Long-acting injectable ART to advance health equity: a descriptive analysis of US clinic perspectives on barriers, needed support and programme goals for implementation from applications to the ALAI UP Project.

INTRODUCTION: Approval of the first long-acting injectable antiretroviral therapy (LAI ART) medication heralded a new era of HIV treatment. However, the years since approval have been marked by implementation challenges. The "Accelerating Implementation of Multilevel Strategies to Advance Long-Acting Injectable for Underserved Populations (ALAI UP Project)" aims to accelerate the systematic and equitable delivery of LAI ART. METHODS: We coded and analysed implementation barriers according to the Consolidated Framework for Implementation Research (CFIR) domains, desired resources and programme goals from questionnaire short-answer responses by clinics across the United States responding to ALAI UP's solicitation to participate in the project between November 2022 and January 2023. RESULTS: Thirty-eight clinics responded to ALAI UP's solicitation. The characteristics of LAI ART as an innovation (cost, complexity of procurement, dosing interval, limited eligibility) precipitated and interacted with barriers in other CFIR domains. Barriers included obtaining coverage for the cost of medication (27/38 clinics) (outer setting); need for new workflows and staffing (12/38) and/or systems to support injection scheduling/coordination (16/38), transportation and expanded clinic hours (13/38) (inner setting); and patient (10/38) and provider (7/38) education (individuals). To support implementation, applicants sought: technical assistance to develop protocols and workflows (18/38), specifically strategies to address payor challenges (8/38); additional staff for care coordination and benefits navigation (17/38); opportunities to share experiences with other implementing clinics (12/38); patient-facing materials to educate and increase demand (7/38); and support engaging communities (6/38). Clinics' LAI ART programme goals varied. Most prioritized delivering LAI ART to their most marginalized patients struggling to achieve viral suppression on oral therapy, despite awareness that current US Food and Drug Administration approval is only for virally suppressed patients. The goal for LAI ART reach after 1 year of implementation ranged from ≤10% of patients with HIV on LAI ART (17/38) to ≥50% of patients (2/38). CONCLUSIONS: Diverse clinic types are interested in offering LAI ART and most aspire to use LAI ART to support their most vulnerable patients sustain viral suppression. Dedicated resources centred on equity and relevant to context and population are needed to support implementation. Otherwise, the introduction of LAI ART risks exacerbating, not ameliorating, health disparities.

Severe Mpox Among People With Advanced Human Immunodeficiency Virus Receiving Prolonged Tecovirimat in New York City.

Severe mpox has been observed in people with advanced human immunodeficiency virus (HIV). We describe clinical outcomes of 13 patients with advanced HIV (CD4 <200 cells/µL), severe mpox, and multiorgan involvement. Despite extended tecovirimat courses and additional agents, including vaccinia immune globulin, cidofovir, and brincidofovir, this group experienced prolonged hospitalizations and high mortality.

A Prolonged Case of Severe Mpox as an Opportunistic Infection in Advanced AIDS.

The case report discusses a 29-year-old male with advanced HIV who experienced one of the longest, confirmed cases of monkeypox (mpox) infection. Despite treatment with antivirals and supportive care, including intravenous tecovirimat and vaccinia immune globulin, the patient's condition worsened over a six-and-a-half-month period. He suffered from widespread ulcerative, necrotic lesions and multiple complications, including acute kidney injury, multi-drug resistant bacterial infections, and respiratory failure. Despite repeated treatments, including brincidofovir, the patient remained PCR-positive for monkeypox virus (MPXV) with low cycle threshold (Ct) values, indicating active infection. The case underscores the severity of mpox in immunocompromised individuals, particularly those with advanced HIV, and highlights the challenges in managing such cases. The patient's persistently low CD4 count and unsuppressed HIV viral load likely contributed to the inability to clear the virus. The report emphasizes the need for further research to optimize treatment strategies for MPXV infection, especially in people living with HIV.

Get2PrEP2-A Provider Messaging Strategy to Improve PrEP Uptake: A Randomized Controlled Quality Improvement Project.

