A secondary gendered analysis of interviews with Latina cisgender women indicated for HIV pre-exposure prophylaxis.

HIV infections disproportionately impact Latinx populations in the United States, yet oral pre-exposure prophylaxis (PrEP) uptake is low. This study was a secondary gendered analysis of interviews with Latina cisgender women (n = 20) recruited from an urban safety net hospital inNew York City between August 2019 and October 2022. All women were indicated for PrEP by the provider. In-depth interviews were conducted with participants in English and Spanish and asked about social determinants of health, sexual partnerships and behaviors, and PrEP-specific enablers and barriers. Secondary thematic content analysis was conducted to identify gender-related factors influencing PrEP uptake. The following themes emerged from the data:structural factors (e.g., employment), partner-related factors, low sexual health knowledge, and resilience and empowerment. Partner-related factors were the most salient; partner infidelity served as reasons for initiating PrEP. Despite being constrained by low power in relationships, women made empowered choices to initiate PrEP and protect themselves. Findings indicated that the impact of gender inequity was an important factor in Latina women's PrEP decision making, pointing to a need to address partner-driven HIV risk, imbalance of power in relationships, and gender norms.

Factors associated with loss to follow-up in outpatient parenteral antimicrobial therapy: A retrospective cohort study.

We assessed factors associated with increased risk to loss of follow-up with infectious diseases staff in OPAT patients. Discharge to subacute healthcare facilities is strongly associated with loss to follow-up. We did not identify sociodemographic disparities. Poor communication between OPAT providers and subacute healthcare facilities remains a serious issue.

EquiPrEP: An implementation science protocol for promoting equitable access and uptake of long-acting injectable HIV pre-exposure prophylaxis (LAI-PrEP).

BACKGROUND: Long-acting injectable HIV pre-exposure prophylaxis (LAI-PrEP) was approved by the U.S. Food and Drug Administration in December 2021. This initial phase of implementation represents a prime opportunity to ensure equitable LAI-PrEP provision to communities often underrepresented in PrEP care before disparities in access and uptake emerge. Herein, we describe the EquiPrEP Project which utilizes an equity-oriented implementation science framework to optimize LAI-PrEP rollout in an urban safety-net clinic in New York City. METHODS: The primary objectives of this project are to: (1) increase LAI-PrEP initiation overall; (2) increase uptake among groups disproportionately impacted by the HIV epidemic; (3) preserve high PrEP retention while expanding use; and (4) identify barriers and facilitators to LAI-PrEP use. EquiPrEP will enroll 210 PrEP-eligible participants into LAI-PrEP care with planned follow-up for one year. We will recruit from the following priority populations: Black and/or Latine men who have sex with men, Black and/or Latine cisgender women, and transgender women and nonbinary individuals. To evaluate implementation of LAI-PrEP, we will utilize equity-focused iterations of the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and the Consolidated Framework for Implementation Research (CFIR), in addition to longitudinal surveys and qualitative interviews. DISCUSSION: Novel LAI-PrEP formulations carry tremendous potential to revolutionize the field of HIV prevention. Implementation strategies rooted in equity are needed to ensure that marginalized populations have access to LAI-PrEP and to address the structural factors that hinder initiation and retention in care.

Implementation and early outcomes of a telehealth visit model to deliver tecovirimat for mpox infection in New York City.

The 2022 mpox outbreak in New York City posed challenges to rapidly scaling up treatment capacity. We describe a telehealth treatment model launched during this outbreak that facilitated healthcare provider treatment capacity, and was able to adhere to a Centers for Disease Control and Prevention (CDC)-sponsored expanded access investigational new drug (EA-IND) protocol for tecovirimat. Sixty-nine patients were evaluated and prescribed tecovirimat for mpox through telehealth visits at NYC Health + Hospitals/Bellevue and NYU Langone Health from June to August 2022. Thirty-two (46.4%) were previously diagnosed with HIV. Forty-four (63.8%) reported full recovery, with the remainder lost to follow-up. Most patients (n = 60, 87.0%) attended at least one follow-up visit (either in person or through telehealth) after starting treatment. We observed favorable treatment outcomes, with no serious adverse events, hospitalizations, or deaths related to mpox. While equitable access to telehealth remains a limitation that needs to be addressed, this telehealth model enabled a rapid scale-up of tecovirimat prescription during the mpox outbreak, and should be considered as an important tool used to respond to future infectious disease outbreaks.

Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public-private hospital partnership during the 2022 NYC mpox outbreak.

During the 2022 mpox outbreak, tecovirimat was accessed through an expanded access investigational new drug (EA-IND) protocol. We leveraged a unique public/private hospital partnership in New York City to create a novel infrastructure to navigate the EA-IND's regulatory requirements and rapidly provide tecovirimat to patients.

Critical Elements of an Mpox Vaccination Model at the Largest Public Health Hospital System in the United States.

In the spring of 2022, mpox spread to non-endemic countries, including the United States. In New York City (NYC), vaccine demand grew as quickly as case counts. With the leadership of the Regional Emerging Special Pathogens Treatment Center (RESPTC) at NYC Health and Hospitals/Bellevue (NYC H+H)-part of the largest public hospital system in the United States-an innovative vaccination model was established that overcame challenges involving health inequities, inadequate access, and lack of vaccine uptake, to successfully administer JYNNEOS vaccines to over 12,000 patients. Transmission has slowed since its peak in August 2022, which has been attributed to successful vaccination campaigns, infection-induced immunity, and behavioral changes among those at highest risk; however, a Centers for Disease Control and Prevention (CDC) assessment released on 4 April 2023 suggests jurisdictions with low vaccination levels (<35%) remain at risk for an mpox resurgence. Here, we summarize the critical aspects of our mpox vaccination model in NYC, which include integration into routine clinical care, prioritization of health equity, and reutilization of COVID-19 vaccination systems, to provide valuable insights for healthcare institutions as we move into the next stage of this ongoing outbreak.

The Role of a Tertiary Level Safety Net Hospital in New York City's 2022 Mpox Outbreak.

Similar to the early phases of the COVID-19 pandemic, New York City was the national epicenter of the ongoing 2022 mpox (formerly monkeypox) outbreak. Cases quickly began to rise in July 2022, primarily in gay, bisexual, or other men who have sex with men. Tools in the form of a reliable diagnostic test, an effective vaccine, and a viable treatment option have been available from the onset, although logistically complex to roll out. The special pathogens program at NYC Health + Hospitals/Bellevue, the flagship facility for the largest public hospital system in the United States, collaborated with multiple departments within Bellevue, the hospital system, and the NYC Department of Health and Mental Hygiene, to swiftly establish ambulatory testing, immunizations, patient-centered inpatient care, and outpatient therapeutics. With the ongoing mpox outbreak, hospitals and local health departments must prepare a systemwide response to identify and isolate patients and provide high-quality care. Findings from our experience can help guide institutions in developing a multipronged, comprehensive response to the ongoing mpox outbreak.

Sustaining PrEP Prescriptions at a Safety-Net Hospital in New York City During COVID-19: Lessons Learned.

To understand the impact of COVID-19-related disruptions on PrEP services, we reviewed PrEP prescriptions at NYC Health + Hospitals/Bellevue from July 2019 through July 2021. PrEP prescriptions were examined as PrEP person-equivalents (PrEP PE) in order to account for the variable time of refill duration (i.e., 1-3 months). To assess "PrEP coverage", we calculated PrEP medication possession ratios (MPR) while patients were under study observation. Pre-clinic closure, mean PrEP PE = 244.2 (IQR 189.2, 287.5; median = 252.5) were observed. Across levels of clinic closures, mean PrEP PE = 247.3, (IQR 215.5, 265.4; median = 219.9) during 100% clinic closure, 255.4 (IQR 224, 284.3; median = 249.0) during 80% closure, and 274.6 (IQR 273.0, 281.0; median = 277.2) during 50% closure were observed. Among patients continuously prescribed PrEP pre-COVID-19, the mean MPR mean declined from 83% (IQR 72-100%; median = 100%) to 63% (IQR 35-97%; median = 66%) after the onset of COVID-19. For patients newly initiated on PrEP after the onset of COVID-19, the mean MPR was 73% (IQR 41-100%; median = 100%). Our ability to sustain PrEP provisions, as measured by both PrEP PE and MPR, can likely be attributed to our pre-COVID-19 system for PrEP delivery, which emphasizes navigation, same-day initiation, and primary care integration. In the era of COVID-19 as well as future unforeseen healthcare disruptions, PrEP programs must be robust and flexible in order to sustain PrEP delivery.

