Medicine and Health Sciences Commons^™

The Caregiving Experience: Comparing Stress And Quality Of Life Among Caregivers Of Children With And Without Autism Spectrum Disorder, Mona Khayal

Antioch University Dissertations & Theses

This comparative cross-sectional study investigated caregiving burden, quality of life, and anxiety among primary caregivers of children with autism spectrum disorder compared to caregivers of typically developing children. Using Bronfenbrenner’s Ecological Systems Theory, 66 caregivers (31 autism, 35 comparison) of children aged 6-18 completed the Zarit Burden Interview-12, WHO Quality of Life-BREF, and GAD-7. According to the results, autism caregivers reported substantially higher burden (M = 31.26 vs. 13.23, d = 2.42) and anxiety (M = 9.13 vs. 4.63, d = 1.04), with 90% exceeding clinical burden thresholds compared to 26% of comparison caregivers. Quality of life was lower across …

Reimagining Occupational Justice Beyond Anthropocentrism: A Humane Education Approach To Occupational Therapy Education, Macy Sutton

Antioch University Dissertations & Theses

Occupational therapy positions itself as a holistic, justice-oriented profession, yet many of its theories, practices, and educational standards reflect Eurocentric values and assumptions. Even occupational justice, the disciplinary concept specifically concerned with advancing a more just world, is steeped in coloniality. Critical scholars have increasingly critiqued particular oppressive structures embedded in the field, such as ableism and white supremacy; however, anthropocentrism remains largely unchallenged. In the occupational justice literature, anthropocentrism operates primarily through omission; that is, animals are absent from most scholarly works. This gap is significant because anthropocentrism contributes to prejudice, oppression, and discrimination not only toward animals and …

A Delphi Study Of Ethical Best Practices For Psychedelic Assisted Therapy, Alyssa K. Griskiewicz

Antioch University Dissertations & Theses

The purpose of this Delphi study was to establish areas of ethical consensus regarding psychedelic-assisted therapy (PAT) from the perspectives of an expert panel of practitioners, with attention to issues of equity and access. Participants (N = 29) include individuals with two or more years of experience in one or more of the following domains of psychedelic expertise: clinical/professional practice, scholarly/research contributions, or guided community/ceremonial facilitation. In Round 1, qualitative data were collected through open-ended questions and analyzed using thematic analysis to generate Delphi statements. In Round 2, panelists (N = 24) rated these statements using a Likert-type scale to …

"Why Don't I Talk To A Therapist?": Motivations And Reflections Of Female-Identifying Chinese Immigrants Seeking Psychotherapy For Depression, Qiuyi Wei

Antioch University Dissertations & Theses

This phenomenological study explored the lived experiences of Chinese immigrants and temporary residents struggling with depressive symptoms and their process of seeking and accepting psychotherapy support. The study aimed to describe the factors that motivated participants to enter therapy for depression while also addressing their internal concerns about treatment. Nine female-identified Chinese immigrant adults with such experiences were recruited. Participants’ perceptions of their depressive symptoms and the factors contributing to their decision to seek professional therapy were explored through in-depth, semi-structured qualitative interviews conducted in Mandarin. The interview transcripts were analyzed in Mandarin using interpretative phenomenological analysis, through which four …

Beyond The Rabbit Hole: Dmt, Death, And The Hereafter, Abby Molina

Antioch University Dissertations & Theses

This dissertation explores a proposed relationship between death and N,N-dimethyltryptamine (DMT) within the context of contemporary clinical psychology and the current psychedelic renaissance. Building on Rick Strassman’s hypothesis that DMT may be released at the moment of death and Imants Barušs’ conceptualization of death as an altered state of consciousness, this project examines the phenomenological similarities between DMT-induced experiences (psychedelic “trips”) and near-death experiences (NDEs). Through review of neurobiological research, psychedelic-assisted therapy literature, religious and cultural ceremonial practices, and documented DMT trip and NDE reports, this work evaluates the plausibility that endogenous DMT contributes to altered states of consciousness observed …

