Development and Validation of HIV-ASSIST, an Online, Educational, Clinical Decision Support Tool to Guide Patient-Centered ARV Regimen Selection.

BACKGROUND: Multiple antiretroviral (ARV) regimens are effective at achieving HIV viral suppression, but differ in pill burden, side effects, barriers to resistance, and impact on comorbidities. Current guidelines advocate for an individualized approach to ARV regimen selection, but synthesizing these modifying factors is complex and time-consuming. METHODS: We describe the development of HIV-ASSIST (https://www.hivassist.com), a free, online decision support tool for ARV selection and HIV education. HIV-ASSIST ranks potential ARV options for any given patient scenario using a composite objective of achieving viral suppression while maximizing tolerability and adherence. We used a multiple-criteria decision analysis framework to construct mathematical algorithms and synthesize various patient-specific (eg, comorbidities and treatment history) and virus-specific (eg, HIV mutations) attributes. We then conducted a validation study to evaluate HIV-ASSIST with prescribing practices of experienced HIV providers at 4 large academic centers. We report on concordance of provider ARV selections with the 5 top-ranked HIV-ASSIST regimens for 10 diverse hypothetical patient-case scenarios. RESULTS: In the validation cohort of 17 experienced HIV providers, we found 99% concordance between HIV-ASSIST recommendations and provider ARV selections for 4 case-scenarios of ARV-naive patients. Among 6 cases of ARV-experienced patients (3 with and 3 without viremia), there was 84% and 88% concordance, respectively. Among 3 cases of ARV-experienced patients with viremia, providers reported 20 different ARV selections, suggesting substantial heterogeneity in ARV preferences in clinical practice. CONCLUSIONS: HIV-ASSIST is a novel patient-centric educational decision support tool that provides ARV recommendations concordant with experienced HIV providers for a diverse set of patient scenarios.

Economic and epidemiologic impact of guidelines for early ART initiation irrespective of CD4 count in Spain.

INTRODUCTION: Emerging data suggest that early antiretroviral therapy (ART) could reduce serious AIDS and non-AIDS events and deaths but could also increase costs. In January 2016, the Spanish guidelines were updated to recommend ART at any CD4 count. However, the epidemiologic and economic impacts of early ART initiation in Spain remain unclear. METHODS: The Johns Hopkins HIV Economic-Epidemiologic Mathematical Model (JHEEM) was utilized to estimate costs, transmissions, and outcomes in Spain over 20 years. We compared implementation of guidelines for early ART initiation to a counterfactual scenario deferring ART until CD4-counts fall below 350 cells/mm3. We additionally studied the impact of early ART initiation in combination with improvements to HIV screening, care linkage and engagement. RESULTS: Early ART initiation (irrespective of CD4-count) is expected to avert 20,100 [95% Uncertainty Range (UR) 11,100-83,000] new HIV cases over the next two decades compared to delayed ART (28% reduction), at an incremental health system cost of €1.05 billion [€0.66 - €1.63] billion, and an incremental cost-effectiveness ratio (ICER) of €29,700 [€13,700 - €41,200] per QALY gained. Projected ICERs declined further over longer time horizon; e.g., an ICER of €12,691 over 30 years. Furthermore, the impact of early ART initiation was potentiated by improved HIV screening among high-risk individuals, averting an estimated 41,600 [23,200-172,200] HIV infections (a 58% decline) compared to delayed ART. CONCLUSIONS: Recommendations for ART initiation irrespective of CD4-counts are cost-effective and could avert > 30% of new cases in Spain. Improving HIV diagnosis can amplify this impact.

Challenges in the Evaluation of Interventions to Improve Engagement Along the HIV Care Continuum in the United States: A Systematic Review.

In the United States (US), there are high levels of disengagement along the HIV care continuum. We sought to characterize the heterogeneity in research studies and interventions to improve care engagement among people living with diagnosed HIV infection. We performed a systematic literature search for interventions to improve HIV linkage to care, retention in care, reengagement in care and adherence to antiretroviral therapy (ART) in the US published from 2007-mid 2015. Study designs and outcomes were allowed to vary in included studies. We grouped interventions into categories, target populations, and whether results were significantly improved. We identified 152 studies, 7 (5%) linkage studies, 33 (22%) retention studies, 4 (3%) reengagement studies, and 117 (77%) adherence studies. 'Linkage' studies utilized 11 different outcome definitions, while 'retention' studies utilized 39, with very little consistency in effect measurements. The majority (59%) of studies reported significantly improved outcomes, but this proportion and corresponding effect sizes varied substantially across study categories. This review highlights a paucity of assessments of linkage and reengagement interventions; limited generalizability of results; and substantial heterogeneity in intervention types, outcome definitions, and effect measures. In order to make strides against the HIV epidemic in the US, care continuum research must be improved and benchmarked against an integrated, comprehensive framework.

Effect of the US National HIV/AIDS Strategy targets for improved HIV care engagement: a modelling study.

BACKGROUND: The recently updated White House National HIV/AIDS Strategy (NHAS) includes specific progress indicators to improve the HIV care continuum in the USA, but the economic and epidemiological effect of achieving those indicators remains unclear. We aimed to project the impact of achieving NHAS goals on HIV incidence, prevalence, mortality, and costs among adults in the USA over 10 years. METHODS: We constructed a dynamic transmission model of HIV progression and care engagement based on literature sources and the most recent published US Centers for Disease Control and Prevention data. We specifically considered achievement of the 2020 targets set forth in NHAS progress indicator 1 (90% awareness of serostatus), indicator 4 (85% linkage within 1 month), and indicator 5 (90% of diagnosed individuals in care). FINDINGS: At current rates of engagement in the HIV care continuum, we project 524,000 (95% uncertainty range 442,000-712,000) new HIV infections and 375,000 deaths (364,000-578,000) between 2016 and 2025. Achievement of NHAS progress indicators 1 and 4 has modest epidemiological effect (new infections reduced by 2·0% and 3·9%, respectively). By contrast, increasing the proportion of diagnosed individuals in care (NHAS indicator 5) averts 52% (95% UR 47-56) of new infections. Achievement of all NHAS targets resulted in a 58% reduction (95% UR 52-61) in new infections and 128 000 lives saved (106,000-223,000) at an incremental health system cost of US$105 billion. INTERPRETATION: Achievement of NHAS progress indicators for screening, linkage, and particularly improving retention in care, can substantially reduce the burden of HIV in the USA, but continued and increased financial investment will be required. FUNDING: The National Institutes of Health, the B Frank and Kathleen Polk Assistant Professorship in Epidemiology, Emory University CFAR, Johns Hopkins University CFAR, and CDC/NCHHSTP Epidemiological and Economic Modeling Agreement (5U38PS004646).