Pharmacokinetics and Safety of Remdesivir in Pregnant and Non-Pregnant Women with COVID-19: Results from IMPAACT 2032.

BACKGROUND: Pregnant people with COVID-19 experience higher risk for severe disease and adverse pregnancy outcomes, but no pharmacokinetic (PK) data exist to support dosing of COVID-19 therapeutics during pregnancy. We report PK and safety data for intravenous remdesivir in pregnancy. METHODS: IMPAACT 2032 was a phase IV prospective, open-label, non-randomized opportunistic study of hospitalized pregnant and non-pregnant women receiving intravenous remdesivir as part of clinical care. Intensive PK sampling was performed on infusion days 3, 4, or 5 with collection of plasma and peripheral blood mononuclear cells (PBMCs). Safety data were recorded from first infusion through 4 weeks post-last infusion and at delivery. Geometric mean ratios (GMR) (90% confidence intervals [CI]) of PK parameters between pregnant and non-pregnant women were calculated. RESULTS: Fifty-three participants initiated remdesivir (25 pregnant; median (IQR) gestational age 27.6 (24.9, 31.0) weeks). Plasma exposures of remdesivir, its two major metabolites (GS-704277 and GS-441524), and the free remdesivir fraction were similar between pregnant and non-pregnant participants. Concentrations of the active triphosphate (GS-443902) in PBMCs increased 2.04-fold (90% CI 1.35, 3.03) with each additional infusion in non-pregnant versus pregnant participants. Three adverse events in non-pregnant participants were related to treatment (one Grade 3; two Grade 2 resulting in treatment discontinuation). There were no treatment-related adverse pregnancy outcomes or congenital anomalies detected. CONCLUSIONS: Plasma remdesivir PK parameters were comparable between pregnant and non-pregnant women, and no safety concerns were identified based on our limited data. These findings suggest no dose adjustments are indicated for intravenous remdesivir during pregnancy.

In Support of Breast/Chest Feeding by People with HIV in High-Income Settings.

Given that HIV can be transmitted through breastfeeding, historically, breastfeeding among women with HIV in the United States and other resource rich settings was actively discouraged. Formula feeding was mandated as the only feeding option primarily out of concern for breastmilk transmission of HIV, which occurred in 16-24%1-3 of cases pre-antiretroviral therapy (ART) use. In January 2023, the United States' Department of Health and Human Services (DHHS) Perinatal Guidelines were updated to support shared decision making for infant feeding choices4. Updated data from clinical trials in low- and middle-income settings suggest that the actual rate of HIV transmission through breastmilk in the context of maternal ART or neonatal post-exposure prophylaxis (PEP) is 0.3-1%1-3. High income countries are reporting increasing numbers of people with HIV breastfeeding their infants without cases of HIV transmission to date5-10. Here we will present the reasons for fully embracing breast/chestfeeding as a viable and safe infant feeding option for HIV-exposed infants in high-income settings now, while acknowledging unanswered questions and the need to continually craft more nuanced clinical guidance.

Projecting the Potential Clinical and Economic Impact of Human Immunodeficiency Virus Prevention Resource Reallocation in Tennessee.

BACKGROUND: In 2023, Tennessee replaced $6.2 M in US Centers for Disease Control and Prevention (CDC) human immunodeficiency virus (HIV) prevention funding with state funds to redirect support away from men who have sex with men (MSM), transgender women (TGW), and heterosexual Black women (HSBW) and to prioritize instead first responders (FR), pregnant people (PP), and survivors of sex trafficking (SST). METHODS: We used a simulation model of HIV disease to compare the clinical impact of Current, the present allocation of condoms, preexposure prophylaxis (PrEP), and HIV testing to CDC priority risk groups (MSM/TGW/HSBW); with Reallocation, funding instead increased HIV testing and linkage of Tennessee-determined priority populations (FR/PP/SST). Key model inputs included baseline condom use (45%-49%), PrEP provision (0.1%-8%), HIV testing frequency (every 2.5-4.8 years), and 30-day HIV care linkage (57%-65%). We assumed Reallocation would reduce condom use (-4%), PrEP provision (-26%), and HIV testing (-47%) in MSM/TGW/HSBW, whereas it would increase HIV testing among FR (+47%) and HIV care linkage (to 100%/90%) among PP/SST. RESULTS: Reallocation would lead to 166 additional HIV transmissions, 190 additional deaths, and 843 life-years lost over 10 years. HIV testing reductions were most influential in sensitivity analysis; even a 24% reduction would result in 287 more deaths compared to Current. With pessimistic assumptions, we projected 1359 additional HIV transmissions, 712 additional deaths, and 2778 life-years lost over 10 years. CONCLUSIONS: Redirecting HIV prevention funding in Tennessee would greatly harm CDC priority populations while conferring minimal benefits to new priority populations.