Linker-Free Gold-Sputtered Tapered Optical Fiber Plasmonic Sensors For High-Sensitivity Refractive Index Detection In Microfluidic Platforms, Erem Ujah, Gymama Slaughter

Center for Bioelectronics Publications

Gold-sputtered tapered optical fiber (Au-TOF) sensors were developed for high-sensitivity refractive-index (RI) detection using aqueous glucose standards spanning 1.33–1.41 RIU (0–50% w/v). The sensors were fabricated using a reproducible workflow combining flame-brushing tapering, plasma surface preparation, and rotational magnetron sputtering, enabling azimuthally uniform gold coatings without the use of thiol or sulfur linker chemistries. Two sputtering durations (24 s and 30 s) were investigated to examine thickness-dependent plasmonic coupling and sensing performance. Optical measurements were conducted using a broadband supercontinuum source and compact spectrometer within a 20 µL microfluidic sensing chamber. Increasing glucose concentration produced a monotonic decrease in transmission …

Neighborhood Socioeconomic Deprivation And Physical Activity Associate With Extracellular Vesicle Size And Cargo In A Community-Based Cohort Of Women, Yvonne Baumer, Elizabeth M. Aquino Peterson, Matthew R. Bavuso, Noel Miller, Cristhian A. Gutierrez-Huerta, Nithya P. Vijayakumar, Sam J. Neally, Kaveri Curlin, Valerie M. Mitchell, Billy S. Collins, Neelam R. Redekar, Subrata Paul, Anca D. Dobrian, Tiffany M. Powell-Wiley

Department of Biomedical and Translational Sciences Faculty Publications

African American (AA) women face disproportionate cardiovascular disease (CVD) risk due to adverse social determinants of health (SDoH), including lower socioeconomic status (SES). Physical activity (PA) and plasma extracellular vesicles (EVs) modulate CVD risk, but their relationships with SDoH remain unclear. This study examines associations between SDoH, PA, and plasma EVs in a Washington, DC-based cohort of at-risk AA women. Participants (N = 24, Age: 57 ± 12, BMI: 35 ± 6, ASCVD: 9 ± 5) joined the Step It Up Community-Engaged, Digital Health Physical Activity Intervention pilot study. EVs were isolated from fasting plasma samples. Multivariable regression, adjusted for …

Yk-4-250, A Synthetic Telmisartan-Tempol Conjugate: Crystal Structure Of A Stabilized Free Radical Containing An Angiotensin At₁ Receptor Inhibitor, Simon Friedrich, Yali Kong, Faik N. Musayev, Milton L. Brown, B. Frank Gupton

Department of Biomedical and Translational Sciences Faculty Publications

We report the first crystal structure of the telmisartan-tempol conjugate 2,2,6,6-tetramethyl-1-(λ'-oxidaneyl)piperidin-4-yl 4'-[(1,7'-dimethyl-2'-propyl-1H,3'H-[2,5'-bibenzo[d]imidazol]-3'-yl)methyl]-[1,1'-biphenyl]-2-carboxylate free radical (YK-4-250, C₄₂H₄₆N₅O₃), a dual-function inhibitor designed to target both the angiotensin II type 1 receptor (AT₁R) and reactive oxygen species (ROS). Structural analysis reveals a unique crystal architecture in which the nitroxide radical is stabilized within a sterically protected environment while preserving the telmisartan pharmacophore essential for high-affinity receptor antagonism. YK-4-250 is a novel small-molecule conjugate of telmisartan and tempol that incorporates a catalytic stabilized nitroxide radical and was rationally designed to mitigate gastrointestinal acute radiation syndrome (GI-ARS).

