Developing a Brief Negotiational Intervention for Alcohol Use Among Injury Patients in Tanzania
Phase: NA
Conditions: Alcohol Use
Sponsor: Duke University

 
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NCT02828267 
 
Developing a Brief Negotiational Intervention for Alcohol in Tanzania 
 
 
 
US Principal Investigator: 
Catherine A. Staton, MD MScGH 
Assistant Professor of Surgery 
Division of Emergency Medicine 
Duke Global Health Institute 
catherine.Staton@duke.edu 
US cell (908) 872-9208 
 
Tanzanian Principal Investigator 
Blandina Mmbaga 
Director, KCMC/Duke Collaboration 
Kilimanjaro Christian Medical Center 
blaymt@gmail.com 
 
Other Investigators 
Mark Mvungi, MD 
Director, Casualty Department 
Kilimanjaro Christian Medical Center 
Something like an email address 
 
 
 
 
 
 
 
 

 
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Table of Contents 
Title Page ................................................................................................................... Error! Bookmark not defined. 
Abstract: ....................................................................................................................................................................... 3 
Abbreviations: .............................................................................................................................................................. 3 
Introduction: ................................................................................................................................................................. 4 
Literature Review: ....................................................................................................................................................... 5 
Injuries .................................................................................................................................................................. 5 
Alcohol .................................................................................................................................................................. 5 
Brief Negotiational Intervention ......................................................................................................................... 5 
Statement of the Problem: ......................................................................................................................................... 6 
Rationale: ..................................................................................................................................................................... 7 
Broad Objectives: ........................................................................................................................................................ 7 
Specific Objectives: .................................................................................................................................................... 7 
Methods: ....................................................................................................................................................................... 7 
Aim 1: Identify patients, families, healthcare providers’ and the public’s current perspectives on alcohol 
use. ........................................................................................................................................................................... 8 
Study Design: ...................................................................................................................................................... 8 
Study Population: .............................................................................................................................................. 10 
Inclusion/ Exclusion Criteria: ........................................................................................................................... 10 
Sample Size Calculation: ................................................................................................................................. 11 
Data Collection: ................................................................................................................................................. 11 
Data Analysis: .................................................................................................................................................... 11 
Aim 2: Develop a culturally- and linguistically-appropriate, nurse-delivered BNI; validate measures to 
test its effectiveness ............................................................................................................................................. 12 
Summary: ........................................................................................................................................................... 12 
Validation of Alcohol Outcome Scales: .......................................................................................................... 14 
Aim 3: Conduct a pilot trial of the intervention. ................................................................................................. 15 
Introduction and Rationale: .............................................................................................................................. 15 
Research Design: ............................................................................................................................................. 15 
Participants and Recruitment: ......................................................................................................................... 15 
Follow up Procedures:...................................................................................................................................... 16 
Feasibility Trial Outcomes ............................................................................................................................... 16 
Sample Size ....................................................................................................................................................... 17 
References: ................................................................................................................................................................ 20 
 

 
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Abstract: 
Annually, there are 1.8 million global deaths due to alcohol. 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 safe alcohol use behavior. Like many other limited 
resource settings, there are few treatment facilities or addiction practitioners in the Kilimanjaro 
region of Tanzania. This project allow for the cultural adaptation, validation, and pilot testing of a 
brief negotiational interview for alcohol use. To do so, the project will 1) describe the current 
knowledge and perceptions about alcohol use in Tanzania, 2) adapt an evidence-based 
intervention to the Tanzanian setting and, 3) pilot this intervention in preparation for a large-
scale trial. The intervention, a brief negotiational interview, based on a motivational interviewing 
framework, has proven effective in the US but has not been adapted or implemented in an 
African context.  
 
Abbreviations: 
BNI brief negotiational interview 
CAB Community Advisory Board  
DALY disability-adjusted life-years  
LMIC low and middle income countries 
SBI screening and brief intervention  
WHO WMH-CIDI World Health Organization World Mental Health Composite International 
Diagnostic Interview.  
 
