PRACT to Investigate Controlling Alcohol Related Harms in a Low-Income Setting; Emergency Department BIs in Tanzania
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Change in number of binge drinking days (previous 4 weeks) [Baseline, 3 months, 6 months, 9 months, 12 months, 24 months]
Secondary Outcome Measures
- 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]
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.
- Change in alcohol use disorder [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.
- Change in depression [Baseline, 3 months, 6 months, 9 months, 12 months, 24 months]
Depression measured with Patient Health Questionnaire 9 (PHQ-9)
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kilimanjaro Christian Medical Centre | Moshi | Kilimanjaro | Tanzania |
Sponsors and Collaborators
- Duke University
- Kilimanjaro Christian Medical Centre, Tanzania
Investigators
- Principal Investigator: Catherine A Staton, MD, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00103724
- R01AA027512