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PA 12-5-2799 A practical trial: a pragmatic randomized adaptive clinical trial investigating controlling alcohol use and related harms in a low-income setting
  1. Catherine A Staton1,
  2. Joao Ricardo Nickenig Vissoci1,
  3. Monica Swahn2,
  4. Jon Mark Hirshon3,
  5. John Bartlett1,
  6. Blandina Mmbaga4
  1. 1Duke University, Durham, NC, USA
  2. 2Georgia State University, Atlanta, GA, USA
  3. 3University of Maryland, Baltimore, MD, USA
  4. 4Kilimanjaro Clinical Research Institute, Moshi, Tanzania


Alcohol abuse treatment in low resourced settings lacks trained personnel and infrastructure. Implementing evidence based interventions, like a Brief Intervention (BI) administered to Emergency Department injury patients, will require adaptation to the setting, population and culture. This study aims to rapidly optimize and evaluate the impact of a BI to control alcohol use and related harms.

Our single-blinded pragmatic adaptive randomized controlled trial is designed to determine the most effective BI to reduce hazardous alcohol use among acute injury patients. Phase 1 of this ‘seamless Phase 1/Phase 2’ adaptive trial will determine if a BI with or without SMS booster is more effective than usual care. With statistical efficiency, Phase 2 will compare if a BI is more effective with or without SMS booster. Finally, Phase 3, will compare the more effective arm in Phase 2 to a new BI arm with personalized SMS booster. The study will occur among acute injury patients presenting to Kilimanjaro Christian Medical Center referral hospital in Northern Tanzania who 1) are alcohol breathalyzer positive on arrival to the hospital, 2) have an Alcohol Use Disorder Identification Test of 8 or above or 3) have reported drinking alcohol prior to suffering their injury. The intervention consists of a nurse-administered brief motivational interviewing session with or without a standard or personalized SMS booster; the control group will be a no-contact group until the time of follow-up. The primary outcome for the study is reduction of alcohol-related consequences by the Drinker Inventory of Consequences; the secondary outcome for the study is mean weekly consumption and number of binge drinking events.

Findings Will be important for all low resource settings. Through this trial, we will identify the most effective nurse-driven intervention which can be integrated into the standard of care nationally.

Trial registration NCT02828267

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