aaPDD alcohol adapted Perceived Devaluation Scale 
 

 
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Introduction: 
Violence and injuries are a global health crisis.  Almost 6 million people die annually from, or 
related to their injuries.1 Over 90% of unintentional injuries and 90% of disability-adjusted life-
years (DALYs) lost occur in low and middle income countries (LMIC).1, In most countries around 
the world, a large proportion of adults consume alcohol. Globally, alcohol causes 3.2% of all 
deaths or 1.8 million deaths annually and accounts for 4.0% of the disease burden.2  Many of 
these deaths are the result of injuries caused by hazardous and harmful drinking.2  Substance 
use has been shown to not only increase injury risk and severity but also to worsen outcome.3-14 
Just as injury disproportionally affects LMIC, alcohol-related injuries are particularly concerning 
in LMIC where consumption rates are increasing, and public health infrastructure is not 
equipped to curb these injuries.2  
 
In high-income settings, secondary prevention initiatives such as a screening and brief 
intervention (SBI) administered by healthcare practitioners has been demonstrated in primary 
healthcare settings to reduce a patient’s alcohol intake for up to two years post-intervention and 
has been proven to be cost-effective.15 16 17  SBI have also been shown to be efficacious for 
patients who suffered alcohol related injuries in the acute setting, leading to a decrease in 
overall post injury alcohol use at one year post injury as well as a 48% reduction in injury 
recurrence rate within 3 years post injury.18 While SBI has not been validated in LMIC, 
understanding current practitioner knowledge, attitudes and practices on alcohol use disorders, 
and alcohol related injuries will assist in developing a culturally appropriate and resource 
feasible SBI. 
 

 
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Literature Review: 
 
Injuries 
Violence and injuries are a global health crisis.  Almost 6 million people die annually from, or 
related to their injuries.1  Overall, injuries account for about 10% of the world’s deaths.1 While 
injuries affect all age groups, they have a particular impact on young people especially those 
between 5 and 44 years of age.1 Road traffic injuries are one of the top three causes of death 
for people between 5 and 44 years of age.1 Injuries are not only a leading cause of mortality but 
also morbidity. In addition to the 6 million people who die annually, there are approximately 650 
million people worldwide who are living with disabilities due to injury which accounted for about 
138 million disability-adjusted life-years (DALYs) lost in 2004 alone.1,19 Over 90% of 
unintentional injuries and 90% of DALYs occur in low and middle income countries (LMIC).1,19 
The highest burden of injury mortality and morbidity occurs in LMIC and coincides with the 
greatest challenges providing care, the weakest evidence base to guide interventions, and the 
fewest resources and infrastructure to institute effective change. 
 
Alcohol  
In most countries around the world, a large proportion of adults consume alcohol. Alcohol is 
associated with adverse consequences for the drinker and society at large.  Globally, alcohol 
causes 3.2% of all deaths or 1.8 million deaths annually and accounts for 4.0% of the disease 
burden.2  Many of these deaths are the result of injuries caused by hazardous and harmful 
drinking.2  Of the total number of alcohol attributable deaths, 32% are from unintentional injuries 
and 13.7% are from intentional injuries.2  Overall, half of all deaths attributable to alcohol are 
due to injuries.  Some studies have estimated the proportion of injuries with alcohol involvement 
between 6% and 45% depending on the country.2 Substance use has been shown to not only 
increase injury risk and severity but also to worsen outcome.3-14 Just as injury disproportionally 
affects LMIC, alcohol-related injuries are particularly concerning in LMIC where consumption 
rates are increasing, and public health infrastructure is not equipped to curb these injuries.2 
Collection of accurate data on alcohol and injuries at hospitals is vital to understanding both the 
scope and nature of the problem specifically in Tanzania.  
 
Brief Negotiational Intervention. 
Since patients in Emergency Departments seeking care for alcohol related injuries have been 
shown to have continued alcohol use, increased impaired driving and an increased mortality 

 
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rate20, they are those that should receive an intervention to reduce their harmful alcohol use. A 
brief negotiational intervention (BNI) administered in an Emergency Department (ED) setting  
has been shown to cost-effectively reduce a patient’s alcohol intake for up to two years post-
intervention.15-17,21,22 A BNI are short, 5-60 minutes counseling sessions administered by non- 
addiction specialists based on the concepts of motivational interviewing.21 The FRAMES model 
for motivational interviewing (Table 1) 
 is a well-accepted framework whereby a 
provider and patient discuss alcohol use in 
a non-judgmental manner, where the 
patient establishes goals of alcohol 
reduction after accepting responsibility for 
his/her actions.23 BNIs are successful due to 
their non-judgmental, informative motivational nature infused with both information about alcohol 
use consequences and self-determined goals of substance use reduction that increase self-
efficacy. The 1990 landmark Institute of Medicine report recommended brief interventions based 
on a motivational interviewing framework aimed at mild to moderate alcohol use given the sheer 
strength of the literature supporting brief interventions.24 25 In the late 1990s, admitted United 
States trauma patients who received an alcohol BNI at discharge were shown to have a 
decrease in overall post injury alcohol use at one year post injury as well as a 48% reduction in 
injury recurrence rate within 3 years post injury.18 Hospital EDs are able to offer large 
populations of high-risk alcohol use populations who would be amenable to behavior 
modification intervention following an acute traumatic injury.2,26,27 28 
 
