Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study Expansion Cohort

Introduction The National Heart, Lung, and Blood Institute (NHLBI) is seeking a Study Coordinating Center (SCC) to serve as an expansion of the existing contract program titled Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study cohort. The purpose of this announcement is to provide a Pre-solicitation Notice for the release of Solicitation No. 75N98026R00074. THIS IS A SYNOPSIS. THIS IS NOT A SOLICITATION. Background The Division of Cardiovascular Sciences of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), is conducting a market survey to assess the availability and potential technical capability of small business firms to perform the necessary steps to design a longitudinal cohort study within the Southern Plains region of the U.S. to serve as an expansion of the existing contract program titled Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study cohort. The National Heart, Lung, and Blood Institute (NHLBI) intends to expand the footprint of RURAL to increase representation of the U.S. rural population within the study. This expansion cohort will identify up to four (4) rural counties in the Southern Plains region using rurality criteria comparable to the original cohort in the RURAL Heart and Lung study. The selected counties should be demographically representative of the targeted area of the rural Southern Plains region, with enrollment targets that will enable valid inferences across key continuous and dichotomous factors of risk and resilience with respect to key population subgroups. Where feasible, counties should be selected to mirror and enhance the ecological design of RURAL higher risk and lower risk counties with respect to cardiopulmonary outcomes; secure suitable mobile examination unit(s) (semi-trailer, customized RV, etc.) to conduct a clinical examination of participants that is comparable in scope to the baseline clinical examination conducted in the RURAL Original cohort; conduct cohort follow-up to ascertain health status and accrue cardiovascular and pulmonary events for the purpose of assessing progression from subclinical disease to clinical disease in a manner identical to the RURAL Original cohort; establish and maintain data and biospecimen repositories, enabling their use to test new ancillary study hypotheses (adding new ancillary study data and biospecimens as they become available); and engage the communities within the selected RURAL Expansion counties to facilitate recruitment and retention of study participants and to understand and work to improve the overall health of the communities. THIS PRE-SOLICITATION NOTICE ADDRESSES THE EXPANSION COHORT OF THE EXISTING RURAL HEART AND LUNG STUDY ONLY. It is anticipated that one (1) award may be made on or about June 1, 2027 for a period of four (4) years and three (3) months. The Risk Underlying Rural Areas Longitudinal (RURAL) Heart and Lung Study was initially funded as a Cooperative Agreement (U01HL146382), with the first Notice of Award being issued on May 2, 2019. The initial recruitment goal of the RURAL Heart and Lung Study (https://theruralstudy.org) was to enroll a cohort of 4,600 participants, ages 25-64, in the rural Southeastern U.S. to better understand the health of those living in rural, underserved communities. The design of RURAL utilizes a mobile exam unit (MEU) to enroll and examine participants in six (6) high risk, and four (4) low risk, rural Southeastern counties in Alabama (AL), Mississippi (MS), Louisiana (LA), and Kentucky (KY). Enrollment in MS (2 counties), LA (2 counties), and KY (4 counties) have an ecological paired design, in that rural counties at high risk for cardiopulmonary outcomes are paired with counties at lower risk based on county level demographic profiles. In AL, both counties are at high risk as demographically similar lower risk counties were not found. Key components of the baseline exam include the following: anthropometry, biospecimen collection, behavioral/medical/demographic assessments, gated cardiac CT, inspiratory and expiratory chest CT, pulmonary function testing, Echocardiography, and an mHealth component that includes a smartphone with an embedded RURAL app, a Fitbit, and suite of questionnaires to comprehensively characterize Social Determinants of Health (SDoH). The RURAL Heart and Lung Study was renewed in 2026 as a 5-year contract (Contract No. 75N98026D00018) to conduct a second comprehensive examination in previously enrolled participants, as well as prospectively follow participants through annual follow-up contacts and ascertainment of heart and lung events of clinical significance. Objectives The objective of this proposed acquisition is to designate a study coordinating center to provide the necessary expertise, solicit appropriate sub-awards, and manage relevant activities to carry out the necessary functions to achieve the overall objectives of the program. The scientific objectives are to: (1) recruit and examine participants in rural, underserved areas in the U.S. Southern Plains region to further enhance understanding of risk factor progression or identify potential factors of resilience with respect to cardiopulmonary health; (2) provide sufficient statistical power to perform analyses of biological, social, and behavioral predictors of subclinical disease or risk factors within relevant population groups defined by sex and race and ethnicity; (3) study the progression of subclinical to clinical CVD and pulmonary complications; and (4) identify new risk factors or interactions among factors that inform disease pathophysiology. The operational goals are to: (1) support the key study infrastructure including community level recruitment and retention for the optimizing participant clinical examinations, a data management center, support cohort follow-up and data collection on clinical events; (2) provide to the RURAL Expansion communities lay reports based on data collected during the expansion cohort baseline examination that summarize key findings to enhance awareness of health conditions, inform participants and communities of the relationship of risk factors to disease, and promote healthy behaviors; (3) provide for maintenance of a data repository (adding new ancillary study data as they become available) and biospecimen repositories and integration of data resources with the RURAL Original cohort baseline materials to facilitate their use to test new hypotheses; and (4) foster scientific collaborations in particular among early career investigators. Project Requirements The important overall technical requirements associated with this proposed acquisition for the expansion cohort of the existing RURAL Heart and Lung Study include the following: 1. Develop and maintain a web-based data collection system and provide other services as necessary to enable regular follow-up contacts of participants through geocoded updates of addresses. (Task Area A) 2. Conduct regular follow-up contacts with participants. (Task Area A) 3. Develop and maintain a web-based data collection system and provide other services as necessary to investigate participant's self-report of clinical events by collecting supporting medical records, death certificates, and other relevant materials; perform abstraction of data from such records required for events ascertainment; and conduct expert review and classification thereof. (Task Area A) 4. In collaboration with the program office, identify a minimum of two (2) and maximum of four (4) rural counties within the U.S. Southern Plains region using criteria comparable to the identification of the rural counties in the RURAL Original cohort study design. Population sampling within the identified counties should be broadly representative of the population groups of the targeted region. Recruitment targets should permit comparisons of key cardiopulmonary risk or resilience factors by key demographic groups. (Task A) 5. Procure appropriate mobile examination unit(s) for a clinical examination of enrolled participants. Solicit proposals from potential vendors, establish criteria for evaluation of proposals and oversee the procurement process. Secure insurance to provide reasonable coverage protecting from losses due to theft, weather related damage, and damage from unforeseen acts. Ensure appropriate and reasonable liability insurance. Establish a maintenance program utilizing spare parts and local contractors to minimize any loss of time for participant examinations. (Task Areas A, B) 6. Design and implement appropriate quality assurance and quality control programs with particular attention to minimize manual entry of participant data. (Task Areas A, B) 7. Perform administrative, operational, and technical duties to support productive collaboration among the study personnel at all supported Institutions, outside researchers, and collaborations with RURAL Original cohort investigators…