Baseline characteristics of SARS-CoV-2 vaccine non-responders in a large population-based sample.

INTRODUCTION: Studies indicate that individuals with chronic conditions and specific baseline characteristics may not mount a robust humoral antibody response to SARS-CoV-2 vaccines. In this paper, we used data from the Texas Coronavirus Antibody REsponse Survey (Texas CARES), a longitudinal state-wide seroprevalence program that has enrolled more than 90,000 participants, to evaluate the role of chronic diseases as the potential risk factors of non-response to SARS-CoV-2 vaccines in a large epidemiologic cohort. METHODS: A participant needed to complete an online survey and a blood draw to test for SARS-CoV-2 circulating plasma antibodies at four-time points spaced at least three months apart. Chronic disease predictors of vaccine non-response are evaluated using logistic regression with non-response as the outcome and each chronic disease + age as the predictors. RESULTS: As of April 24, 2023, 18,240 participants met the inclusion criteria; 0.58% (N = 105) of these are non-responders. Adjusting for age, our results show that participants with self-reported immunocompromised status, kidney disease, cancer, and "other" non-specified comorbidity were 15.43, 5.11, 2.59, and 3.13 times more likely to fail to mount a complete response to a vaccine, respectively. Furthermore, having two or more chronic diseases doubled the prevalence of non-response. CONCLUSION: Consistent with smaller targeted studies, a large epidemiologic cohort bears the same conclusion and demonstrates immunocompromised, cancer, kidney disease, and the number of diseases are associated with vaccine non-response. This study suggests that those individuals, with chronic diseases with the potential to affect their immune system response, may need increased doses or repeated doses of COVID-19 vaccines to develop a protective antibody level.

Long-term immune response to SARS-CoV-2 infection and vaccination in children and adolescents.

BACKGROUND: This analysis examined the durability of antibodies present after SARS-CoV-2 infection and vaccination in children and adolescents. METHODS: Data were collected over 4 time points between October 2020-November 2022 as part of a prospective population-based cohort aged 5-to-19 years (N = 810). Results of the (1) Roche Elecsys® Anti-SARS-CoV-2 Immunoassay for detection of antibodies to the SARS-CoV-2 nucleocapsid protein (Roche N-test); and (2) qualitative and semi-quantitative detection of antibodies to the SARS CoV-2 spike protein receptor binding domain (Roche S-test); and (3) self-reported antigen/PCR COVID-19 test results, vaccination and symptom status were analyzed. RESULTS: N antibody levels reached a median of 84.10 U/ml (IQR: 20.2, 157.7) cutoff index (COI) ~ 6 months post-infection and increased slightly to a median of 85.25 (IQR: 28.0, 143.0) COI at 12 months post-infection. Peak S antibody levels were reached at a median of 2500 U/mL ~6 months post-vaccination and remained for ~12 months (mean 11.6 months, SD 1.20). CONCLUSIONS: This analysis provides evidence of robust durability of nucleocapsid and spike antibodies in a large pediatric sample up to 12 months post-infection/vaccination. This information can inform pediatric SARS-CoV-2 vaccination schedules. IMPACT: This study provided evidence of robust durability of both nucleocapsid and spike antibodies in a large pediatric sample up to 12 months after infection. Little is known about the long-term durability of natural and vaccine-induced SARS-CoV-2 antibodies in the pediatric population. Here, we determined the durability of anti-SARS-CoV-2 spike (S-test) and nucleocapsid protein (N-test) in children/adolescents after SARS-CoV-2 infection and/or vaccination lasts at least up to 12 months. This information can inform future SARS-CoV-2 vaccination schedules in this age group.

SARS-CoV-2 Serostatus and COVID-19 Illness Characteristics by Variant Time Period in Non-Hospitalized Children and Adolescents.