The Lived Experience Of Tenders Of Community Grief Rituals, Margaret Y. Wilson

Antioch University Dissertations & Theses

The purpose of this research study is to gain an understanding of the lived experience of tenders of community grief rituals, and how tenders make meaning of their experiences. This study utilized photo elicitation and a reflexive thematic analysis. Participants (N = 11) provided one to three photographs that captured their experience of grief and/or tending grief rituals. The results identified 10 themes supported by subthemes: (a) Grief Tender Wisdom About the Nature of Grief, (b) Life’s Many Experiences are Sources of Grief, (c) The Multifaceted Impacts of Grief-Body, Anger, Compassion, Empathy, Resilience, Gratitude, Joy, and Love, (d) The Nuances …

A Quantitative Analysis Of Barriers To College Students’ Seasonal Vaccination Intentions And Behaviors, Kelly S. Clemens, John Matkovic

Faculty Publications – Health Sciences

Objective
Vaccination is crucial to college student health, but quantitative analyses of barriers in this population are limited. The present study expands the work of Su and Chen to determine the relative influence of structural, psychological, and social vaccination barriers.

Participants
Participants were 650 students from a large, midwestern university during the 2024 vaccination season.

Methods
Participants were recruited from a college campus and randomized to respond to items assessing their barriers to, intentions to receive, and uptake of the COVID-19 or influenza vaccination.

Results
Structural, psychological, and social barriers were differentially important to vaccinations and to intentions vs. uptake …

Healthcare Provider Perspectives On A Clinical Decision Tool To Support Individualized Exercise Prescriptions And Discussions For Breast Cancer Survivors, Jinani Jayasekera, Oliver W. A. Wilson, Kaitlyn M. Wojcik, Eleanor M. Kerr, Rachelle Brick, David Berrigan, Jennifer Yeong-Shin Sheng, Takeo Fujii, Kathleen Thomas, Henri K. Parson, Padma Sheila Rajagopal, Richard L. Street Jr.

Department of Medicine Faculty Publications

Purpose: We evaluated healthcare providers' current knowledge, practices, and perspectives on a novel clinical decision tool (beta-version) to facilitate individualized exercise prescriptions and discussions in clinical settings.

Methods: We recruited healthcare providers who had treated or provided care to breast cancer survivors aged >= 35-years in the past 12 months. The participants were presented with a tool to provide individualized exercise recommendations considering women's individual, clinical, and contextual characteristics. Validated and reliable pre-existing instruments were used to survey providers' current knowledge, practices regarding exercise discussions, and perspectives on the beta-version (paper-draft) of the novel tool.

Results: The sample consisted of …

Chronobiology Of Meal Timing In Early-Stage Hypertension: A Controlled Feeding Pilot Study Investigating The Effects On Renal And Vascular Function, Natalie J. Bohmke, Brittany Barton, Patrice Wiecek, Paula Rodriguez-Miguelez, Dave L. Dixon, Youngdeok Kim, Salvatore Carbone, Danielle L. Kirkman

EVMS School of Health Professions Faculty Publications

Lifestyle intervention is critical for young adults with early-stage hypertension. A Western diet has negative effects on kidney function and blood pressure; however, time-of-day effects are understudied. We hypothesized that consumption of a Western-style meal that is misaligned with the endogenous circadian rhythm would have adverse effects on blood pressure, kidney function, and vascular function. Ten young adults with elevated blood pressure or stage 1 hypertension (means ± SD: 26 ± 8 yr, 50% female) underwent a randomized crossover, isocaloric controlled feeding intervention. Participants were allocated to receive a Western-style meal high in sodium, sugar, and saturated fat in the …

The Treatment Of Obesity In The Context Of The Obesity Paradox In Patients With Heart Failure: A Narrative Review, Pamela L. Alebna, Sarah Martey, Anurag Mehta, Carl J. Lavie, Salvatore Carbone

EVMS School of Health Professions Faculty Publications

Purpose of review

While excess adiposity is a known risk factor for incident heart failure ( HF), once the condition is established, observational data suggest that increased body mass index (BMI) may confer a survival advantage. This paradox has emphasized the underlying roles of cardiorespiratory fitness (CRF), and body composition, particularly lean mass (LM), in influencing clinical outcomes.

