Clinical Epidemiology Commons^™

Cabotegravir And Rilpivirine For Treatment Of Hiv Infection In Africa: Week 96 Results From The Phase 3b Randomized, Open-Label, Noninferiority Cares Trial, Cissy Kityo, Ivan Mambule, Joseph Musaazi, Simiso Sokhela, Henry Mugerwa, Henry Mugerwa, Ibrahim Yawe, Fiona Cresswell, Abraham Siika, Reena Shah

Internal Medicine, East Africa

Evaluation of the durable efficacy and safety of long-acting injectable therapy for HIV is needed in African populations. In a multicenter, open-label phase 3b trial, 512 African adults with HIV-1, stable on first-line oral therapy, with screening plasma viral load (VL) < 50 copies ml−1 and without past virologic failure were randomized (1:1) to continue oral therapy or switch to cabotegravir (600 mg) and rilpivirine (900 mg) intramuscular injections every 8 weeks (optional 4-week oral lead-in). VL was monitored every 24 weeks. Here the primary outcome for our analysis up to 96 weeks was VL < 50 copies ml−1, using the Food and Drug Administration snapshot algorithm (noninferiority margin 10%) in the intention-to-treat exposed population. At 96 weeks, 247/255 (97%) in the long-acting group and 250/257 (97%) in the oral therapy group had VL < 50 copies ml−1 (difference −0.4%; 95% confidence interval −3.1% to 2.0%), demonstrating noninferiority. Adverse events of severity grade ≥3 occurred in 41/255 (16%) in the long-acting group and in 22/257 (9%) in the oral therapy group, mostly considered unrelated to the study drug; only one treatment-related adverse event in the long-acting group led to a decision to discontinue treatment (injection-site abscess). Cabotegravir and rilpivirine long-acting therapy produced durable virologic suppression, met the prespecified noninferiority endpoint compared with oral therapy and demonstrated an acceptable safety and tolerability profile. Long-acting therapy may be considered for use in African treatment programs. PACTR registration: 202104874490818.

Strain-Specific Variability In Viral Kinetics, Cytokine Response, And Cellular Damage In Air-Liquid Cultures Of Human Nasal Organoids After Infection With Sars-Cov-2, Gina M Aloisio, Trevor J Mcbride, Letisha Aideyan, Emily M Schultz, Ashley M Murray, Anubama Rajan, Erin G Nicholson, David Henke, Laura Ferlic-Stark, Amal Kambal, Hannah L Johnson, Elina A Mosa, Fabio Stossi, Sarah E Blutt, Pedro A Piedra, Vasanthi Avadhanula

Faculty, Staff and Students Publications

SARS-CoV-2 variants have demonstrated distinct epidemiological patterns and clinical presentations throughout the COVID-19 pandemic. Understanding variant-specific differences at the respiratory epithelium is crucial for understanding their pathogenesis. Here, we utilized human nasal organoid air-liquid interface (HNO-ALI) cell cultures to compare the viral replication kinetics, innate immune response, and epithelial damage of six different strains of SARS-CoV-2 (B.1.2, WA, Alpha, Beta, Delta, and Omicron). All variants replicated efficiently in HNO-ALIs, but with distinct replication kinetic patterns. The Delta variant exhibited delayed replication kinetics, achieving a steady state at 6 days post-infection compared to 3 days for other variants. Cytokine analysis revealed …

Sars-Cov-2 Nsp13 Interacts With Tead To Suppress Hippo-Yap Signaling, Fansen Meng, Jong Hwan Kim, Chang-Ru Tsai, Jeffrey D Steimle, Jun Wang, Yufeng Shi, Rich G Li, Bing Xie, Vaibhav Deshmukh, Shijie Liu, Xiao Li, James F Martin

Faculty, Staff and Students Publications

The Hippo pathway controls organ development, homeostasis, and regeneration primarily by modulating YAP/TEAD-mediated gene expression. Although emerging studies report Hippo-YAP dysfunction after viral infection, it is largely unknown in the context of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Here, we analyzed RNA sequencing data from human-induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs) and SARS-CoV-2-infected human lung samples, and observed a decrease in YAP target gene expression. In screening SARS-CoV-2 nonstructural proteins, we found that nonstructural protein 13 (NSP13), a conserved coronavirus helicase, inhibits YAP transcriptional activity independent of the upstream Hippo kinases LATS1/2. Consistently, introducing NSP13 into mouse cardiomyocytes suppresses …

Artificial Intelligence In Head And Neck Cancer: Towards Precision Medicine, Jacob Hagen, Logan Hornung, William Barham, Supratik Mukhopadhyay, Adam Bess, Kevin Contrera, Devraj Basu, Vlad Sandulache, Guillaume Spielmann, Sagar Kansara