OBJECTIVE: To describe COVID-19 illness characteristics, risk factors, and SARS-CoV-2 serostatus by variant time period in a large community-based pediatric sample. DESIGN: Data were collected prospectively over four timepoints between October 2020 and November 2022 from a population-based cohort ages 5 to 19 years old. SETTING: State of Texas, USA. PARTICIPANTS: Participants ages 5 to 19 years were recruited from large pediatric healthcare systems, Federally Qualified Healthcare Centers, urban and rural clinical practices, health insurance providers, and a social media campaign. EXPOSURE: SARS-CoV-2 infection. MAIN OUTCOME(S) AND MEASURE(S): SARS-CoV-2 antibody status was assessed by the Roche Elecsys® Anti-SARS-CoV-2 Immunoassay for detection of antibodies to the SARS-CoV-2 nucleocapsid protein (Roche N-test). Self-reported antigen or PCR COVID-19 test results and symptom status were also collected. RESULTS: Over half (57.2%) of the sample (N = 3911) was antibody positive. Symptomatic infection increased over time from 47.09% during the pre-Delta variant time period, to 76.95% during Delta, to 84.73% during Omicron, and to 94.79% during the Omicron BA.2. Those who were not vaccinated were more likely (OR 1.71, 95% CI 1.47, 2.00) to be infected versus those fully vaccinated. CONCLUSIONS: Results show an increase in symptomatic COVID-19 infection among non-hospitalized children with each progressive variant over the past two years. Findings here support the public health guidance that eligible children should remain up to date with COVID-19 vaccinations.

Incidence and Predictors of Breakthrough and Severe Breakthrough Infections of SARS-CoV-2 After Primary Series Vaccination in Adults: A Population-Based Survey of 22 575 Participants.

BACKGROUND: Breakthrough infections of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are well documented. The current study estimates breakthrough incidence across pandemic waves, and evaluates predictors of breakthrough and severe breakthrough infections (defined as those requiring hospitalization). METHODS: In total, 89 762 participants underwent longitudinal antibody surveillance. Incidence rates were calculated using total person-days contributed. Bias-corrected and age-adjusted logistic regression determined multivariable predictors of breakthrough and severe breakthrough infection, respectively. RESULTS: The incidence was 0.45 (95% confidence interval [CI], .38-.50) during pre-Delta, 2.80 (95% CI, 2.25-3.14) during Delta, and 11.2 (95% CI, 8.80-12.95) during Omicron, per 10 000 person-days. Factors associated with elevated odds of breakthrough included Hispanic ethnicity (vs non-Hispanic white, OR = 1.243; 95% CI, 1.073-1.441), larger household size (OR = 1.251 [95% CI, 1.048-1.494] for 3-5 vs 1 and OR = 1.726 [95% CI, 1.317-2.262] for more than 5 vs 1 person), rural versus urban living (OR = 1.383; 95% CI, 1.122-1.704), receiving Pfizer or Johnson & Johnson versus Moderna, and multiple comorbidities. Of the 1700 breakthrough infections, 1665 reported on severity; 112 (6.73%) were severe. Higher body mass index, Hispanic ethnicity, vaccine type, asthma, and hypertension predicted severe breakthroughs. CONCLUSIONS: Breakthrough infection was 4-25 times more common during the Omicron-dominant wave versus earlier waves. Higher burden of severe breakthrough infections was identified in subgroups.

Antibody Duration After Infection From SARS-CoV-2 in the Texas Coronavirus Antibody Response Survey.

Understanding the duration of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus that causes COVID-19 is important to controlling the current pandemic. Participants from the Texas Coronavirus Antibody Response Survey (Texas CARES) with at least 1 nucleocapsid protein antibody test were selected for a longitudinal analysis of antibody duration. A linear mixed model was fit to data from participants (n = 4553) with 1 to 3 antibody tests over 11 months (1 October 2020 to 16 September 2021), and models fit showed that expected antibody response after COVID-19 infection robustly increases for 100 days postinfection, and predicts individuals may remain antibody positive from natural infection beyond 500 days depending on age, body mass index, smoking or vaping use, and disease severity (hospitalized or not; symptomatic or not).

Methodology to estimate natural- and vaccine-induced antibodies to SARS-CoV-2 in a large geographic region.

Accurate estimates of natural and/or vaccine-induced antibodies to SARS-CoV-2 are difficult to obtain. Although model-based estimates of seroprevalence have been proposed, they require inputting unknown parameters including viral reproduction number, longevity of immune response, and other dynamic factors. In contrast to a model-based approach, the current study presents a data-driven detailed statistical procedure for estimating total seroprevalence (defined as antibodies from natural infection or from full vaccination) in a region using prospectively collected serological data and state-level vaccination data. Specifically, we conducted a longitudinal statewide serological survey with 88,605 participants 5 years or older with 3 prospective blood draws beginning September 30, 2020. Along with state vaccination data, as of October 31, 2021, the estimated percentage of those 5 years or older with naturally occurring antibodies to SARS-CoV-2 in Texas is 35.0% (95% CI = (33.1%, 36.9%)). This is 3× higher than, state-confirmed COVID-19 cases (11.83%) for all ages. The percentage with naturally occurring or vaccine-induced antibodies (total seroprevalence) is 77.42%. This methodology is integral to pandemic preparedness as accurate estimates of seroprevalence can inform policy-making decisions relevant to SARS-CoV-2.

Comparison of Persistent Symptoms Following SARS-CoV-2 Infection by Antibody Status in Nonhospitalized Children and Adolescents.

BACKGROUND: The prevalence of long-term symptoms of coronavirus disease 2019 (COVID-19) in nonhospitalized pediatric populations in the United States is not well described. The objective of this analysis was to examine the presence of persistent COVID symptoms in children by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody status. METHODS: Data were collected between October 2020 and May 2022 from the Texas Coronavirus Antibody REsponse Survey, a statewide prospective population-based survey among 5-90 years old. Serostatus was assessed by the Roche Elecsys Anti-SARS-CoV-2 Immunoassay for detection of antibodies to the SARS-CoV-2 nucleocapsid protein. Self-reported antigen/polymerase chain reaction COVID-19 test results and persistent COVID symptom status/type/duration were collected simultaneously. Risk ratios for persistent COVID symptoms were calculated versus adults and by age group, antibody status, symptom presence/severity, variant, body mass index and vaccine status. RESULTS: A total of 82 (4.5% of the total sample [n = 1813], 8.0% pre-Delta, 3.4% Delta and beyond) participants reported persistent COVID symptoms (n = 27 [1.5%] 4-12 weeks, n = 58 [3.3%] >12 weeks). Compared with adults, all pediatric age groups had a lower risk for persistent COVID symptoms regardless of length of symptoms reported. Additional increased risk for persistent COVID symptoms >12 weeks included severe symptoms with initial infection, not being vaccinated and having unhealthy weight (body mass index ≥85th percentile for age and sex). CONCLUSIONS: These findings highlight the existence of nonhospitalized youth who may also experience persistent COVID symptoms. Children and adolescents are less likely to experience persistent COVID symptoms than adults and more likely to be symptomatic, experience severe symptoms and have unhealthy weight compared with children/adolescents without persistent COVID symptoms.

Health Burden and Service Utilization in Texas Medicaid Deliveries from the Prenatal Period to 1 Year Postpartum.

OBJECTIVE: To describe health burden and health service utilization from the prenatal period to 1 year postpartum among women with births covered by Texas Medicaid, focusing on the major contributors to maternal mortality after 60 days postpartum in Texas. METHODS: We analyzed diagnoses and health service utilization during the prenatal, early postpartum (5-60 days postpartum), and late postpartum (> 60 days to 1 year postpartum) periods, using administrative medical claims data for women ages 18-44 years with a Medicaid-paid delivery in 2017 residing in selected regions in Texas (n = 49,302). RESULTS: Overall, 12.6% and 17.5% of women had diagnoses of cardiovascular/coronary conditions and substance use disorder, respectively. Mental health conditions affected 30% of women, with anxiety (47.1%) and depression (34.3%) accounting for the greatest proportion of diagnosed mental health conditions. The prevalence of these conditions was higher during the late (19.4%) versus early (9.9%) postpartum period. About 47.8% of women had other chronic health conditions, including obesity, diabetes mellitus, and hypertension. Among women with the selected health conditions, utilization of any health services was higher during the prenatal period compared to early and late postpartum periods (e.g., any mental health service utilization: prenatal period (57.4%) versus early postpartum (26.9%) and late postpartum (25.5%) periods). However, among women with the selected health conditions, there was a high utilization of emergency room services during the late postpartum period [e.g., emergency room service utilization among those with mental health conditions: prenatal period (35.6%); postpartum period: early (5.5%) and late (30.1%)]. CONCLUSIONS FOR PRACTICE: Increasing access to the full range of recommended services during the prenatal period through 1 year postpartum has potential to help improve vulnerable women's birth outcomes.

