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Completed

NCT Number: NCT04535011

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kilimanjaro Christian Medical Centre

Moshi, Kilimanjaro, Tanzania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 Booster

Behavioral

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 Booster

Behavioral

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.

Primary outcomes

  1. Change in number of binge drinking days (previous 4 weeks)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Secondary outcomes

  1. Change in frequency of alcohol use (previous 2 weeks)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

  2. Change in quantity of alcohol use (previous 2 weeks)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

  3. Change in alcohol-related harms measured by the Drinker Inventory of Consequences (DrInC)

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

    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.

  4. Change in alcohol use disorder

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

    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.

  5. Change in depression

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

    Depression measured with Patient Health Questionnaire 9 (PHQ-9)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Kilimanjaro Christian Medical Centre, Tanzania
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: PRACT

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2020
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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