Clinical trial NCT04535011: PRACT to Investigate Controlling Alcohol Related Harms in a Low-Income Setting; Emergency Department BIs in Tanzania
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Injury Traumatic
Trauma
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Kilimanjaro Christian Medical Centre, Tanzania
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-09-01
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in number of binge drinking days (previous 4 weeks)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Secondary outcomes:
measure: Change in frequency of alcohol use (previous 2 weeks)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
measure: Change in quantity of alcohol use (previous 2 weeks)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
measure: Change in alcohol-related harms measured by the Drinker Inventory of Consequences (DrInC)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
measure: Change in alcohol use disorder
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
measure: Change in depression
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 24 months
Other outcomes:
Locations:
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre
state: Kilimanjaro
Study officials:
affiliation: Duke University
name: Catherine A Staton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.