Infant Mortality and Maternal Risk Factors in Texas: Highlighting Zip Code Variations in 2 At-Risk Counties, 2011-2015.

INTRODUCTION: Stark differences in the infant mortality rate (IMR) exist by geography in Texas. The Healthy Families initiative sought to understand how evidence-informed practices implemented in the community can improve pregnancy-related outcomes in 2 counties in Texas with a high prevalence of maternal chronic conditions. The objective of this study was to examine associations between maternal risk factors and infant deaths to inform strategies to improve outcomes. METHODS: Two counties with high prevalence of maternal chronic conditions were selected as Healthy Families sites: one with lower prenatal care usage than other counties in the state but an IMR lower than Texas, and the other with a higher IMR among minority racial and ethnic groups compared with other women in the county and Texas overall. Cohort-linked birth and infant death records from 2011 through 2015 provided by the Texas Department of State Health Services were analyzed by using logistic regression to examine associations of maternal sociodemographic and pregnancy risk factors with infant death. The data were mapped at the zip code level. Analyses were limited to births to women aged 15 to 49 years who resided in Texas from 2011 through 2015 (n = 1,942,899 births). RESULTS: The Texas IMR was 5.4 per 1,000 live births, compared with 4.6 and 7.5 per 1,000 live births for Hidalgo and Smith counties, respectively. Congenital malformations were the leading cause of infant death in both counties for infants born in 2015, which was similar to Texas overall. In both counties, maternal marital status, education, multiple gestation, and cesarean delivery were significantly associated with infant mortality. Wide zip code-level variations in IMR and maternal risk factors were observed in both counties. CONCLUSION: Variations in IMR and key maternal risk factors observed at the zip code level helped drive local strategies to maximize outreach of services to disproportionately affected communities.

Financing Benefits and Barriers to Routine HIV Screening in Clinical Settings in the United States: A Scoping Review.

The Centers for Disease Control and Prevention recommends everyone between 13-64 years be tested for HIV at least once as a routine procedure. Routine HIV screening is reimbursable by Medicare, Medicaid, expanded Medicaid, and most commercial insurance plans. Yet, scaling-up HIV routine screening remains a challenge. We conducted a scoping review for studies on financial benefits and barriers associated with HIV screening in clinical settings in the U.S. to inform an evidence-based strategy to scale-up routine HIV screening. We searched Ovid MEDLINE®, Cochrane, and Scopus for studies published between 2006-2020 in English. The search identified 383 Citations; we screened 220 and excluded 163 (outside the time limit, irrelevant, or outside the U.S.). Of the 220 screened articles, we included 35 and disqualified 155 (did not meet the eligibility criteria). We organized eligible articles under two themes: financial benefits/barriers of routine HIV screening in healthcare settings (9 articles); and Cost-effectiveness of routine screening in healthcare settings (26 articles). The review concluded drawing recommendations in three areas: (1) Finance: Incentivize healthcare providers/systems for implementing HIV routine screening and/or separate its reimbursement from bundle payments; (2) Personnel: Encourage nurse-initiated HIV screening programs in primary care settings and educate providers on CDC recommendations; and (3) Approach: Use opt-out approach.

Strategies to Estimate Prevalence of SARS-CoV-2 Antibodies in a Texas Vulnerable Population: Results From Phase I of the Texas Coronavirus Antibody Response Survey.

