"When a man drinks alcohol it's cool but when a woman drinks she is a hoe": A qualitative exploration of alcohol, gender, stigma, and sexual assault in Moshi, Tanzania.

Alcohol's ever-increasing global use poses a distinct threat to human well-being, with intake and associated burdens rising especially quickly in low- and middle-income countries like Tanzania. Prior research has shown alcohol use and related consequences differ by gender in Moshi, Tanzania, with important implications for both clinical care and future alcohol-reduction interventions. This study builds upon this knowledge by providing a deeper understanding of how gender differences affect alcohol-related stigma and sexual assault among Emergency Department (ED) and Reproductive Health Center (RHC) patients at Kilimanjaro Christian Medical Center (KCMC) in Moshi. In-depth interviews were conducted among ED and RHC KCMC patients (n = 19) selected for participation via purposive sampling. A mix of inductive and deductive coding schemes was used to identify themes and subthemes. All data were analyzed through a grounded theory approach. Gender roles that linked men with financial responsibilities and women with child caretaking led to different expectations on alcohol intake, with alcohol use encouraged for men but vilified for women. Women who drank, for example, were deemed poor mothers and undesirable spouses. Patients likewise emphasized that both alcohol-related stigma and sexual violence disproportionately impacted women, the latter fueled through alcohol use, with serious and lasting acts of discrimination and isolation from community members seen among women alcohol users but not for men. Women alcohol users in Moshi are subject to severe social consequences, facing disproportionate stigma and sexual violence as compared to men. Alcohol-related treatment for women should be mindful of the disproportionate burdens present in this context while treatment for men should be cognizant of the social pressures to drink. Strategies to address and/or mitigate these factors should be incorporated in subsequent care and interventions.

Alcohol use among emergency medicine department patients in Tanzania: A comparative analysis of injury versus non-injury patients.

BACKGROUND: Alcohol is a leading behavioral risk factor for death and disability worldwide. Tanzania has few trained personnel and resources for treating unhealthy alcohol use. In Emergency Medicine Departments (EMDs), alcohol is a well-known risk factor for injury patients. At Kilimanjaro Christian Medical Center (KCMC) in Moshi, Tanzania, 30% of EMD injury patients (IP) test positive for alcohol upon arrival to the ED. While the IP population is prime for EMD-based interventions, there is limited data on if non-injury patients (NIP) have similar alcohol use behavior and potentially benefit from screening and intervention as well. METHODS: This was a secondary analysis of a systematic random sampling of adult (≥18 years old), KiSwahili speaking, KCMC EMD patients surveyed between October 2021 and May 2022. When medically stable and clinically sober, participants provided informed consent. Information on demographics (sex, age, years of education, type of employment, income, marital status, tribe, and religion), injury status, self-reported alcohol use, and Alcohol Use Disorder (AUD) Identification Test (AUDIT) scores were collected. Descriptive statistics were analyzed in RStudio using frequencies and proportions. RESULTS: Of the 376 patients enrolled, 59 (15.7%) presented with an injury. The IP and NIP groups did not differ in any demographics except sex, an expected difference as females were intentionally oversampled in the original study design. The mean [SD] AUDIT score (IP: 5.8 [6.6]; NIP: 3.9 [6.1]), drinks per week, and proportion of AUDIT ≥8 was higher for IP (IP:37%; NIP: 21%). However, alcohol preferences, drinking quantity, weekly expenditure on alcohol, perceptions of unhealthy alcohol use, attempts and reasons to quit, and treatment seeking were comparable between IPs and NIPs. CONCLUSION: Our data suggests 37% of injury and 20% of non-injury patients screen positive for harmful or hazardous drinking in our setting. An EMD-based alcohol treatment and referral process could be beneficial to reduce this growing behavioral risk factor in non-injury as well as injury populations.

"A Man Never Cries": A Mixed-Methods Analysis of Gender Differences in Depression and Alcohol Use in Moshi, Tanzania.