Introduction: HIV preexposure prophylaxis (PrEP), a key strategy for preventing HIV transmission, requires awareness and access to PrEP services. Although all patients should be made aware of HIV PrEP; the diagnosis of bacterial sexually transmitted infections (STIs) is an important indicator of potential HIV PrEP need. In a previous evaluation of Get2PrEP (G2P), we found that an electronic medical record laboratory comments did not increase the frequency of PrEP discussions between patients and providers. In Get2PrEP2 (G2P2), we hypothesized that active, personalized messaging to providers about HIV PrEP would increase the documentation of PrEP discussions, referrals, and/or provision of HIV PrEP to individuals diagnosed with an STI. Methods: G2P2 was a parallel 3-arm, unblinded, randomized controlled design. Participants were allocated 2:1 to intervention or control. Participants in the intervention arm were further allocated to receive provider messaging through the electronic medical record chat message or e-mail. Results: The 191 randomized encounters resulted in a modest 7.8% (odds ratio, 1.078; confidence interval, 1.02-1.13) increase in documented PrEP discussions in intervention encounters versus none in the standard care group. There was no statistical difference by intervention modality. All documented discussions occurred in the outpatient or emergency department and were more frequent in women and those aged <25 years. Discussion: An e-mail or electronic medical record chat message sent to providers of patients testing positive for an STI had a small but significant effect on documented patient-provider PrEP discussions. Further investigation is required to determine whether provider messaging can increase PrEP uptake among eligible patients and longer-term outcomes.

Management of Pustules and Vesicles in Afebrile Infants ≤60 Days Evaluated by Dermatology.

OBJECTIVES: To assess the management and outcomes of afebrile infants who received a pediatric dermatology consultation for pustules and/or vesicles. METHODS: Medical records were reviewed for all infants 60 days of age or younger who received a pediatric dermatology consult across 6 academic institutions between September 1, 2013 and August 31, 2019 to identify those infants with pustules and/or vesicles. RESULTS: Of the 879 consults, 183 afebrile infants presented with pustules and/or vesicles. No cerebrospinal fluid cultures or blood cultures were positive for bacteria. No concordant positive urine cultures were identified in infants with cutaneous infection. Nine infants were diagnosed with herpes simplex virus (HSV). Five preterm infants were diagnosed with angioinvasive fungal infections. CONCLUSIONS: No serious bacterial infections attributable to a skin source were identified, yet 53% of these infants received parenteral antibiotics. HSV was diagnosed in 7% of this cohort, 77.8% (7/9) of whom were term infants and 22.2% (2 of 9) of whom were preterm. Angioinvasive fungal infection was diagnosed in 3%, all of whom (100%, 5 of 5) were extremely preterm at <28 weeks gestational age. These findings suggest that in full-term afebrile infants ≤60 days, the likelihood of a life-threatening etiology of isolated pustules or vesicles is low once HSV infection is excluded. In preterm infants with pustules and/or vesicles, a high index of suspicion must be maintained, and broad infectious evaluation is recommended. HSV testing is recommended for all infants with vesicles, grouped pustules and/or punched-out erosions.

Evaluating Dual Process Decision-Making Along the PrEP Consumer Journey: New Insights for Supporting PrEP Use.

With the rise of new and emerging Pre-Exposure Prophylaxis (PrEP) modalities, greater attention is needed to better understand how people who could benefit from PrEP make decisions to initiate, stop, pause, or switch PrEP regimens. In this study we borrow from the field of consumer research to create a consumer-derived PrEP Consumer Journey Model that describes key decision-making touchpoints a PrEP consumer moves through within and outside of a clinical context. Using in-depth interviews (n = 29) with gay and bisexual men who have sex with men, we evaluate which system 1 (emotional) and system 2 (cognitive) attributes are used for decision-making at different touchpoints along the PrEP Consumer Journey. Our results suggest system 1 attributes, such as feeling protected, reducing anxiety, enhancing pleasure, social norms, and taking ownership over health were more salient when consumers moved from pre-contemplation to information gathering, as well as evaluating post-uptake experience. System 2 attributes, including cost, side effects, dosing schedule, and sexual frequency, were present throughout the PrEP Consumer Journey, but particularly influential in the information gathering stage and when pausing, switching, or opting out of PrEP. We contend the PrEP Consumer Journey, and our findings related to decision-making, can help orient medical providers to anticipated patient concerns around PrEP use and ultimately provide more supportive and engaging PrEP counseling and services.