Recent findings

In this review, we explore the multifaceted nature of the obesity paradox in HF, with a focus on emerging anti-obesity incretin-mimetic therapies, such as glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists. These agents …

Fill The Void - An Introductory Guide For Learning Medical Imaging, Reid Faith, Peter Gahan, Adam Trusty, Aleksandr Zyskin, Chukwuka Ukekwe, Denise Nchinda, Amanda K. Burbage, Alberto E. Musto

EVMS School of Health Professions Faculty Publications

No standardized, comprehensive approach for radiological image interpretation exists among medical schools in the United States of America. In order to rectify this, we outline a model aimed to help improve how medical imaging can be taught in medical schools. The VOID (Visualization, Orientation/Observation, Identification, Description) guide is a proposed universal, stepwise approach to medical image identification, interpretation, and communication. This structured guideline is aimed at building a foundation for students in early medical education. The VOID was applied to CT (Computed Tomography), MRI (Magnetic Resonance Imaging), and x-ray modalities as integrated sessions for medical students during human anatomy laboratory. …

Sglt2 Inhibitors In Cardio-Oncology: A Systematic Review And Meta-Analysis, Luigi Spadafora, Marco Bernardi, Gianmarco Sarto, Beatrice Simeone, Erica Rocco, Salvatore Carbone, Laura Adelaide Dalla Vecchia, Roberto Franco Enrico Pedretti, Valentina Valentine, Rachele Di Mario, Maurizio Forte, Giacomo Frati, Antonio Abbate, Michele Golino, Francesco Versaci, Mariangela Peruzzi, Pierre Sabouret, Giuseppe Biondi Zoccai, Sebastiano Sciarretta

EVMS School of Health Professions Faculty Publications

Background

According to available evidence, sodium-glucose cotransporter-2 inhibitors (SGLT2i) may confer cardioprotection in patients with cancer undergoing chemotherapy.

Objectives

The objective of the study was to evaluate the impact of SGLT2i on all-cause mortality and heart failure (HF) outcomes in this population.

Methods

We searched PubMed, Cochrane CENTRAL, and Embase through August 2025 for studies of SGLT2i in adult patients with cancer. Random-effects models were used to pool effects for all-cause mortality and an HF composite (new-onset HF and/or HF hospitalization) in cancer patients >18 years. Meta-regression tested effect modification by beta-blockers, statins, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, age, and …

Acute Lower Leg Transcutaneous Electrical Nerve Stimulation Increases Leg Blood Flow And Exercise Capacity In Patients With Peripheral Arterial Disease, Thomas K. Pellinger, Catherine B. Neighbors, Joshua C. Hefta, Patrick H. Luo, Carl B. Suarez, Erotokritos T. Varlas, Grant H. Simmons, Brett J. Wong

EVMS School of Health Professions Faculty Publications

We tested the hypothesis that two different durations of lower leg transcutaneous electrical nerve stimulation (TENS) increase post-TENS popliteal artery blood flow (PABF), popliteal vascular conductance (PVC), and 6-min walk distance (6MWD) in patients with peripheral artery disease (PAD). Seven subjects (5 male, 2 female) with PAD (67.9 ± 7.4 years; claudication: ankle-brachial index (ABI) < 0.90) participated in three randomized treatment sessions: control or bilateral TENS (3.0 Hz burst mode, 250 µs) for either 15 or 45 min. PABF (Doppler ultrasound) was measured before and after treatment. 6MWD and time/distance to claudication onset were measured 25 min post-treatment during each session. PABF, PVC and 6MWD increased after both 15 and 45 min of TENS (P < 0.05, post-TENS vs. pre-TENS baseline/control). Our preliminary results suggest that as little as 15 min of lower leg TENS increases leg blood flow and exercise capacity in individuals with PAD.

