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

Study Overview
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Brief Summary
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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.

Official Title
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PRACT: A Pragmatic Randomized Adaptive Clinical Trial to Investigate Controlling Alcohol Related Harms in a Low-Income Setting; Emergency Department Brief Interventions in Tanzania

Conditions
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Alcohol Use Disorder, Injury Traumatic, Trauma

Intervention / Treatment
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* Behavioral: PPKAY (brief intervention)
* Behavioral: Standard Booster
* Behavioral: Personalized Booster


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Study Phase 1: The investigators will evaluate whether PPKAY with personalized text booster or PPKAY with standard text booster will reduce the quantity or frequency of alcohol use, the number of binge drinking events or the number of alcohol-related consequences based on the Drinker Inventory of Consequences (DrInC) compared to usual care. Study Phase 2: The investigators will evaluate whether PPKAY alone is an inferior supplement to PPKAY plus standard or personalized text booster
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>No prevention or educational information verbally or written coinciding with current usual care | |
| Experimental: PPKAY<br>One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use | Behavioral: PPKAY (brief intervention)<br>* 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.<br>|
| Experimental: PPKAY with Standard Booster<br>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) | Behavioral: PPKAY (brief intervention)<br>* 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.<br>Behavioral: Standard Booster<br>* 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.<br>|
| Experimental: PPKAY with Personalized Booster<br>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].) | Behavioral: PPKAY (brief intervention)<br>* 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.<br>Behavioral: Personalized Booster<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of binge drinking days (previous 4 weeks) |  | Baseline, 3 months, 6 months, 9 months, 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frequency of alcohol use (previous 2 weeks) |  | Baseline, 3 months, 6 months, 9 months, 12 months, 24 months | 
| Change in quantity of alcohol use (previous 2 weeks) |  | Baseline, 3 months, 6 months, 9 months, 12 months, 24 months | 
| Change in alcohol-related harms measured by the Drinker Inventory of Consequences (DrInC) | 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 | 
| Change in alcohol use disorder | 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. | Baseline, 3 months, 6 months, 9 months, 12 months, 24 months | 
| Change in depression | Depression measured with Patient Health Questionnaire 9 (PHQ-9) | Baseline, 3 months, 6 months, 9 months, 12 months, 24 months |