Evaluating a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania (BNI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02828267
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : August 1, 2018
Kilimanjaro Christian Medical Centre, Tanzania
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Duke University

Brief Summary:
A brief negotiational interview (BNI), administered in an Emergency Department setting for both hazardous and harmful drinkers has been shown to cost-effectively reduce a patient's alcohol intake and re-injury rate up to 3 years post intervention. A BNI is a short (5-60 minute) counseling session administered by non-addiction specialists based on the concepts of the FRAMES model of motivational interviewing. The investigators will conduct a pilot study to test the feasibility of the study protocols, acceptance of the intervention, and patient enrollment and retention rates, as we prepare for a fully powered randomized controlled trial of the intervention for patients seen at the Kilimanjaro Christian Medical Center (KCMC) Emergency Department.(ED)

Condition or disease Intervention/treatment Phase
Alcohol Use Behavioral: Brief Negotiational Intervention Not Applicable

Detailed Description:

Research Design: This will be a pilot randomized feasibility and acceptability trial.

Participants and Recruitment: The investigators will prospectively enroll (n=60, 30 intervention, 30 control) patients who present to the KCMC ED for care of acute injuries and meet inclusion and exclusion criteria.Trained research nurses will describe the intervention as a health assessment, and eligible interested participants will be enrolled, provide informed consent and a randomization packet chosen. The research nurses will then administer patient demographic, injury, alcohol use surveys and the intervention if appropriate all lasting less than 45 minutes.

Follow-up Procedures: Both groups will provide two phone numbers where participants can be reached in order to facilitate follow-up. All participants will be contacted at 30, 60, and 120 days for follow-up survey administration. Surveys are expected to be less than 20 minutes. All patients will be contacted by text message at the conclusion of the study to inform them about availability of the results of the study.

Feasibility Trial Outcomes: The investigators will conduct a feasibility assessment subjectively through self-assessments as well as objectively through Event Analyses, understanding causes of deviations from protocol, Intervention Observations and Questionnaires.

Study Procedures: To evaluate the study procedures, the investigators will evaluate any protocol deviation events, and compare length of survey times. The investigators will also perform assessments of intervention fidelity through real-time observations of BNI administration using the BNI Assessment Scale.

Intervention and Trial Acceptability: The investigators will assess acceptability of participation in the trial and intervention through questions administered after the final follow-up time point for both the research team as well as participants. This will include assessment about the length of surveys, and method and quantity of follow-up.

Enrollment and Retention: The primary outcome measure will be recruitment and retention rates, anticipated at 30% and 80%, respectively. Secondarily, the investigators will qualitatively assess the inclusion and exclusion criteria, reasons for non-enrollment or non-retention, to the extent possible. Finally, the investigators will administer follow-up questions about compensation procedures in order to improve enrollment or retention.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Developing a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
No Intervention: Usual Care
In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction
Experimental: BNI
In the BNI arm, patients will receive a 5-10 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions.
Behavioral: Brief Negotiational Intervention
This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.

Primary Outcome Measures :
  1. Recruitment Rates [ Time Frame: 4 months ]
    The primary outcome will be delineating the recruitment rates estimated at 30%. This outcome will inform the fully powered randomized controlled trial

Secondary Outcome Measures :
  1. Retention Rates [ Time Frame: 30 day follow up ]
  2. Retention Rates [ Time Frame: 60 day follow up ]
  3. Retention Rates [ Time Frame: 120 day follow up ]
  4. Change in retention rates [ Time Frame: baseline, 4 months ]
  5. Acceptability of participation in trial and intervention as measured by questionnaire [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >18 years of age
  • be clinically sober at the time of enrollment
  • have capacity to give informed consent
  • converse in the local language Swahili or in English
  • have either:

    • reported ingesting alcohol in the 6 hours prior to injury,
    • have a positive breathalyzer test, or
    • have an Alcohol Use Disorder Identification Test with a score of ≥8.

Exclusion Criteria:

  • <18 years of age
  • being clinically intoxicated
  • being injured so severely that participants do not have the capacity to give informed consent
  • not able to converse in Swahili or English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02828267

Contact: Catherine A. Staton, MD, MSc +1 (919) 681-0196

Kilimanjaro Christian Medical Center Recruiting
Moshi, Tanzania
Contact: Catherine S. Staton, MD   
Contact: Blandina Mmbaga, MD   
Sponsors and Collaborators
Duke University
Kilimanjaro Christian Medical Centre, Tanzania
John E. Fogarty International Center (FIC)
Principal Investigator: Catherine A. Staton, MD, MSc Duke University

Responsible Party: Duke University Identifier: NCT02828267     History of Changes
Other Study ID Numbers: Pro00062061
K01TW010000 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
Alcohol Use
Brief Intervention

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs