John Apolzan, PhD, Pennington Biomedical Research Center
David Welsh, MD, LSU Health-New Orleans
E-cigarette use is dramatically increasing particularly among underserved populations including people living with HIV (PLWH). E-cigarette, or vaping, product use–associated lung injury (EVALI) highlights the hazards of the uptake of new substance use behaviors without adequate understanding of the medical consequences. The overall objective of the study is to determine changes in lung metabolites associated with e-cigarettes, or vaping, and to examine how gut microbiota moderate vaping associated lung injury markers in PLWH to help discover therapeutic targets.
Emily Harville, PhD, Tulane University
This project, which involves a collaboration among investigators from 3 IDeA states (Louisiana, Oklahoma, and North Dakota), will clearly accomplish the NOSI goal of increasing research specifically directed at women's health and health disparities and expanding the capacity of IDeA states to conduct women's health research, with particular relevance to addressing underlying causes of maternal and infant morbidity and mortality.
Peter Katzmarzyk, PhD, Pennington Biomedical Research Center
In the US, COVID-19 has unveiled a disproportionate health burden in low income and underserved segments of society. In Louisiana, some of the greatest health and economic consequences are evident in our Black communities. There is an urgent need to establish effective testing strategies in these communities as the Fall/Winter virus surges unfold. The Louisiana Clinical and Translational Science (LA CaTS) Center provides the essential infrastructure and key foundational support for biomedical research in our region and is uniquely positioned to lead a community-engaged testing research project to determine differences in COVID-19 testing rates between community-based (churches, community centers, and schools) and medical clinic-based testing sites, and determine approaches that will increase uptake of testing in underserved Black communities in the South. We plan to address these issues using a two-pronged approach. First, we will use a community based participatory research approach to determine differences in SARS-CoV-2 testing rates across distinct types of test sites within five urban underserved Black communities in the American South. We will use a multimedia campaign to promote and conduct RT-PCR testing on salivary samples obtained from 2,000 adults at 1) medical clinics, 2) schools, 3) community centers, and 4) churches (in random order) within five ZIP codes with known low socioeconomic status (SES) and a high representation of Black residents. The primary outcome will be the number of tests performed at each type of test site. We will collect information on age, sex, race, BMI, employment, social determinants of health using an aggregate SES score to identify important correlates of testing rates. Second, we will further leverage our strong and well-integrated partnership with the Baton Rouge Mayor's Healthy City Initiative together with our LA CaTS Community Advisory Boards (CABs) to conduct community-based focus groups to obtain qualitative data about the perceptions and attitudes related to testing access and potential barriers affecting such. We will use this information to determine community-driven approaches that are effective in reducing barriers and create strategies to increase SARS-CoV-2 testing uptake in urban underserved Black communities. Results of this project will greatly increase our understanding of the factors that have led to a disproportionate COVID-19 health burden in these underserved populations and lay the groundwork for developing strategies to reduce these disparities in all underserved Black communities. Resulting data will inform the equitable deployment of future virus/flu testing and a SARS-CoV-2 vaccine.
Lucio Miele, MD, PhD, LSU Health-New Orleans
Emergence of a novel coronavirus, now known as severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), has resulted in human disease (COVID-19) that has swept the globe in pandemic proportions with more than eight million confirmed cases and >440,000 deaths to date. Surges of COVID-19 have occurred throughout the United States (US) with urban centers such as New York City and New Orleans hardest hit. COVID-19 clinical descriptions have evolved from what was initially felt to be a respiratory illness to a multisystem disease with protean manifestations. Moreover, disparities in outcomes have been described with African Americans having higher infection and mortality rates. Populations residing in rural areas are often poorer, older, and have multiple co-morbidities such as type 2 diabetes, obesity and hypertension, raising questions about disease manifestations and outcomes that may differ from those described in urban areas. COVID-19 cases and mortality in rural areas continues to climb with multiple outbreaks, many of which have been related to meat packing plants and prison clusters. The National COVID Cohort Collaborative (N3C) has been established by the National Center for Data to Health (CD2H) in partnership with the National Center for Advancing Translational Sciences (NCATS) for purposes of building a centralized national data resource for the study of COVID-19. As N3C will facilitate translation of data into knowledge urgently needed to effectively address the COVID-19 pandemic, it is critically important that this resource contain patient outcomes data from diverse populations throughout the US – both urban and rural – with inclusion of populations of color, Native Americans, and others. The Institutional Development Award Program Clinical Translational Research Centers (IDeA CTRs) are located in diverse areas of the US, serving rural populations as well as other vulnerable groups, including Native Americans and persons of color. IDeA CTRs are well poised to provide outcomes data that relate to a diverse group of medically underserved persons that may otherwise not receive adequate representation in the N3C. Specifically, eight IDeA CTRs located in Delaware, Louisiana, Maine, Mississippi, Nebraska, Oklahoma, Rhode Island, and West Virginia have established relationships with healthcare organizations that have, to date, have conducted SARS CoV-2 testing among more than 285,000 persons, of whom more than 25,000 have tested positive. This project will enable rapid contribution of COVID-19 patient data from IDeA states to N3C, enhancing understanding of COVID-19 in the US and driving further research addressing COVID-19 patient outcomes in multiple underserved populations.
Lucio Miele, MD, PhD, LSU Health-New Orleans
Daniel Sarpong, PhD, Xavier University
We hypothesize that prolonged COVID19 illness, re-infection, and/or post-vaccine infection in patients with chronic conditions are associated with specific SARS-CoV-2 lineages or mutations, and that increasing the awareness of the potential danger posed by variants of concern will improve testing adherence and variant tracking. We propose to use our established FDA- authorized COVID19 sequencing platform in combination with innovative data analytics and clinical bioinformatics as well as our BMI and community engagement KCAs. Our proposal addresses four of the priority areas indicated by NOT-GM-21-031, specifically: • Are there different variants present in the study population, and how has the number of cases caused by different variants changed over time in the study population? • How are different variants distributed among different racial, ethnical, gender, and/or age groups? • Are specific variants associated with different levels of manifestation of COVID19 symptoms? • Do vaccinated study participants still acquire the SARS-CoV-2 virus, and if so, what variants do they carry? We propose these Specific Aims: Specific Aim 1. To improve surveillance of COVID19 by integrating SARS-CoV-2 sequencing and clinical data with a focus on under-represented, vulnerable and remote populations. Using highly automated processes, we will identify variants/mutations associated with clinical phenotypes, including prolonged asymptomatic/antibody-positive individuals, re-infected, and vaccinated populations. All trend data will be integrated in the AWS cloud where it can be accessed by relevant stakeholders including testing and vaccine program partners. Specific Aim 2. To develop and validate simulation models that incorporate SARS-CoV-2 genetic data with clinical outcomes to predict COVID19 case severity in Louisiana by region as vaccination levels increase. Specific Aim 3. To design and deploy culturally and linguistically appropriate outreach material on SARS-CoV-2 and determine whether increased knowledge of the potential danger of adaptive mutations improves acceptance of testing and vaccination.
Project Leads: Judd Shellito, MD, LSU Health-New Orleans
Vivian Fonseca, MD, Tulane University
Frank Greenway, MD, Pennington Biomedical Research Center
This is a combined retrospective and prospective, longitudinal, observational meta-cohort of individuals who will enter the cohort with and without SARS-CoV-2 infection and at varying stages before and after infection. Individuals with and without SARS-CoV-2 infection and with or without Post-Acute Sequelae of COVID-19 (PASC) symptoms will be followed to identify risk factors and occurrence of PASC. This study will be conducted in the United States and subjects will be recruited through inpatient, outpatient, and community-based settings. Study data including age, demographics, social determinants of health, medical history, vaccination history, details of acute SARS-CoV-2 infection, overall health and physical function, and PASC symptom screen will be reported by subjects or collected from the electronic health record using a case report form at specified intervals. Biologic specimens will be collected at specified intervals, with some tests performed in local clinical laboratories and others performed by centralized research centers or banked in the Biospecimen Repository. Advanced clinical examinations and radiologic examinations will be performed at local study sites with cross-site standardization.
Project Lead: Peter Katzmarzyk, PhD, Pennington Biomedical Research Center
In the US, COVID-19 unveiled a disproportionate health burden in low income and underserved segments of society. In Louisiana, some of the greatest health and economic consequences are evident in our Black communities. Furthermore, despite the widespread availability of SARS-CoV-2 vaccines, approximately 30% of the US population reports that they will not get vaccinated, and Black citizens and those with lower socio- economic status are more likely to have vaccine hesitancy. Thus, there is an urgent need to address vaccine hesitancy within the context of the COVID-19 pandemic and the current testing environment. The Louisiana Clinical and Translational Science (LA CaTS) Center provides the essential infrastructure and key foundational support for biomedical research in our region and is uniquely positioned to lead a community-engaged research project to determine solutions to decrease vaccine hesitancy and improve testing rates in our most underserved populations. Faith-based organizations (churches, mosques, temples, etc.) are trusted sources of information, especially among Black communities, and may represent an opportunity to convey accurate, unbiased health information regarding COVID-19 vaccinations and testing to the community. Many Black churches have well-developed health ministries that integrate faith and health for their members and the communities they serve. We will use a mixed-methods study design to determine the effectiveness of training church health ministers to educate their congregations about the safety and efficacy of COVID-19 vaccines for decreasing vaccine hesitancy and improving testing knowledge in underserved Black communities. We will randomize 98 participants from five churches to an intervention group that will receive counseling from their health ministers on the benefits of getting vaccinated and tested, or to a delayed intervention control group. The effects of the intervention on the primary outcome, vaccine hesitancy measured by a structured questionnaire, will be studied after three weeks. Following the three-week control period, the delayed intervention control group will also receive the intervention. We will then conduct focus groups among a sub-sample of participants to obtain more granular information on sources of vaccine hesitancy and for their vaccine-related decisions. The achievement of the study's goals will significantly increase our understanding of vaccine hesitancy within Black urban communities in Louisiana. Our results will inform the development of targeted interventions to increase vaccine coverage in the large, underserved populations across the American South.