Clinical decompensation after trauma laparotomy: It's probably not a pulmonary embolus.

Introduction Computed Tomography (CT) to rule out pulmonary embolus (PE) is often ordered during post-trauma laparotomy clinical decompensation (CD) involving fever, tachycardia, tachypnea, and/or leukocytosis. We hypothesize this diagnostic modality is low-yield in the postoperative period when surgery-related sequelae are more probable. Methods This is a single-center retrospective cohort study of patients who underwent trauma laparotomy and had subsequent CT for CD from March 19, 2019 to June 30, 2022. Descriptive statistics and multiple logistic regression were performed. The primary outcome was saddle and lobar PE incidence. Results 1032 adult patients underwent trauma laparotomy with 434 undergoing CT for CD: 137 CT abdomen and pelvis only, 30 CTPE, 265 both. The majority (80.2 %) was male, age 33[interquartile range (IQR) 24-45], suffered penetrating mechanism (57 %), and had ISS 23[IQR16-30]. Injuries at laparotomy included 47 % solid organ, 62 % GI tract, 7 % biliary, 11 % vascular, and 42 % other. 176 (41 %) required damage control laparotomy. Median time to CT post-laparotomy was 174 h [111-235] with saddle and lobar PE in 3 (1 %), peripheral PE 18 (5 %), and abdominal abscess, leak, fluid, or pseudoaneurysm in 222 (51 %). Clinical management was altered (40 %) by antibiotics, therapeutic anticoagulation, drainage, aspiration, filter, thrombectomy, or surgical operation. Patients for whom CT findings changed management were more likely to have had GI tract surgery (69% vs 57 %, p = 0.021), higher white blood cell (WBC) (16.4 [13.1-20.5] vs 15.1 [9.9-19.5], p = 0.002), more hours between CT and laparotomy (184 [141-245] vs 162 [89-230], p = 0.002), and lower mortality (2% vs 8 %, p = 0.008). In-hospital mortality was 5 %; none were PE-related. Predictors of clinical intervention required based on CT imaging were GI tract injury (AOR: 1.65, p = 0.0182), and elevated WBC (AOR: 1.038, p = 0.010 Conclusion Saddle and lobar PE incidence post-trauma laparotomy is low. SIRS-type symptoms prompting postoperative CT commonly have no procedural or antibiotic requirement. Postoperative decompensation is more likely related post-operative complications, and less likely a PE.

Evaluation of a Novel Battery-Operated Tumbler Device for Use in the Detection of Mouse Pathogens for Rodent Health Monitoring.

The search for alternatives to live animal sentinels in rodent health monitoring programs is fundamental to the 3Rs (Reduction, Replacement, and Refinement) of animal research. We evaluated the efficacy of a novel battery-operated tumbler device that rotates soiled bedding in direct contact with sample media against the use of exhaust sample media and soiled bedding sentinel (SBS) mice. Four rodent racks were used, each with 3 test cages: a cage with a tumbler device that rotated for 10 min twice a week (TUM10), a cage with a tumbler device that rotated for 60 min twice a week (TUM60), and a cage housing 2 female Crl:CD1(ICR) mice. Every 2 wk, each test cage received soiled bedding collected from all cages on each respective rack. In addition to soiled bedding, the tumbler device contained various sample collection media: a contact Reemay filter (3 mo-cRF) that remained in the tumbler for the duration of the study, a contact Reemay filter (1 mo-cRF) that was replaced monthly, adhesive swabs (AS) that were added at every biweekly cage change, and an exhaust Reemay filter located at the exhaust outlet of the cage. All analyses were performed by direct PCR for both sample media in the animal-free methods, and fecal pellet, body swab, and oral swabs were collected from sentinel mice. Out of 16 total pathogens detected, assessment of 1 mo-cRF from both TUM10 and TUM60 cages detected 84% and 79% of pathogens, respectively, while SBS samples detected only 47% of pathogens. AS in TUM60 and TUM10 cages detected the fewest pathogens (24% and 13%, respectively). These results indicate that the novel tumbler device is an effective and reliable tool for rodent health monitoring programs and a suitable replacement for live animal sentinels. In this study, 1 mo-cRF in TUM10 cages detected the highest number of pathogens.

