不适用

Integrating Addiction Treatment and HIV Services Into Primary Care Clinics in Ukraine

Yale University1 个研究点 分布在 1 个国家目标入组 1,458 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,458
试验地点
1
主要终点
Average percentage of recommended Quality Health Indicator services accessed by participants to assess efficacy

研究概览

简要总结

A randomized controlled trial to:

  1. To compare both primary (composite quality health indicator (QHI) scores) and secondary (individual HIV/methadone maintenance treatment (MMT)/TB/primary care QHI scores, quality of life, and stigma) outcomes in an anticipated 1,350 people who inject drugs (PWID) receiving MMT from 13 regions (clusters) and 39 clinical settings using a stratified, phase-in, controlled design over 24 months. After stratifying PWIDs based on their current receipt of MMT, they will be randomized to receive MMT in specialty addiction clinics (N=450) or in an ECHO-IC/QI-enhanced primary care clinic with (N=450) or without (N=450) pay for performance (P4P) incentives.
  2. Using a multi-level implementation science framework, to examine the contribution of client, clinician and organizational factors that contribute to the comprehensive composite (primary outcome) and individual (secondary) QHI scores.

详细描述

Original outcomes were edited and Implementation outcomes were added November 2023.

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

  • Interested in MMT
  • Meets DSM-V criteria for Opioid Dependence

排除标准

  • Not willing to consent

结局指标

主要结局

Average percentage of recommended Quality Health Indicator services accessed by participants to assess efficacy

时间窗: every 6 months up to 24 months

The total average percentage of the 17 recommended Quality Health Indicator screenings and services that were accessed by participants to assess efficacy. Recommended QHI screenings are as follows: General medical examination; blood analysis; urine analysis; cardiogram; mammogram; cervical cancer screening; prostate cancer screening; hepatitis B screening; hepatitis C screening; HIV screening; CD4 or viral load; ART treatment; TB screening; TB treatment; received take-home MMT; adequate MMT dose; on MMT for 12 months.

次要结局

  • Average percentage of recommended HIV Quality Health Indicator services accessed to assess efficacy(every 6 months up to 24 months)
  • Average percentage of recommended MMT Quality Health Indicator services accessed to assess efficacy(every 6 months up to 24 months)
  • Average percentage of recommended TB Quality Health Indicator services accessed to assess efficacy(every 6 months up to 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验