School of Medicine Faculty Publications

Over the past 20 years, the capabilities of artificial intelligence (AI) have gained significant interest. While AI has been implemented to various degrees in several disciplines, its unique applications in head and neck cancer (HNC) remain underdeveloped. This narrative review examines the existing body of literature regarding the use of AI in HNC. Studies to date have demonstrated AI’s utility across multiple phases of the HNC treatment continuum. Despite its promise, integrating AI into clinical practice faces several challenges, including concerns about system integrity, generalizability, privacy, and bias. In this review, we address these challenges and offer insights into future …

Prevalence And Factors Associated With Depression, Anxiety And Post-Traumatic Stress Disorder Among Healthcare Workers From Sub-Saharan Africa: Systematic Review, Ezra Too, Peninah Wachira, Solomon Njenga, Sabina Odero, Eunice Ndirangu, Amina Abubakar

Institute for Human Development, East Africa

Background: Depression, anxiety and post-traumatic stress disorder (PTSD) are prevalent among healthcare workers (HCWs), including those from sub-Saharan Africa (SSA). However, there are limited summary data on the burden and factors associated with these disorders in this region. We conducted this systematic review (registration no. CRD42022349136) to fill this gap.

Aims: The aim of this review was to systematically summarise the available evidence on the prevalence and factors associated with depression, anxiety and PTSD, or their symptoms, among HCWs from SSA.

Method: We searched African Index Medicus, African Journals Online, CINAHL, PsycINFO and PubMed for articles published, from database inception …

Determinan Ketidakpatuhan Kunjungan Pengambilan Obat Antiretroviral Pasien Hiv/Aids Di Kabupaten Bekasi Tahun 2023-2024, Intan Ully Athalia Sihombing, Mondastri Korib Sudaryo, Helda Helda, Helwiah Umniyati, Irva Zulviya Hasyim

Jurnal Epidemiologi Kesehatan Indonesia

Non-adherence to scheduled antiretroviral (ARV) medication pickup can reduce treatment effectiveness, increase the risk of drug resistance, and contribute to poor HIV infection control. This study aimed to identify factors associated with missed ARV pickup appointments among people living with HIV/AIDS in Bekasi District. An analytical cross-sectional study was conducted using secondary data from HIV/AIDS patients undergoing ARV therapy in 2023–2024. Data were analyzed descriptively (univariate), using Chi-square tests (bivariate), and log-binomial regression (multivariate). Among 811 patients, 341 (42%) were recorded as non-adherent to their medication pickup schedule. The results showed that having an unsuppressed viral load (>50 copies/ml) …

Causes Of Symptoms And Symptom Persistence In Long Covid And Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Anthony L Komaroff, Robert Dantzer

Faculty, Staff and Student Publications

Debilitating symptoms for many years can follow acute COVID-19 ("long COVID"), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and various post-acute infection syndromes (PAISs). Together, long COVID and ME/CFS affect 60-400 million individuals, globally. Many similar underlying biological abnormalities have been identified in both conditions including autoantibodies against neural targets, endothelial dysfunction, acquired mitochondrial dysfunction, and a pro-inflammatory gut microbiome. Each of these abnormalities may directly cause some of the symptoms. In addition, the symptoms also may be caused by ancient, evolutionarily conserved symptomatic and metabolic responses to vital threats-sickness behavior and torpor-responses mediated by specific, recently discovered neural circuits. These neural …

Symptom Clusters And Their Association With Health-Related Quality Of Life In Pediatric Cancer Survivors After Treatment Completion, Krishtee Napit

Theses & Dissertations

A critical area of cancer research, symptom management, has evolved from focusing on individual symptoms to recognizing the complexity of co-occurring symptoms, commonly referred to as symptom clusters. However, most studies on pediatric cancer symptom clusters have focused primarily on the treatment phase or long-term survivorship, overlooking the early post-treatment period. This dissertation examines the prevalence of multiple symptoms and symptom clusters in pediatric cancer survivors post-treatment; factors associated with the total number of symptoms and symptom clusters; and the association of the total number of symptoms and symptom clusters with health-related quality of life (HRQoL). We developed and tested …

A Comprehensive Evidence-Based Educational Initiative For Improving Hand Hygiene, Lyanna L. Chan

Master's Projects and Capstones

Abstract

Problem: Healthcare-associated infections (HAIs) are a persistent concern in assisted living facilities, often resulting from inconsistent hand hygiene practices. Although national guidelines exist, adherence remains suboptimal, especially where staff training and compliance monitoring are limited.

