PRACT to Investigate Controlling Alcohol Related Harms in a Low-Income Setting; Emergency Department BIs in Tanzania

Not Applicable

Recruiting

• Conditions: Trauma; Injury Traumatic; Alcohol Use Disorder
• Interventions: Behavioral: PPKAY (brief intervention); Behavioral: Standard Booster; Behavioral: Personalized Booster

• Registration Number: NCT04535011
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-09-01
• Study Start: 2020-10-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-21
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 864

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PPKAY with Standard Booster	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 with Personalized Booster	PPKAY (brief intervention)	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 with Personalized Booster	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	PPKAY (brief intervention)	One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use
PPKAY with Standard Booster	PPKAY (brief intervention)	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")

Primary Outcome Measures

Name	Time	Method
Change in number of binge drinking days (previous 4 weeks)	Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Secondary Outcome Measures

Name	Time	Method
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	Depression measured with Patient Health Questionnaire 9 (PHQ-9)
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	Alcohol use disorder measured with 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.
Change in alcohol-related harms measured by the Drinker Inventory of Consequences (DrInC)	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.

Trial Locations

Locations (1)

Kilimanjaro Christian Medical Centre; 🇹🇿 Moshi, Kilimanjaro, Tanzania