Advancing Adolescent and Young Adult HIV Prevention and Care and Treatment Through Use of Multi-level Theories and Frameworks: A Scoping Review and Adapted HIV Ecological Framework.

While multi-level theories and frameworks have become a cornerstone in broader efforts to address HIV inequities, little is known regarding their application in adolescent and young adult (AYA) HIV research. To address this gap, we conducted a scoping review to assess the use and application of multi-level theories and frameworks in AYA HIV prevention and care and treatment empirical research. We systematically searched five databases for articles published between 2010 and May 2020, screened abstracts, and reviewed eligible full-text articles for inclusion. Of the 5890 citations identified, 1706 underwent full-text review and 88 met the inclusion criteria: 70 focused on HIV prevention, with only 14 on care and treatment, 2 on both HIV prevention and care and treatment, and 2 on HIV-affected AYA. Most authors described the theory-based multi-level framework as informing their data analysis, with only 12 describing it as informing/guiding an intervention. More than seventy different multi-level theories were described, with 38% utilizing socio-ecological models or the eco-developmental theory. Findings were used to inform the adaptation of an AYA World Health Organization multi-level framework specifically to guide AYA HIV research.

HIV and women in the USA: what we know and where to go from here.

New diagnoses of HIV infection have decreased among women in the USA overall, but marked racial and geographical disparities persist. The federal government has announced an initiative that aims to decrease the number of new infections in the nation by 90% within the next 10 years. With this in mind, we highlight important recent developments concerning HIV epidemiology, comorbidities, treatment, and prevention among women in the USA. We conclude that, to end the US HIV epidemic, substantially greater inclusion of US women in clinical research will be required, as will better prevention and treatment efforts, with universal access to health care and other supportive services that enable women to exercise agency in their own HIV prevention and care. Ending the epidemic will also require eliminating the race, class, and gender inequities, as well as the discrimination and structural violence, that have promoted and maintained the distribution of HIV in the USA, and that will, if unchecked, continue to fuel the epidemic in the future.

Realizing the promise of long-acting antiretroviral treatment strategies for individuals with HIV and adherence challenges: an illustrative case series.

BACKGROUND: Adherence to antiretroviral treatment (ART) remains the cornerstone of optimal HIV outcomes, including viral suppression (VS), immune recovery, and decreased transmission risk. For many people with HIV (PWH), particularly those with early-acquired HIV, structural, behavioral, and cognitive barriers to adherence and competing priorities related to life events may be difficult to overcome, resulting in nonadherence. Long-acting injectable antiretroviral therapies (LAI-ART) may be a useful strategy to overcome some of these barriers. However, to date, the approved LAI-ART strategies (e.g., cabotegravir and rilpivirine (CAB/RPV)) have targeted those who have already attained viral suppression, precluding their use in the 40% of adolescents and young adults (AYA) that VS has eluded. CASE PRESENTATION: Ms. X is a 30-year-old woman with perinatally-acquired HIV and barriers to adherence. Despite many interventions, she remained persistently viremic, with resultant immune suppression and multiple comorbid opportunistic conditions, and viral load (VL) > 10,000,000 copies/ml. Given her longstanding history of poor adherence to an oral regimen, a switch to monthly intramuscular (IM) injections and biweekly infusions of ibalizumab were initiated leading to decreased viral load to 8,110 copies/ml within two weeks. Ms. H is a 33-year-old woman with cognitive limitations due to childhood lead poisoning. Her viral load trajectory took a downward turn, precipitated by various life events, remaining elevated despite intensive case management. Initiation of LAI-ART (CAB/RPV) in this patient led to an undetectable VL (< 20 copies/ml) within two months of treatment initiation. Miss Y. is a 37-year-old woman with perinatally-acquired HIV and chronic challenges with nonadherence and longstanding immunosuppression with CD4 < 200 cells/mm3 for > 5 years. She received a 1-month oral lead-in (OLI) of cabotegravir/rilpivirine, followed by the injectable loading dose. She has since adhered to all her monthly dosing appointments, sustained VS, and transitioned to a bi-monthly injection schedule. CONCLUSION: These three individuals with HIV (perinatally and non-perinatally acquired) with longstanding nonadherence and persistent viremia were successfully initiated on LAI-ART through the process of care coordination and the collective efforts of the care team, highlighting the barriers, challenges, and the multidisciplinary coordination needed to assure successful implementation of this strategy for the most vulnerable of patients.