Mechanism-Driven Therapy For Diabetic Cardiovascular Disease, Fabian Sanchis-Gomar, Carl J. Lavie, Salvatore Carbone, Ian J. Neeland

EVMS School of Health Professions Faculty Publications

[Introduction] Diabetic cardiovascular disease is a network disorder, not a glucose-only complication

Diabetes accelerates cardiovascular (CV) target-organ damage through multiple interacting biological modules that amplify risk even when glycemia is modestly controlled^[1]. These modules include (i) adipose tissue dysfunction with altered adipokine secretion and immune-cell infiltration; (ii) ectopic lipid deposition in liver, myocardium, and perivascular/epicardial fat (iii) endothelial dysfunction with impaired nitric oxide bioavailability and heightened oxidative stress (iv) chronic kidney disease (CKD)-mediated volume, pressure, and uremic-toxin stress, and (v) autonomic and neurohormonal activation that promotes hypertension, arrhythmias, and remodeling^[1]. The clinical spectrum includes macrovascular disease …

Turnover Time In Neuroangiography Suites: Comparison Between Cases Performed At An Ambulatory Neurosurgery Center Versus A Tertiary Hospital, Pui Man Rosalind Lai, Vinay Jaikumar, Erika L. Leasher, Varun Sridhar, Gustavo M. Cortez, Aimee C. Degaetano, Elad I. Levy

EVMS School of Health Professions Faculty Publications

Background:

Efficient turnover time (TOT) and adherence to first-start time (FST) in operating and angiography suites are critical for optimizing workflow, reducing costs, and maximizing patient satisfaction. Hospitals face challenges in maintaining these metrics due to operational constraints and unexpected emergent cases. Our goal was to compare TOT, FST, and total admission time for elective cases performed in angiography suites at an ambulatory neurosurgery center (ANSC) versus a tertiary hospital (TH).

Methods:

We conducted a retrospective analysis of data for patients who underwent elective diagnostic or interventional neuroendovascular procedures at the TH or ANSC from January 2024 through October 2024. …

Implementation And Clinical Utility Of Ultra-Low-Field Portable Magnetic Resonance Imaging For Postprocedural Neurological Evaluation In Ambulatory Neurosurgery: Illustrative Cases, Devan Patel, Vinay Jaikumar, Taysia P. T. Morioka, Laz Rifkin, Kenneth S. Jacoby, Jaims Lim, Anais Andrade, Aimee C. Degaetano, Pui Man Rosalind Lai, Elad I. Levy

EVMS School of Health Professions Faculty Publications

BACKGROUND

Elective endovascular neurosurgical procedures are increasingly performed in ambulatory neurosurgery centers, enabled by advances in catheter technology, safety of conscious sedation, and refined patient selection. Although complication rates are low, rapid evaluation of postprocedural neurological deficits remains critical. Conventional MRI is often impractical in outpatient or procedural settings, whereas ultra-low-field portable MRI (ULF-pMRI) systems (such as Swoop) allow bedside imaging with favorable diagnostic performance.

OBSERVATIONS

Two women in their 60s developed acute neurological deficits at an ambulatory neurosurgery center (ANSC) after diagnostic cerebral angiography in one case and elective internal carotid artery flow diversion in the other. In both …

First-Generation Medical School Applicants: A Quantitative Study Designed To Identify Areas Of Educational Support, Bethsabe Romero, Amanda K. Burbage

EVMS School of Health Professions Faculty Publications

First-generation (First Gen) students are unique medical school applicants. Due to their lived experience, they approach patient care by prioritizing trust, comfort and understanding. They have proven ability to overcome obstacles and were found to be more resilient than their continuing generation (Cont Gen) peers. Despite these notable attributes, they face unique challenges in gaining medical school acceptance. There are very few quantitative studies examining this student subpopulation, and our study identifies characteristics of first-generation medical school applicants while highlighting areas of needed support. This cross-sectional study used deidentified Application and Matriculating Student Questionnaire survey data that was obtained from …

Determinants Of Patient Satisfaction In An Academic Primary Care Setting: A Cross-Sectional Study Of The Postpandemic Era, Alvin Maliakal, Rajita Kanapareddy, Zooha Altaf, Janani Anbazhagan, Kristin Olson, Cynthia Avila, Rehan Qayyum

Department of Medicine Faculty Publications

Background

Patient satisfaction, a key indicator of healthcare quality, is associated with improved adherence, continuity, and outcomes. However, limited evidence describes determinants of patient satisfaction in contemporary primary care settings reflecting the postpandemic era, when care delivery models and patient expectations have evolved substantially.

