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

Chan, Justin; DiTullio, David J; Pagan Pirallo, Patricia; Foote, Mary; Knutsen, Dorothy; Kottkamp, Angelica Cifuentes; McPherson, Tristan D; Mukherjee, Vikramjit; Pitts, Robert; Wallach, Andrew; Wong, Marcia; Mazo, Dana; Mgbako, Ofole
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.
PMID: 37632124
ISSN: 1758-1109
CID: 5564092

Comparing Predictive Ability of Two Objective Adherence Measures in a Community-Based Cohort on Antiretroviral Therapy in South Africa: Tenofovir Diphosphate Concentrations and Electronic Adherence Monitors

Jennings, Lauren; Ferraris, Christopher M; Castillo-Mancilla, Jose R; Robbins, Reuben N; Nguyen, Nadia; Leu, Cheng-Shiun; Dolezal, Curtis; Hsiao, Nei-Yuan; Mgbako, Ofole; Joska, John; Myer, Landon; Anderson, Peter L; Remien, Robert H; Orrell, Catherine
BACKGROUND:Electronic adherence (EA) and tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) are objective measures of antiretroviral therapy (ART) adherence. We characterized the association between these measures in a prospective cohort of persons with HIV (PWH) on ART. SETTING:Four primary health clinics in Cape Town, South Africa. METHODS:We enrolled 250 virally suppressed PWH receiving tenofovir-based ART. We collected EA data, monthly viral load, and TFV-DP in DBS for 12 months. We used logistic regression to estimate the adjusted odds ratio (aOR) and 95% confidence intervals (CIs) for future viral breakthrough (VB) (>400 copies/mL) for each adherence measure. Receiver operating characteristics (ROCs) provided the predictive power of these measures. RESULTS:Participants had a median (IQR) age of 34 (27-42); 78% were women. Twenty-one (8%) developed VB. Logistic regression showed that when percent EA and TFV-DP concentrations increased, the odds of VB decreased. This relationship was consistent at the time of VB (aOR of 0.41 [95% CI: 0.25 to 0.66] for TFV-DP and aOR of 0.64 [95% CI: 0.54 to 0.76] for EA) and for up to 2 months before VB. Both adherence measures predicted future VB at both 1 month and 2 months before viral load measurement. CONCLUSION:We established that 2 objective adherence measures, EA and TFV-DP in DBS, have a positive association with, and are both strongly predictive of, VB in a community-based South African cohort on ART. Future research is needed to determine the feasibility of implementing these adherence measures in resource-limited settings to facilitate adherence interventions.
PMID: 36976520
ISSN: 1944-7884
CID: 5538132

An Equity-Focused Care Continuum Framework for Mpox and Future Infectious Disease Outbreaks: A Public Health of Consequence, July 2023 [Comment]

Pitts, Robert A; Cifuentes Kottkamp, Angelica; Mgbako, Ofole
PMID: 37285568
ISSN: 1541-0048
CID: 5541292

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

Mgbako, Ofole; Chan, Justin; Pitts, Robert A.; Dilorenzo, Madeline A.; Knutsen, Dorothy; Mazo, Dana
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.
ISSN: 2732-494x
CID: 5548652

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

Piccolo, Anthony J Lo; Chan, Justin; Cohen, Gabriel M; Mgbako, Ofole; Pitts, Robert A; Postelnicu, Radu; Wallach, Andrew; Mukherjee, Vikramjit
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.
PMID: 37514954
ISSN: 2076-393x
CID: 5559082

Rapid or Immediate ART, HIV Stigma, Medical Mistrust, and Retention in Care: An Exploratory Mixed Methods Pilot Study

Mgbako, Ofole; Loughran, Claire; Mathu, Rachel; Castor, Delivette; McLean, Jacob; Sobieszczyk, Magdalena E; Olender, Susan; Gordon, Peter; Lopez-Rios, Javier; Remien, Robert H
Rapid or immediate antiretroviral therapy (iART) after HIV diagnosis improves linkage to care and time to viral suppression. However, iART may affect or be affected by HIV-related stigma and medical mistrust. In this mixed-methods pilot study, we examined the bi-directional role of HIV stigma, medical mistrust, and visit adherence (VA) in the context of iART in a diverse, newly diagnosed patient population. Participants were recruited from an HIV clinic in New York City and we utilized a convergent parallel design integrating quantitative data from demographic surveys, the HIV Stigma Survey (HIVSS), the Medical Mistrust Index (MMI) and electronic medical records, and qualitative data from in-depth interviews. Among the sample (N = 30), 26% (N = 8) initiated ART same-day or within 3 days, while the majority (N = 17) initiated between 4 and 30 days, and 17% (N = 5) initiated ART > 30 days. The median (range) age was 35, and most were English-speaking, Black or Hispanic men and identified as gay. Time to ART initiation was associated with time to linkage to care and time to viral suppression. Day 0-3 group's major theme was iART as stigma prevention, and they had the highest mean HIVSS, lowest MMI score, and a visit adherence of 0.86. Day 4-30 group's major theme was alleviation of internalized stigma, and they had the lowest mean HIVSS score, and highest visit adherence of 0.91. Day > 30 group's major theme was exacerbation of perceived or anticipated stigma, had the highest MMI score and a visit adherence of 0.85. iART implementation requires equitable strategies that address HIV-stigma and mistrust.
PMID: 37071333
ISSN: 1573-3254
CID: 5466072