Safety, Tolerability, and Pharmacokinetics of a Long-Acting Broadly Neutralizing Human Immunodeficiency Virus Type 1 (HIV-1) Monoclonal Antibody VRC01LS in HIV-1-Exposed Newborn Infants.

BACKGROUND: Perinatal human immunodeficiency virus type 1 (HIV-1) continues to occur due to barriers to effective antiretroviral prevention that might be mitigated by long-acting broadly neutralizing monoclonal antibodies (bNAbs). METHODS: An extended half-life bNAb, VRC01LS, was administered subcutaneously at 80 mg/dose after birth to HIV-1-exposed, nonbreastfed (cohort 1, n = 10) and breastfed (cohort 2, n = 11) infants. Cohort 2 received a second dose (100 mg) at 12 weeks. All received antiretroviral prophylaxis. VRC01LS levels were compared to VRC01 levels determined in a prior cohort. RESULTS: Local reactions (all grade ≤2) occurred in 67% and 20% after dose 1 and dose 2, respectively. The weight-banded dose (mean 28.8 mg/kg) of VRC01LS administered subcutaneously achieved a mean (standard deviation) plasma level of 222.3 (71.6) µg/mL by 24 hours and 44.0 (11.6) µg/mL at week 12, prior to dose 2. The preestablished target of ≥50 µg/mL was attained in 95% and 32% at weeks 8 and 12, respectively. The terminal half-life was 37-41 days. VRC01LS level after 1 dose was significantly greater (P <.002) than after a VRC01 dose (20 mg/kg). No infants acquired HIV-1. CONCLUSIONS: VRC01LS was well tolerated with pharmacokinetics that support further studies of more potent long-acting bNAbs as adjunct treatment with antiretrovirals to prevent infant HIV-1 transmission.

Perinatal Depressive Symptoms, Human Immunodeficiency Virus (HIV) Suppression, and the Underlying Role of Antiretroviral Therapy Adherence: A Longitudinal Mediation Analysis in the IMPAACT P1025 Cohort.

BACKGROUND: Women with HIV have higher risk of depressive symptoms in the perinatal period. Evidence on how perinatal depressive symptoms affect viral suppression (VS) and adherence to antiretroviral therapy (ART) remains limited. METHODS: Perinatal depressive symptoms were assessed using 6 items from the AIDS Clinical Trials Group (ACTG) Quality of Life questionnaire. VS (viral load <400 copies/mL) was the outcome. Adherence was defined as no missed dose in the past 1-4 weeks using the ACTG Adherence Questionnaire. Generalized mixed-effects structural equation models estimated the association of depressive symptoms on VS and the mediating role of ART adherence among women enrolled in the IMPAACT P1025 Perinatal Core Protocol (2002-2013). RESULTS: Among 1869 participants, 47.6% were 21-29 years, 57.6% non-Hispanic Black. In the third trimester, the mean depressive symptoms score was 14.0 (±5.2), 68.0% had consistent adherence, and 77.3% achieved VS. At 6 months postpartum, depressive symptoms declined while adherence and VS fell to 59.8% and 53.0%, respectively. In the fully adjusted model, a 1-SD increase in depressive symptoms was associated with a 3.8-percentage-point (95% CI: -5.7, -1.9) decline in VS. This effect is the sum of the indirect effect of depressive symptoms on VS via ART adherence (-0.4; 95% CI: -.7, -.2) and the direct effect through other pathways (-3.4; -5.2, -1.5). The decline in adherence driven by depressive symptoms accounted for ≥11% of the total negative effect of depressive symptoms on VS. CONCLUSIONS: Perinatal depressive symptoms were associated with decreased adherence and VS, highlighting the need to screen for, diagnose, and treat perinatal depression to optimize maternal outcomes. CLINICAL TRIALS REGISTRATION: NCT00028145.

