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

Alcohol Use Disorder Clinical Trial

— PRACT  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04535011
• Other study ID #: Pro00103724
• Secondary ID: R01AA027512
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: May 1, 2025

Study information

• Verified date: December 2023
• Source: Duke University
• Contact: Blandina T Mmbaga, MD
• Phone: +255272754201
• Email: b.mmbaga[@]kcri.ac.tz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 864
• Est. completion date: May 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Emergencies
• Injury Traumatic
• Trauma
• Wounds and Injuries

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Tanzania	Kilimanjaro Christian Medical Centre	Moshi	Kilimanjaro

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Kilimanjaro Christian Medical Centre, Tanzania, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of binge drinking days (previous 4 weeks)		Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Secondary	Change in frequency of alcohol use (previous 2 weeks)		Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Secondary	Change in quantity of alcohol use (previous 2 weeks)		Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Secondary	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
Secondary	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
Secondary	Change in depression	Depression measured with Patient Health Questionnaire 9 (PHQ-9)	Baseline, 3 months, 6 months, 9 months, 12 months, 24 months