Sustained Impact of the Coronavirus Disease 2019 Pandemic on Hepatitis C Virus Treatment Initiations in the United States.

BACKGROUND: Recent reports indicated declines in hepatitis C virus (HCV) testing during the first half of 2020 in the United States due to coronavirus disease 2019 (COVID-19), but the longer-term impact on HCV testing and treatment is unclear. METHODS: We obtained monthly state-level volumes of HCV antibody, RNA and genotype testing, and HCV treatment initiation, stratified by age and gender, spanning January 2019 until December 2020 from 2 large national laboratories. We performed segmented regression analysis for each state from a mixed-effects Poisson regression model with month as the main fixed predictor and state as a random intercept. RESULTS: During the pre-COVID-19 period (January 2019-March 2020), monthly HCV antibody and genotype tests decreased slightly whereas RNA tests and treatment initiations remained stable. Between March and April 2020, there were declines in the number of HCV antibody tests (37% reduction, P < .001), RNA tests (37.5% reduction, P < .001), genotype tests (24% reduction, P = .023), and HCV treatment initiations (31%, P < .001). Starting April 2020 through the end of 2020, there were significant increases in month-to-month HCV antibody (P < .001), RNA (P = .035), and genotype tests (P = .047), but only antibody testing rebounded to pre-COVID-19 levels. HCV treatment initiations remained low after April 2020 throughout the remainder of the year. CONCLUSIONS: HCV testing and treatment dropped by >30% during April 2020 at the start of the COVID-19 pandemic, but although HCV testing increased again later in 2020, HCV treatment rates did not recover. Efforts should be made to link HCV-positive patients to treatment and revitalize HCV treatment engagement by healthcare providers.

Let's TOC Fertility: A stepped wedge cluster randomized controlled trial of the Telehealth Oncofertility Care (TOC) intervention in children, adolescent and young adult cancer survivors.

INTRODUCTION: Children, adolescent, and young adult cancer survivors experience overall increased risks of infertility that are preventable through effective fertility preservation services prior to starting cancer treatment. Oncofertility care is the evidence-based practice of informing newly diagnosed cancer patients about their reproductive risks and supporting shared decision-making on fertility preservation services. Despite longstanding clinical guidelines, oncofertility care delivery continues to be limited and highly variable across adult and pediatric oncology settings. MATERIALS AND METHODS: We describe the design of a stepped wedge cluster randomized clinical trial to evaluate the effectiveness of the multi-component Telehealth Oncofertility Care (TOC) intervention conducted in 20 adult and pediatric oncology clinics across three health systems in Southern California. Intervention components are: 1) electronic health record-based oncofertility needs screen and referral pathway to a virtual oncofertility hub; 2) telehealth oncofertility counseling through the hub; and 3) telehealth oncofertility financial navigation through the hub. We hypothesize the intervention condition will be associated with increased proportions of patients who engage in goal-concordant oncofertility care (i.e., engagement in reproductive risk counseling and fertility preservation services that meet the patient's fertility goals) and improved patient-reported outcomes, compared to the usual care control condition. We will also evaluate intervention implementation in a mixed-methods study guided by implementation science frameworks. DISCUSSION: Our overall goal is to speed implementation of a scalable oncofertility care intervention at cancer diagnosis for children, adolescent and young adult cancer patients to improve their future fertility and quality of life. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05443737.

Intervening on women's health for rural young breast cancer survivors: A study protocol.

INTRODUCTION: From diagnosis to post-treatment, many young breast cancer survivors (YBCS) experience infertility, limited contraception choices, concern about pregnancy safety, and menopausal symptoms. Clinical guidelines recommend oncofertility care (counseling and/or clinical services that meet fertility, contraception, pregnancy health and/or menopausal symptom management needs) throughout the cancer care continuum. However, significant oncofertility care gaps exist in rural, community oncology settings. MATERIALS AND METHODS: We describe the design of an interrupted time series, effectiveness-implementation hybrid clinical trial that evaluates a multi-component intervention to improve YBCS engagement in oncofertility care. The intervention is comprised of 1) oncology clinic-based oncofertility needs screen; 2) a women's health survivorship care plan in Spanish and English; 3) remote patient navigation; and 4) telehealth oncofertility consultation. During the pre-intervention period (12 months), usual care will be delivered. During the intervention period (15 months), the multi-component intervention will be implemented at two rural oncology clinics with largely Latina, Spanish-speaking populations. The primary outcome of YBCS (n = 135) engagement in oncofertility care will be collected from medical record review. We will also collect validated patient-reported outcomes. Informed by the Exploration Preparation Implementation Sustainment (EPIS) implementation science framework, we will integrate qualitative and quantitative data to explore whether and how the intervention was effective, acceptable, appropriate, and delivered with fidelity. DISCUSSION: Our overall goal is to speed implementation of a scalable oncofertility care intervention for YBCS in underserved areas to reduce disparities and improve reproductive health and quality of life. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05414812.

Assessment of Health Insurance Benefit Mandates for Fertility Preservation Among 11 US States.

Importance: Multiple US states recently passed laws mandating health insurance coverage for fertility preservation (FP) services to improve access to care for patients with cancer, for whom FP service expenses can be prohibitive. Key unanswered questions include how heterogeneous benefit mandate laws and regulations are and how this variation may affect implementation, access, and utilization. Objective: To describe the design of state-level FP health insurance benefit mandate laws and regulations and derive guidance on best practices and implementation needs. Design, Setting, and Population: Legal mapping and implementation science framework-guided analyses were conducted on 11 US state laws that mandate health insurance benefit coverage for FP services for patients at risk of iatrogenic infertility from medical treatments and on related insurer regulations. Design features of laws and regulations and the implementation process were summarized by themes (eg, coverage specification). Exposures: State jurisdiction. Main Outcomes and Measures: Main outcomes were the scope and specificity of mandated FP insurance coverage and the role of clinical practice guidelines and insurer regulations in implementation. Results: Between June 2017 and March 2021, 11 states passed FP benefit mandate laws. States took a median (range) of 283 (0-640) days to implement mandates, and a majority issued regulatory guidance after the law was in effect. While standard-of-care procedures such as embryo cryopreservation require medical evaluation, medications, ultrasonography and laboratory monitoring, oocyte retrieval, embryo derivation, cryopreservation, and storage, there was variation in which services were specified for inclusion or exclusion in the laws and/or regulator guidance. The majority of state laws and regulator guidance reference medical society clinical practice guidelines and federal policies (Affordable Care Act and Health Insurance Portability and Accountability Act). Conclusions and Relevance: In this qualitative assessment of 11 state-level FP benefit mandates, variation that may influence patient access was identified in the design and implementation of the mandates. As clinical stakeholders aim to understand and/or shape these laws and their implementation, key considerations included specificity and flexibility of benefit design to be clinically meaningful, expansion of clinical practice guidelines to inform benefit coverage, inclusion of publicly insured and self-insured populations for universal access, and consistency between state and federal policies.