There have been no large-scale controlled studies in sub-saharan Africa evaluating the 
effectiveness of a BNI for alcohol. Given Sub-Saharan African patients have limited care-
seeking behaviors and limited harmful alcohol use treatment options with a growing burden of 
alcohol, the unique opportunity to screen and intervene upon high proportions of high-risk 
alcohol behavior patients during a “teachable moment” in the ED in Tanzania, warrants an 
evaluation of an alcohol BNI effectiveness.  
 
Statement of the Problem: 
 
Currently, we know that the injury patients who present to the KCMC Casualty Department have 
a high prevalence of harmful and hazardous drinking behaviors which might be amenable to 
intervention. While we have an intervention that has shown to be effective in high income 
FRAMES Model 
Feedback 
Give feedback on the risks and negative consequences of 
substance use. 
Seek the client's reaction and listen 
Responsibility 
Emphasize the individual’s responsibility for making his/ 
her own decision about his/her alcohol use 
Advice 
Give straightforward advice on modifying alcohol use 
Menu of 
options 
Give menu of options to choose from, fostering the client's 
involvement in decision-making 
Empathy 
Be empathetic, respectful and non-judgmental. 
Self-Efficacy 
Express optimism about his/her ability to modify his/her 
substance abuse.  
Table 1: FRAMES Model 

 
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settings, we have not had an intervention which is translated and validated for the Tanzanian 
environment to address high risk alcohol use.  
 
Rationale: 
Given this need and potential intervention, this project will gather information in order to define 
the stigma, customs and cultures around alcohol use and will prepare and test an intervention 
for alcohol use in Tanzania.  
 
Broad Objectives: 
Broad Objective 1: Describe the current perspectives on alcohol use 
Broad Objectives 2: Develop a culturally appropriate intervention for alcohol use.  
Broad Objectives 3: Conduct a pilot trial of the intervention. 
 
Specific Objectives: 
Specific Objective 1: Define patient’s current perspectives on alcohol use. 
Specific Objective 2: Define families’ and the public’s current perspectives on alcohol use. 
Specific Objective 3: Define healthcare providers’ current perspectives on alcohol use.  
Specific Objective 4: Translate, and iteratively improve a culturally-appropriate nurse-delivered 
brief negotiational interview (BNI) utilizing motivational interviewing, to be delivered in the 
KCMC Emergency Department.  
Specific Objective 5: Validate measures which will be utilized to evaluate the intervention. 
Specific Objective 6: Conduct a pilot trial of the intervention in order to validate study 
procedures. 
Specific Objective 7: Conduct a pilot trial in order to evaluate the intervention acceptability. 
Specific Objective 8: Conduct a pilot trial in order to evaluate the enrollment and retention rates.  
 
Methods: 
 
Setting: Moshi, a city in the Kilimanjaro region of Northern Tanzania with a population of 
143,799, is home to Kilimanjaro Christian Medical Center (KCMC), the third largest hospital in 
the country and the referral hospital for northwestern Tanzania.7 KCMC is a regional training 
center for all types of healthcare workers and supports research as an integral part of its 
charter. Over the last 17 years, Duke and KCMC have developed a research infrastructure with 
proven success in NIH funded grants. Our current data from the KCMC Casualty (Emergency) 

 
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Department suggests that 28% of all the patients who arrive to the Casualty Department for 
treatment of an injury consumed alcohol prior to their injury and therefore are ‘Hazardous 
drinkers’ who would be amenable to the proposed intervention 29. 
 
Research Team: The research team who will conduct Aim1-3 is planned to be our current 
research team in Tanzania who have experience with research ethics, informed consent, data 
collection, data integrity, patient safety, focus groups and good clinical practices. All data 
collection nurses and data management personnel will have both their updated CITI 
certification, good clinical practices training updated as well as be trained in the protocol prior to 
any data collection. Study procedures and piloting of all questionnaires and study documents 
will take place prior to formal use of the documents.  
 