Primary Care Guidance for Persons With Human Immunodeficiency Virus: 2020 Update by the HIV Medicine Association of the Infectious Diseases Society of America.

Advances in antiretroviral therapy (ART) have made it possible for persons with human immunodeficiency virus (HIV) to live a near expected life span, without progressing to AIDS or transmitting HIV to sexual partners or infants. There is, therefore, increasing emphasis on maintaining health throughout the life span. To receive optimal medical care and achieve desired outcomes, persons with HIV must be consistently engaged in care and able to access uninterrupted treatment, including ART. Comprehensive evidence-based HIV primary care guidance is, therefore, more important than ever. Creating a patient-centered, stigma-free care environment is essential for care engagement. Barriers to care must be decreased at the societal, health system, clinic, and individual levels. As the population ages and noncommunicable diseases arise, providing comprehensive healthcare for persons with HIV becomes increasingly complex, including management of multiple comorbidities and the associated challenges of polypharmacy, while not neglecting HIV-related health concerns. Clinicians must address issues specific to persons of childbearing potential, including care during preconception and pregnancy, and to children, adolescents, and transgender and gender-diverse individuals. This guidance from an expert panel of the HIV Medicine Association of the Infectious Diseases Society of America updates previous 2013 primary care guidelines.

Innovations in Human Immunodeficiency Virus (HIV) Care Delivery During the Coronavirus Disease 2019 (COVID-19) Pandemic: Policies to Strengthen the Ending the Epidemic Initiative-A Policy Paper of the Infectious Diseases Society of America and the HIV Medicine Association.

The goal of the Ending the HIV Epidemic Initiative is to reduce new infections in the United States by 90% by 2030. Success will require fundamentally changing human immunodeficiency virus (HIV) prevention and care delivery to engage more persons with HIV and at risk of HIV in treatment. While the coronavirus disease 2019 (COVID-19) pandemic reduced in-person visits to care facilities and led to concern about interruptions in care, it also accelerated growth of alternative options, bolstered by additional funding support. These included the use of telehealth, medication delivery to the home, and increased flexibility facilitating access to Ryan White HIV/AIDS Program services. While the outcomes of these programs must be studied, many have improved accessibility during the pandemic. As the pandemic wanes, long-term policy changes are needed to preserve these options for those who benefit from them. These new care paradigms may provide a roadmap for progress for those with other chronic health issues as well.

Modeling Adherence Interventions Among Youth with HIV in the United States: Clinical and Economic Projections.

The Adolescent Medicine Trials Network for HIV/AIDS Interventions is evaluating treatment adherence interventions (AI) to improve virologic suppression (VS) among youth with HIV (YWH). Using a microsimulation model, we compared two strategies: standard-of-care (SOC) and a hypothetical 12-month AI that increased cohort-level VS in YWH in care by an absolute ten percentage points and cost $100/month/person. Projected outcomes included primary HIV transmissions, deaths and life-expectancy, lifetime HIV-related costs, and incremental cost-effectiveness ratios (ICERs, $/quality-adjusted life-year [QALY]). Compared to SOC, AI would reduce HIV transmissions by 15% and deaths by 12% at 12 months. AI would improve discounted life expectancy/person by 8 months at an added lifetime cost/person of $5,300, resulting in an ICER of $7,900/QALY. AI would be cost-effective at $2,000/month/person or with efficacies as low as a 1 percentage point increase in VS. YWH-targeted adherence interventions with even modest efficacy could improve life expectancy, prevent onward HIV transmissions, and be cost-effective.

RESUMEN: La Red de Ensayos Médicos sobre Adolescentes para Realizar Intervenciones sobre el VIH/SIDA está evaluando intervenciones de adherencia (IAs) al tratamiento para mejorar la supresión virológica (SV) entre los jóvenes con VIH (JCV). Usando un modelo de microsimulación, comparamos dos estrategias: cuidado convencional (CC) y una intervención de adherencia hipotética durando 12 meses que aumentaría la SV a nivel de cohorte entre JCV en tratamiento por 10 puntos de porcentuales y que costaría US$ 100/mes/persona. Resultados proyectados incluyeron transmisiones de VIH primarias, muertes y esperanza de vida, costos de por vida asociados con el VIH, y razones incrementales de costo-efectividad (RICEs, $/año de vida ajustado por la calidad [AVAC]). Comparado al CC, la IA reduciría transmisiones de VIH por 15% y muertes por 12% a los 12 meses. La IA mejoraría esperanza de vida descontada/persona por 8 meses a un costo de por vida adicional/persona de US$ 5.300, resultando en una RICE de US$ 7.900/AVAC. La IA sería costo-efectiva a un costo de US$ 2.000/mes/persona o si mejorara SV por al menos un punto porcentual. Intervenciones de adherencia dirigidas a jóvenes con una eficacia incluso modesta podrían mejorar esperanza de vida, prevenir transmisiones de VIH, y ser costo-efectivas.