Sexually Transmitted Infections in the Emergency Department.

As the United States faces a worsening epidemic of sexually transmitted infections (STIs), emergency departments (EDs) play a critical role in identifying and treating these infections. The growing health inequities in the distribution and disproportionate impact of STIs add to the urgency of providing high-quality sexual health care through the ED. Changes in population health are reflected in the new Centers for Disease Control recommendations on screening, diagnostic testing, and treatment of STIs. This review covers common, as well as and less common or emerging STIs, and discusses the state-of-the-art guidance on testing paradigms, extragenital sampling, and antimicrobial treatment and prevention of STIs.

Update on Mpox: What the Primary Care Clinician Should Know.

Mpox is a viral infection, which primarily caused sporadic outbreaks in West and Central Africa until causing a global epidemic in 2022. The disease has disproportionately affected people with human immunodeficiency virus and men who have sex with men. Transmission is through close physical contact, including sexual contact. Infection presents with a characteristic rash, with frequent anogenital involvement-polymerase chain reaction of skin lesions is diagnostic. Vaccination is available for primary prevention and postexposure prophylaxis. Treatment consists of supportive care, with antiviral medications available via clinical trials and/or for patients with severe disease.

Mpox in Children: 3 Cases.

Although the 2022 mpox outbreak mostly affected adults, its effect on children and adolescents was also substantial. In this report, we describe the clinical course and treatment of the first 3 known cases of mpox in children in New York City. These cases are instructive because they illustrate various routes of transmission, clinical presentations, and diagnostic challenges that differ from previous reports of mpox in endemic countries and previous mpox outbreaks. Of note is that each of the 3 patients received treatment with tecovirimat under an US Food and Drug Administration expanded access investigational new drug application and improved without exhibiting adverse reactions.

Mpox in people with past infection or a complete vaccination course: a global case series.

BACKGROUND: Since May, 2022, a large global outbreak of human mpox (formerly known as monkeypox) has predominantly affected men who have sex with men. The strain responsible, Clade IIb, has mutated substantially from precursors originating from the 2017-18 outbreak in Nigeria. Immunity to smallpox, another orthopoxvirus, via previous infection or vaccination provides lifelong immunity. However, since the 2022 mpox outbreak, recent clusters were described in individuals with presumed immunity through recent infection or vaccination. We aim to describe the epidemiological and clinical characteristics of mpox in individuals with past infection or vaccination to improve the understanding of this disease in the setting of previous immunity. METHODS: In this global case series, international collaborators from nine countries provided data on individuals with PCR-confirmed mpox after documented previous infection or vaccination between May 11, 2022, and June 30, 2023. We excluded cases that could not confirm vaccination status or cases with partial immunisation or any doses received before the current multi-national mpox outbreak (cutoff date May 1, 2022). Data were collected via a case report spreadsheet that reported on dates of infection and vaccination, route of immunisation, demographic characteristics, clinical findings, HIV status, concomitant sexually transmitted infections, and markers of disease severity (mpox severity score system). We describe case epidemiology, clinical course, and mpox severity scores; all analyses were descriptive. FINDINGS: We report mpox infections in 37 gay and bisexual men who have sex with men: seven individuals had mpox reinfections, 29 individuals had mpox infections that occurred after two appropriately spaced Modified Vaccinia Ankara-Bavarian Nordic vaccine courses, and one individual had an infection that met the criteria for both reinfection and infection after vaccination. The median age of individuals was 36 years (IQR 30-45; range 21-58). Those with natural immunity after initial infection had a shorter disease course with less mucosal disease upon reinfection than with their initial infection. Infections post-vaccination were characterised by few lesions, little mucosal disease, and minimal analgesia requirements; two people received oral tecovirimat. Overall, there were no deaths, no bacterial superinfections, and all individuals were managed in the ambulatory clinic with one hospital admission for a necrotising neck lesion. INTERPRETATION: The epidemiology of people with mpox reinfection or infection post-vaccination was similar to other published cohorts during the 2022 outbreak-predominantly young, sexually active gay and bisexual men who have sex with men. Clinical features and outcomes of repeat infection and infection after vaccination appear to be less clinically severe than those described in 2022 case literature. Specifically, compared with the 2022 case series, these individuals in the present study had fewer confluent lesions, less mucosal involvement, reduced analgesia requirement, and fewer admissions. Natural immunity and vaccine-induced immunity are not fully protective against mpox infection. However, in this small series both disease duration and severity appear to be reduced. FUNDING: None.