Aim 1: Identify patients, families, healthcare providers’ and the public’s current 
perspectives on alcohol use. 
Study Design: We will conduct short surveys for KCMC ED patients, families and healthcare 
practitioners as well as focus groups for KCMC ED patients, families and community members 
to determine the 1) current perspectives of alcohol use including stigma associated with alcohol 
use, 2) harmful alcohol use behaviors and 3) barriers to intervention effectiveness. 
 
Focus Group Methodology: Focus groups will be held in Swahili with patients or family 
members of patients of KCMC ED, as well as the KCMC Community Advisory Board (CAB) to 
better understand their perspective on: availability of alcohol, stigma associated with alcohol 
use or reporting behavior, alcohol-related consequences, and any cultural barriers or 
culturally relevant solutions for a successful intervention. Patients (or family members) will be 
identified in the KCMC ED waiting or treatment areas, after treatment or stabilization, and will be 
offered participation in the focus group. The focus groups will occur in a small quiet room near 
to the Casualty Department where patients or family members can freely discuss their thoughts 
and opinions. No members of the treatment team will be in the room and patients will be in 
different focus groups from their family members so that they can talk more freely about their 
thoughts on alcohol. We will attend a monthly CAB meeting after giving prior knowledge about 
the research activity in order to utilize this groups experience with research as well as their 
perspective as members of the public to conduct a focus group.  
 

 
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Focus Group Data Collection: Participants will take part in an informed consent process 
approved by the Duke and Tanzanian ethics committees before joining the focus group. Focus 
groups will be formed once 5-10 eligible interested participants are identified. Focus groups, led 
by trained research nurses, will be audiotaped and transcribed for formal qualitative analysis 
utilizing thematic analyses. For the CAB, we will announce our intention to conduct a focus 
group during their scheduled meeting. We will enroll participants after informed consent and will 
have about 40 members of the CAB available to share their experiences about alcohol.  
Transcriptions will occur within the days of the focus group and research nurse notes will be 
included in to these transcriptions about the content. We expect to host 8 focus groups or until 
saturation is reached. 
 
Focus Group Data Analysis: After transcription, each of the focus groups will be translated 
and the final transcript will be discussed by the research nurses present in the focus group for 
content validation. Then a thematic analysis will be undertaken for each of the above main 
questions from the focus groups. All data will be analyzed with NVivo 10.0. All transcripts, 
audiotapes and other study documents will be kept for 6 years following conclusion of the data 
the conclusion of the study. 
 
Survey Methodology: Based on prior and similar studies, we will conduct 3 separate cross-
sectional surveys to determine attitudes and perceptions of alcohol use: 1) for patients >18 
years of age who have suffered an injury; 2) for patients’ family members > 18 years of age; and 
3) for healthcare professionals who are currently working clinically in the KCMC Emergency 
Department.30 31 The surveys for patients will have a primary aim of determining at-risk and 
harmful alcohol use based on the AUDIT tool (See Appendix), an inclusion criterion for Aim 3. 
Additionally, the surveys for patients and families will determine knowledge of drinking norms 
and alcohol use consequences, perspectives on drinking and on reducing alcohol use, 
perception of availability of alcohol, age of first alcohol ingestion and current treatment 
options in the community for harmful alcohol use. A large portion of the survey will be adapted 
from the World Health Organization World Mental Health Composite International Diagnostic 
Interview. (WHO WMH-CIDI) Stigma associated with alcohol use will be determined with the 
alcohol adapted Perceived Devaluation Scale. (aaPDD) A validated tool for assessing alcohol 
related perceived stigma. Surveys for healthcare practitioners will also query their role and 
responsibility in diagnosing and treating harmful alcohol use behavior. The survey will 
include both short answer and open-ended questions to determine if there are more locally- 

 
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relevant perceptions about alcohol use or treatment/ rehabilitation amongst patients with 
harmful alcohol use. After informed consent, patients or family members will be administered 
the survey by trained bilingual research nurses verbally in the native language of Swahili in a 
quiet room near the KCMC ED. For healthcare practitioners, surveys will be self-administered in 
written format in the medical language, English at participants’ leisure.  
 