Assessment of risk factors associated with outpatient parenteral antimicrobial therapy (OPAT) complications: A retrospective cohort study.

Objective: To characterize factors associated with increased risk of outpatient parenteral antimicrobial therapy (OPAT) complication. Design: Retrospective cohort study. Setting: Four hospitals within NYU Langone Health (NYULH). Patients: All patients aged ≥18 years with OPAT episodes who were admitted to an acute-care facility at NYULH between January 1, 2017, and December 31, 2020, who had an infectious diseases consultation during admission. Results: Overall, 8.45% of OPAT patients suffered a vascular complication and 6.04% suffered an antimicrobial complication. Among these patients, 19.95% had a 30-day readmission and 3.35% had OPAT-related readmission. Also, 1.58% of patients developed a catheter-related bloodstream infection (CRBSI). After adjusting for key confounders, we found that patients discharged to a subacute rehabilitation center (SARC) were more likely to develop a CRBSI (odds ratio [OR], 4.75; P = .005) and to be readmitted for OPAT complications (OR, 2.89; P = .002). Loss to follow-up with the infectious diseases service was associated with increased risks of CRBSI (OR, 3.78; P = .007) and 30-day readmission (OR, 2.59; P < .001). Conclusions: Discharge to an SARC is strongly associated with increased risks of readmission for OPAT-related complications and CRBSI. Loss to follow-up with the infectious diseases service is strongly associated with increased risk of readmission and CRBSI. CRBSI prevention during SARC admission is a critically needed public health intervention. Further work must be done for patients undergoing OPAT to improve their follow-up retention with the infectious diseases service.

The influence of hospitalization and HIV severity on gastrointestinal PCR panel evaluation of HIV-related acute diarrhea in New York City: a retrospective, cross-sectional study.