Context: This project took place in a 53-bed assisted living facility without a formal system to track or reinforce hand hygiene. The aim was to improve staff knowledge and promote infection prevention through education.

Interventions: A Clinical Nurse Leader (CNL) led an evidence-based hand hygiene education program. The intervention included interactive training, visual reminders, personal sanitizers, and leadership support during clinical huddles.

Measures: Pre- …

Measuring The Impact Of A Delay In Care On Pediatric Otolaryngologic Surgery Completion, Geethanjeli N Mahendran, Ching Siong Tey, Mary Frances Musso, Grace Shebha Anand, Jeffrey Larson, Mitesh Mehta, Lara Reichert, Kara Prickett, Nikhila Pinnapureddy Raol

Faculty, Staff and Students Publications

Objective: To determine if postponement of elective pediatric otorhinolaryngology surgeries results in a change in overall healthcare utilization and if there is any commensurate impact on disease progression.

Methods: We identified patients ≤18 years of age whose surgeries were postponed at the onset of the COVID-19 pandemic-related shutdown. We then tracked patients' rate of and patterns of rescheduling surgery. Surveys were also sent to caregivers to better characterize his/her decision regarding moving forward with his/her child's surgery during COVID-19.

Results: A total of 1915 pediatric patients had elective surgeries canceled, of which 992 (51.8%) were rescheduled within 4 months. No …

Evaluating The Impact Of Medicaid Expansion On Non-Small Cell Lung Cancer Care And Health Disparities, Marvin Idoteyin Okon

All Dissertations

Persistent disparities in non-small cell lung cancer (NSCLC) outcomes reflect broader structural inequities shaped by race, place, and socioeconomic conditions. This dissertation examined trends in NSCLC outcomes over the past two decades and evaluated the impact of Medicaid Expansion (ME) under the Affordable Care Act on improving outcomes and reducing disparities, especially in marginalized communities.

Using nationally representative datasets, three interrelated studies were conducted. The first assessed trends in NSCLC incidence, early-stage diagnosis, and 3-year survival from 2002-2021, stratified by metropolitan status, deprivation (Social Deprivation Index), and segregation (Index of Concentration at the Extremes). While incidence declined and early-stage diagnosis …

Explore Toolkit, Kimberly Page, Janet Page Reeves, Ivan De La Rosa, Marie Alice Scott, Christina Phillips, Maria Sanchez, Andrew Gorvetzian, Joe Albright, Cynthia Killough, Randall Benalli

Epidemiology, Biostatistics, and Preventive Medicine

Welcome to the Exploring Health Beliefs for Community Engagement and Diversity in Clinical Trials (EXPLORE) Toolkit, a resource designed to support researchers and frontline workers addressing substance use in the Borderlands. The EXPLORE Toolkit was designed by an interdisciplinary team of epidemiologists, social workers, anthropologists, and public health professionals to enhance the engagement of underrepresented communities in substance use clinical trials. Utilizing a strength-based approach, the toolkit addresses equity, stigma, and participation barriers, promoting culturally sensitive and community-centered research practices. This toolkit is an ideal tool for clinical trials researchers and community health workers who are interested in learning more …

Age-Friendly Care And Mobility In Hospitalized Older Adults With Cognitive Impairment: A Feasibility Quality Improvement Initiative, Jasmine K. Vickers, Richard E. Kennedy, Shari Harrell, David H. James, Katrina Booth, Emily Simmons, Cynthia J. Brown, Kellie L. Flood

School of Medicine Faculty Publications

BACKGROUND: Hospitalized older adults with cognitive impairment (CI) have an increased risk for adverse outcomes. Acute Care for Elders (ACE) Units were developed to reduce functional decline in hospitalized older adults. INTERVENTION: We developed a quality improvement (QI) initiative to disseminate ACE care processes to non-ACE units, converting them into "Virtual ACE" units. The aim of this evaluation is to examine the impact of this intervention on the mobilization of patients with CI. POPULATION: Older adults with CI admitted to a study unit (ACE Unit or seven Virtual ACE units). METHODS: We conducted a pre/post-intervention evaluation of the proportion of …

Impact Of Delivery Mode On Neonatal Serum Bilirubin Levels And Jaundice Risk In Melati Husada Women And Children Hospital, Malang, Andreas Budi Wijaya, Harjoedi Adji Tjahjono

Preventia: The Indonesian Journal of Public Health

It is anticipated that between 60 and 80 percent of healthy, full-term newborns would exhibit idiopathic neonatal jaundice. Mode of delivery has recently been associated with idiopathic neonatal jaundice. As seen at Melati Husada Women and Children Hospital in Malang, the increasing number of caesarean section was followed by increased frequency of neonatal hyperbilirubinemia. This hyperbilirubinemia should be resolved within two weeks, therefore, prolonged jaundice should be deeply investigated. This research aimed to investigate the relationship between mode of delivery and neonatal serum bilirubin at 48 hours after birth at Melati Husada Women and Children Hospital in Malang. During observational …

