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

Kaul, Christina M; Moore, Brandi E; Kaplan-Lewis, Emma; Casey, Eunice; Pitts, Robert A; Pagan Pirallo, Patricia; Lim, Sahnah; Kapadia, Farzana; Cohen, Gabriel M; Khan, Maria; Mgbako, Ofole
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.
PMCID:10508596
PMID: 37725628
ISSN: 1932-6203
CID: 5599042

Self-Assessed Severity as a Determinant of COVID-19 Symptom Specificity: A Longitudinal Cohort Study

Bershteyn, Anna; Dahl, Angela M; Dong, Tracy Q; Deming, Meagan E; Celum, Connie L; Chu, Helen Y; Kottkamp, Angelica C; Greninger, Alexander L; Hoffman, Risa M; Jerome, Keith R; Johnston, Christine M; Kissinger, Patricia J; Landovitz, Raphael J; Laufer, Miriam K; Luk, Alfred; Neuzil, Kathleen M; Paasche-Orlow, Michael K; Pitts, Robert A; Schwartz, Mark D; Stankiewicz Karita, Helen C; Thorpe, Lorna E; Wald, Anna; Zheng, Crystal Y; Wener, Mark H; Barnabas, Ruanne V; Brown, Elizabeth R
COVID-19 symptom definitions rarely include symptom severity. We collected daily nasal swabs and symptom diaries from contacts of SARS-CoV-2 cases. Requiring ≥1 moderate or severe symptom reduced sensitivity to predict SARS-CoV-2 shedding from 60.0% (CI: 52.9-66.7%) to 31.5% (CI: 25.7-38.0%), but increased specificity from 77.5% (CI:75.3-79.5%) to 93.8% (CI: 92.7-94.8%).
PMID: 35152299
ISSN: 1537-6591
CID: 5175542

Risk of Severe Acute Respiratory Syndrome Coronavirus 2 Acquisition Is Associated With Individual Exposure but Not Community-Level Transmission

Friedman-Klabanoff, DeAnna J; Fitzpatrick, Meagan C; Deming, Meagan E; Agrawal, Vaidehi; Sitar, Sandra; Schaafsma, Torin; Brown, Elizabeth; Neuzil, Kathleen M; Barnabas, Ruanne V; Laufer, Miriam K; ,
BACKGROUND:Transmission rates after exposure to a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-positive individual within households and healthcare settings varies significantly between studies. Variability in the extent of exposure and community SARS-CoV-2 incidence may contribute to differences in observed rates. METHODS:We examined risk factors for SARS-CoV-2 infection in a randomized controlled trial of hydroxychloroquine as postexposure prophylaxis. Study procedures included standardized questionnaires at enrollment and daily self-collection of midturbinate swabs for SARS-CoV-2 polymerase chain reaction testing. County-level incidence was modeled using federally sourced data. Relative risks and 95% confidence intervals were calculated using modified Poisson regression. RESULTS:Eighty-six of 567 (15.2%) household/social contacts and 12 of 122 (9.8%) healthcare worker contacts acquired SARS-CoV-2 infection. Exposure to 2 suspected index cases (vs 1) significantly increased risk for both household/social contacts (relative risk [RR], 1.86) and healthcare workers (RR, 8.18). Increased contact time also increased risk for healthcare workers (3-12 hours: RR, 7.82, >12 hours: RR, 11.81, vs ≤2 hours), but not for household/social contacts. County incidence did not impact risk. CONCLUSIONS:In our study, increased exposure to SARS-CoV-2 within household or healthcare settings led to higher risk of infection, but elevated community incidence did not. This reinforces the importance of interventions to decrease transmission in close contact settings.
PMCID:8903329
PMID: 35134185
ISSN: 1537-6613
CID: 5653292

Digestive Health in Sexual and Gender Minority Populations

Vélez, Christopher; Casimiro, Isabel; Pitts, Robert; Streed, Carl; Paul, Sonali
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.
PMID: 35537864
ISSN: 1572-0241
CID: 5289012

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

Kaul, Christina M; Haller, Matthew; Yang, Jenny; Solomon, Sadie; Wang, Yaojie; Wu, Rong; Meng, Yu; Pitts, Robert A; Phillips, Michael S
OBJECTIVE/UNASSIGNED:To characterize factors associated with increased risk of outpatient parenteral antimicrobial therapy (OPAT) complication. DESIGN/UNASSIGNED:Retrospective cohort study. SETTING/UNASSIGNED:Four hospitals within NYU Langone Health (NYULH). PATIENTS/UNASSIGNED: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/UNASSIGNED:< .001). CONCLUSIONS/UNASSIGNED: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.
PMCID:9672913
PMID: 36406163
ISSN: 2732-494x
CID: 5383982

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

Verma, Abhishek; Hine, Ashley M; Joelson, Andrew; Mei, Rena; Pitts, Robert A; Lebwohl, Benjamin; Axelrad, Jordan E
Introduction/UNASSIGNED: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/UNASSIGNED: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/UNASSIGNED:, giardiasis, and multiple pathogens. MSM status independently predicted enteric infection (aOR 1.93, 95% CI: 1.02-3.67). Conclusions/UNASSIGNED: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/UNASSIGNED:
PMCID:9058368
PMID: 35509422
ISSN: 1756-283x
CID: 5216292