Background: Unhealthy alcohol use negatively impacts many components of health and wellness, including mental health conditions like major depressive disorder (MDD). Globally, gender differences are common for both alcohol use behaviors and MDD, but these differences have not been studied within Moshi, Tanzania. To provide more effective and culturally appropriate mental health treatments, gender nuances around these conditions must be known. As such, this study aims to explore gender differences in MDD, alcohol use, and other aspects of mental well-being among patients at Kilimanjaro Christian Medical Center (KCMC) in Moshi. Methods: Six hundred and seventy-six patients presenting for care at the KCMC Emergency Department (ED) and Reproductive Health Centre (RHC) were enrolled in this mixed-methods study between October 2021 and May 2022. Patients were selected through systematic random sampling and completed quantitative surveys including the Alcohol Use Disorder Identification Test (AUDIT) and the Patient Health Questionnaire 9 (PHQ-9). Nineteen patients were purposively chosen from the study population to participate in in-depth interviews (IDIs) exploring topics related to alcohol use, gender, and depression. Descriptive frequencies, univariate log-binomial regressions, and a linear regression model were used to analyze quantitative data, all of which were analyzed in RStudio. A grounded theory approach was used to analyze all IDIs in NVivo. Results: Average [SD] PHQ-9 scores were 7.22 [5.07] for ED women, 4.91 [4.11] for RHC women, and 3.75 [4.38] among ED men. Similarly, ED women held the highest prevalence of MDD (25%) as compared to RHC women (11%) and ED men (7.9%) (p<0.001). Depressive symptoms were associated with higher AUDIT scores only for ED men (R2 = 0.11, p<0.001). Our qualitative analysis showed that while present for women, social support networks were notably absent for men in Moshi, the lack of which was seen to play a role in alcohol use. For men, alcohol was described as a coping mechanism for stress. Conclusion: Intersectionality of gender, alcohol use, and depression is influenced by sociocultural and behavioral norms in Moshi. As such, multi-layered, gender-differentiated programming should be considered for the treatment of substance use and mental health conditions in this region.

Clinical evaluation of the alcohol use disorders identification test (AUDIT) in Moshi, Tanzania.

BACKGROUND: Alcohol use disorder is a major cause of morbidity and mortality in low- and middle-income countries. Alcohol screening using a validated tool is a useful way to capture high-risk patients and engage them in early harm reduction interventions. Our objectives were to 1) evaluate the psychometric evidence the Alcohol Use Disorders Identification Test (AUDIT) and its subscales in the general population of Moshi, Tanzania, and 2) evaluate the usefulness of the tool at predicting alcohol-related harms. METHODS: Two hundred and fifty-nine adults living in Moshi, Tanzania were included in the study. We used the AUDIT and its subscales to determine the classification of harmful and hazardous drinking. To analyze the internal structure of AUDIT and the model adequacy we used Confirmatory Factor Analysis (CFA). The reliability of AUDIT was analyzed for Cronbach's alpha, Omega 6 and Composite Reliability. The optimal cut off point for the AUDIT was determined by the receiver operating characteristic (ROC) curve, using the Youden approach to maximize sensitivity and specificity. RESULTS: The median score of the AUDIT was 1 (inter-quartile range: 0-7). The internal structure of the AUDIT showed factor loadings ranging from 0.420 to 0.873. Cronbach's alpha, Omega and Composite Reliability produced values above 0.70. The Average Variance Extracted was 0.530. For the AUDIT, a score of 8 was identified as the ideal cut-off value in our population. CONCLUSIONS: This study validates AUDIT in the general population of Moshi and is one of the only studies in Africa to include measures of the internal structure of the AUDIT and its subscales.

A mixed-methods comparison of gender differences in alcohol consumption and drinking characteristics among patients in Moshi, Tanzania.

