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ImportancePregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads.MethodsRECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators.DiscussionRECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero.Clinical trials.gov identifierClinical Trial Registration: http://www.clinicaltrials.gov. Unique identifier: NCT05172011.

ImportanceSARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis.MethodsRECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms.DiscussionRECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options.RegistrationNCT05172024.

BackgroundPatient navigation, a patient-centered intervention to promote comprehensive health care, is an emerging innovation in obstetrics to optimize postpartum care. We aimed to evaluate the implementation of a novel postpartum patient navigation program at an urban academic medical center.MethodsThis mixed-methods study analyzed the implementation of a postpartum patient navigation program within an ongoing randomized control trial. This study analyzed three navigators' logs of interactions with 50 patients, care team members, and community organizations throughout patients' first year postpartum. We categorized and quantified interactions by topic addressed, care team member interacted with, and communication mode used. We also conducted semi-structured interviews with each navigator every three months (5 interviews per navigator), emphasizing navigation experiences, relationships with patients and care teams, integration in the care team, and healthcare system gaps. Interview data were analyzed using the constant comparative method to identify themes using the constructs of the Consolidated Framework for Implementation Research (CFIR).ResultsAnalysis of navigator logs revealed a high patient need level, especially in the first 3 months postpartum. CFIR-guided analysis of intervention characteristics revealed positive perceptions of navigation's utility due to its adaptability. Navigation's complexity, however, posed an early obstacle to implementation that diminished over time. Outer setting analysis indicated navigators addressed patient needs through interactions with multiple systems. Despite clinicians' initial unfamiliarity with navigation, inner setting analysis suggested ongoing communication and electronic medical record use facilitated integration into the care team. Regarding individual and process characteristics, findings emphasized how navigator self-efficacy and confidence increased with experience (individual) and was facilitated by comprehensive training and reflection (process). Overall, barriers to implementation included unfamiliarity, varied patient engagement, and innovation complexity. Facilitators included high patient need, communication with outside organizations, medical record usage, navigator characteristics (self-efficacy, communication skills, and personal growth), a comprehensive training period, consistent reflection, high relative advantage, and high adaptability to patient need.ConclusionPatient navigation is a promising innovation to improve postpartum care coordination and support care team efforts. The successful implementation of navigation in this study indicates that, if shown to improve patient outcomes, obstetric navigation could be a component of patient-centered postpartum care.

BackgroundThe rising prevalence of hepatitis C virus (HCV) infection and the availability of direct acting antivirals for HCV treatment has prompted a public health goal of HCV eradication. Despite the availability of treatment for HCV, treatment programs have generally excluded pregnant individuals. Our objective was to query patients and clinicians to identify barriers to including pregnant individuals in HCV treatment programs.Methods and findingsThis qualitative investigation included obstetricians and previously/currently pregnant individuals with HCV. Participants completed interviews regarding knowledge of and attitudes towards HCV treatment and perceived barriers to treatment during pregnancy. Data were analyzed using the constant comparative method. Obstetricians (N = 18) and patients (N = 21) described concerns about equity, access, and cost. Both expressed uncertainty about safety and confirmed a need for clinician education. Obstetricians emphasized the lack of professional guidelines. Although some clinicians expressed concern about patient adherence and engagement, patients were largely desirous of treatment; both groups identified potential benefits of antenatal treatment.ConclusionsBoth patients and obstetricians were generally receptive to HCV treatment in pregnancy and recognized pregnancy as an important window of opportunity for treatment. Our findings suggest the need for further research on maternal-fetal safety of HCV treatment as well as on interventions to ensure fair and appropriate access to HCV treatment for pregnant individuals.

BackgroundChanges to the healthcare system due to COVID-19 have altered care delivery during birth and the postpartum period, a transitional time that requires intensive healthcare support and that is complicated by well-established health disparities. Our objective was to identify additional challenges to healthcare interactions that emerged for low-income postpartum individuals during the pandemic.MethodsThis is a qualitative investigation of low-income postpartum individuals enrolled in a trial of postpartum care, who gave birth in the United States in the first three months of the COVID-19 pandemic. Participants completed in-depth semi-structured interviews that addressed healthcare experiences during and after birth, both for in-person and telemedicine encounters. Transcripts were analyzed using the constant comparative method.ResultsOf 46 eligible individuals, 87% (N = 40) completed an interview, with 50% identifying as non-Hispanic Black and 38% as Hispanic. Challenges were organized into three domains: unanticipated changes in the birth experience, delayed care, and perceived disadvantages of telemedicine. Changes in the birth experience addressed uncertainty about COVID-19 status, COVID-19 testing, separation from newborn, and visitor restrictions. Delayed care themes addressed logistical challenges, postpartum care, health maintenance, and pediatric care. Participants reported multiple telemedicine-related challenges, including difficulty establishing rapport with providers.ConclusionsUnderstanding the challenges experienced by low-income peripartum individuals as the COVID-19 pandemic evolves is critical to informing guidelines and diminishing inequities in healthcare delivery. Potential solutions that may mitigate limitations to care in the pandemic include emphasizing shared decision-making in care processes and developing communication strategies to improve telemedicine rapport.

ObjectiveIn 2012, recommendations for universal tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccination during pregnancy were released. Our objective was to determine if Tdap, influenza, and pneumococcal vaccine uptake during pregnancy changed after the release of the guidelines, and identify factors associated with receiving the Tdap and influenza vaccine after 2012.MethodsWe conducted a retrospective cohort study on pregnant individuals who initiated prenatal care before 20 weeks' gestation between 11/2011-11/2012 ("pre-guideline") and 12/2012-12/2015 ("post-guideline"). Vaccine uptake dates were abstracted from medical records. The pre and post-guideline cohorts were compared to determine if Tdap vaccine uptake and timing improved after the new Tdap guidelines. We additionally examined influenza and pneumococcal vaccine uptake before and after guidelines. Factors associated with receipt of the Tdap and influenza vaccine during pregnancy in the post-guideline cohort were evaluated using multivariable logistic regression models.ResultsOf 2,294 eligible individuals, 1,610 (70.2%) received care in the post-guideline cohort. Among the pre-guideline cohort, 47.4% received Tdap, whereas Tdap uptake increased to 86.1% after the guidelines (pConclusionsReceipt and timing of Tdap vaccine improved after implementation of the 2012 ACIP guidelines. Receipt of influenza vaccine uptake also improved during the study period, while uptake of the pneumococcal vaccine remained low. Significant racial disparities exist in receipt of Tdap and influenza vaccine during pregnancy.