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The Role of the Multidisciplinary HIV Care Center in Mitigating Social Isolation Among Patients with HIV During the Early COVID-19 Pandemic

Mgbako, Ofole; Loughran, Claire; Vaughn, Michael P; Felder, Jason; Augustin, Ashley; Gordon, Peter; Remien, Robert H; Olender, Susan
As the COVID-19 pandemic began in 2020, significant public health mitigation efforts were vital to combat an unprecedented health crisis. These efforts, which involved social distancing and self-quarantine, likely worsened a public health crisis of social isolation and loneliness in the U.S., particularly among people with HIV (PWH). Multidisciplinary HIV care centers, which served as the main source of clinical care for PWH and in some cases the only point of social contact, faced evolving dynamics of in-person visits during the COVID-19 pandemic, as well as a shift to telehealth services. Using in-depth interviews, we explored the role that multidisciplinary HIV care centers and providers played in the experience of social isolation among PWH in New York City. We recruited participants (n = 30) from a multidisciplinary HIV care center in NYC between October 2020 and June 2021. We conducted semi-structured interviews to understand the specific domains of social isolation that were mitigated. In this cohort, the major theme that drove both in-person and telehealth care continuity was the strength of the patient-provider relationship. We found that participants saw members of the HIV care center as part of their social network, and providers served both as a source of emotional support and provided important social resources and benefits. Thus, in times of heightened social isolation, HIV care centers can play a critical role in providing social support in addition to clinical care.
PMID: 38856843
ISSN: 1573-3254
CID: 5668822

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

Garcia, Elizabeth A; Foote, Mary M K; McPherson, Tristan D; Lash, Maura K; Bosompem, Amma N; Bouscaren, Alyssa; Chan, Justin; DiLorenzo, Madeline A; Feihel, Dennis; Fowler, Randal C; Gandhi, Vani; Jenny-Avital, Elizabeth R; Kopping, Erik J; Mazo, Dana; McLean, Jacob; Mgbako, Ofole; Sayegh, Mark N; Shaw, Raphael N; Su, Michelle; Meissner, Jeanne Sullivan; Wang, Jade C; Wen, Wendy; Winters, John C; Zeana, Cosmina B; Zucker, Jason; Wong, Marcia
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.
PMID: 38868307
ISSN: 2328-8957
CID: 5668382

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.
PMID: 37043053
ISSN: 1573-3254
CID: 5590632

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: 5598892

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: 5591792

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