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

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

Study Overview

• Status: Recruiting
• Conditions: Trauma; Alcohol Use Disorder; Injury Traumatic
• Intervention / Treatment: Behavioral: PPKAY (brief intervention); Behavioral: Standard Booster; Behavioral: Personalized Booster

• Study Type: Interventional
• Enrollment (Estimated): 864
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Blandina T Mmbaga, MD; Phone Number: +255272754201; Email: b.mmbaga@kcri.ac.tz
• Study Contact Backup: Name: Catherine A Staton, MD; Phone Number: 919-681-2981; Email: catherine.staton@duke.edu

Study Locations

• Tanzania
  • Kilimanjaro
    • Moshi, Kilimanjaro, Tanzania
      • Recruiting
      • Kilimanjaro Christian Medical Centre
      • Contact: Blandina T Mmbaga, MD; Email: b.mmbaga@kcri.ac.tz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; No prevention or educational information verbally or written coinciding with current usual care
Experimental: PPKAY; One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use	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.
Experimental: PPKAY with Standard Booster; 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")	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.
Experimental: PPKAY with Personalized Booster; 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].")	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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in number of binge drinking days (previous 4 weeks)	Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency of alcohol use (previous 2 weeks)		Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Change in quantity of alcohol use (previous 2 weeks)		Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Change in alcohol-related harms measured by the Drinker Inventory of Consequences (DrInC)	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.	Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Change in alcohol use disorder	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.	Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Change in depression	Depression measured with Patient Health Questionnaire 9 (PHQ-9)	Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Kilimanjaro Christian Medical Centre, Tanzania
• Investigators: Principal Investigator: Catherine A Staton, MD, Duke University

Publications and helpful links

General Publications

• Staton CA, Zadey S, O'Leary P, Phillips A, Minja L, Swahn MH, Hirshon JM, Boshe J, Sakita F, Vissoci JRN, Mmbaga BT. PRACT: a pragmatic randomized adaptive clinical trial protocol to investigate a culturally adapted brief negotiational intervention for alcohol use in the emergency department in Tanzania. Trials. 2022 Feb 5;23(1):120. doi: 10.1186/s13063-022-06060-y.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Substance-Related Disorders; Disease Attributes; Alcoholism; Emergencies; Wounds and Injuries
• Other Study ID Numbers: Pro00103724; R01AA027512 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No