Haptoglobin genotype is a risk factor for coronary artery disease in prediabetes: A case-control study.

Objective: Coronary artery disease (CAD) prediction remains inconsistent with many unappreciated risk factors. Haptoglobin genotype determines the haptoglobin protein's effectiveness to bind free hemoglobin and prevent oxidative stress, a contributor to atherosclerosis. The haptoglobin 2-2 genotype increases the prevalence of cardiovascular disease (CVD) approximately five times compared to the 1-1 genotype in individuals with diabetes. The risk is unknown in prediabetes. The purpose of this study was to determine an association between haptoglobin genotype and CAD in prediabetes. Methods: The researchers used case-control convenience sampling from two cardiovascular disease prevention clinics in Memphis, TN, and Spokane, WA, from January 1, 2016 to March 31, 2020. Participants were ages 35-70, had prediabetes, and free of chronic inflammatory or infectious diseases. Cases had a history of subclinical or clinical CAD, while controls did not have a history of CAD. Differences between cases and controls and among haptoglobin genotypes were analyzed using t-tests and ANOVA for continuous variables and chi-square or Fisher's exact tests for categorical variables. Associations among Hp genotypes and CAD were estimated using logistic regression. Results: The sample (N = 178; 72 cases and 106 controls) was 96 % white and 64 % male. Cases had lower total cholesterol (p = 0.0001) and high-sensitivity C-reactive protein (p = 0.021). Except for CAD, haptoglobin genotype was independent of any demographic or clinical variable. Haptoglobin 2-2 genotype had 4.0 times higher odds of CAD than haptoglobin 1-1 (p = 0.01). Conclusion: Haptoglobin 2-2 genotype had approximately four times higher odds of having CAD compared to the haptoglobin 1-1 genotype. Cases had more desirable clinical profiles, likely attributable to more aggressive treatment of traditional risk factors than controls. Haptoglobin genotype is a potentially important CAD risk factor in prediabetes (88 million Americans). Further studies are needed for interventions to reduce the oxidative stress associated with the Hp 2-2 genotype and glycosylated hemoglobin and for CAD reduction.

Mortality and Ankylosing Spondylitis in the US population: leading causes and associated factors.

OBJECTIVE: Ankylosing Spondylitis (AS) is a chronic inflammatory condition that affects the axial skeleton. Recent studies have shown that mortality risk is higher in AS patients and that it is possibly related to disease activity and duration. Our aim was to investigate the leading causes and factors associated with mortality in hospitalized AS patients in the USA. METHODS: This is a case-control study using the Cerner Health Facts® database between 2015 and 2017. The search was done using ICD codes and administrative claims. Cases were hospitalized AS patients who died during that hospitalization, while controls were patients who survived. In addition to demographics, we collected data on the inpatient use of medications such as NSAIDs, as well as different comorbidities and systemic disease manifestations. The discharge diagnoses for deceased patients were collected to infer causes of mortality. Analysis of association was performed using chi-square tests, t-tests, Wilcoxon rank-sum tests, and logistic regression methods. RESULTS: The leading causes of death were cardiovascular, infectious, respiratory, and traumatic. The Elixhauser comorbidity index was the factor most associated with mortality (p-value < 0.0001), with congestive heart failure and renal disease the most contributing. Drug use disorder was associated with mortality (adjusted OR = 10.9; p = 0.001). Inpatient NSAIDs use was not associated with increased odds for mortality (p-value 0.33). CONCLUSION: Cardiovascular and renal comorbidities are associated with mortality and need to be targeted early on to lower the odds of mortality as patients age. Strategies to prevent opioid and drug abuse should be strengthened in the AS population. Key Points • Cardiovascular and renal comorbidities are associated with mortality and need to be screened for and targeted early on to lower the odds of mortality as patients age. • Drug use disorder including opioid dependence is associated with mortality, and strategies to prevent opioid and drug abuse should be strengthened in the AS population.

Oral Health and Behavior Patterns of Women with Eating Disorders-A Clinical Pilot Study.