Introduction: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and immunity remains uncertain in populations. The state of Texas ranks 2nd in infection with over 2.71 million cases and has seen a disproportionate rate of death across the state. The Texas CARES project was funded by the state of Texas to estimate the prevalence of SARS-CoV-2 antibody status in children and adults. Identifying strategies to understand natural as well as vaccine induced antibody response to COVID-19 is critical. Materials and Methods: The Texas CARES (Texas Coronavirus Antibody Response Survey) is an ongoing prospective population-based convenience sample from the Texas general population that commenced in October 2020. Volunteer participants are recruited across the state to participate in a 3-time point data collection Texas CARES to assess antibody response over time. We use the Roche Elecsys® Anti-SARS-CoV-2 Immunoassay to determine SARS-CoV-2 antibody status. Results: The crude antibody positivity prevalence in Phase I was 26.1% (80/307). The fully adjusted seroprevalence of the sample was 31.5%. Specifically, 41.1% of males and 21.9% of females were seropositive. For age categories, 33.5% of those 18-34; 24.4% of those 35-44; 33.2% of those 45-54; and 32.8% of those 55+ were seropositive. In this sample, 42.2% (89/211) of those negative for the antibody test reported having had a COVID-19 test. Conclusions: In this survey we enrolled and analyzed data for 307 participants, demonstrating a high survey and antibody test completion rate, and ability to implement a questionnaire and SARS-CoV-2 antibody testing within clinical settings. We were also able to determine our capability to estimate the cross-sectional seroprevalence within Texas's federally qualified community centers (FQHCs). The crude positivity prevalence for SARS-CoV-2 antibodies in this sample was 26.1% indicating potentially high exposure to COVID-19 for clinic employees and patients. Data will also allow us to understand sex, age and chronic illness variation in seroprevalence by natural and vaccine induced. These methods are being used to guide the completion of a large longitudinal survey in the state of Texas with implications for practice and population health.

Experiences and Perspectives on Adopting New Practices for Social Needs-targeted Care in Safety-net Settings: A Qualitative Case Series Study.

INTRODUCTION: Clinical settings are being encouraged to identify and address patients' social needs within the clinic or through partner organizations. The purpose of this qualitative study was to describe the current practice of social needs-targeted care in 3 Texas safety net clinics, and facilitators and barriers to adopting new social needs-targeted care tools and practices. METHODS: Interviews were conducted with staff at 3 safety net clinics serving small and mid-sized communities. Analysis focused on perspectives and decisions around adopting new tools or practices related to social needs-targeted care, including standardized screening tools and community resource referral platforms. RESULTS: Nine staff across 3 organizations were interviewed. Two organizations were currently using a standard social needs screening tool in their routine practice, and a third was considering doing so. One organization had adopted a community resource referral platform in partnership with a large community collaboration. Three case studies illustrate a range of facilitators, barriers, perceived benefits, and drawbacks influencing social needs-targeted practices. Benefits of systematic data collection on social needs included the generation of data for community action. Drawbacks include concerns about data privacy. Community resource referral platforms were seen as valuable for creating accountability, but required an influential community partner and adequate community resources. Concerns about disempowering clients and blurring roles were voiced, and potential to increase provider job satisfaction was identified. CONCLUSIONS: Benefits and drawbacks of adopting new tools and practices related to social needs-targeted care are strongly influenced by the community context. For the adoption of community resource referral platforms, the outer setting is particularly relevant; adoption readiness is best assessed at the community or regional level rather than the clinic system level. While screening tools are much easier than referral platforms for clinics to adopt, the ability to address identified needs remains heavily based on the outer setting.

A Participatory, State-Community-Academic Model to Improve Pregnancy Outcomes in Texas: The Healthy Families Initiative.

BACKGROUND: While the Texas infant mortality rate (IMR) is below the Healthy People 2020 objective (5.7 per 1,000 live births), stark differences in IMR are seen across Texas communities. Health indicators for the state suggest important missed opportunities for improving maternal and infant outcomes. The Healthy Families initiative was a collaboration between a Texas state agency, community partners, and academic institutions to understand how evidence-based interventions could be identified, adapted, and implemented to address community priorities and reduce disparities in pregnancy outcomes. METHOD: The Healthy Families initiative included two Texas counties, one with low utilization of prenatal care and one with persistent disparities in infant mortality. The model served to (1) identify community factors influencing IMR and maternal morbidity through stakeholder engagement and secondary data, (2) build community capacity to link pregnant women with existing and newly developed services, and (3) develop partnerships within the community and clinics to improve access to and sustainability of services. RESULTS: A community-based participatory approach focused on stakeholder engagement was used to identify, design, and adapt strategies to address community-identified priorities. CONCLUSIONS: The Healthy Families initiative is a unique state-community-academic partnership aimed at improving pregnancy outcomes in vulnerable communities, with a focus on promotion of capacity building, maintenance, and sustainability of maternal and infant health programs.