Excessive alcohol use stands as a serious threat to individual and community well-being, having been linked to a wide array of physical, social, mental, and economic harms. Alcohol consumption differs by gender, a trend seen both globally and in Moshi, Tanzania, a region with especially high rates of intake and few resources for alcohol-related care. To develop effective gender-appropriate treatment interventions, differences in drinking behaviors between men and women must be better understood. Our study aims to identify and explore gender-based discrepancies in alcohol consumption among Kilimanjaro Christian Medical Center (KCMC) patients. A systematic random sampling of adult patients presenting to KCMC's Emergency Department (ED) or Reproductive Health Center (RHC) was conducted from October 2021 until May 2022. Patients answered demographic and alcohol use-related questions and completed brief surveys, including the Alcohol Use Disorder Identification Test (AUDIT). Through purposeful sampling, 19 individuals also participated in in-depth interviews (IDIs) that focused on identifying gender differences in alcohol use. Quantitative data was analyzed in RStudio through descriptive frequencies, proportions, ANOVA, and Chi-squared tests, while IDIs were analyzed in Nvivo following a grounded theory approach. During the 8-month data collection timeline, 676 patients were enrolled. Men and women patients at KCMC's ED and RHC were found to have significant differences in their alcohol use behaviors. For our quantitative data, this included lower average AUDIT scores among women (average [SD] AUDIT scores were 6.76 [8.16] among ED men, 3.07 [4.76] among ED women, and 1.86 [3.46] among RHC women). A subsequent IDI analysis revealed greater social restrictions around women's drinking and more secretive alcohol use behaviors for where and when women would drink. For men, excess drinking was normalized within Moshi, tied to men's social interactions with other men, and generally motivated by stress, social pressure, and despair over lack of opportunity. Significant gender differences in drinking behaviors were found, primarily influenced by sociocultural norms. These dissimilarities in alcohol use suggest that future alcohol-related programs should incorporate gender in their conceptualization and implementation.

"When a man drinks alcohol it's cool but when a woman drinks she is a hoe": A Qualitative Exploration of Alcohol, Gender, Stigma, and Sexual Assault in Moshi, Tanzania.

Background: Alcohol's ever-increasing global use poses a distinct threat to human well-being, with intake and associated burdens rising especially quickly in low- and middle-income countries like Tanzania. Prior research has shown alcohol use and related consequences differ by gender in Moshi, Tanzania, with important implications for both clinical care and future alcohol-reduction interventions. This study builds upon this knowledge by providing a deeper understanding of how gender differences affect alcohol-related stigma and sexual assault among Emergency Department (ED) and Reproductive Health Center (RHC) patients at Kilimanjaro Christian Medical Center (KCMC) in Moshi. Methods: In-depth interviews (IDIs) were conducted among ED and RHC KCMC patients (n = 19) selected for participation via purposive sampling. A mix of inductive and deductive coding schemes was used to identify themes and subthemes. All data were analyzed through a grounded theory approach. Results: Gender roles that linked men with financial responsibilities and women with child caretaking led to different expectations on alcohol intake, with alcohol use normalized for men but vilified for women. Women who drank, for example, were deemed poor mothers and undesirable spouses. Patients likewise emphasized that both alcohol-related stigma and sexual violence disproportionately impacted women, the latter fueled through alcohol use, with serious and lasting acts of discrimination and isolation from community members seen among women alcohol users but not for men. Conclusion: Women alcohol users in Moshi are subject to severe social consequences, facing disproportionate stigma and sexual violence as compared to men. Alcohol-related treatment for women should be mindful of the disproportionate burdens present in this context and incorporate strategies to address and/or mitigate these harms in subsequent care and interventions.

A Mixed-Methods Comparison of Gender Differences in Alcohol Consumption and Drinking Characteristics among Patients in Moshi, Tanzania.