BACKGROUND: Chronic stomach regurgitation associated with eating disorders (EDs) poses a high risk for tooth erosion. This study investigated oral health conditions, behavioral patterns, and tooth erosion in women with EDs. METHODS: 16 ED and 13 healthy women were enrolled; 14 ED and 10 healthy control subjects completed the study. Subjects completed demographic, medical, oral, and behavioral health history questionnaires. Dental caries status was recorded as Decayed, Missing and Filled Teeth (DMFT)index and the severity of tooth erosion as Basic Erosive Wear Examination (BEWE) scores. Saliva was collected for flow rate, pH, and buffering capacity analysis. RESULTS: The ED group had a lower stimulated saliva flow rate and higher DMFT index but no significant difference in BEWE scores compared to the controls (t-test, significance level 0.05). Five of the fourteen ED subjects exhibited extensive tooth erosion, which may have been exacerbated by their tooth-brushing behavior. CONCLUSIONS: Although some ED subjects showed extensive tooth erosion in this pilot study, the average BEWE score of the ED group was not significantly different from the controls. Extensive tooth erosion in ED may relate to the low stimulated salivary flow. A larger-scale clinical study is necessary to validate these results.

Plant-based dietary patterns and fasting insulin: a cross-sectional study from NHANES 2017-2018.

BACKGROUND: Previous studies have created plant-based diet indices to assess the health effects of specific dietary patterns. OBJECTIVE: To examine the association between the plant-based content of diet and fasting insulin in adults from the NHANES 2017-2018 database. METHODS: Demographic, dietary, lab and clinical data and fasting insulin were obtained from the NHANES 2017-2018 database. From two 24-h dietary recalls, we created a plant-based diet index (PDI) and a healthy plant-based diet index (hPDI). A high PDI score indicated more plants were consumed versus animal foods. A high hPDI score indicated healthier, plant materials (whole grains, whole fruits, vegetables, legumes, vegetable oils, seeds and nuts) were consumed. The relationships between the natural log of fasting insulin, PDI, and hPDI were analyzed using multiple linear regression adjusting for body mass index (BMI) and alanine aminotransferase (ALT). RESULTS: Analyses were based on 1,714 participants, 897 women and 817 men with a median age of 52 years. In this sample, 610 (35.6%) were white, 407 (23.8%) were black, 231 (13.5%) were Mexican, 207 (12.1%) were Asian, 157 (9.2%) were other Hispanic, and 102 (6%) were other or mixed race. Median fasting insulin was 9.74 µU/mL (IQR: 6.2, 15.56). For every 1 unit increase in PDI, the natural log of fasting insulin decreased 0.0068 ± 0.003 µU/mL (CI: -0.00097, -0.013) (p = 0.02). After adjusting for BMI and ALT, the PDI did not significantly predict fasting insulin as the association was not robust due to multicollinearity. The hPDI was inversely and significantly associated with the natural log of fasting insulin (-0.0027 ± 0.00134, CI: -0.000087, -0.0053) (p = 0.043) in a multivariable model including BMI and ALT. CONCLUSION: A healthy plant-based diet is associated with a decrease in fasting insulin levels. Healthfulness of the diet is an important factor when considering the benefit of a plant-based diet.

Measuring Effects of Counseling to Increase Pre-Exposure Prophylaxis Adherence and Partner Support in South Africa Using the Healthy Relationship Assessment Tool.

INTRODUCTION: In response to the diverse roles and strong influence that male partners may have in women's decisions and ability to use HIV prevention products, we previously developed the counselor-administered Healthy Relationship Assessment Tool (HEART). This tool helps counselors tailor pre-exposure prophylaxis (PrEP) adherence support counseling to women's relationship dynamics with their sexual partners, suggesting modules for counselors to deliver. In this study, we examined the extent to which counselors used the HEART to guide the delivery of intervention modules and whether changes in subsequent HEART scores reflected the counseling module(s) received. METHODS: We conducted this study during a randomized controlled trial of the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) counseling intervention in Johannesburg, South Africa. Trained lay counselors administered the HEART to intervention group participants at enrollment (n=203) and at 3- and 6-month follow-up visits between October 2018 and April 2021. The HEART auto-calculated participants' response scores to recommend relevant counseling modules. We compared the mean scores for the 5 HEART scales across groups receiving different counseling modules. We also assessed changes in scale scores over time by the counseling module received. RESULTS: Although counselors could override HEART counseling module recommendations based on additional knowledge of participants' cases, they consistently agreed with the HEART recommendations. The HEART also triggered the sorting of women into counseling modules that they were positioned to successfully leverage. Additionally, participants' HEART scores changed over time in predictable ways based on the type of counseling module received. CONCLUSION: Overall, the tool performed as predicted and was consistent with past validation efforts of the HEART, indicating that the HEART may provide an efficient means to tailor women's counseling to address relationship-related challenges to PrEP adherence.