Development and Pilot of an Mpox Severity Scoring System.

Clinical severity scores facilitate comparisons to understand risk factors for severe illness. For the 2022 multinational monkeypox clade IIb virus outbreak, we developed a 7-item Mpox Severity Scoring System (MPOX-SSS) with initial variables refined by data availability and parameter correlation. Application of MPOX-SSS to the first 200 patients diagnosed with mpox revealed higher scores in those treated with tecovirimat, presenting >3 days after symptom onset, and with CD4 counts <200 cells/mm3. For individuals evaluated repeatedly, serial scores were concordant with clinical observations. The pilot MPOX-SSS demonstrated good discrimination, distinguished change over time, and identified higher scores in expected groups.

Prolonged Mpox Disease in People With Advanced HIV: Characterization of Mpox Skin Lesions.

We report 3 complicated and prolonged cases of mpox in people with advanced human immunodeficiency virus (HIV) not on antiretroviral therapy (ART) at mpox diagnosis. Multiple medical countermeasures were used, including prolonged tecovirimat treatment and immune optimization with ART initiation. Immunofluorescence of skin biopsies demonstrated a dense immune infiltrate of predominantly myeloid and CD8+ T cells, with a strong type I interferon local response. RNAscope detected abundant replication of monkeypox virus (MPXV) in epithelial cells and dendritic cells. These data suggest that prolonged mpox in people with advanced HIV may be due to ongoing MPXV replication, warranting aggressive medical countermeasures and immune optimization.

Examining Patient Preferences for Express, Telemedicine, and Standard Visits in a Sexual Health Clinic in New York City.

ABSTRACT: This study, completed at an sexually transmitted infection (STI) clinic in 2019 to 2020, evaluated patient preferences for telemedicine, express, and standard visits. Active PrEP users preferred telemedicine and express visits, patients with prior STIs preferred express visits, and cisgender women preferred standard visits. Configuring STI clinic visit types requires shared decision making and individualization.

Using a Health Information Exchange to Characterize Changes in HIV Viral Load Suppression and Disparities During the COVID-19 Pandemic in New York City.

Background: HIV viral suppression requires sustained engagement in care. The COVID-19 pandemic challenged care accessibility for many people living with HIV (PLWH). We used health information exchange data to evaluate the effect of pandemic-related disruptions in HIV care on viral load suppression (VLS) and to examine racial/ethnic disparities in VLS. Methods: We performed a retrospective observational cohort study of PLWH using data from a regional health information exchange in the New York City region between 1 January 2018 and 31 December 2022. We established 2 cohorts: PLWH who received HIV care in 2020 (cohort A) and PLWH who did not receive HIV care in 2020 (cohort B). We categorized HIV VLS outcomes as suppressed or not suppressed and calculated the prevalence of VLS between 2018 and 2022. We compared proportions using chi-square tests and used unadjusted and adjusted logistic regression to estimate the association among variables, including race/ethnicity, cohort, and VLS. Results: Of 5 301 578 patients, 34 611 met our inclusion criteria for PLWH, 11 653 for cohort A, and 3141 for cohort B. In 2019, cohort B had a lower prevalence of VLS than cohort A (86% vs 89%, P < .001). Between 2019 and 2021, VLS dropped significantly among cohort B (86% to 81%, P < .001) while staying constant in cohort A (89% to 89%, P = .62). By 2022, members of cohort B were less likely than cohort A to be receiving HIV care in New York City (74% vs 88%, P < .001). Within both cohorts, Black and Hispanic patients had lower odds of VLS than White patients. Conclusions: In New York City, VLS remained high among PLWH who continued to receive care in 2020 and dropped among PLWH who did not receive care. VLS was lower among Black and Hispanic patients even after controlling for receipt of care.