Background: Excessive alcohol use stands as a serious threat to individual and community well-being, having been linked to a wide array of physical, social, mental, and economic harms. Alcohol consumption differs by gender, a trend seen both globally and in Moshi, Tanzania, a region with especially high rates of intake and few resources for alcohol-related care. To develop effective gender-appropriate treatment interventions, differences in drinking behaviors between men and women must be better understood. Our study aims to identify and explore gender-based discrepancies in alcohol consumption among Kilimanjaro Christian Medical Center (KCMC) patients. Methods: A systematic random sampling of adult patients presenting to KCMC's Emergency Department (ED) or Reproductive Health Center (RHC) was conducted from October 2020 until May 2021. Patients answered demographic and alcohol use-related questions and completed brief surveys including the Alcohol Use Disorder Identification Test (AUDIT). Through purposeful sampling, 19 subjects also participated in in-depth interviews (IDIs) focused on identifying gender differences in alcohol use. Results: During the 8-month data collection timeline, 655 patients were enrolled. Men and women patients at KCMC's ED and RHC were found to have significant differences in their alcohol use behaviors including lower rates of consumption among women, (average [SD] AUDIT scores were 6.76 [8.16] among ED men, 3.07 [4.76] among ED women, and 1.86 [3.46] among RHC women), greater social restrictions around women's drinking, and more secretive alcohol use behaviors for where and when women would drink. For men, excess drinking was normalized within Moshi, tied to men's social interactions with other men, and generally motivated by stress, social pressure, and despair over lack of opportunity. Conclusion: Significant gender differences in drinking behaviors were found, primarily influenced by sociocultural norms. These dissimilarities in alcohol use suggest that future alcohol-related programs should incorporate gender in their conceptualization and implementation.

COVID-19 Booster Vaccine Hesitancy in the Emergency Department.

STUDY OBJECTIVE: Little is known about COVID-19 booster vaccine hesitancy. We sought to determine the uptake of booster vaccines, as well as the prevalence of and reasons for booster hesitancy in emergency department (ED) patients. METHODS: We performed a cross-sectional survey study of adult patients at 5 safety-net hospital EDs in 4 US cities from mid-January to mid-July 2022. Participants were fluent in English or Spanish and had received at least one COVID-19 vaccine. We assessed the following parameters: (1) the prevalence of nonboosted status and reasons for not getting a booster; (2) the prevalence of booster vaccine hesitancy and reasons for hesitancy; and (3) the association of hesitancy with demographic variables. RESULTS: Of 802 participants, 373 (47%) were women, 478 (60%) were non-White, 182 (23%) lacked primary care, 110 (14%) primarily spoke Spanish, and 370 (46%) were publicly insured. Of the 771 participants who completed their primary series, 316 (41%) had not received a booster vaccine; the primary reason for nonreceipt was lack of opportunity (38%). Of the nonboosted participants, 179 (57%) expressed hesitancy, citing need for more information (25%), concerns about side effects (24%), and the belief that a booster was unnecessary after the initial series (20%). In the multivariable analysis, Asian participants were less likely to be booster hesitant than White participants (adjusted odds ratio [aOR] 0.21, 95% confidence interval [CI] 0.05 to 0.93), non-English-speaking participants were more likely to be booster hesitant than English-speaking participants (aOR 2.35, 95% CI 1.49 to 3.71), and Republican participants were more likely to be booster hesitant than Democrat participants (aOR 6.07, 95% CI 4.21 to 8.75). CONCLUSION: Of almost half of this urban ED population who had not received a COVID-19 booster vaccine, more than one third stated that lack of opportunity to receive one was the primary reason. Furthermore, more than half of the nonboosted participants were booster hesitant, with many expressing concerns or a desire for more information that may be addressed with booster vaccine education.

Effect of COVID-19 Vaccine Messaging Platforms in Emergency Departments on Vaccine Acceptance and Uptake: A Cluster Randomized Clinical Trial.

