NCT04535011

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 864 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Use Disorder
• Injury Traumatic
• Trauma

Interventions

Type	Name	Description
BEHAVIORAL	PPKAY (brief intervention)	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.
BEHAVIORAL	Standard Booster	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.
BEHAVIORAL	Personalized Booster	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.

Timeline

• Start date: 2020-10-12
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2020-09-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: Tanzania