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

NCT04535011 | Completed DMC

• 2 other identifiers: Pro00103724R01AA027512
• Study Type: interventional
• Target: 674
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Secondary Outcomes (5)

• 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)

  Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

• Change in alcohol use disorder

  Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

• Change in depression

  Baseline, 3 months, 6 months, 9 months, 12 months, 24 months

Study Arms (4)

Usual Care

NO INTERVENTION

No prevention or educational information verbally or written coinciding with current usual care

PPKAY

EXPERIMENTAL

One-time, 15-minute, nurse-led motivational interview discussing safe drinking behaviors, and negotiating change in alcohol use

Behavioral: PPKAY (brief intervention)

PPKAY with Standard Booster

EXPERIMENTAL

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); Behavioral: Standard Booster

PPKAY with Personalized Booster

EXPERIMENTAL

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); Behavioral: Personalized Booster

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.

PPKAY; PPKAY with Personalized Booster; PPKAY with Standard Booster

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.

PPKAY with Standard Booster

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.

PPKAY with Personalized Booster

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• do not speak the native Swahili language
• too ill or unable to communicate
• prior enrollment in this study
• decline informed consent.

Sponsors & Collaborators

• Duke University: lead
• Kilimanjaro Christian Medical Centre, Tanzania: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Kilimanjaro Christian Medical Centre

Moshi, Kilimanjaro, Tanzania

Location

Related Publications (3)

• Staton CA, Minja L, de Souza JVP, Gallis JA, Santos PCP, Buono M, Sakita F, Ngowi K, Boshe J, Phillips AJ, Vissoci JRN, Mmbaga BT. Effectiveness of a brief intervention and text-based booster in the emergency department to reduce harmful and hazardous alcohol use: A pragmatic randomized adaptive clinical trial in Moshi, Tanzania. PLoS Med. 2025 Oct 27;22(10):e1004548. doi: 10.1371/journal.pmed.1004548. eCollection 2025 Oct.

  PMID: 41144564 DERIVED

• Staton CA, Agnihotri D, Phillips AJ, Ngowi K, Huo L, Boshe J, Sakita F, Tupetz A, Suffoletto B, Mmbaga BT, Vissoci JRN. Development of culturally-appropriate text message booster content to follow a brief intervention focused on reducing alcohol related harms for injury patients in Moshi, Tanzania. PLOS Glob Public Health. 2024 Jul 25;4(7):e0002717. doi: 10.1371/journal.pgph.0002717. eCollection 2024.

  PMID: 39052647 DERIVED

• 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.

  PMID: 35123566 DERIVED

MeSH Terms

Conditions

Alcoholism; Wounds and Injuries

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Catherine A Staton, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study Phase 1: The investigators will evaluate whether PPKAY with personalized text booster or PPKAY with standard text booster will reduce the quantity or frequency of alcohol use, the number of binge drinking events or the number of alcohol-related consequences based on the Drinker Inventory of Consequences (DrInC) compared to usual care. Study Phase 2: The investigators will evaluate whether PPKAY alone is an inferior supplement to PPKAY plus standard or personalized text booster

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: October 12, 2020
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)