Mpox and HIV-Collision of Two Diseases.

PURPOSE OF REVIEW: The global outbreak of mpox has brought renewed attention to a previously neglected disease which is particularly severe in people with underlying untreated HIV co-infection. For this population, the disease is progressive, severe, and often lethal. In this review, we examine the pathogenesis of mpox disease and its collision with co-existent HIV infection and discuss key considerations for management as well as emerging clinical dilemmas and areas for future research. RECENT FINDINGS: Co-existent untreated HIV infection characterized by severe immunocompromise potentiates the nefarious effects of monkeypox virus infection leading to severe manifestations of mpox. Treating mpox in the context of HIV requires mpox-directed therapies, supportive care, and HIV-specific treatment to restore immune function. Preventative measures for PWH are like those in healthy individuals, but the effectiveness and durability of protection conferred by existing vaccines in PWH remain to be fully characterized. Mpox is an important opportunistic infection in PWH. Clinicians should be aware of the unique features of the disease in this population and approaches to care and management of mpox in PWH.

The Index of Engagement in PrEP Care: Evaluation of Psychometric Properties and Predictive Potential.

BACKGROUND: The Index of Engagement in HIV Care is a psychometrically valid 10-item self-report measure with predictive power to classify individuals to higher and lower odds of disengaging from HIV care. Given high rates of disengagement from preexposure prophylaxis (PrEP) care, we adapted the HIV Index to PrEP. METHODS: We evaluated the psychometric properties of the PrEP-Index in a cross-sectional validation among PrEP-eligible persons seen in an HIV Prevention Program and conducted exploratory analysis to assess its potential utility as a prognostic tool. The PrEP Index contains 10 items with answers ranging from (1) not at all to (5) extremely. Possible PrEP-Index scores ranged from 10 to 50, with higher sum scores representing higher levels of engagement. RESULTS: Study participants were cisgender men who have sex with men, and racially and ethnically diverse (non-Hispanic White = 39.2%). Factor analyses supported the 1-factor structure. Among 347 respondents, 118 individuals (34.0%) were available for predictive validity analysis. The PrEP Index score was positively associated with visit constancy at 6 months ( = 0.2261; 95% confidence interval: 0.0363 to 0.4051). Finally, a patient scoring 45 on the PrEP-Index will be classified as not returning within 6 months (sensitivity = 0.73, specificity = 0.65). CONCLUSIONS: The PrEP-Index is a psychometrically valid and reliable scale that demonstrates potential utility in identifying individuals at elevated risk of falling out of PrEP care by 6 months, the time point by which the majority of PrEP discontinuations occur. The PrEP-Index could be a useful clinical prognostic tool to allow for efficient resource targeting by clinics to improve engagement in PrEP care.

Predictors of missed HIV screening opportunities among newly diagnosed individuals at an urban medical center in New York City, 2018-2022.