The Latent Human Immunodeficiency Virus (HIV) Reservoir Resides Primarily in CD32-CD4+ T Cells in Perinatally HIV-Infected Adolescents With Long-Term Virologic Suppression.

Background: High-level expression of the Fcγ receptor, CD32hi, on CD4+ T cells was associated with enhanced human immunodeficiency virus (HIV) infection of the latent reservoir in a study of adults receiving antiretroviral therapy. We tested the hypothesis that CD32 was the preferential marker of the latent HIV reservoir in virally suppressed, perinatally HIV-infected adolescents. Methods: The frequency of CD32hiCD4+ T cells was determined by flow cytometry (N = 5) and the inducible HIV reservoir in both CD32hi and CD32-CD4+ T cells was quantified (N = 4) with a quantitative viral outgrowth assay. Viral outgrowth was measured by the standard p24 enzyme-linked immunosorbent assay and an ultrasensitive p24 assay (Simoa; Quanterix) with lower limits of quantitation. Results: We found a 59.55-fold enrichment in the absolute number of infectious cells in the CD32- population compared with CD32hi cells. Exponential HIV replication occurred exclusively in CD32-CD4+ T cells (mean change, 17.46 pg/mL; P = .04). Induced provirus in CD32hiCD4+ T cells replicated to substantially lower levels, which did not increase significantly over time (mean change, 0.026 pg/mL; P = .23) and were detected only with the Simoa assay. Conclusions: Our data suggests that the latent HIV reservoir resides mainly in CD32-CD4+ T cells in virally suppressed, perinatally HIV-infected adolescents, which has implications for reservoir elimination strategies.

Gonorrhoea and chlamydia in persons with HIV: number needed to screen.

OBJECTIVES: Current guidelines recommend screening sexually active persons with HIV (PWH) for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) at least annually. Yet, screening rates in many HIV clinics remain low. In this study, we estimated the number needed to screen (NNS) to detect a NG and/or CT infection at each anatomic site among different subpopulations of PWH. NNS provides a concrete, practical measure to aid in assessing the practical impact of screening. METHODS : We included adults in care at three HIV Research Network sites in 2011-2014. Restricting to first tests within each year, annual NNS was defined as number of persons tested divided by number positive. We computed urogenital and extragenital NNS by age and risk group (women, men who have sex with women (MSW) and men who have sex with men (MSM)). RESULTS : A total of 16 864 NG/CT tests were included. Among patients aged ≤25 years, urogenital NNS was similar among women (15 (95% CI 6 to 71)), MSW (21 (95% CI 6 to 167)) and MSM (20 (95% CI 12 to 36)). Over 25, urogenital NNS increased to a greater extent for women (363 (95% CI 167 to 1000)) and MSW (160 (95% CI 100 to 333)) than MSM (46 (95% CI 38 to 56)). The increase for women versus MSM >25 remained significant (p<0.01) in multivariable analysis. Among MSM, rectal NNS was 5 (95% CI 3 to 7) and 10 (95% CI 9 to 12) for ≤25 and for >25 years and pharyngeal NNS values were 8 (95% CI 5 to 13) and 20 (95% CI 16 to 24). CONCLUSIONS: These findings suggest the importance of regular, at least annual NG/CT screening, particularly extragenital, of HIV positive MSM of all ages. They provide some support for age-based cutoffs for women and MSW (eg, universal screening for those aged ≤25 and targeted screening for those aged >25 years).

Caring for youth living with HIV across the continuum: turning gaps into opportunities.