Changes in relationships, HIV risk, and feelings towards PrEP: findings from a qualitative explanatory study among participants in the CHARISMA intervention trial.

BACKGROUND: Intimate partner violence (IPV) and other relationship-based challenges have been demonstrated to reduce women's ability to use pre-exposure prophylaxis (PrEP) effectively for HIV prevention. The Community Health Clinical Model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) intervention was designed to mitigate these challenges and increase South African women's agency to use PrEP. The CHARISMA randomized controlled trial did not identify statistically significant differences in PrEP adherence or relationship dynamics between the intervention and control arms. As such, the aim of this explanatory qualitative sub-study was to understand women's experiences with the CHARISMA trial and explore reasons for the null results. METHODS: Twelve CHARISMA trial participants were purposively selected to participate in serial in-depth interviews, which took place at the trial end and 3 months later. Participants represented individuals who had received each of the three counselling modules, 1) healthy communication counselling, 2) PrEP disclosure counselling, or 3) IPV counselling, as well as those in the control arm who received IPV standard-of-care counselling. RESULTS: A thematic case analysis revealed numerous positive relationship outcomes among intervention participants, including identifying and ending unhealthy relationships, gaining a sense of personal empowerment, and enacting more positive behaviors and HIV risk reduction strategies in subsequent relationships. These positive shifts were occasionally described as contributing to decisions to discontinue PrEP use, which may partly explain the limited impact of the intervention on PrEP adherence. CONCLUSIONS: Future investigations of counselling interventions addressing relationship-based barriers to PrEP use should account for changing risk dynamics and need for PrEP.

Development of a relationship counselling website to identify and mitigate risk of intimate partner violence in the context of women's PrEP use.

Discreet, accessible interventions are urgently needed to mitigate the risk of intimate-partner violence (IPV) and other relationship barriers that women encounter to using HIV prevention methods such as pre-exposure prophylaxis (PrEP). We adapted a counsellor-administered intervention, CHARISMA, into a mobile-optimized website to enhance accessibility and reduce human resources required for HIV prevention and relationship counseling. Using human-centered design and participatory methods, CHARISMA was adapted through workshops with former CHARISMA in-person intervention participants (n = 14; ages 18-45) and web development 'sprints' combined with cognitive interviews (n = 24). 'CHARISMA mobile' was then beta-tested with 81 women naïve to the in-person intervention. In beta-testing, participants used a 'think aloud' process to provide feedback on ease of use and rated design, functionality, comprehension, confidentiality, safety, and usefulness on a scale of 1 to 5 via a survey. Data were conducted in four rounds, interspersed with rapid assessment according to go/no-go criteria, and website adaptations. The updated website was pilot tested for 'real-world' feasibility and acceptability among 159 women using their own smartphones at a location of their choice. Feedback was measured via surveys and website analytics. Workshops and cognitive interviews generated insights on technology use, contextual adaptations, and confidentiality, which were integrated into the beta version. The beta version met all 'go' criteria and was further adapted for pilot testing. In pilot testing, users found the website was useful (mean rating 4.54 out of 5), safe (4.5 out of 5), and had few concerns about confidentiality (1.75, representing low concern). On average, users rated the website more than 4 stars out of 5. Beta and pilot-testing suggested the smartphone-optimized website was well-accepted, relevant, engaging, feasible to administer, discreet and safe. Results contributed to a refined website, suitable for adaptations to other contexts and further evaluation where outcomes related to PrEP use and relationships should be assessed.

Nationwide analysis of unplanned conversion during minimally invasive distal pancreatectomy for pancreatic adenocarcinoma.

