PRACT: A Pragmatic Randomized Adaptive Clinical Trial to Investigate Controlling Alcohol Related Harms in a Low-Income Setting; Emergency Department Brief Interventions in Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 674
- 试验地点
- 1
- 主要终点
- Change in number of binge drinking days (previous 4 weeks)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •do not speak the native Swahili language
- •too ill or unable to communicate
- •prior enrollment in this study
- •decline informed consent.
研究组 & 干预措施
Usual Care
No prevention or educational information verbally or written coinciding with current usual care
PPKAY
One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use
干预措施: PPKAY (brief intervention) (Behavioral)
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")
干预措施: PPKAY (brief intervention) (Behavioral)
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")
干预措施: Standard Booster (Behavioral)
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].")
干预措施: PPKAY (brief intervention) (Behavioral)
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].")
干预措施: Personalized Booster (Behavioral)
结局指标
主要结局
Change in number of binge drinking days (previous 4 weeks)
时间窗: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
次要结局
- Change in quantity of alcohol use (previous 2 weeks)(Baseline, 3 months, 6 months, 9 months, 12 months, 24 months)
- Change in depression(Baseline, 3 months, 6 months, 9 months, 12 months, 24 months)
- Change in frequency of alcohol use (previous 2 weeks)(Baseline, 3 months, 6 months, 9 months, 12 months, 24 months)
- Change in alcohol use disorder(Baseline, 3 months, 6 months, 9 months, 12 months, 24 months)
- Change in alcohol-related harms measured by the Drinker Inventory of Consequences (DrInC)(Baseline, 3 months, 6 months, 9 months, 12 months, 24 months)