Maternal comorbidity index and severe maternal morbidity during delivery hospitalizations in Texas, 2011-2014.

BACKGROUND: Severe maternal morbidity (SMM) prevalence was 194.0 per 10 000 deliveries in Texas in 2015. Chronic, behavioral, and pregnancy-induced conditions, as captured by a maternal comorbidity index, increase the risk for delivery-related morbidity and mortality. The objective of the study was to examine the association between maternal comorbidity index and SMM among delivery hospitalizations in Texas. METHODS: Delivery-related hospitalizations among Texan women aged 15-49 years were identified using the 2011-2014 Texas all-payer inpatient hospitalization public use data files (n = 1 434 441). The primary outcome of interest was SMM, based on the Alliance for Innovation on Maternal Health's coding scheme. The exposure of interest was a maternal comorbidity index. Multivariable logistic regression model was used to examine the association between maternal comorbidity index and SMM. RESULTS: SMM prevalence remained consistent between 2011 and 2014 (196.0-197.0 per 10 000 deliveries, P > .05; n = 1 434 441). Nearly 40% of delivery-related hospitalizations had a maternal comorbidity index of at least 1, and the proportion of deliveries in the highest risk category of comorbidity index (≥5) increased by 12.0% from 2011 to 2014. SMM prevalence was highest among the youngest and oldest age groups. With each unit increase in maternal comorbidity index, the odds of SMM increase was 1.43 (95% CI 1.42-1.43). CONCLUSIONS: Maternal comorbidity index is associated with SMM; however, the low predictive power of the model suggests that other, unmeasured factors may influence SMM in Texas. These findings highlight a need to understand broader contextual factors (practitioner, facility, systems of care, and community) that may be associated with SMM to reduce maternal morbidity and mortality in Texas.

Commentary: Texas Has a Secret Weapon Against Cancer.

Cancer is the No. 2 cause of death in Texas and across the United States. The good news is that things change, and we can be active agents in making sure that they change for the better. The Cancer Prevention and Research Institute of Texas (CPRIT) was established by a voter-supported constitutional amendment in 2007. It is a unique Texas resource, and is now second only to the National Institutes of Health in overall cancer research funding. On Nov. 5, voters will have the opportunity to extend CPRIT's important work for an additional 10 years and $3 billion. If approved, Texas will continue to lead the nation and the world in the fight against cancer. If the new funding is not approved, far too much of this important work will end. Reauthorization of CPRIT would do more than keep the ball rolling; it would save lives.

Immediate Postpartum Long-Acting Reversible Contraception Programs in Texas Hospitals Following Changes to Medicaid Reimbursement Policy.

OBJECTIVES: Provision of long-acting reversible contraception (LARC) after delivery and prior to discharge is safe and advantageous, yet few Texas hospitals offer this service. Our study describes experiences of Texas hospitals that implemented immediate postpartum LARC (IPLARC) programs, in order to inform the development of other IPLARC programs and guide future research on system-level barriers to broader adoption. METHODS: Eight Texas hospitals that had implemented an IPLARC program were identified, and six agreed to participate in the study. Interviews with 19 key hospital staff covered (1) factors that led the development of an IPLARC program; (2) billing, pharmacy, and administrative operations related to implementation; (3) patient demand and readiness; (4) the consent process; (5) staff training; and (6) hospital plans for monitoring and evaluation of IPLARC services. RESULTS: Most hospitals in this study primarily served Medicaid and un- or under-insured populations. Participants from all six hospitals perceived high levels of patient demand for IPLARC and provider interest in providing this service. The major challenges were related to financing IPLARC programs. Participants from half of the hospitals reported that leadership had concerns about financial viability of providing IPLARC. The hospitals with the longest-running IPLARC programs were safety net hospitals with family planning training programs. CONCLUSIONS FOR PRACTICE: We found that hospitals with IPLARC programs all had strong support from both providers and hospital leadership and had funding sources to offset costs that were not reimbursed. Strategies to reduce the financial risks related to IPLARC provision could provide the impetus for new programs to launch and support their sustainability.