BACKGROUND: Utilization of minimally-invasive distal pancreatectomy (MIDP) for pancreatic adenocarcinoma has increased. While unplanned conversion to an open procedure during MIDP is associated with inferior short-term outcomes, the long-term consequences of conversion have not been adequately examined. METHODS: Patients with pancreatic adenocarcinoma undergoing MIDP were selected from the National Cancer Database (2010-2015) and subdivided based on the occurrence of unplanned conversion. Post-operative outcomes and overall survival (OS) were examined. Conversion was additionally compared to a matched group of planned open resections. RESULTS: Among 592 patients undergoing attempted MIDP, unplanned conversion occurred in 23.1%. Despite increased 90-day mortality among patients experiencing conversion, there was no difference in median OS between groups (25.0 vs 27.8 months, p = 0.095). For patients undergoing conversion, post-operative outcomes and long-term survival were similar when compared to a propensity-matched group of patients undergoing planned open resection. On multivariable analysis, treatment at an academic facility (OR 0.63) and a robotic approach (OR 0.50) were both significantly associated with completed MIDP. CONCLUSION: Despite inferior post-operative outcomes compared to successful MIDP, unplanned conversion did not result in significantly reduced long term survival. MIDP can be attempted selectively but treatment at experienced centers via a robotic approach should be considered.

Opinion: Common Errors, Omissions, and Presentation Problems in the Conduct and Reporting of Animal-based Research.

As experienced authors, statisticians, editors, and scientists, we present the following comments to highlight some usages or omissions that are common in research manuscripts. Consideration of these comments will improve practices of data analysis and reporting.

Multilevel Stigma and Its Associations with Medical Care Ratings Among Men Who Have Sex With Men in HPTN 078.

INTRODUCTION: Our research assessed associations between stigma-related variables and medical care ratings among clients with HIV in HIV Prevention Trials Network (HPTN) 078 who were men who have sex with men (MSM). METHODS: Logistic regression explored care ratings, stigma, socio-demographics (N = 637). Qualitative thematic coding and themes explored stigmatizing experiences in different settings (N = 111). RESULTS: Whites were twice as likely as African-Americans to report high care ratings (P < .05). Clients who reported familial exclusion due to having sex with men were 40% less likely to report high medical care ratings (P < .05). Clients who agreed healthcare providers think people with HIV "sleep around" were half as likely to report high care ratings (P < .08). Stigmatization included "treating me like they'll catch HIV from my hand," and care avoidance so others didn't "know I was having sex with men". CONCLUSIONS: Providers can promote African American MSM client retention with more affirming healthcare provision, namely minimizing assumptions and addressing identities and client needs beyond just HIV care.

Preferred product attributes of a multipurpose vaginal ring: Findings from a phase 1 trial.

Introduction: Most women face multiple and co-occurring risks from unwanted pregnancy, human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs) at some point during their lifetime. While a range of contraceptive methods exist and options for HIV prevention are increasing, to date, only male and female condoms provide multipurpose protection from both pregnancy and disease. Methods: From September 2017 to December 2018, 60 women from the United States and the Dominican Republic, randomized 1:1 to continuous or interrupted use and 4:1 to active vs. placebo ring, participated in a Phase I trial to assess the safety and tolerability of a three-month multipurpose intravaginal ring (IVR) containing the antiviral tenofovir and the contraceptive levonorgestrel. This study examines survey responses from all participants and qualitative data from a subset of 17 women to assess acceptability of and preferences for IVR characteristics. Results: Overall, women liked the concept of a multipurpose IVR and found it easy to insert and remove. Initial concerns about the size or thickness of the ring generally disappeared with use experience. Women weighed trade-offs between the ease of continuous use for a longer duration against concerns about hygiene and discoloration of the ring when left in place during menses. Whether randomized to continuous or interrupted use, most women found ring attributes (size, thickness, flexibility) very acceptable. They provided recommendations via survey and qualitative interviews for ring modifications that would further increase acceptability. Insights into women's use experiences also suggest the need for clear counseling messages and introduction strategies that can facilitate women's choice and use of prevention methods. Discussion: Study findings suggest that a multipurpose IVR would make a valuable contribution to women's sexual and reproductive health options, and that both continuous and interrupted use strategies may be preferred.

Intrauterine contraceptive discontinuation reasons among female trial participants living with HIV in Cape Town, South Africa: A qualitative analysis.