Transforming Primary Care: Innovative Post Graduate Pa Training For Real-World Solutions, Kenneth Botelho, James Ali

Lynchburg Journal of Medical Science

The ongoing crisis in primary care demands innovative and scalable strategies to prepare and retain advanced practice providers. This article introduces the Primary Care Practitioner (PCP) Program, a conceptual postgraduate training model designed for certified physician associates/assistants (PAs) who aim to serve in underserved and rural communities. The program integrates advanced clinical training, leadership development, telehealth competencies, VR-enhanced simulation, and evidence-based strategies to promote provider resilience. Rooted in systems-based thinking and real-world applicability, the PCP Program culminates in capstone projects that encourage innovation in care delivery and population health.

Aligned with national frameworks such as the HRSA Primary Care Training …

Childhood Myopia Part I: Contemporary Treatment Options., Safal Khanal Dr, Erin S. Tomiyama Dr, Síofra Harrington Dr

Articles

Abstract

Childhood myopia is a growing global public health concern. Treatments to control myopia are a priority because myopia, particularly high myopia, poses significant lifelong risks of vision loss from myopia-associated ocular pathologies. Intensive research efforts over the past two decades have led to the development of several effective strategies for controlling myopia in children: increased time outdoors, atropine eye drops, dual-focus and multifocal contact lenses, orthokeratology lenses, and specialized spectacle lenses. While the efficacy of these strategies is variable, evidence is growing regarding the potential benefits of applying these interventions in children with myopia, although none completely halt myopia …

Childhood Myopia Part Ii: Treatment Mechanisms, Emerging Options, And Considerations, Safal Khanal Dr, Erin S. Tomiyama Dr, Síofra Harrington Dr

Articles

Abstract

The rapidly increasing prevalence of myopia and its association with vision-threatening complications in later life has intensified efforts to identify treatments that can prevent the onset and slow the progression of myopia in children. These efforts have led to the development of several optical, environmental, and pharmacological myopia control treatments. Investigations of additional treatment options are ongoing and have shown great promise for clinical translation. Although significant progress has been made in identifying potential pathways and modes of action of these treatments, a complete mechanistic understanding is still lacking. This critical review article explores the potential mechanisms underlying the …

Characteristic Profiling Of Cho-Cell Expressed Mers-Cov Rbd-Fc, Mashal M Almutairi, Yi-Lin Chen, Jungsoon Lee, Zhuyun Liu, Ulrich Strych, Peter J Hotez, Maria Elena Bottazzi, Wen-Hsiang Chen

Faculty, Staff and Students Publications

The ongoing circulation of the Middle East Respiratory Syndrome coronavirus (MERS-CoV) in camels across Asia, the Middle East, and Africa, along with its occasional transmission to humans, demonstrates a need for a MERS vaccine. Previously, we have reported a receptor binding domain (RBD) of MERS-CoV fused with human Fc as a promising vaccine antigen (MERS-CoV RBD-Fc). We generated a stable recombinant CHO cell line expressing such a protein and developed a basic production process suitable for future technological transfer to pilot-scale manufacture. In this study, we employed various in-house analytical assays to examine the characteristics of purified RBD-Fc protein and …

Airway Immune Signatures In Severe And Fatal Infection With Covid-19, Naresh Doni Jayavelu, Jing Jing Qi, Slim Fourati, Farrah Kheradmand, Charles R Langelier, Lauren I R Ehrlich, Joann Diray-Arce, Annmarie Hoch, Monica Kraft, Patrice M Becker, Matthew C Altman, Ruth R Montgomery

Faculty, Staff and Students Publications

No abstract provided.

Machine Learning For Preeclampsia Prediction: Enhancing Screening In Primary Health Care, Dwirani Amelia, Asri Adisasmita, Kemal N. Siregar, Detty Siti Nurdiati

Kesmas

Preeclampsia is a leading cause of maternal morbidity and mortality worldwide, with early detection being critical for reducing adverse outcomes. This study aimed to develop a machine learning model for predicting the risk of preeclampsia using readily available maternal characteristics such as body mass index, mean arterial pressure, and clinical history of hypertension or diabetes mellitus. Secondary data from 2,250 pregnancies were analyzed, addressing challenges such as missing data and class imbalance through preprocessing. Various algorithms, including support vector machines, random forest, and logistic regression, were evaluated. Herein, a support vector machines model with threshold adjustment showed the best performance, …