Importance: Large segments of the US population's primary health care access occurs in emergency departments (EDs). These groups have disproportionately high COVID-19 vaccine hesitancy and lower vaccine uptake. Objective: To determine whether provision of COVID-19 vaccine messaging platforms in EDs increases COVID-19 vaccine acceptance and uptake in unvaccinated patients. Design, Setting, and Participants: This prospective cluster randomized clinical trial was conducted at 7 hospital EDs in 4 US cities from December 6, 2021, to July 28, 2022. Noncritically ill adult patients who had not previously received COVID-19 vaccines were enrolled. Interventions: A 3-pronged COVID-19 vaccine messaging platform (an English- or Spanish-language 4-minute video; a 1-page informational flyer; and a brief, scripted message from an ED physician or nurse) was delivered during patient waiting times. Main Outcomes and Measures: The 2 primary outcomes were (1) COVID-19 vaccine acceptance, assessed by survey responses in the ED, and (2) receipt of a COVID-19 vaccine within 30 days, ascertained by ED confirmation of vaccination, electronic health record review, and telephone follow-up. Results: Of the 496 participants enrolled (221 during intervention weeks and 275 during control weeks), the median (IQR) age was 39 (30-54) years, 205 (41.3%) were female, 193 (38.9%) were African American, 97 (19.6%) were Latinx, and 218 (44.0%) lacked primary care physicians. More intervention group participants, compared with control participants, stated that they would accept the vaccine in the ED (57 [25.8%] vs 33 [12.0%]; adjusted difference, 11.9 [95% CI, 4.5-19.3] percentage points; number needed to treat [NNT], 8 [95% CI, 5-22]). More intervention group participants than control participants received a COVID-19 vaccine within 30 days of their ED visit (44 [20.0%] vs 24 [8.7%]; adjusted difference, 7.9 [95% CI, 1.7-14.1] percentage points; NNT, 13 [95% CI, 7-60]). The intervention group had greater outcome effect sizes than the control group in participants who lacked a primary care physician (acceptance, 38 of 101 [37.6%] vs 16 of 117 [13.7%] [P for interaction = .004]; uptake, 31 of 101 [30.7%] vs 11 of 117 [9.4%] [P for interaction = .006]), as well as in Latinx persons (acceptance, 23 of 52 [44.2%] vs 5 of 48 [10.4%] [P for interaction = .004]; uptake, 22 of 52 [42.3%] vs 4 of 48 [8.3%] [P for interaction < .001]). Conclusions and Relevance: Results of this cluster randomized clinical trial showed that with low NNT, implementation of COVID-19 vaccine messaging platforms in EDs leads to greater vaccine acceptance and uptake in unvaccinated ED patients. Broad implementation in EDs could lead to greater COVID-19 vaccine delivery to underserved populations whose primary health care access occurs in EDs. Trial Registration: ClinicalTrials.gov Identifier: NCT05142332.

Perspectives of COVID-19 vaccine-hesitant emergency department patients to inform messaging platforms to promote vaccine uptake.

OBJECTIVES: Efforts to promote COVID-19 vaccine acceptance must consider the critical role of the emergency department (ED) in providing health care to underserved patients. Focusing on patients who lacked primary care, we sought to elicit the perspectives of unvaccinated ED patients regarding COVID-19 vaccination concerns and potential approaches that might increase their vaccine acceptance. METHODS: We conducted this qualitative interview study from August to November 2021 at four urban EDs in San Francisco, California; Seattle, Washington; Durham, North Carolina; and Philadelphia, Pennsylvania. We included ED patients who were ≥18 years old, fluent in English or Spanish, had not received a COVID-19 vaccine, and did not have primary care physicians or clinics. We excluded patients who were unable to complete an interview, in police custody, under suspicion of active COVID-19 illness, or presented with a psychiatric chief complaint. We enrolled until we reached thematic saturation in relevant domains. We analyzed interview transcripts with a content analysis approach focused on identifying concerns about COVID-19 vaccines and ideas regarding the promotion of vaccine acceptance and potential trusted messengers. RESULTS: Of 65 patients enrolled, 28 (43%) identified as female, their median age was 36 years (interquartile range 29-49), and 12 (18%) interviews were conducted in Spanish. Primary concerns about COVID-19 vaccines included risk of complications, known and unknown side effects, and fear of contracting COVID-19 from vaccines. Trust played a major role for patients in deciding which sources to use for vaccine information and in engendering vaccine acceptance. Health care providers and family or friends were commonly cited as trusted messengers of information. CONCLUSIONS: We characterized concerns about COVID-19 vaccines, uncovered themes that may promote vaccine acceptance, and identified trusted messengers-primarily health care professionals. These data may inform the development of nuanced COVID-19 vaccine messaging platforms to address COVID-19 vaccine hesitancy among underserved ED populations.