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

Mclaughlin, Stephanie E; Kapadia, Farzana; Greene, Richard E; Pitts, Robert
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.
PMID: 34879782
ISSN: 1758-1052
CID: 5110312

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

Kaplan-Lewis, Emma; Banga, Jaspreet; Khan, Maria; Casey, Eunice; Mazumdar, Medha; Bratu, Simona; Abdallah, Marie; Pitts, Robert; Leider, Jason; Hennessey, Karen; Cohen, Gabriel M; Cleland, Charles M; Salama, Carlos
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.
PMID: 34780305
ISSN: 1557-7449
CID: 5046482

Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial

Barnabas, Ruanne V; Brown, Elizabeth R; Bershteyn, Anna; Stankiewicz Karita, Helen C; Johnston, Christine; Thorpe, Lorna E; Kottkamp, Angelica; Neuzil, Kathleen M; Laufer, Miriam K; Deming, Meagan; Paasche-Orlow, Michael K; Kissinger, Patricia J; Luk, Alfred; Paolino, Kristopher; Landovitz, Raphael J; Hoffman, Risa; Schaafsma, Torin T; Krows, Meighan L; Thomas, Katherine K; Morrison, Susan; Haugen, Harald S; Kidoguchi, Lara; Wener, Mark; Greninger, Alexander L; Huang, Meei-Li; Jerome, Keith R; Wald, Anna; Celum, Connie; Chu, Helen Y; Baeten, Jared M; ,
BACKGROUND:Effective prevention against coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is currently limited to nonpharmaceutical strategies. Laboratory and observational data suggested that hydroxychloroquine had biological activity against SARS-CoV-2, potentially permitting its use for prevention. OBJECTIVE:To test hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection. DESIGN:Household-randomized, double-blind, controlled trial of hydroxychloroquine postexposure prophylaxis. (ClinicalTrials.gov: NCT04328961). SETTING:National U.S. multicenter study. PARTICIPANTS:Close contacts recently exposed (<96 hours) to persons with diagnosed SARS-CoV-2 infection. INTERVENTION:Hydroxychloroquine (400 mg/d for 3 days followed by 200 mg/d for 11 days) or ascorbic acid (500 mg/d followed by 250 mg/d) as a placebo-equivalent control. MEASUREMENTS:Participants self-collected mid-turbinate swabs daily (days 1 to 14) for SARS-CoV-2 polymerase chain reaction (PCR) testing. The primary outcome was PCR-confirmed incident SARS-CoV-2 infection among persons who were SARS-CoV-2 negative at enrollment. RESULTS: = 0.026). LIMITATION:The delay between exposure, and then baseline testing and the first dose of hydroxychloroquine or ascorbic acid, was a median of 2 days. CONCLUSION:This rigorous randomized controlled trial among persons with recent exposure excluded a clinically meaningful effect of hydroxychloroquine as postexposure prophylaxis to prevent SARS-CoV-2 infection. PRIMARY FUNDING SOURCE:Bill & Melinda Gates Foundation.
PMID: 33284679
ISSN: 1539-3704
CID: 5865992

IMPROVING FELLOW COMFORT WITH STATIN PRESCRIPTION IN PATIENTS WITH CORONARY ARTERY DISEASE AND HUMAN IMMUNODEFICIENCY VIRUS ON ANTI-RETROVIRAL THERAPY [Meeting Abstract]

Jemal, N; Webster, T; Pitts, R A; Iqbal, S
Background Despite increased cardiovascular mortality in patients with HIV, studies have shown suboptimal rates of statin prescription among qualifying patients. Our initial trainee needs assessment survey revealed a lack of comfort and modifiable barriers to prescribing statins to patients with CAD and HIV on anti-retroviral therapy (ART). We sought to create a tool to mitigate these barriers and improve comfort and self-reported practice in prescribing statins to this population. Methods A 1-page tool detailing statin-ART co-administration regimens, common drug interactions and potential side effects was created and introduced to 24 cardiology and 8 infectious disease fellows at NYU School of Medicine. Ten weeks later, a post-intervention survey was conducted to assess comfort, barriers, and self-reported practice when prescribing statins to patients with HIV. Data was de-identified by a 3rd party. Results were excluded for lack of consent for study participation and incomplete and/or duplicate survey responses. Results Of the included 11 cardiology and 6 infectious disease fellows, 53% report using the tool in clinical decision making over 10 weeks. Of these, 78% report the tool increased comfort initiating and/or adjusting statin therapy and 89% report the tool increased overall comfort managing statins in patients with HIV. In our prior needs assessment survey, the majority of fellows cited one or more barriers to prescribing statins to patients with HIV and a minority reported always considering HIV status when deciding to initiate statin therapy. After introduction of the tool, however, over half of fellows report no barriers to prescribing statins to this population and 100% report they will now always consider HIV status when deciding to initiate statin therapy. Ultimately, 65% of fellows plan to use the 1-page tool in the future and 82% recommend that it be provided to future trainees. Conclusion Introduction and use of our 1-page tool improved trainee comfort, reduced known barriers, and improved self-reported practice when prescribing statins to patients with HIV. Integration of such a tool into the curriculum can improve trainee education in caring for a vulnerable population.
Copyright
EMBASE:2005038757
ISSN: 0735-1097
CID: 4358952