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

NCT02828267 | Completed Results

• 2 other identifiers: Pro00062061K01TW010000
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 (5-30 minute) counseling session administered by non-addiction specialists based on the concepts of the FRAMES model of motivational interviewing. Text based boosters have been proposed to prolong the impact of this intervention, either with a standardized or personalized content. 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 pragmatic randomized adaptive controlled trial of the intervention for patients seen at the Kilimanjaro Christian Medical Center (KCMC) Emergency Department.(ED)

Conditions

Alcohol Use

Keywords

Tanzania; Alcohol Use; Brief Intervention

Outcome Measures

Primary Outcomes (2)

• Enrollment Rate

  The average number of participants enrolled per week over the course of the study.

  over the course of the study, approximately 8 months

• Drinker Inventory of Consequences (DrInC) Score

  The DrInC is a self-administered 50-item questionnaire designed to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Scales are combined to assess total adverse consequences, with higher scores indicating more adverse consequences. This is a mean and standard deviation of the number of consequences suffered by participants since enrollment. The total DrInC score is reported where is 0 (no consequences) to 50 (every consequence experienced).

  6 weeks, 3 months, 6 months

Secondary Outcomes (2)

• Retention Rates

  6 weeks, 3 months, 6 months

• Alcohol Use Disorder Identification Test (AUDIT) Score

  6 weeks, 3 months, 6 months

Study Arms (4)

Usual Care

NO INTERVENTION

In the Usual Care arm, patients will have standard discharge information and instructions without any further health or wellness instruction

BNI

EXPERIMENTAL

In the BNI arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions.

Behavioral: Brief Negotiational Intervention

BNI plus standard booster

ACTIVE COMPARATOR

In the BNI plus standard booster arm, patients will receive the 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a test focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. The messages will be standard messages for all those in this arm.

Behavioral: Brief Negotiational Intervention; Behavioral: Standard Booster

BNI plus personalized booster

ACTIVE COMPARATOR

In the BNI plus personalized booster arm, patients will receive a 5-30 minute brief negotiational intervention about their alcohol use as well as the standard discharge information and instructions. Then after discharge patients will receive a text focused on reducing alcohol use to a SMS capable cell phone weekly for a total of 6 months of follow up. In the personalized arm, the text sent will be personalized based on information obtained about the patient's reasons for reducing their drinking found in the BNI.

Behavioral: Brief Negotiational Intervention; Behavioral: Personalized Booster

Interventions

Brief Negotiational Intervention BEHAVIORAL

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.

BNI; BNI plus personalized booster; BNI plus standard booster

Standard Booster BEHAVIORAL

This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use.

BNI plus standard booster

Personalized Booster BEHAVIORAL

This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use. Information in this text will be personalized based on the participants specific reasons for reducing their alcohol use rather than a standard text content.

BNI plus personalized booster

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• Duke University: lead
• Kilimanjaro Christian Medical Centre, Tanzania: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Kilimanjaro Christian Medical Center

Moshi, Tanzania

Location

Related Publications (2)

• Staton CA, Agnihotri D, Phillips AJ, Ngowi K, Huo L, Boshe J, Sakita F, Tupetz A, Suffoletto B, Mmbaga BT, Vissoci JRN. Development of culturally-appropriate text message booster content to follow a brief intervention focused on reducing alcohol related harms for injury patients in Moshi, Tanzania. PLOS Glob Public Health. 2024 Jul 25;4(7):e0002717. doi: 10.1371/journal.pgph.0002717. eCollection 2024.

  PMID: 39052647 DERIVED

• Staton CA, Friedman K, Phillips AJ, Minnig MC, Sakita FM, Ngowi KM, Suffoletto B, Hirshon JM, Swahn M, Mmbaga BT, Vissoci JRN. Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania. PLoS One. 2023 Aug 3;18(8):e0288458. doi: 10.1371/journal.pone.0288458. eCollection 2023.

  PMID: 37535693 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Results Point of Contact

• Title: Catherine Staton
• Organization: Duke University Medical Center

catherine.staton@duke.edu

9196845537

Study Officials

• Catherine A. Staton, MD, MSc

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcome assessors are not privy as to which arm patients were randomized to. Participants obviously are aware if they participate in a discussion and receive texts.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an feasiblity trial of a three stage adaptive clinical trial. Stage one has three arms (UC, BNI, BNI+ Standard booster). Stage two drops usual care arm. Stage three continues the strongest arm for phase two (which was choosen as BNI + Standard Booster for this feasiblity trial not powered to determine efficacy) and a new arm BNI + Personalized Booster.

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 11, 2016
• Study Start: July 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 11, 2021
• Results First Posted: August 11, 2021

Record last verified: 2021-07

Locations

TA (1)