Introduction: While young women in South Africa may navigate both HIV infection and pregnancy risks, intrauterine contraceptive (IUC) use is low. Though IUCs have low failure rates, concerns exist about whether the IUC is an appropriate method choice for women living with HIV (WLHIV). In this qualitative study, we explore WLHIVs' experiences of using IUC and reasons for discontinuation. Methods: This qualitative study included in-depth interviews (IDIs) with 17 WLHIV who electively discontinued their allocated IUC while participating in a randomized controlled trial comparing the safety of the levonorgestrel intrauterine system (LNG-IUS) and the copper intrauterine device (C-IUD) in Cape Town, South Africa. The transcripts were coded and emergent themes were grouped to examine women's experiences with IUC use and reasons for discontinuation, highlighting experiential differences between the two methods. Results: Women's experience with the allocated IUC related most commonly to bleeding and/or abdominal pain just after insertion. Most C-IUD discontinuers, but only one LNG-IUS discontinuer, complained of pain and/or increased bleeding as the main reason for removal. Three women (two LNG-IUS, one C-IUD) requested removal because they desired pregnancy, while two others discontinued due to fears the IUC was exacerbating non-gynecologic conditions (hypertension, diabetes). Generally, women acknowledged advantages of IUC use and many expressed their desire to continue use if not for the side effects. Conclusions: In the South African context, IUC use for WLHIV should be promoted with specific counseling considerations. Both providers and potential users should receive specific information about potential menstrual-related side effects and countering common misperceptions to enable informed contraceptive decision-making.

Topical Anesthetics for Analgesia in Acute Corneal Abrasion: Eye Care Providers Survey.

STUDY OBJECTIVES: To evaluate the current attitudes of ophthalmologists and optometrists regarding topical anesthetic (TA) use in the emergency department (ED) for analgesia in corneal abrasions. METHODS: A survey was distributed through email to ophthalmologists and optometrists, and their responses were deidentified. Three scenarios were presented involving the addition of tetracaine in addition to usual care in the setting of uncomplicated corneal abrasion. A 250-character space for comments and demographic questionnaire followed. A chi-square test, Fisher exact test, or sign test, at a significance level of 0.05, was used. RESULTS: Of the 978 individuals surveyed, 486 responded (MD/DOs: 47.1% and ODs: 52.9%). Topical anesthetic favorability significantly decreased with shorter practice length when the patient was only examined by an ED provider. Topical anesthetic favorability was significantly impacted by respondents' degree type. When respondents were posed with using TAs if the respondents were the patient, the respondents were 22.6% more likely to use TA when compared with their answers in the scenario where the ED provider examined the patient and 20.0% more likely when compared with the scenario where a MD/OD examined the patient. Most did not support tetracaine use. CONCLUSIONS: Although treating pain is associated with improved quality of life, most respondents did not support TA use in the ED. Practice length and degree type significantly impacted responses. Respondents were more inclined to use TAs when the respondents were the patient. Results suggest that eye care providers need additional research data supporting safety before routine use in the ED, given the potential for adverse events with TAs.

Tough Talks COVID-19 Digital Health Intervention for Vaccine Hesitancy Among Black Young Adults: Protocol for a Hybrid Type 1 Effectiveness Implementation Randomized Controlled Trial.