PROmotion of COvid-19 VA(X)ccination in the Emergency Department-PROCOVAXED: study protocol for a cluster randomized controlled trial.

BACKGROUND: We conducted in-depth interviews to characterize reasons for COVID-19 vaccine hesitancy in emergency department (ED) patients and developed messaging platforms that may address their concerns. In this trial, we seek to determine whether provision of these COVID-19 vaccine messaging platforms in EDs will be associated with greater COVID-19 vaccine acceptance and uptake in unvaccinated ED patients. METHODS: This is a cluster-randomized controlled trial (RCT) evaluating our COVID-19 vaccine messaging platforms in seven hospital EDs (mix of academic, community, and safety-net EDs) in four US cities. Within each study site, we randomized 30 1-week periods to the intervention and 30 1-week periods to the control. Adult patients who have not received a COVID-19 vaccine are eligible with these exclusions: (1) major trauma, intoxication, altered mental status, or critical illness; (2) incarceration; (3) psychiatric chief complaint; and (4) suspicion of acute COVID-19 illness. Participants receive an orally administered Intake survey. During intervention weeks, participants then receive three COVID-19 vaccine messaging platforms (4-min video, one-page informational flyer and a brief, scripted face-to-face message delivered by an ED physician or nurse); patients enrolled during non-intervention weeks do not receive these platforms. Approximately, an hour after intake surveys, participants receive a Vaccine Acceptance survey during which the primary outcome of acceptance of the COVID-19 vaccine in the ED is ascertained. The other primary outcome of receipt of a COVID-19 vaccine within 32 days is ascertained by electronic health record review and phone follow-up. To determine whether provision of vaccine messaging platforms is associated with a 7% increase in vaccine acceptance and uptake, we will need to enroll 1290 patients. DISCUSSION: Highlighting the difficulties of trial implementation during the COVID-19 pandemic in acute care settings, our novel trial will lay the groundwork for delivery of public health interventions to vulnerable populations whose only health care access occurs in EDs. CONCLUSIONS: Toward addressing vaccine hesitancy in vulnerable populations who seek care in EDs, our cluster-RCT will determine whether implementation of vaccine messaging platforms is associated with greater COVID-19 vaccine acceptance and uptake in unvaccinated ED patients. TRIAL STATUS: We began enrollment in December 2021 and expect to continue through 2022. TRIAL REGISTRATION: ClinicalTrials.gov NCT05142332 . Registered 02 December 2021.

Patient-level interventions to reduce alcohol-related harms in low- and middle-income countries: A systematic review and meta-summary.