Introduction: Diarrhea is common in persons living with HIV (PLWH)/AIDS. With the increasing utilization of multiplex gastrointestinal PCR panel (GI panel) testing, we aimed to characterize the roles of CD4 count and hospitalization in GI panel assessments of PLWH with acute diarrhea. Methods: We performed a cross-sectional study of adult PLWH with acute diarrhea who underwent GI panel testing at two urban academic centers. Demographic, HIV disease, GI panel result, and hospitalization data were collected, and patients were cohorted by CD4 count (CD4 < 200, CD4 200-499, CD4 > = 500). The primary outcome was enteric infection as detected by GI panel, and hospitalization. Results: Of 298 PLWH, 119 (39.9%) had a CD4 count below 200, 195 (65.4%) were hospitalized, and 137 (46.0%) had enteric infection. Bacterial infection correlated with higher CD4 count (41.9% (CD4 > = 500) vs 31.2% (CD4 200-499) vs 25.2% (CD4 < 200), p = 0.041). Hospitalization correlated with poorly controlled HIV and fewer enteric infections (34.4% vs 68.0%, p < 0.001). After adjusting for HIV disease severity, a negative GI panel remained independently associated with hospitalization (adjusted odds ratio (aOR) 5.32, 95% confidence interval (CI) 2.72-10.9), even in patients tested within 72 hours of hospitalization. Despite better HIV control, men who have sex with men (MSM) had more frequent infectious diarrhea, including from E. coli, giardiasis, and multiple pathogens. MSM status independently predicted enteric infection (aOR 1.93, 95% CI: 1.02-3.67). Conclusions: GI panel results vary by HIV disease severity and hospitalization in PLWH. Clinicians - especially in the inpatient setting - should carefully consider these factors when interpreting GI panel results. Further characterization of diarrheal etiology in PLWH with a negative GI panel is needed. Plain Language Summary: PCR stool test results are affected by certain factors in HIV-related diarrhea Diarrhea is common in people living with HIV (PLWH) and has a variety of causes, including infections, medications, and HIV itself. Multiplex polymerase chain reaction (PCR) stool testing simultaneously evaluates for a variety of common viral, bacterial, and parasitic infections of the gastrointestinal tract, and is increasingly being used in patients with diarrhea. However, patients with HIV and diarrheal illness may have uncommon infections not typically present in those with normal immune function - and thus not routinely evaluated for in stool testing. It is not known what factors, if any, might affect the results of PCR testing in HIV-related diarrhea.In this study, we examined all PLWH who underwent stool PCR testing for diarrhea over a 4-year period. We separated the patients into groups based on HIV disease severity as measured by CD4 T-cell count, or the count of the immune cells affected by HIV. We examined whether there were differences among groups in infection rates as detected by PCR stool testing. Separately, we studied the role of hospitalization in stool PCR test results.Of 298 PLWH who underwent stool PCR testing for diarrhea, 119 had a CD4 count less than 200 (low CD4 count), 195 were hospitalized at time of testing, and 137 had a positive stool PCR test. Compared to those with a low CD4 count, subjects with less severe HIV disease were more likely to have a bacterial infection on stool PCR testing and less likely to be hospitalized. Hospitalized patients were more likely to have a negative PCR stool test, regardless of CD4 count. Many patients with a low CD4 count had diarrheal etiologies not evaluated by multiplex stool PCR. In PLWH who experience diarrhea, stool PCR testing results vary by CD4 count and hospitalization. Providers should be mindful of these factors when interpreting stool PCR test results.

Digestive Health in Sexual and Gender Minority Populations.

It has been over 50 years since the Stonewall Inn Riots in June 1969, a seminal event for the lesbian, gay, bisexual, transgender, queer, intersex, and other sexual and gender-diverse minorities (LGBTQI+, or lesbian, gay, bisexual, transgender, queer, intersex, and everyone else) rights movement. However, sexual and gender minority (SGM) individuals still face discrimination and harassment due to their sexual orientation or gender identity. As such, the National Institute on Minority Health and Health Disparities has identified SGM communities as a "health disparity population." Broadly, there are higher rates of sexually transmitted infections, substance use and abuse, mental health conditions, obesity and eating disorders, certain cancers (breast, cervical, and anorectal), and cardiovascular disease in SGM communities. Transgender patients, especially those of color, are more likely to be uninsured, experience discrimination, and be denied health care than cisgender patients. In addition, SGM individuals have twice the risk of lifetime exposure to emotional, physical, and sexual trauma compared with heterosexuals. It is expected all these factors would negatively affect digestive health as well. This review summarizes the effects of social determinants of health and discrimination on health care access, highlights important digestive diseases to consider in the SGM population, and offers solutions to improve and prioritize the health of these communities. We aim to draw attention to SGM-specific issues that affect gastrointestinal health and spur research that is desperately lacking.

Self-Assessed Severity as a Determinant of Coronavirus Disease 2019 Symptom Specificity: A Longitudinal Cohort Study.

Coronavirus disease 2019 symptom definitions rarely include symptom severity. We collected daily nasal swab samples and symptom diaries from contacts of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) case patients. Requiring ≥1 moderate or severe symptom reduced sensitivity to predict SARS-CoV-2 shedding from 60.0% (95% confidence interval [CI], 52.9%-66.7%) to 31.5% (95% CI, 25.7%- 38.0%) but increased specificity from 77.5% (95% CI, 75.3%-79.5%) to 93.8% (95% CI, 92.7%-94.8%).

Capturing missed HIV pre-exposure prophylaxis opportunities-sexually transmitted infection diagnoses in the emergency department.