OBJECTIVE: To identify demographic and clinical factors predictive of having a missed opportunity (MO) for HIV screening. DESIGN: Retrospective cohort study. METHODS: Electronic medical records were queried for individuals newly diagnosed with HIV in different sites within a large urban academic medical center in New York City between 2018 and 2022. The primary outcome was having one or more MO for HIV screening within the institution, defined as any encounter at which screening was not performed in the 365 days preceding the HIV diagnosis. RESULTS: Over one third of new diagnoses had at least one MO in the preceding year. Older individuals, cisgender women and those assigned female sex at birth, and heterosexual individuals were more likely to have at least one MO. An initial CD4 < 200 cells/ul was more likely among men who have sex with women specifically. Most MOs occurred in the emergency department and outpatient settings, with minimal HIV prevention discussions documented during each MO. CONCLUSIONS: These findings suggest that populations perceived to be at lower risk for HIV are more likely to have MOs and possibly late diagnoses, and that universal HIV screening must be implemented into the workflows of emergency department and outpatient settings to facilitate early diagnosis and reduce the incidence of HIV.

Otolaryngologic manifestations among MPOX patients: A systematic review and meta-analysis.

PURPOSE: MPOX has numerous otolaryngologic presentations that have been recognized as clinically important, especially with the onset of the 2022 outbreak. However, how these features vary across region and outbreak have yet to be elucidated or supported by meta-analysis. The objective of this study is to identify the otolaryngologic manifestations of MPOX across previous and current outbreaks and among endemic and non-endemic regions. BASIC PROCEDURES: Data sources of MEDLINE (PubMed), the Cochrane Library, Scopus, Embase, Web of Science, Google Scholar, and OpenGrey were searched through August 2022. All observational studies reporting data on laboratory-confirmed MPOX patients with otolaryngologic symptoms were included. Two authors independently performed the screening process while a third resolved disagreements. Data were extracted into a structured form by two authors independently. We performed a meta-analysis of the prevalence of otorhinolaryngologic symptoms using MetaXL software (version 5.3) under a random-effects model. MAIN FINDINGS: 38 studies with 5952 patients were included. The four most prevalent manifestations were headache at 31 % (95 % CI [0.16-0.49], I 2  = 99 %), sore throat at 22 % (95 % CI [0.09-0.37], I 2  = 99 %), cough at 16 % (95 % CI [0.05-0.30], I 2  = 99 %), and cervical lymphadenopathy at 10 % (95 % CI [0.01-0.26], I 2  = 100 %). Otolaryngologic features were more prevalent in previous outbreaks as compared to the 2022 outbreak including 37 % prevalence of headache (95 % CI [0.11-0.66], I 2  = 100 %), 33 % prevalence of cough (95 % CI [0.21-0.47], I 2  = 98 %), 27 % prevalence of sore throat (95 % CI [0.07-0.53], I 2  = 99 %), 15 % prevalence of cervical lymphadenopathy (95 % CI [0.00-0.428], I 2  = 100 %), 13 % prevalence of oral ulcers (95 % CI [0.02-0.30], I 2  = 99 %), 6 % prevalence of oral exanthem (95 % CI [0.00-0.17], I 2  = 99 %), 5 % prevalence of dysphagia (95 % CI [0.00-0.18], I 2  = 99 %), and 5 % prevalence of tonsillar signs (95 % CI [0.00-0.13], I 2  = 99 %). Features that were more prevalent in endemic areas versus non-endemic areas include 27 % prevalence of cough (95 % CI [0.14-0.41], I 2  = 99 %), 15 % prevalence of oral ulcers (95 % CI [0.02-0.36], I 2  = 99 %), 6 % prevalence of tonsillar signs (95 % CI [0.00-0.18], I 2  = 99 %), and 19 % prevalence of cervical lymphadenopathy (95 % CI [0.00-0.48], I 2  = 100 %), while the only feature more prevalent in non-endemic areas was headache with a prevalence of 36 % (95 % CI [0.24-0.47], I 2  = 96 %). PRINCIPAL CONCLUSIONS: In this systematic review and meta-analysis, four symptoms - headache, sore throat, cough, and cervical lymphadenopathy - were found to be the most prevalent otolaryngologic features of MPOX. Otolaryngologic manifestations of MPOX were more pronounced in prior outbreaks and in endemic areas as compared to the 2022 outbreak and non-endemic areas. These findings may aid MPOX recognition in an otolaryngology setting.