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

Last updated: January 23, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Alcohol Use Disorder

Hyponatremia

Alcohol Dependence

Treatment

Standard Booster

PPKAY (brief intervention)

Personalized Booster

Clinical Study ID

NCT04535011
Pro00103724
R01AA027512
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ≥8on the AUDIT, 3) test positive (>0.0 g/dL) by alcohol breathalyzer.

Exclusion

Exclusion Criteria:

  • do not speak the native Swahili language

  • too ill or unable to communicate

  • prior enrollment in this study

  • decline informed consent.

Study Design

Total Participants: 864
Treatment Group(s): 3
Primary Treatment: Standard Booster
Phase:
Study Start date:
October 12, 2020
Estimated Completion Date:
May 01, 2025

Connect with a study center

  • Kilimanjaro Christian Medical Centre

    Moshi, Kilimanjaro
    Tanzania

    Active - Recruiting

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