Study Population: We will enroll at least 323 patients, 226 patient family members and 45 
healthcare practitioners including nurses, advanced medical officers and physicians from the 
KCMC ED to participate in the surveys. Focus groups with patients or patient family members 
will have 5-10 participants per group, totaling 60 participants. All participants will be >18 years 
of age and be able to speak Swahili (patients or families) or English (healthcare practitioners). 
We will exclude patients with inability to respond to the survey due to the severity of their illness 
or injury. 
Inclusion/ Exclusion Criteria:  
Patients must be >17 years of age, be seeking care at KCMC for an acute (<6 hours) injury, be 
clinically sober at the time of enrollment, be medically stable, be able to communicate in Swahili 
or English and consent to participate. Patients will be excluded from enrollment if they are 
medically unstable or have a deteriorating condition, are too critically ill to participate, do not 
speak English or Swahili, are <18 years of age, are presenting for non-injury related complaints, 
are presenting or recheck or a second visit for their injury or are presenting after 6 hours after 
their injury, or do not consent to be enrolled.  
 
Family members must be a family member of a patient who is able to be enrolled in the study 
who also agrees to participate, speaks English or Swahili, and feels like he/she knows the 
patient well enough to give perspectives on his/her alcohol use. For CAB members, we will 
enroll all interested participants who are >17 years of age and are present at the CAB meeting 
when we conduct the focus group discussion.  
All ED Pt/wk 
Injury 
Patients/ 
wk,  
Potential 
Enrollment 
per week  
# weeks 
enrolling 
Potentially 
Enrolled 
Patients  
Injury Pts 1,2,3 
120 
49 
16 
778 
Family 
Members 1,2,3,4 
120 
34 
16 
544 

 
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Healthcare practitioners 
who work in the Casualty 
Department/Emergency 
Department at KCMC and 
have patient contact are 
eligible to be enrolled.  
 
Sample Size Calculation: For the injury patient surveys, sample size will be calculated to 
determine the proportion of harmful alcohol use based upon the AUDIT tool, (see Appendix) 
which will be an inclusion criterion for Aim 3. A sample size of 323 injury patients will allow us to 
estimate our anticipated AUDIT positive (>8) proportion of patients anticipated at 30% to within 
+/- 5% (95% confidence interval). However, given the patient volume, we likely will recruit 
additional patients. Surveys will be conducted for 16-24 weeks. Conservative estimates of 
patients who could be enrolled are seen in Table 4.  
For family member surveys, our goal is to get 1 family member per patient yet recognizing that 
approximately 30% of patients may have no accompanying family members. Thus, our sample 
of family members is estimated to be at least 226 family members. As for the healthcare 
practitioners, there are 50 professionals affiliated or connected to the emergency department, 
considering a 10% loss due to rotation or annual leave, our aim is to get at least 45 practitioners 
included in the survey. 
 
Data Collection: Surveys will be verbally administered to patients and families due to variable 
literacy rates. Surveys will be self-administered by healthcare providers in the standard medical 
language of English or Swahili. Focus groups will be conducted, once weekly until saturation, 
and will be audiotaped, transcribed, and translated. They will focus on the prevalence of 
harmful and hazardous alcohol use, the cultural acceptance of alcohol, moderators of 
alcohol use, and current perspectives on the feasibility and potential impact of a brief 
intervention.  
 
Data Analysis: Survey results will be analyzed through a range of descriptive and analytical 
techniques. Pertinent outcome variables are expected to be dichotomous. (e.g., hazardous 
drinking, care-seeking behavior, injury outcomes). Then, for all three surveys (patients, family 
and healthcare providers) basic descriptive associations of sociodemographic characteristics 
 
Total ED 
Personnel 
Anticipated 
Enrollment  
 
HealthCare 
Professionals 2 
50 
45 
45 
Community 
Advisory Board 
60 
40  
40 
Table 4: Potential Survey Enrollment: 150% during enrollment hours, 210% refusal, 310% 
Lost to Follow up, 470% with family member 

 
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and binary outcomes (when applicable) 
will be examined using chi-square tests, 
and logistic regression analyses. Our goal 
is to determine patterns of associations 
between sociodemographic variables, 
harmful alcohol use and related injury, and 
attitudes and practices towards alcohol 
use. Open-ended survey items and focus 
group data will be analyzed into response 
categories using nVivo. Latent Semantic 
Analysis and Sentiment Analysis will be used to investigate latent concepts or positive/negative 
tones behind the qualitative answers.  
 
