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

Catherine A Staton, Siddhesh Zadey, Paige O'Leary, Ashley Phillips, Linda Minja, Monica H Swahn, Jon Mark Hirshon, Judith Boshe, Francis Sakita, Joao Ricardo Nickenig Vissoci, Blandina T Mmbaga, Catherine A Staton, Siddhesh Zadey, Paige O'Leary, Ashley Phillips, Linda Minja, Monica H Swahn, Jon Mark Hirshon, Judith Boshe, Francis Sakita, Joao Ricardo Nickenig Vissoci, Blandina T Mmbaga

Abstract

Background: Alcohol use in resource-limited settings results in significant morbidity and mortality. These settings lack the necessary specialty-trained personnel and infrastructure. Therefore, implementing evidence-based interventions from high-income settings, like a brief negotiational intervention (BNI) for alcohol, will require rapid production of evidence of effectiveness to guide implementation priorities. Thus, this study describes a clinical trial protocol to rapidly optimize and evaluate the impact of a culturally adapted BNI to reduce alcohol-related harms and alcohol consumption among injury patients.

Methods: Our pragmatic, adaptive, randomized controlled trial (PRACT) is designed to determine the most effective intervention approach to reduce hazardous alcohol use among adult (≥18 years old) in acute (< 24 h) injury patients. Our culturally adapted, nurse-delivered, intervention (PPKAY) has been augmented with evidence-based, culturally appropriate standards and will be evaluated as follows. Stage 1 of the trial will determine if PPKAY, either with a standard short-message-service (SMS) booster or with a personalized SMS booster is more effective than usual care (UC). While optimizing statistical efficiency, Stage 2 drops the UC arm to compare the PPKAY with a standard SMS booster to PPKAY with a personalized SMS booster. Finally, in Stage 3, the more effective arm in Stage 2 is compared to PPKAY without an SMS booster. The study population is acute injury patients who present to Kilimanjaro Christian Medical Centre, Tanzania, who (1) test alcohol positive by breathalyzer upon arrival; (2) have an Alcohol Use Disorder Identification Test of 8 or above; and/or (3) have reported drinking alcohol prior to their injury. Outcome measures will be evaluated for all arms at 3, 6, 9, 12, and 24 months. The primary outcome for the study is the reduction of the number of binge drinking days in the 4 weeks prior to follow-up. Secondary outcomes include alcohol-related consequences, measured by the Drinker Inventory of Consequences.

Discussion: The findings from this study will be critically important to identify alcohol harm reduction strategies where alcohol research and interventions are scarce. Our innovative and adaptive trial design can transform behavior change research and identify the most effective nurse-driven intervention to be targeted for integration into standard care.

Trial registration: ClinicalTrials.gov NCT04535011 . Registered on September 1, 2020.

Keywords: Alcohol drinking; Binge drinking; Harm reduction; Low-income populations; Pragmatic clinical trial; Randomized controlled trial; Wounds and injuries.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Diagram of the PRACT study design with trial conditions
Fig. 2
Fig. 2
Scenarios of potential adaptations to the PRACT

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