BACKGROUND: Interventions for increasing the uptake of COVID-19 vaccination among Black young adults are central to ending the pandemic. Black young adults experience harms from structural forces, such as racism and stigma, that reduce receptivity to traditional public health messaging due to skepticism and distrust. As such, Black young adults continue to represent a priority population on which to focus efforts for promoting COVID-19 vaccine uptake. OBJECTIVE: In aims 1 and 2, the Tough Talks digital health intervention for HIV disclosure will be adapted to address COVID-19 vaccine hesitancy and tailored to the experiences of Black young adults in the southern United States (Tough Talks for COVID-19). In aim 3, the newly adapted Tough Talks for COVID-19 digital health intervention will be tested across the following three southern states: Alabama, Georgia, and North Carolina. METHODS: Our innovative digital health intervention study will include qualitative and quantitative assessments. A unique combination of methodological techniques, including web-based surveys, choose-your-own-adventures, digital storytelling, user acceptability testing, and community-based participatory approaches, will culminate in a 2-arm hybrid type 1 effectiveness implementation randomized controlled trial, wherein participants will be randomized to the Tough Talks for COVID-19 intervention arm or a standard-of-care control condition (N=360). Logistic regression will be used to determine the effect of the treatment arm on the probability of vaccination uptake (primary COVID-19 vaccine series or recommended boosters). Concurrently, the inner and outer contexts of implementation will be ascertained and catalogued to inform future scale-up. Florida State University's institutional review board approved the study (STUDY00003617). RESULTS: Our study was funded at the end of April 2021. Aim 1 data collection concluded in early 2022. The entire study is expected to conclude in January 2025. CONCLUSIONS: If effective, our digital health intervention will be poised for broad, rapid dissemination to reduce COVID-19 mortality among unvaccinated Black young adults in the southern United States. Our findings will have the potential to inform efforts that seek to address medical mistrust through participatory approaches. The lessons learned from the conduct of our study could be instrumental in improving health care engagement among Black young adults for several critical areas that disproportionately harm this community, such as tobacco control and diabetes prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT05490329; https://clinicaltrials.gov/ct2/show/NCT05490329. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41240.

Predictors of early neurologic deterioration (END) following stroke thrombectomy.

BACKGROUND: Early neurologic deterioration (END) following ischemic stroke is a serious event and is associated with poor outcomes. However, the incidence and predictors of END after stroke thrombectomy for emergent large vessel occlusion are largely unknown. METHODS: The baseline characteristics of patients enrolled in the COMPASS trial (NCT02466893) were analyzed. The primary outcome was worsening of ≥4 National Institutes of Health Stroke Scale (NIHSS) points 24 hours post thrombectomy (4+ END24) and the secondary outcome was deterioration of ≥2 points (2+ END24). RESULTS: Among 270 patients, 27 (10%) developed 4+ END24 and 42 (16%) had 2+ END24. Those with 4+ END24 were older (76.4±12.9 vs 70.9±12.9 years; p=0.04), had a higher prevalence of hypertension (96% vs 69%; p=0.003), diabetes (41% vs 27%; p=0.13) and higher pretreatment systolic blood pressure (SBP) (170.4±32.6 vs 157.6±28.1 mmHg; p=0.03). More 4+ END24 patients had failed reperfusion: Thrombolysis in Cerebral Infarction ≤2a (26% vs 8%; p=0.003). In unadjusted analysis, older patients and those with hypertension, diabetes, elevated SBP and failed reperfusion had higher odds of 4+ END24. In adjusted analysis, age increase by 5 years led to an increase in 4+ END24 of 28%, diabetes increased odds of 2.6 and failed reperfusion increased odds of 4.5. In the multivariable analysis for the secondary outcome, age (OR 1.33; 95% CI 1.109 to 1.593), diabetes (OR 2.7; 95% CI 1.247 to 5.764) and failed reperfusion (OR 7.2; 95% CI 0.055 to 0.349) were also significant predictors of 2+ END24. CONCLUSIONS: Older patients with acute ischemic stroke who have a history of diabetes or hypertension, with elevated pretreatment SBP and failed reperfusion are at a higher risk of END following stroke thrombectomy for emergent large vessel occlusion.

Examining Associations Between Mental Health, IPV Exposure, HIV Risk Behaviors, and PrEP Use in South African Women: An Analysis of Data from the Charisma Study.

Intimate partner violence (IPV) has been associated with poorer mental health outcomes and increased human immunodeficiency virus (HIV) risk behaviors. We examine the relations between IPV, mental health symptomology (defined as psychological distress and alcohol misuse), and engagement in HIV risk behaviors among a sample of South African women who participated in a randomized controlled trial of CHARISMA, an intervention to increase women's agency to use oral pre-exposure prophylaxis (PrEP) safely and consistently as well as mitigate relationship challenges. We also examined the impact of trial participation on women's mental health, as well as the impact of psychological distress on the effectiveness of the CHARISMA intervention. Mental health symptomology and IPV exposure were prevalent and associated with some HIV risk and protective behaviors. Trial participation reduced psychological distress. There was no evidence for mental health symptomology impacting the effectiveness of the CHARISMA intervention.