Aim 2: Develop a culturally- and linguistically-appropriate, nurse-delivered BNI; validate 
measures to test its effectiveness  
Summary: We will adapt, translate, and validate a BNI based on its content, adherence to the 
FRAMES platform of motivational interviewing, and face validity. In preparation for our 
pragmatic BNI trial we will also validate the evaluation tools of BNI effectiveness (AUDIT, DrInC, 
IBC, in C5.3) in Swahili.  (See Figure 3) 
  
Creation/adaptation of the BNI:  
Translation: First, we will create the 
BNI script based on US guidelines 
then, translate and back-translate the 
BNI script. We will use experienced 
local translators with knowledge of the 
local language to ensure correct 
terminology. After individual 
translations, a group assessment of 
the translation will be performed by 
our research nurses and project 
coordinator to ensure comprehension 
and appropriate word selection. We 
will also conduct 2-4 focus groups with 
Outcome Scales 
Internationally 
Validation 
Tanzanian 
Validation 
Alcohol Use Disorder 
Identification Test 
(AUDIT) 
Yes 32,33 
No 
Drinker Inventory of 
Consequences 
No 
No 
Quantity/Frequency 
N/A 
N/A 
Injury Behavior Checklist 
No 
No 
Table 6: Outcome Scales 
FRAMES Model 
Feedback 
Give feedback on the risks and negative 
consequences of substance use. 
Seek the client's reaction and listen 
Responsibility 
Emphasize the individual’s responsibility for 
making his/ her own decision about his/her 
alcohol use 
Advice 
Give straightforward advice on modifying 
alcohol use 
Menu of options 
Give menu of options to choose from, 
fostering the client's involvement in decision-
making 
Empathy 
Be empathetic, respectful and non-
judgmental. 
Self-Efficacy 
Express optimism about his/her ability to 
modify his/her substance abuse.  
Table 5: FRAMES Model 

 
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5-10 healthcare professionals and community members each in order to choose the appropriate 
translation of key important terminology for the intervention. (‘alcohol’, ‘alcoholic’, ‘motivate’ etc) 
Similarly, we will seek their opinions on some specific intervention details and their ‘cultural 
translation.’ For instance, we will ask if data from Tanzania about current drinking behaviors and 
drinking levels which are associated with increased injury or complications will be more 
motivating to patients than international data.   
Content Validity: Next, consistency between the translations and content validity of the script will 
be verified; a panel of local healthcare practitioners will observe the intervention administered to 
a volunteer research nurse and will evaluate its content validity/coherence by 3 domains  
 (language, clarity, relevance/ importance). Suggestions for improvements will be sought from 
this panel with iterations of the BNI re-tested.  
Adherence to FRAMES: This panel will then evaluate the BNI script’s adherence to the 
FRAMES model for motivational interviewing in order to develop the final version of the script 
(Table 5, ie, did the script give the patient feedback, did it empower the patient to choose to 
reduce drinking?).  
Face Validity: Finally, after practicing and piloting the intervention on health practitioner 
volunteers, we will perform face validity testing and inter-rater agreement by having trained 
expert observers assess the intervention using the BNI Adherence Scale. 34 This scale has 
been used in other BNI assessment studies in order to gauge provider adherence to BNI 
protocol. Individual research nurse provider will receive feedback in order to improve BNI 
administration.  
Creation of a SMS based test-based booster for the BNI 
Step 1: We will create the SMS Content by compiling evidence from the literature about the 
specific theoretical framework for behavior change that we wish to utilize. We will use expert 
opinion, behavior change frameworks and any available examples of SMS-based alcohol 
related harm reduction strategies to create potential SMS content. 
Step 2: We will Translate/ Back translate and culturally adapt the SMS content. After the 
content is created in step 1, we will perform an independent translation and back translation as 
well as a consensus translation meeting in order to ensure language translation, cultural 
appropriateness and content validity. We will consult with local physicians, researchers or health 
care workers in order to provide support for the clarity, pertinence to the theoretical domain, 
cultural pertinence and rank their preference of SMS content.  

 
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Step 3: We will ensure cultural adaptation through a cognitive interview of with less than 30 
patients. Based on feedback from these interviews, SMS content will be further adapted before 
advancing to the next steps.  
Step 4: Next, we will Rank content importance and ability to affect behavior change. By 
enrolling 50 patients we will have patients provide feedback on the clarity, rank his/her preferred 
or optimal SMS content, and their perception of how much each statement would likely change 
his/her behavior.  
Step 5: Next, SMS Ranking will be performed so up to 50 injury patients will receive SMS 
content and will receive 2 questions per SMS text content requesting a response of a likert scale 
on how clear the overall texts are and how likely this SMS would change his/her behavior.  
 