Objective

To evaluate the sociodemographic and clinical factors associated with patient satisfaction in an academic primary care setting following the postpandemic era.

Methods

We conducted a cross-sectional survey of adult patients (≥18 years) attending a primary care clinic. Participants completed a self-administered questionnaire including the Visit-Specific Satisfaction Questionnaire (VSQ-9) and measures of sociodemographic and clinical characteristics. …

Crossing The Theory Threshold: The Pedagogical Potential Of Generative Artificial Intelligence In Educational Research, Amanda Burbage, Jennifer L. Styron

EVMS School of Health Professions Faculty Publications

Purpose

This paper presents findings from an educational research graduate course in which generative artificial intelligence (AI) was incorporated to strengthen learners' understanding of threshold concepts related to theoretical frameworks. Medical and health professionals often struggle with the transition from a clinical role into the educational research role.

Methods

The study posits that the use of generative AI will help learners understand and apply theoretical frameworks beyond a superficial level, furthering their understanding, constructing new knowledge, and strengthening their ability to develop sound educational research studies. Journal and AI transcripts were analyzed for 37 participants.

Results

Open-ended codes were grouped …

Development Of A Semi-Mechanistic Population Pharmacokinetic Model For Predicting Tenofovir Disoproxil Fumarate And Tenofovir Alafenamide Exposure In Plasma And Cellular Matrices During Pregnancy And Postpartum, Yifan Yu, Kristina M. Brooks, Gustavo F. Doncel, Brookie M. Best, Mark A. Marzinke, Mark Mirochnick, Peter Anderson, Landon Myer, Connie Celum, Renee Heffron, Jenell Coleman, Dvora Joseph Davey, Craig W. Hendrix, Jeremiah D. Momper, Robert Bies, Rachel K. Scott

CONRAD Publications

Background and Objective

Tenofovir (TFV)-based regimens are backbones of both HIV treatment and pre-exposure prophylaxis during pregnancy. Multiple studies have shown up to one-third decreases in dried blood spot tenofovir-diphosphate concentrations during pregnancy among participants taking tenofovir disoproxil fumarate (TDF). Currently, there are no mechanism-based models describing the pharmacokinetics of tenofovir diphosphate (the active anabolite) in peripheral blood mononuclear cells (PBMCs) of pregnant individuals receiving TDF or tenofovir alafenamide (TAF), and the mechanisms behind observed differences between dried blood spots and PBMCs remain unclear.

Methods

To address this gap, we developed a semi-mechanistic model to simultaneously describe the pharmacokinetics of …

A Comparison Of F/Taf And F/Tdf As Hiv Pre-Exposure Prophylaxis In A Predominantly Cisgender Women Population In East And South Africa: A Randomised, Factorial, Non-Inferiority Trial, Sheena Mccormack, David Dunn, Sylvia Kusemererwa, Patricia Munseri, Nishanta Singh, Wiston William, Gertrude Mutonyi, Henry Bern, Lauriane Goldwirt, Cherry Kingsley, Arne Kkroidl, Christian Holm Hansen, Song Ding, Rachel Kawuma, Mary Amondi, Ubaldo Bahemuka, Deus Buma, Daniel Clutterbuck, Zakir Gaffoor, Angus Jennings, Agricola Joachim, Ayoub Kakande, Berna Kalanzi, Abisai Kisinda, Mabela Matsoso, Thomas Miller, Neetha Mmedsci Morar, Jacqueline Musau, Jane Nabbuto, Ayanda Nzuza, Doreen Pamba, Simona Salomone, Thandiwe Sithole, Edith Tarimo, Kubashni Woeber, Kundai Chinyenze, Glenda Gray, Eligius Lyamuya, Muhammad Bakari, Said Aboud, Lucas Maganga, Gustavo Doncel, Janet Seeley, Jonathan Weber, Pontiano Kaleebu, Julie Fox, Eugene Ruzagira, On Behalf Of The Prepvacc Study Group