The United States Centers for Disease Control and Prevention (CDC) recommends HIV pre-exposure prophylaxis (PrEP) be considered for all patients diagnosed with a sexually transmitted infection (STI). Emergency departments (EDs) are an important site for diagnosis and treatment of STIs for under-served populations. Consequently, we identified 377 patients diagnosed with a bacterial sexually transmitted infection (gonorrhea, chlamydia, and/or syphilis) at a major New York City emergency department between 1/1/2014 and 7/30/2017 to examine associations between key sociodemographic characteristics and missed opportunities for PrEP provision. In this sample, 299 (79%) emergency department patients missed their medical follow-up 90 days after STI diagnosis, as recommended. Results from adjusted generalized estimating equation regression models indicate that patients >45 yo (aOR = 2.2, 95% CI 1.2-3.9) and those with a primary care provider in the hospital system (aOR = 6.8, 95% CI 3.8-12.0) were more likely to return for follow-up visits, whereas Black patients (aOR = 0.44, 95% CI 0.25-0.77) were less likely to return for follow-up visits. These findings indicate that lack of STI treatment follow-up visits are significantly missed opportunities for PrEP provision and comprehensive human immunodeficiency virus prevention care.

HIV Diagnosis and the Clinical Course of COVID-19 Among Patients Seeking Care Within the New York City Public Hospital System During the Initial Pandemic Peak.

Reports conflict on how HIV infection influences the clinical course of COVID-19. The New York City (NYC) public hospital system provides care for over 14,000 people with HIV, was central in responding to the COVID-19 pandemic, and is therefore in a unique position to evaluate the intersection of these concurrent infections. Retrospective chart review of patients presenting to NYC Health and Hospitals (NYC H+H) diagnosed with COVID-19 infection from March 1, 2020, through April 28, 2020, compared people living with HIV (PLWH) and a propensity-matched (PM) control group of patients without HIV to evaluate associations between HIV status and COVID-19 outcomes. Two hundred thirty-four PLWH presented for COVID-19 testing and 110 (47%) were diagnosed with COVID-19. Among 17,413 patients with COVID-19 and without HIV, 1:n nearest neighbor propensity score matching identified 194 patients matched on age, sex, race, and any comorbidity. In the sample with COVID-19 (N = 304), PLWH (9.1%) had lower rates of mortality than controls [19.1%; PM odds ratio (PM-OR): 0.41, 95% confidence interval (CI): 0.19-0.86]. Among hospitalized COVID-19 patients (N = 179), HIV infection was associated with lower rates of mechanical ventilation (PM-OR: 0.31, 95% CI: 0.11-0.84) and mortality (PM-OR: 0.40, 95% CI: 0. 17-0.95). In the extended pandemic period through April 2021, aggregate data by HIV status suggested elevated hospitalization and mortality rates in PLWH versus people without HIV. These results suggest that the direct biological impacts of the HIV virus do not negatively influence COVID-19-related outcomes when controlling for comorbidity and demographic variables.

Lung Malignancies in HIV Infection.

Pulmonary malignancies are a major source of morbidity and mortality in HIV-infected persons. Non-AIDS-defining lung cancers (mostly non-small cell lung cancers) are now a leading cause of cancer death among HIV-infected persons. HIV-associated factors appear to affect the risk of lung cancer and may adversely impact cancer treatment and outcomes. HIV infection also may modify the potential harms and benefits of lung cancer screening with computed tomography. AIDS-defining lung malignancies include pulmonary Kaposi sarcoma and pulmonary lymphoma, both of which are less prevalent with widespread adoption of antiretroviral therapy.

Monocytic adhesion molecule expression and monocyte-endothelial cell dysfunction are increased in patients with peripheral vascular disease versus patients with abdominal aortic aneurysms.