 
Step 1 
Content Creation 
No enrollment 
Step 2 
Translation/Back Translation 
Translation Meeting 
Expert Opinion 
Research Team 
Research Team 
15 local experts 
Step 3 
Cultural adaptation 
Enroll 30 patients for a cognitive interview 
Step 4 
Rank Content 
Enroll 50 patients for a short survey 
Step 5  
SMS Ranking 
Enroll 50 patients for a SMS based survey 
 
 
 
Validation of Measures:  
Outcome Scales: The outcome measures to evaluate the BNI include Alcohol Use Disorder 
Identification Test (AUDIT, See Appendix)32 35, the Drinker Inventory of Consequences (DrInC)32 
36, drinking quantity and frequency data, and the Injury Behavior Checklist (IBC) as seen in 
Table 6.37 38 39,40 The AUDIT is a 10-item self-reported scale [range 0-40], a score of 8 or above 
has a 85% sensitivity and 89% specificity, measuring harmful or at-risk drinking.36,41 A score of 
at least 8,will be used to determine eligibility as scores of 8-15 are most appropriate to simple 
advice interventions.35 The DrInC is 45-item self-report questionnaire on negative 
consequences of drinking including physical, interpersonal, intrapersonal, social responsibility, 

 
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and impulse control (See Appendix).42 The Injury Behavior Checklist (IBC) adapted from the 
Adolescent Health Status Instrument, was revised for adults and allows patients to record the 
number of times they suffered any of 18 injuries in the past year.37 38 39 This combination of 
scales has been used in a prior RCT testing the effectiveness of a BNI on re-injury rates.40  
Validation of Scales: These measures have not been validated in a Swahili speaking KCMC 
patient population. Therefore we will perform validation and reliability testing. A sample of 300 
subjects from general population and patients will be selected for the validation process. This 
sample size is determined by the number of items to be validated in each instrument (ie, DrInC 
has 45 items), we opted to recruit the suggested 5-10 subjects per questionnaire item as 
suggested in the literature.43 Scales (AUDIT, DrInC, IBC) will be administered to 300 subjects 
from the general population and patients in order to assess their psychometric properties and 
assure adequate cross-cultural adaptation and validity. Given the 9 months for enrollment for 
this portion of project, we anticipate that these numbers can be easily obtained from visitors to 
the hospital grounds. We will evaluate internal validity (factor analysis, content, convergent and 
discriminant validity), external validity that is the ability of the test to evaluate what it is supposed 
to measure (concurrent validity) and reliability (internal consistency). Based on preliminary 
enrollment, and finding a few comprehension challenges in our validation phase, we will need to 
enroll more patients at 500 patients in order to ensure appropriate validation. 
 
Aim 3: Conduct a pilot trial of the intervention. Feasibility of 1) study procedures, 2) patient 
acceptability of the intervention and trial, and 3) patient enrollment/retention will be tested in a 
pilot RCT.  
Introduction and Rationale: To test the intervention’s effectiveness for at risk and harmful 
alcohol use reduction, an adequately powered pragmatic clinical trial with maximum external 
validity is the next step to evaluate this intervention.44  To prepare for this clinical trial, a  
feasibility trial should be conducted prior to a large scale trial, as the most essential pre-requisite 
of a trial enhancing the likelihood of success of a RCT.45   
Research Design: This will be a pilot 4, 8 block randomized feasibility and acceptability trial.  
Participants and Recruitment: We will prospectively enroll (n=75, across 4 arms) patients who 
present to the KCMC ED for care of acute injuries and meet inclusion and exclusion 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, and have either 1) reported 
ingesting alcohol in the 6 hours prior to injury, 2) have a positive breathalyzer test, or 3) have an 
Alcohol Use Disorder Identification Test with a score of ≥8. Our trained research nurses will 

 
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describe the intervention as a health assessment, and eligible interested participants will be 
enrolled, provide informed consent and a randomization packet chosen. They will then 
administer patient demographic, injury, alcohol use surveys and the intervention if appropriate 
all lasting less than 45 minutes.  
Figure 1: Pragmatic Randomized Adaprtive Clinical Trial Design 
 