With the increasing proportion of youth living with human immunodeficiency virus (YLHIV) and the aging of the perinatally infected population, there is a need for clinical services that are "youth friendly" to address the multiple challenges YLHIV face in terms of engagement in care and maintenance of combination antiretroviral therapy (cART). Little is known about how and where YLHIV receive their care. Further, the impact of the care structure on engagement and retention outcomes for YLHIV is ill defined. In order to better classify how YLHIV receive care in the United States, we performed a review of published literature characterizing the structure and outcomes of care for YLHIV. Several key concepts emerged: 1. The majority of YLHIV (13-24 years old) are cared for at adult sites, 2. Clinics providing care to YLHIV are varied in terms of the services offered and the types of services offered can impact outcomes, 3. YLHIV cared for in adult clinical sites have poor retention and antiretroviral treatment initiation, and 4. YLHIV cared for at adult sites had poorer retention and cART outcomes compared to YLHIV cared for at pediatric sites. There were no studies identified that specifically examined "youth friendly" care for YLHIV within the context of adult clinical sites. The results of this review highlight disparities for YLHIV and the need for interventions to improve outcomes for YLHIV in the context of adult care.

The interaction between equipoise and logistics in clinical trials: A case study.

INTRODUCTION: Equipoise is usually discussed as an ethical issue in clinical trials. However, it also has practical implications. BACKGROUND: Clinical equipoise is usually construed to mean uncertainty or disagreement among the expert clinician community. However, an individual physician's sense of equipoise may vary by location, based on the local standard of care or availability of specific treatment options, and these differences can affect providers' willingness to enroll participants into clinical trials. There are also logistical barriers to enrollment in international trials due to prolonged timelines for approvals by government agencies and ethical review boards. CASE STUDY: A multinational clinical trial of bridging strategies for treatment of non-adherent HIV-infected youth, experienced differing perceptions of equipoise due to disparities in availability of treatment options by country. Unfortunately, the countries with most demand for the trial were those where the approval process was most delayed, and the study was closed early due to slow accrual. DISCUSSION: When planning multicenter clinical trials, it is important to take into account heterogeneity among research sites and try to anticipate differences in equipoise and logistical factors between sites, in order to plan to address these issues at the design stage.

Healthcare Coverage for HIV Provider Visits Before and After Implementation of the Affordable Care Act.

BACKGROUND: Before implementation of the Patient Protection and Affordable Care Act (ACA) in 2014, 100 000 persons living with human immunodeficiency virus (HIV) (PLWH) lacked healthcare coverage and relied on a safety net of Ryan White HIV/AIDS Program support, local charities, or uncompensated care (RWHAP/Uncomp) to cover visits to HIV providers. We compared HIV provider coverage before (2011-2013) versus after (first half of 2014) ACA implementation among a total of 28 374 PLWH followed up in 4 sites in Medicaid expansion states (California, Oregon, and Maryland), 4 in a state (New York) that expanded Medicaid in 2001, and 2 in nonexpansion states (Texas and Florida). METHODS: Multivariate multinomial logistic models were used to assess changes in RWHAP/Uncomp, Medicaid, and private insurance coverage, using Medicare as a referent. RESULTS: In expansion state sites, RWHAP/Uncomp coverage decreased (unadjusted, 28% before and 13% after ACA; adjusted relative risk ratio [ARRR], 0.44; 95% confidence interval [CI], .40-.48). Medicaid coverage increased (23% and 38%; ARRR, 1.82; 95% CI, 1.70-1.94), and private coverage was unchanged (21% and 19%; 0.96; .89-1.03). In New York sites, both RWHAP/Uncomp (20% and 19%) and Medicaid (50% and 50%) coverage were unchanged, while private coverage decreased (13% and 12%; ARRR, 0.86; 95% CI, .80-.92). In nonexpansion state sites, RWHAP/Uncomp (57% and 52%) and Medicaid (18% and 18%) coverage were unchanged, while private coverage increased (4% and 7%; ARRR, 1.79; 95% CI, 1.62-1.99). CONCLUSIONS: In expansion state sites, half of PLWH relying on RWHAP/Uncomp coverage shifted to Medicaid, while in New York and nonexpansion state sites, reliance on RWHAP/Uncomp remained constant. In the first half of 2014, the ACA did not eliminate the need for RWHAP safety net provider visit coverage.

Accuracy of Provider Predictions of Viral Suppression Among Adolescents and Young Adults With HIV in an HIV Clinical Program.