BACKGROUND: Statin therapy is used in the medical management of patients with peripheral vascular disease (PVD) and abdominal aortic aneurysm (AAA) for the pleiotropic and anti-inflammatory benefits. We hypothesize that the inflammatory mechanisms of monocyte-endothelial cell interactions in endothelial barrier dysfunction are more significant in patients with PVD compared with those with AAA. The purpose of this study was to assess patient peripheral blood monocyte adhesion molecules by flow cytometry and monocyte-induced endothelial barrier dysfunction by using an in vitro endothelial cell layer and electric cell-substrate impedance sensing (ECIS) system. METHODS: Peripheral blood was collected from patients with either PVD (ankle-brachial index <0.9, toe-arm index <0.8, or required lower extremity vascular intervention) or AAA (aortic diameter >3.0 cm). Monocytes were isolated from fresh whole blood using an accuspin-histopaque technique. The separated monocytes underwent flow cytometry analysis to evaluate the expression levels of the cell membrane adhesion molecules: CD18, CD11a/b/c, and very late antigen-4. Endothelial cell function was assessed by adding monocytes to an endothelial monolayer on ECIS arrays and coculturing overnight. Peak changes in transendothelial electrical resistance were measured and compared between patient groups. RESULTS: Twenty-eight monocyte samples were analyzed for adhesion molecules (PVD, 19 and AAA, 9) via flow cytometry, and 11 patients were evaluated for endothelial dysfunction (PVD, 7 and AAA, 4) via ECIS. There was no significant difference between risk factors among PVD and AAA patients except for age, where AAA patients were significantly older than PVD patients in both flow cytometry and ECIS groups (P=0.02 and 0.01, respectively). There were significantly higher levels of adhesion molecules CD11a, CD18, and CD11c (averaged mean fluorescent intensity P values: 0.047, 0.038, and 0.014, respectively) in PVD patients compared with AAA patients. No significant difference was found for CD11b and very late antigen-4 expression (P=0.21 and 0.15, respectively). There was significantly more monocyte-endothelial cell dysfunction in patients with PVD versus patients with AAA, with a maximal effect seen at 15h after monocyte addition (P=0.032). CONCLUSIONS: Patients with PVD have increased expression levels of certain monocyte adhesion molecules and greater monocyte-induced endothelial layer dysfunction compared with those with AAA. This may lead to other methods of targeted therapy to improve outcomes of these vascular patients.

Serum metalloproteinases MMP-2, MMP-9, and metalloproteinase tissue inhibitors in patients are associated with arteriovenous fistula maturation.

OBJECTIVE: Many vascular surgeons construct arteriovenous fistulas (AVFs) for hemodialysis access as the primary choice access. A significant number of AVFs fail to mature, however, leading to patient frustration and repeated operations. Metalloproteinase (MMP) activity, particularly MMP-2 and MMP-9, may be important for AVF maturation. We therefore sought to identify whether serum MMP levels could serve as a biomarker for predicting future successful AVF maturation. METHODS: Blood was collected from patients with chronic renal insufficiency at the time of surgery for long-term hemodialysis access. Serum was separated from whole blood and ultracentrifuged at 1000g for 10 minutes. Serum aliquots were frozen at -80°C until used for analysis. Enzyme-linked immunosorbent assay was used to assay levels of MMP-2, MMP-9, and tissue inhibitor of metalloproteinase type 2 (TIMP-2), and TIMP type 4 (TIMP-4). Clinical end points were used to divide patients into failed and matured AVF groups. Successful maturation was considered in patients who had specific duplex findings or 1 month of successful two-needle cannulation hemodialysis. MMP/TIMP ratios were calculated as an index of the MMP axis activity because MMP activity parallels alterations in TIMP levels. RESULTS: Of 20 enrolled patients, AVF maturation was successful in 13 and failed in 7. Serum levels of MMP-2/TIMP-2 were significantly higher in patients with matured AVFs vs levels in those that failed (P = .003). Similarly, a trend toward increased serum levels of MMP-9/TIMP-4 was found in patients with successful AVF (P = .06). CONCLUSIONS: MMP-2 and TIMP-2 levels were different among patients whose AVF matured vs those who did not. Further follow-up studies to determine the predictability of AVF maturation using relative patient serum levels of MMP-2 and TIMP-2 should be performed.