CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 674 enrolled
Drug / intervention
PPKAY (brief intervention) +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04535011
NCT04535011N/ACompleted

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

Duke University·interventional·Posted Sep 1, 2020·Updated Apr 22, 2026

In Brief

A clinical study evaluating PPKAY (brief intervention), Standard Booster, and 1 other intervention for Alcohol Use Disorder and 2 related conditions. Completed, enrolled 674 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTanzania

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 1, 2020
Enrollment StartOct 12, 2020
Primary CompletionMay 30, 2025
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 5.8 years ago

Interventions

PPKAY (brief intervention)behavioral

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.

Standard Boosterbehavioral

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.

Personalized Boosterbehavioral

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.