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.

Alcohol use is a risk factor for death and disability and is attributed to almost one-third of injury deaths globally. This highlights the need for interventions aimed at alcohol reduction, especially in areas with high rates of injury with concurrent alcohol use, such as Tanzania. The aim of this study is to create a culturally appropriate text messages as a booster to a brief negotiational intervention (BNI), to in the Emergency Department of the Kilimanjaro Christian Medical Centre, Moshi, Tanzania. Creation of text message boosters for an ED-based intervention expands the window of opportunity for alcohol use reduction in this high-risk population. The study followed a two-step approach to create the text message content in English and then translate and culturally adapt to Tanzanian Swahili. The culturalization process followed the World Health Organization's process of translation and adaptation of instruments. Translation, back translation, and qualitative focus groups were used for quality control to ensure text message content accuracy and cultural appropriateness. In total, nearly 50 text messages were initially developed in English, yet only 29 text messages were successfully translated and adapted; they were focused on the themes of Self-awareness, Goal setting and Motivation. We developed culturally appropriate text message boosters in Swahili for injury patients in Tanzania coupled with a BNI for alcohol use reduction. We found it important to evaluate content validation for interventions and measurement tools because the intended text message can often be lost in translation. The process of culturalization is critical in order to create interventions that are applicable and beneficial to the target population. Trial registration: Clinical Trials Registration Number: NCT02828267, NCT04535011

Translation and Adaptation of the Brief Negotiation Interview Adherence Scale for the Tanzanian Culture

Background: Harmful or hazardous alcohol use is a grave public health problem, causing over 3.3 million deaths annually worldwide. A large number of patients who seek medical care at Emergency Department (ED) present alcohol-related injuries. The use of the Brief Negotiation Interview (BNI) by healthcare providers can help reduce alcohol use and modify drinking patterns of patients in this condition. Considering this, the present study’s objectives were to 1) develop a Swahili version of the Brief Negotiation Interview (BNI) Adherence Scale (BAS) adapted to the Tanzanian culture; 2) support the previously published culturally adapted BNI “Reduce Alcohol for Your Health” a nurse-delivered intervention (PPKAY); and, 3) analyze the psychometric properties of the BAS scale such as internal consistency and factor structure. Methods: This study is a cross-sectional evaluation of the adherence of ED health care practitioners to the BNI components among patients with harmful alcohol use presenting for care at the Kilimanjaro Christian Medical Centre (KCMC) in Moshi, Tanzania. The translation and cross-cultural adaptation involved the ‘back-translation’ method. Sample consisted of five research nurses, which evaluated up to twelve BNI sessions, completing 108 individual assessments. To assess the validity related to internal structure of the different models, a Confirmatory Factor Analysis (CFA) was performed. The internal consistency was measured by the Cronbach’s alpha, McDonald’s Omega coefficient and Composite Reliability. Results: Both 2-factor and 3-factor models presented good internal consistency and factor loadings. High values were found for TLI, CFI and NNFI (>0.90). Both RMSEA values were smaller than 0.08. Average extracted variance showed that the 3-factor model could explain 77%, 65% and 65% variables’ variance while the 2-factor model could explain 76% and 53% variables’ variance of each dimension. Conclusions: This is the first study to translate and adapt the BNI Adherence Scale to Tanzanian culture. The 3-factor model performed better with good fit indices. The adapted scale showed to be a reliable instrument to assess healthcare providers’ adherence to BNI and is a supportive tool and important component of the previously culturally adapted BNI “Reduce Alcohol for Your Health” (PPKAY)

Effectiveness of a Brief Negotiational Intervention and Text-Based Booster to Reduce Harmful and Hazardous Alcohol Use in the Emergency Department of a Low-Resource Setting: A Pragmatic Randomized Adaptive Clinical Trial in Moshi, Tanzania

Background: Alcohol use contributes to over 3 million deaths annually. In Tanzania, similar to other low- and middle-income countries, there are no evidence-based culturally adapted interventions to address harmful alcohol use behaviors. We aim to determine the effectiveness of a culturally adapted brief intervention, “Punguza Pombe Kwa Afya Yako/Reduce Alcohol for your Health”, with mobile health-based boosters in reducing alcohol use and consequences at 3 months after discharge for adult acute injury patients presenting for care. Methods: We are conducting a pragmatic adaptive randomized control trial with two distinct stages, of which we are reporting only Stage 1. Stage 1 is a superiority trial comparing a culturally adapted brief intervention with short-message-service (SMS) text boosters versus usual care. Participants eligible for enrollment are adult injury patients (≥18 years of age), who sought care for an acute injury (<24 hours) at the Kilimanjaro Christian Medical Centre Emergency Department. Alcohol-related criteria for inclusion comprise self-disclosed alcohol use prior to the injury, scoring ≥8 on the Alcohol Use Disorder Identification Test (AUDIT), and/or testing positive (>0.0 g/dL) by alcohol breathalyzer. For all stages, the primary outcome was the number of binge drinking days in the previous 4 weeks. Results: During the trial period, 448 patients met inclusion criteria and consented to participate in the study. Of these, 148 were randomized to usual care, and 300 were randomized to the intervention arms. At the 3-month follow-up, significant differences were observed between the intervention arm and the usual care group. In the primary outcome, the intervention arm showed a notable reduction in mean predicted binge drinking days by 2.03 days (95% CI: -3.53 to -0.86; p=0.0035). Additionally, significant reductions were seen in secondary outcomes for the intervention group: the mean predicted number of drinking days (reduction of 1 day; 95% CI: -2.71 to 0.82; p=0.0005), and the predicted mean difference in the number of drinks (-12.22 drinks; 95% CI: -29.5 to 3.32; p=0.0024). However, no significant differences were found between the two groups in terms of drinking-related consequences or depression. Discussion: When compared to the usual care arm, Punguza Pombe Kwa Afya Yako with text booster significantly reduces binge drinking days, binge drinking episodes, and mean number of drinks consumed. These reductions in alcohol use at 3-month follow-up suggest our culturally adapted intervention is effective for alcohol harm reduction in acute injury patients in Tanzania