 
Follow up Procedures: All groups will provide two phone numbers where they can be reached 
in order to facilitate follow up. All participants will be contacted at 6 weeks, 3 months, and 6-
months post-discharge 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: 
Study 
Procedures 
Protocol Deviation 
Event Analysis 
 
Intervention 
Fidelity: BNI 
Assessment 
Observations 
Survey 
Time 
Acceptability 
Questionnaires 
Recruitment & 
Retention 
Enrollment Rate 
Retention Rate 
Enrollment/Retention Failure 
Event Analysis 
Table 7: Feasibility Trial Outcomes 

 
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We 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, we will evaluate any protocol deviation 
events, and compare length of survey times. We will also perform assessments of intervention 
fidelity through real-time observations of BNI administration using the BNI Assessment Scale 
similar to the procedure in Aim 2.  
Intervention and Trial Acceptability: We will assess acceptability of participation in trial and 
intervention through questions after the final follow up timepoint for both the research team as 
well as participants. Assessment about the length of surveys, method of follow-up, number of 
follow-up calls,  
 
Enrollment and Retention: The primary outcome measure will be recruitment and retention 
rates. Secondarily, we will qualitatively assess the inclusion and exclusion criteria, reasons for 
non-enrollment or non-retention, to the extent possible. Finally, follow-up questions about 
remuneration procedures in order to improve enrollment or retention will be administered after 
enrollment or on the completion of follow up.  
 
Sample Size: In total, 75 participants will be recruited (randomized across 4 arms). This sample 
size is based on what is needed to evaluate study process fidelity, intervention acceptability, 
and recruitment and retention assessment. This sample size will allow us to estimate our 
desired minimal recruitment rate of 30% to within +/- 11% (95% confidence interval) and to 
estimate our desired retention rate of 80% within +/- 10%. Further, it is anticipated to provide 
sufficient opportunity to uncover significant acceptability concerns. We are not proposing an 
adequately powered study nor an effect size calculation as pilot studies may not accurately 
represent effect sizes of the main study. 46 
 
Ethical Considerations 
Subject Recruitment and Compensation  
For objective 1, all healthcare workers at KCMC Casualty Department will be offered enrollment 
in in the study.  The only cost to participants is the time spent performing the survey.  The 
participants will not be compensated for their time for this study.  For objective 2, a snowball 
method of sampling key informants will be utilized to recruit subjects for enrollment in the key 

 
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informant interview. Participants will not be compensated for their time spent completing the 
survey. 
 
Consent Process  
For patients and patients’ family members we will be utilizing a written informed consent.  
Participants will be provided with a description of the study objectives and procedures, along 
with information on data safety. Agreement to participate in the survey will serve as consent to 
participate in the study.  
Limitations of the study 
Limitations of the study should be taken into account when planning for the project. This project 
is a multi-step project planned to describe both the general atmosphere around drinking alcohol 
as well as the current culture and stigma in Tanzania. As this employs both qualitative and 
quantitative methods across a broad area, there could be some limitations to the depth of 
understanding of a portion of the culture of drinking in Tanzania. As we are not making this a 
representative sample of the whole region of Tanzania just for Moshi, the generalizability of the 
qualitative data is limited and a repeat study should be performed in order to generalize our 
results to neighboring regions. Tools used in this study are the best available tools used 
currently in high income settings but their translation and adoption to the Tanzanian setting will 
require frequent assessment and an interative process of improvement to continue to use them 
and ensure their successful utility. While we have established sample sizes for both the 
qualitative, the validation and the pilot study based on the literature and current alcohol data 
from Tanzania these sample sizes might be unable to predict smaller subgroup findings. It is for 
this reason that we are conducting this pilot trial in order to gain a better understanding of the 
needed sample size for a larger trial.  
 
Dissemination and Publications: 
Dissemination of results will occur for both the academic literature in the form of international 
presentations and research manuscripts as well as the clinical environment at KCMC. We will 
offer to KCMC leadership to discuss our results during the weekly Clinical Case Conference in 
order to educate KCMC Clinicians. Similarly, presentations in the Casualty Department will take 
place for KCMC Casualty Department staff and all healthcare providers.  We also hope to share 
these results with local mental health care providers and health policy officials in order to 
understand the burden of disease suffered by our patients in hopes of planning for the needs of 
health care professionals for these patients.  

 
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