BACKGROUND: Providers caring for adolescents and young adults with HIV (AYA-HIV) mostly base their adherence counseling during clinical encounters on clinical judgment and expectations of patients' medication adherence. There is currently no data on provider predictions of viral suppression for AYA-HIV. We aimed to assess the accuracy of provider predictions of patients' viral suppression status compared to viral load results. METHODS: Providers caring for AYA-HIV were asked to predict the likelihood of viral suppression of patients before a clinical encounter and give reasons for their predictions. Provider predictions were compared to actual viral load measurements of patients. Patient data were abstracted from electronic health records. The final analysis included 9 providers, 28 patients, and 34 observations of paired provider predictions and viral load results. RESULTS: Provider prediction accuracy of viral suppression was low (59%, Cohen's Kappa = 0.16). Provider predictions of lack of viral suppression were based on nonadherence to medications, new patient status, or structural vulnerabilities (e.g., unstable housing). Anticipated viral suppression was based on medication adherence, history of viral suppression, and the presence of family or other social forms of support. CONCLUSIONS: Providers have difficulty accurately predicting viral suppression among AYA-HIV and may base their counseling on incorrect assumptions. Rapid point-of-care viral load testing may provide opportunities to improve counseling provided during the clinical encounter.

Accuracy of Provider Predictions of Viral Suppression among Adolescents and Young Adults with HIV in an HIV Clinical ProgramProviders caring for adolescents and young adults with HIV (AYA-HIV) mostly base their adherence counseling during clinical encounters on clinical judgment and expectations of patients' medication adherence. Currently, no data exist on provider predictions of viral suppression for AYA-HIV. We aimed to assess the accuracy of provider predictions of patients' viral suppression compared to viral load results. Providers caring for AYA-HIV were asked to predict the likelihood of viral suppression of patients before a clinical encounter with reasons for their predictions. Provider predictions were compared to actual viral load measurements of patients. Patient data were abstracted from electronic health records. The final analysis included nine providers, 28 patients, and 34 observations of paired provider predictions and viral load results. Provider prediction accuracy of viral suppression was low (59%, Cohen's Kappa=0.16). Provider predictions of lack of viral suppression were based on non-adherence to medications, new patient status, or structural vulnerabilities (e.g., unstable housing). Anticipated viral suppression was based on medication adherence, history of viral suppression, and presence of family or other social forms of support. Providers have difficulty predicting viral suppression among AYA-HIV and may base counseling on incorrect assumptions. Rapid point-of-care viral load testing may provide opportunities to improve counseling.

Projecting the Clinical and Economic Impacts of Changes to HIV Care Among Adolescents and Young Adults in the United States: Lessons From the COVID-19 Pandemic.

BACKGROUND: During the COVID-19 pandemic, many US youth with HIV (YHIV) used telehealth services; others experienced disruptions in clinic and antiretroviral therapy (ART) access. METHODS: Using the Cost-effectiveness of Preventing AIDS Complications (CEPAC)-Adolescent HIV microsimulation model, we evaluated 3 scenarios: 1) Clinic: in-person care; 2) Telehealth: virtual visits, without CD4 or viral load monitoring for 12 months, followed by return to usual care; and 3) Interruption: complete care interruption with no ART access or laboratory monitoring for 6 months (maximum clinic closure time), followed by return to usual care for 80%. We assigned higher 1-year retention (87% vs 80%) and lower cost/visit ($49 vs $56) for Telehealth vs Clinic. We modeled 2 YHIV cohorts with non-perinatal (YNPHIV) and perinatal (YPHIV) HIV, which differed by mean age (22 vs 16 years), sex at birth (85% vs 47% male), starting CD4 count (527/µL vs 635/µL), ART, mortality, and HIV-related costs. We projected life months (LMs) and costs/100 YHIV over 10 years. RESULTS: Over 10 years, LMs in Clinic and Telehealth would be similar (YNPHIV: 11 350 vs 11 360 LMs; YPHIV: 11 680 LMs for both strategies); costs would be $0.3M (YNPHIV) and $0.4M (YPHIV) more for Telehealth than Clinic. Interruption would be less effective (YNPHIV: 11 230 LMs; YPHIV: 11 620 LMs) and less costly (YNPHIV: $1.3M less; YPHIV: $0.2M less) than Clinic. Higher retention in Telehealth led to increased ART use and thus higher costs. CONCLUSIONS: Telehealth could be as effective as in-person care for some YHIV, at slightly increased cost. Short interruptions to ART and laboratory monitoring may have negative long-term clinical implications.