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在低收入环境中调查控制酒精相关危害的实践;坦桑尼亚的急诊科 BI (PRACT)

2026年10月13日 更新者:Duke University

PRACT:一项实用的随机适应性临床试验,旨在研究在低收入环境中控制酒精相关危害;坦桑尼亚急诊科的简短干预

Alcohol use is rapidly increasing in low- and middle-income countries, where it is inexpensive, readily available, poorly regulated, and there are few resources devoted to promoting safe alcohol use. A Brief Intervention based on a motivational interviewing framework has been shown to reduce alcohol use and alcohol-related harms. The investigators have translated and adapted a Brief Intervention for alcohol to the Tanzanian context and Swahili language called "Punguza Pombe Kwa Afya Yako (PPKAY)/ Reduce Alcohol for Your Health." This project will evaluate this intervention in injury patients presenting for care at the Kilimanjaro Christian Medical Center in Moshi, Tanzania. By using innovative adaptive clinical trial methods, the investigators will expedite the development of the most effective way to integrate this intervention into clinical care. By the end of this project, investigators will have identified the most effective brief intervention components and be able to characterize the intervention's effect overall. Additionally, investigators will standardize adaptive trial methods to revolutionize the science of clinical trials for behavioral sciences in low-resource settings.

研究概览

研究类型

介入性

注册 (实际的)

673

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kilimanjaro
      • Moshi、Kilimanjaro、坦桑尼亚
        • Kilimanjaro Christian Medical Centre

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • ≥18 years of age)
  • present seeking initial care at the KCMC ED for an acute (<24 hours) injury
  • not clinically intoxicated (i.e., have capacity to consent).
  • one or more of the following: 1) disclosed alcohol use prior to injury, 2) scored ≥8 on the AUDIT, 3) test positive (>0.0 g/dL) by alcohol breathalyzer.

Exclusion Criteria:

  • do not speak the native Swahili language
  • too ill or unable to communicate
  • prior enrollment in this study
  • decline informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:顺序分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
无干预:Usual Care

No prevention or educational information verbally or written coinciding with current usual care

实验性的:PPKAY

One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use

PPKAY is a nurse-administered, one-on-one, 15-minute brief intervention (BI) for alcohol use using FRAMES motivational interviewing techniques. The BI is a four-step discussion: 1) Raise the Subject of Alcohol, 2) Provide Feedback, 3) Enhance Motivation 4) Negotiate and Advice.

实验性的:PPKAY with Standard Booster

One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use.

Weekly standard text booster until final follow-up (e.g., "Reducing your alcohol intake to less than 4 drinks per day reduces your risk of alcohol-related consequences")

PPKAY is a nurse-administered, one-on-one, 15-minute brief intervention (BI) for alcohol use using FRAMES motivational interviewing techniques. The BI is a four-step discussion: 1) Raise the Subject of Alcohol, 2) Provide Feedback, 3) Enhance Motivation 4) Negotiate and Advice.

After discharge from the hospital, a standard motivational text message will be sent to their cell phone twice monthly for the duration of the study. In a rotating fashion, one of four standard motivational texts translated into Swahili will be sent to their cell phones.

实验性的:PPKAY with Personalized Booster

One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use Weekly personalized text booster until final follow-up (e.g., "Remember to reduce your alcohol less than 4 drinks to achieve your goal of… [being a better husband].")

PPKAY is a nurse-administered, one-on-one, 15-minute brief intervention (BI) for alcohol use using FRAMES motivational interviewing techniques. The BI is a four-step discussion: 1) Raise the Subject of Alcohol, 2) Provide Feedback, 3) Enhance Motivation 4) Negotiate and Advice.

After discharge from the hospital, a personalized motivational text message will be sent to participant cell phones twice monthly for the duration of the study. In a rotating fashion, one of four personalized motivational texts will be sent to their cell phones. Personalized texts will be created with the content obtained from the motivational interview sessions. At each session, the research nurse conducting the intervention will record four messages based on the content of the session to be sent as the Personalized Booster.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Number of Binge Drinking Days (Previous 4 Weeks)
大体时间:Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

次要结果测量

结果测量
措施说明
大体时间
Frequency of Alcohol Use (Previous 2 Weeks)
大体时间:Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Reported as the number of drinking days during the past two weeks.

Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Quantity of Alcohol Use (Previous 2 Weeks)
大体时间:Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Reported as the number of drinks consumed during the past two weeks.

Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Alcohol-related Harms Measured by the Drinker Inventory of Consequences (DrInC)
大体时间:Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

The Drinker Inventory of Consequences (DrInC) is a fifty-item questionnaire with scores ranging from 0 to 150, where a higher number indicates a greater number of negative consequences.

Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
AUDIT (Alcohol Use Disorder Identification Test) Score
大体时间:Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Alcohol use disorder as measured by AUDIT (alcohol use disorder identification test) score. AUDIT is a ten-item tool, with scores ranging from 0 to 40, where a higher score indicates higher risk alcohol use.

Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Depression as Measured by Patient Health Questionnaire 9 (PHQ-9)
大体时间:Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

The PHQ-9 consists of 9 simple questions evaluating core symptoms of depression over the past two weeks. Each item is rated on a scale of 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, with higher scores indicating greater symptom severity.

Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Catherine A Staton, MD、Duke University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年10月12日

初级完成 (实际的)

2025年5月30日

研究完成 (实际的)

2025年5月30日

研究注册日期

首次提交

2020年8月27日

首先提交符合 QC 标准的

2020年8月27日

首次发布 (实际的)

2020年9月1日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年10月13日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • Pro00103724
  • R01AA027512 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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