Bictegravir-Induced Drug Reaction with Eosinophilia and Systemic Symptoms in a Patient with Acute Human Immunodeficiency Virus

DiLorenzo, Madeline A.; Medrano, Nicola; Chen, Jason N.; Bawany, Fatima; Tran, Duy C.; Taunk, Pulkit; Meehan, Shane A.; Pomeranz, Miriam Keltz; Mgbako, Ofole
Although drug reaction with eosinophilia and systemic symptoms (DRESS) is associated with antiretrovirals, there are no published reports of bictegravir-induced DRESS. Bictegravir is recommended as first-line treatment for patients with human immunodeficiency virus (HIV). Recognition of DRESS, its skin manifestations, and potential complications is vital for appropriate care and management of acute HIV.
ISSN: 2328-8957
CID: 5461952

Acceptability and Feasibility of Providing Adherence Feedback Based on Tenofovir Diphosphate in Dried Blood Spots: Results from a Pilot Study Among Patients and Providers in Cape Town, South Africa

Ferraris, Christopher M.; D"™avanzo, Paul A.; Jennings, Lauren; Robbins, Reuben N.; Nguyen, Nadia; Leu, Cheng Shiun; Dolezal, Curtis; Mgbako, Ofole; Hsiao, Nei yuan; Joska, John; Castillo-mancilla, Jose R.; Myer, Landon; Anderson, Peter L.; Belaunzarán-zamudio, Pablo F.; Mellins, Claude A.; Orrell, Catherine; Remien, Robert H.
Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) predict viral breakthrough, but their use remains understudied in real-world clinic settings. This pilot study examined acceptability, feasibility, and initial adherence outcomes of providing adherence feedback using TFV-DP concentrations on patient- and provider-levels in Cape Town, South Africa. We enrolled 60 persons with HIV (PWH) receiving tenofovir-containing ART attending a primary health clinic. They were randomized 1:1 to an intervention receiving TFV-DP concentration feedback by research staff vs. no feedback at monthly visits for 4 months. Acceptability among medical providers and level of clinical follow-up of TFV-DP results was examined. Patient acceptability was assessed descriptively. Mean electronic adherence (EA), as measured by WisePill device, and TFV-DP in DBS were compared between the two arms. All participants in the intervention group (100%) reported finding TFV-DP feedback helpful and 86% reported changing adherence behaviors. Medical providers indicated high acceptability of incorporating TFV-DP concentration feedback into the clinic, yet among 29 results < 1000 fmol/punch, only 2 were reviewed with no follow-up actions performed. In the intervention arm, mean TFV-DP concentrations were significantly higher (t = 2.5, p <.01) during follow-up and EA in upper quartile (96"“100%) was greater compared to controls (x2 = 7.8, p ≤.05). This study found high acceptability among patients for receiving adherence feedback based on TFV-DP concentrations. TFV-DP and EA data demonstrated greater adherence in the intervention group. Providers indicated high acceptability of incorporating TFV-DP feedback into the clinic, but few providers reviewed results, which could impact clinic-level feasibility.
ISSN: 1090-7165
CID: 5461042

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

Lo Piccolo, Anthony J; Wallach, Andrew; McPherson, Tristan D; Mgbako, Ofole; Fagan, Ian; Pitts, Robert A; Klinger, Amanda; Foote, Mary; Garcia, Elizabeth A; Zucker, Jason E; Chan, Justin; Bails, Douglas B; Cohen, Gabriel M; Tennill, Patricia Ann; Wong, Marcia; Mukherjee, Vikramjit
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.
PMID: 36862506
ISSN: 2326-5108
CID: 5427702

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/CONCLUSIONS: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.
PMID: 37725628
ISSN: 1932-6203
CID: 5564012