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

Duke University

Status: Enrolling

Conditions: Injury Traumatic; Trauma; Alcohol Use Disorder

Treatments: Behavioral: Standard Booster; Behavioral: PPKAY (brief intervention); Behavioral: Personalized Booster

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04535011

R01AA027512 (U.S. NIH Grant/Contract)

Pro00103724

Details and patient eligibility

About

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.

Enrollment: 864 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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864 participants in 4 patient groups

Usual Care

No Intervention group

Description:

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

PPKAY

Experimental group

Description:

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

Treatment:

Behavioral: PPKAY (brief intervention)

PPKAY with Standard Booster

Experimental group

Description:

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")

Treatment:

Behavioral: PPKAY (brief intervention)

Behavioral: Standard Booster

PPKAY with Personalized Booster

Experimental group

Description:

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].")

Treatment:

Behavioral: Personalized Booster

Behavioral: PPKAY (brief intervention)