BACKGROUND: Disease and disability from alcohol use disproportionately impact people in low- and middle-income countries (LMICs). While varied interventions have been shown to reduce alcohol use in high-income countries, their efficacy in LMICs has not been assessed. This systematic review describes current published literature on patient-level alcohol interventions in LMICs and specifically describes clinical trials evaluating interventions to reduce alcohol use in LMICs. METHODS AND FINDINGS: In accordance with PRISMA, we performed a systematic review using an electronic search strategy from January 1, 1995 to December 1, 2020. Title, abstract, as well as full-text screening and extraction were performed in duplicate. A meta-summary was performed on randomized controlled trials (RCTs) that evaluated alcohol-related outcomes. We searched the following electronic databases: PubMed, EMBASE, Scopus, Web of Science, Cochrane, WHO Global Health Library, and PsycINFO. Articles that evaluated patient-level interventions targeting alcohol use and alcohol-related harm in LMICs were eligible for inclusion. No studies were excluded based on language. After screening 5,036 articles, 117 articles fit our inclusion criteria, 75 of which were RCTs. Of these RCTs, 93% were performed in 13 middle-income countries, while 7% were from 2 low-income countries. These RCTs evaluated brief interventions (24, defined as any intervention ranging from advice to counseling, lasting less than 1 hour per session up to 4 sessions), psychotherapy or counseling (15, defined as an interaction with a counselor longer than a brief intervention or that included a psychotherapeutic component), health promotion and education (20, defined as an intervention encouraged individuals' agency of taking care of their health), or biologic treatments (19, defined as interventions where the biological function of alcohol use disorder (AUD) as the main nexus of intervention) with 3 mixing categories of intervention types. Due to high heterogeneity of intervention types, outcome measures, and follow-up times, we did not conduct meta-analysis to compare and contrast studies, but created a meta-summary of all 75 RCT studies. The most commonly evaluated intervention with the most consistent positive effect was a brief intervention; similarly, motivational interviewing (MI) techniques were most commonly utilized among the diverse array of interventions evaluated. CONCLUSIONS: Our review demonstrated numerous patient-level interventions that have the potential to be effective in LMICs, but further research to standardize interventions, populations, and outcome measures is necessary to accurately assess their effectiveness. Brief interventions and MI techniques were the most commonly evaluated and had the most consistent positive effect on alcohol-related outcomes. TRIAL REGISTRATION: Protocol Registry: PROSPERO CRD42017055549.

PROmotion of COvid-19 VA(X)ccination in the Emergency Department - PROCOVAXED: Study Protocol for a Cluster Randomized Controlled Trial.

Background We conducted in-depth interviews to characterize reasons for COVID-19 vaccine hesitancy in emergency department (ED) patients and developed messaging platforms that may address their concerns. In this trial we seek to determine whether provision of these COVID-19 vaccine messaging platforms in EDs will be associated with greater COVID-19 vaccine acceptance and uptake in unvaccinated ED patients. Methods This is a cluster-randomized controlled trial (RCT) evaluating our COVID-19 vaccine messaging platforms in seven hospital EDs (mix of academic, community, and safety-net EDs) in four US cities. Within each study site, we randomized 30 one-week periods to the intervention and 30 one-week periods to the control. Adult patients who have not received a COVID-19 vaccine are eligible with these exclusions: 1) major trauma, intoxication, altered mental status, or critical illness; 2) incarceration; 3) psychiatric chief complaint; and 4) suspicion of acute COVID-19 illness. Participants receive an orally administered Intake survey. During intervention weeks participants then receive three COVID-19 vaccine messaging platforms (4-minute video, one-page informational flyer and a brief, scripted face-to-face message delivered by ED physicians and nurses); patients enrolled during non-intervention weeks do not receive these platforms. Approximately an hour after intake surveys, participants receive a Vaccine Acceptance survey during which the primary outcome of acceptance of the COVID-19 vaccine in the ED is ascertained. The other primary outcome of receipt of a COVID-19 vaccine within 32 days is ascertained by electronic health record review and phone follow-up. To determine whether provision of vaccine messaging platforms is associated with a 7% increase in vaccine acceptance and uptake, we will need to enroll 1290 patients. Discussion Highlighting the difficulties of trial implementation during the COVID-19 pandemic in acute care settings, our novel trial will lay the groundwork for delivery of public health interventions to vulnerable populations whose only health care access occurs in EDs. Trial Status: We began enrollment in December 2021 and expect to continue through 2022. Conclusions Toward addressing vaccine hesitancy in vulnerable populations who seek care in EDs, our cluster-RCT will determine whether implementation of vaccine messaging platforms is associated with greater COVID-19 vaccine acceptance and uptake in unvaccinated ED patients.