Using narratives to inform the development of a digital health intervention related to COVID-19 vaccination in Black young adults in Georgia, North Carolina and Alabama.

Interactive stories are a relatively newer form of storytelling with great potential to correct misinformation while increasing self-efficacy, which is crucial to vaccine acceptance. To address COVID-19 vaccine hesitancy and medical mistrust in young Black adults (BYA), we sought to adapt a pre-existing application ("app"; Tough Talks) designed to address HIV disclosure decision-making through choose-your-own adventure (CYOA) narratives and other activities. The adapted app (Tough Talks - COVID) uses a similar approach to situate COVID-19 vaccination decision-making within social contexts and to encourage greater deliberation about decisions. To inform content for the CYOA narratives, we conducted an online survey that was used to elicit the behavioral, cognitive, and environmental determinants influencing COVID-19 vaccine hesitancy among 150 BYA (ages 18-29) in Georgia, Alabama, and North Carolina. The survey included scenario questions that were developed with input from a youth advisory board to understand responses to peer and family influences. In two scenarios that involved discussions with family and friends about vaccination status, most respondents chose to be honest about their vaccination status. However, vaccinated individuals perceived more social pressure and stigma about not being vaccinated than unvaccinated respondents who were not as motivated by social pressure. Personal choice/agency in the face of perceived vaccine risks was a more common theme for unvaccinated respondents. Results suggest that relying on changing social norms alone may not impact barriers to vaccination in unvaccinated young adults without also addressing other barriers to vaccination such as concerns about autonomy and vaccine safety. Based on these findings, CYOA narratives in the app were adapted to include discussions with family and friends but also to touch on themes of personal choice as well as other topics that influence behaviors besides norms such as safety, side effects, and risk of COVID-19 in an evolving pandemic.

Randomized, placebo controlled phase I trial of the safety, pharmacokinetics, pharmacodynamics and acceptability of a 90 day tenofovir plus levonorgestrel vaginal ring used continuously or cyclically in women: The CONRAD 138 study.

Multipurpose prevention technologies (MPTs), which prevent sexually transmitted infection(s) and unintended pregnancy, are highly desirable to women. In this randomized, placebo-controlled, phase I study, women used a placebo or tenofovir (TFV) and levonorgestrel (LNG) intravaginal ring (IVR), either continuously or cyclically (three, 28-day cycles with a 3 day interruption in between each cycle), for 90 days. Sixty-eight women were screened; 47 were randomized to 4 arms: TFV/LNG or placebo IVRs used continuously or cyclically (4:4:1:1). Safety was assessed by adverse events and changes from baseline in mucosal histology and immune mediators. TFV concentrations were evaluated in multiple compartments. LNG concentration was determined in serum. Modeled TFV pharmacodynamic antiviral activity was evaluated in vaginal and rectal fluids and cervicovaginal tissue ex vivo. LNG pharmacodynamics was assessed with cervical mucus quality and anovulation. All IVRs were safe with no serious adverse events nor significant changes in genital tract histology, immune cell density or secreted soluble proteins from baseline. Median vaginal fluid TFV concentrations were >500 ng/mg throughout 90d. TFV-diphosphate tissue concentrations exceeded 1,000 fmol/mg within 72hrs of IVR insertion. Mean serum LNG concentrations exceeded 200 pg/mL within 2h of TFV/LNG use, decreasing quickly after IVR removal. Vaginal fluid of women using TFV-containing IVRs had significantly greater inhibitory activity (87-98% versus 10% at baseline; p<0.01) against HIV replication in vitro. There was a >10-fold reduction in HIV p24 antigen production from ectocervical tissues after TFV/LNG exposure. TFV/LNG IVR users had significantly higher rates of anovulation, lower Insler scores and poorer/abnormal cervical mucus sperm penetration. Most TFV/LNG IVR users reported no change in menstrual cycles or fewer days of and/or lighter bleeding. All IVRs were safe. Active rings delivered high TFV concentrations locally. LNG caused changes in cervical mucus, sperm penetration, and ovulation compatible with contraceptive efficacy. Trial registration: ClinicalTrials.gov #NCT03279120.