Keep your trial on track: A data visualization approach to data collection monitoring in clinical trials

Background: Ensuring the quality of data collected in clinical trials can be a challenging task. Additional challenges arise in trials deployed in emergency department settings where factors such as low participant enrollment and loss of follow-up may be more prevalent. In this study, we describe the development of a data quality dashboard platform to provide real-time information on critical aspects of trial management for the trial “A Pragmatic Randomized Adaptive Clinical Trial to Investigate a Culturally Adapted Brief Negotiational Intervention for Alcohol Use in the Emergency Department in Tanzania” (NIH/NIAAA R01AA027512, PI Staton; https://clinicaltrials.gov/ct2/show/NCT04535011) . Methods: We used an open-source solution named Shiny, based on the R programming language to develop a data quality monitoring dashboard to assess key parameters from an adaptive clinical trial. Briefly, the indicators included in the dashboard and the system requirements were defined after a needs assessment process addressing the specifications requested by trial sponsors and regulatory policies. Results: The resulting dashboard (available at: http://rapid-1698.vm.duke.edu:3842/pract/) is capable of providing real-time information on various aspects of trial management, including enrollment trends, record errors and missing data, patient follow-up status, and patient safety. The automated nature of the tool allows trial investigators and staff to inspect the data at a glance, without the need for direct access to sensitive data and coding skills. Overall, the integration of the dashboard into the trial management process increased the efficiency that decisions are made, thus ensuring adherence to regulatory policies and improving the care provided to patients. Conclusions: This work shows that data visualization solutions such as dashboards can aid in the management of clinical trials by addressing complex tasks and improving adherence to protocols and guidelines. However, it is important to note that the findings of this study may not be generalizable to other clinical trials with different designs, protocols, software, or infrastructures

Using the ADAPT guidance to culturally adapt a brief intervention to reduce alcohol use among injury patients in Tanzania

Background Harmful alcohol use is a leading risk factor for injury-related death and disability in low- and middle-income countries (LMICs). Brief negotiational interventions (BNIs) administered in emergency departments (EDs) to injury patients with alcohol use disorders (AUDs) are effective in reducing post-hospital alcohol intake and re-injury rates. However, most BNIs to date have been developed and implemented in high-income countries. The effectiveness of BNIs in LMICs is largely unknown as few studies have undertaken the rigorous task of culturally adapting these interventions to new settings. Given the high prevalence of alcohol-related injury in the Kilimanjaro region of Tanzania, we culturally adapted a BNI to reduce post-injury alcohol use for implementation in this patient population. Methods Following the ADAPT guidance, we used an iterative, multiphase process to culturally adapt a high-income country BNI to the Tanzanian context. Our team consisted of local healthcare professionals with vast experience in counseling patients and an international team of academic and clinical professionals to integrate our extensive mixed-methods patient data to adapt this intervention. Design group discussions were used to discuss research results, interpret findings, discuss the goals of the intervention, and identify and suggest areas of adaptation of the intervention as well as specific adaptations to the BNI protocol. Objective assessments of our BNI protocol as well as a BNI assessment scale was developed to guide intervention fidelity. Results We developed the Punguza Pombe Kwa Afya Yako (PPKAY); a one-time, 15-minute nurse-led BNI that encourages safe alcohol use and motivates change in alcohol use behaviors among injury patients in the Kilimanjaro region of Tanzania. Adaptations to the original intervention protocol include changes regarding the interventionist, how a patient is greeted, how the topic of alcohol use is raised, how a patient is informed of their harmful alcohol use, how graphics are visualized within the intervention protocol, how behavior change is motivated, and which behavior changes are encouraged. Similarly, we developed a BNI assessment scale to accompany the PPKAY which evaluates adherence to the protocol and motivational interviewing tenants. Conclusions The PPKAY intervention is the first alcohol BNI which was culturally adapted for delivery to injury patients in an African ED. Our study demonstrates our approach to adapting substance use interventions for use in low resource settings and shows that cultural adaptation of alcohol use interventions is feasible, beneficial and empowering for our team. Our study lays a framework and method for other low resourced settings to integrate cultural adaptation into the implementation of a BNI in low resource EDs