CONRAD Publications

Background:

F/TAF was shown to be non-inferior to F/TDF as pre-exposure prophylaxis (PrEP) in men, but approval was not extended to cisgender women. We report the results of PrEPVacc, in which a predominantly female population was randomly allocated to receive daily oral F/TDF or F/TAF for ∼6 months within a HIV-1 prophylactic vaccine trial.

Setting:

Five study sites in three African countries (Uganda, Tanzania, South Africa).

Methods:

The two regimens were compared by the averted infections ratio (AIR) - the proportion of infections averted by F/TAF relative to F/TDF. The counterfactual HIV incidence, an essential component of this metric, was …

Longitudinal Changes In Plasma Biomarkers Of Immune Activation, Neuronal Inflammation And Injury In Persons With Hiv Initiating Art, Merle Henderson, Peter Dutey-Magni, Carolina Herrera, Wolfgang Stöhr, Alejandro Arenas-Pinto, Owen Swann, Amanda Heslegrave, Henrik Zetterberg, John Tregoning, Sarah Fidler, François Raffi, Andrea Calcagno, Ab Babiker, Alan Winston

CONRAD Publications

Background

Data on changes in biomarkers of brain health, and their associations with cognitive function in adults commencing either dual- or triple-antiretroviral therapy (ART) are sparse.

Methods

Plasma biomarkers (neurofilament light [NfL], glial fibrillary acidic protein [GFAP], sCD14, CXCL10, neopterin and IL-6) were measured at baseline and after 96 weeks on ART in individuals randomized to darunavir/ritonavir and either tenofovir-DF/emtricitabine (triple-ART, n = 119) or raltegravir (dual-ART, n = 119) in NEAT-001/ANRS143. Regression models examined associations of baseline and week-96 biomarker concentrations with HIV clinical parameters, composite cognitive test scores (Standardized neuropsychological test [NPZ], 7-domains) and treatment arm.

Results

In …

Formulation Development Of Topical Inserts Containing Doxycycline And Doxycycline Combined With Tenofovir Alafenamide And Elvitegravir For The Prevention Of Sexually Transmitted Infections, Vivek Agrahari, M. Melissa Peet, Jasmin Monpara, Rijo John, Sriramakamal Jonnalagadda, Pardeep K. Gupta, Meredith R. Clark, Gustavo F. Doncel

CONRAD Publications

Despite advances in oral and injectable HIV prevention options and oral prophylaxis for sexually transmitted infections (STIs) of bacterial origin, there remains a critical need for effective on-demand topical (vaginal and rectal) products for pre- and post-exposure prophylaxis (PrEP and PEP). To fill this gap, we have developed single and first-in-kind multi-active topical inserts for bacterial STIs and HIV/STIs prevention. We have formulated two different inserts, one containing doxycycline (DOX) at 10, 50, and 100 mg doses for bacterial STI prevention, and a multipurpose prevention product (TED insert) that combines DOX (10 mg) with the antiretrovirals tenofovir alafenamide (TAF; 20 …

Artificial Intelligence And Machine Learning In Smart Vaginal Formulation Development, Deborah A. Ogundemuren, Vivek Agrahari, Andrew P. Wong, Carolina Herrera, Margaret O. Ilomuanya, Gustavo F. Doncel

CONRAD Publications

Vaginal drug delivery in women's health remains underutilized and insufficiently studied, largely due to the complexity and dynamic nature of the vaginal microenvironment. Variations in vaginal pH, hormonal levels, and microbiota composition introduce significant biological variability, complicating formulation design and contributing to inconsistent therapeutic outcomes and poor patient adherence. Conventional vaginal formulations often fail to account for these individual differences, highlighting the need for more adaptive and predictive approaches. Emerging advances in artificial intelligence (AI) and machine learning (ML) offer promising strategies to address these challenges by enabling multi-parameter, data-driven formulation development that explicitly considers biological variability. Despite their transformative …

Partial Post-Exposure Protection By Topical Inserts Containing Tenofovir Alafenamide Fumarate/Elvitegravir In A Macaque Model Of Rectal Simian Hiv (Shiv) Infection, Natalia Makarova, Tyana Singletary, M. Melissa Peet, Kristen Kelley, Ryan Johnson, Vivek Agrahari, Maria Mendoza, Yi Pan, Walid Heneine, Meredith R. Clark, J. Gerardo García Lerma, Gustavo F. Doncel, James W. Smith

CONRAD Publications

On-demand topical inserts for HIV prevention may be a good option for people who have a low frequency of sexual activity. We recently demonstrated in a preclinical macaque model that rectal application of inserts containing tenofovir alafenamide fumarate (TAF) and elvitegravir (EVG) conferred protection against SHIV infection (93% efficacy) when applied as pre-exposure prophylaxis 4 hours before SHIV exposure. Here, we show that the same inserts provide significant postexposure protection (82.9% efficacy) when applied 4 hours after SHIV exposure. Our findings further support the ongoing clinical development of TAF/EVG inserts for on-demand HIV prevention.

Proof-Of-Concept Development And Preclinical Evaluation Of A Microarray Patch Platform For Codelivery Of Multiple Broadly Neutralizing Antibodies For Hiv Prevention, M. Melissa Peet, Vivek Agrahari, Parbeen Singh, Lam Luong Hoai Nguyen, Louise A. Ouattara, Eun Sung Yang, Carolina Herrera, Amarendra Pegu, Theodore C. Pierson, Thanh D. Nguyen, Gustavo F. Doncel

CONRAD Publications

Broadly neutralizing antibodies (bnAbs) are advancing as a preventative or treatment option for HIV infection, but currently must be administered parenterally, typically as a large injection or infusion, an invasive method of delivery, especially for the pediatric population. Here, we present proof-of-concept data on a minimally invasive microneedle (MN) patch platform codelivering three bnAbs, PGT121, VRC07-523LS, and PGDM1400LS, from separate MN patch units or pixels. Each 1 cm² patch pixel, fabricated via solvent casting, contained ∼2 mg of one bnAb. In ex vivo porcine skin tests, the MNs effectively penetrated the skin. When tested in vitro in PBS buffer, MNs …

Proof-Of-Concept Development And Preclinical Evaluation Of A Microarray Patch Platform For Codelivery Of Multiple Broadly Neutralizing Antibodies For Hiv Prevention, M. Melissa Peet, Vivek Agrahari, Parbeen Singh, Lam Luong Hoai Nguyen, Louise A. Ouattara, Eun Sung Yang, Carolina Herrera, Amarendra Pegu, Theodore C. Pierson, Thanh D. Nguyen, Gustavo F. Doncel

CONRAD Publications

Broadly neutralizing antibodies (bnAbs) are advancing as a preventative or treatment option for HIV infection, but currently must be administered parenterally, typically as a large injection or infusion, an invasive method of delivery, especially for the pediatric population. Here, we present proof-of-concept data on a minimally invasive microneedle (MN) patch platform codelivering three bnAbs, PGT121, VRC07-523LS, and PGDM1400LS, from separate MN patch units or pixels. Each 1 cm² patch pixel, fabricated via solvent casting, contained similar to 2 mg of one bnAb. In ex vivo porcine skin tests, the MNs effectively penetrated the skin. When tested in vitro in PBS …