dbGaP Study Accession: phs002741

NIH Institute/Center: NIMHD

RADx Data Program: RADx-UP

DOI: 10.60773/q2xk-0f98

Release Date: 08/30/2023

Updated Date: 04/17/2024

Study Description: SARS-CoV-2, the virus that causes COVID-19, has ravaged underserved and vulnerable populations in the United States (US), including in the US territories of Puerto Rico (PR) and the US Virgin Islands (USVI). Pre-pandemic data from the Eastern Caribbean Health Outcomes Research Network (ECHORN) Cohort Study (ECS) (NIH/NIMHD U24MD006938; Pl: Nunez-Smith) indicate nearly 61% of the population-based representative sample (n=3000) has at least one chronic condition making them high risk for severe complications from COVID-19. Nearly 30% of ECS participants report food insecurity. These ECS data were recently requested by the Congressional Ways and Means Committee to scope the threat of the COV1D-19 pandemic to the Caribbean US territories. This competitive revision leverages the Yale Transdisciplinary Collaborative Center for Health Disparities Research focused on Precision Medicine (Yale-TCC; NIH/NIMHD U54MD010711; MPI: Nunez-Smith), which supports broader scientific engagement across ECHORN members. ECHORN was founded in 2011 as a consortium of researchers and non-academic stakeholder partners, using a participatory action research approach, to address the epidemic of non-communicable diseases in the region. The Yale-TCC is a community-engaged and stakeholder-driven network with a consortium comprised of 60 individuals representing 35 organizations spanning academia, research, health policy, faith-based organizations, community-based organizations, and civic societies. The Yale-TCC Governing Board guides prioritization. The goal of the proposed community-engaged research was to, in concert with the RADx-UP consortium, understand factors that have led to the disproportionate disease burden and deploy interventions that improve the reach, access, uptake and impact of COVID-19 testing technologies and strategies across FQHCs, local CBOs, and clinical laboratories in the USVl and PR. Rigorous quasi-experimental designs were used to evaluate the proposed testing intervention projects. This was achieved through the following specific aims: Aim 1: Enhance testing implementation strategies in the USVI and PR utilizing community-based assets and cultural responsiveness to address barriers to full participation in the testing continuum from diagnosis through to seif-isolation. An initial partnership with 3 FQHCs (two in USVI and one in PR) and 2 CBOs (one in USVI and one in PR) was leveraged to refine and implement a multi-component intervention to increase testing, contact tracing, and safe and effective quarantine and isolation, with a focus on the most vulnerable populations. An interrupted time series study design was used to analyze the effect of the intervention on the primary implementation outcome of reach. Secondary Implementation outcomes of adoption, fidelity, acceptability, and sustainability were assessed, as is the secondary effectiveness outcome of ER utilization. Community partners were engaged throughout the intervention refinement, implementation, and evaluation process. Aim 2: Assess the diffusion and uptake of FDA authorized and approved testing technologies across existing and emerging testing models. Through stakeholder and community engagement meetings, intervention components that provide the necessary education/health promotion information, training, and resources that were needed to address barriers at the FQHC, CBO, and community-level to adopt, implement, and disseminate new testing technologies were determined. Sustainability of this model for integration of future technologies or vaccines was addressed and assessed.

Principal Investigator: Nunez-Smith, Marcella

Has Data Files: Yes

Study Domain: Virological Testing; Diagnostic Testing; Testing Rate/Uptake

Data Collection Method: Survey; Contact Tracing

Keywords: Caribbean US Populations; Emergency Room (ER) Utilization

Study Design: Interventional/Clinical Trial

Multi-Center Study: TRUE

Study Sites: Frederiksted Health Care (St. Croix; USVI); St. Thomas East End Medical Center (St. Thomas; USVI); Health ProMed (San Juan; Puerto Rico); Puerto Rico Science; Technology and Research Trust (San Juan; Puerto Rico)

Data Types: Clinical; Questionnaires/Surveys; Behavioral; Electronic Medical Records

Study Start Date: 09/22/2020

Study End Date: 08/31/2022

Species: Human Data

Estimated Cohort Size: 650

Study Population Focus: Adults; Older Adults or Elderly; Children; Underserved/Vulnerable Population

Acknowledgement Statement: This study was supported through funding, 3U54MD010711-05S1, for the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. MPI: Nunez-Smith. We would like to thank each of our site teams for their invaluable collaboration and leadership on this project: Frederiksted Health Care (St. Croix, USVI), St. Thomas East End Medical Center (St. Thomas, USVI), Health ProMed (Puerto Rico) and Puerto Rico Science, Technology, and Research Trust. Approved users should acknowledge the provision of data access by dbGaP for accession phs002741.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PA-20-135

NIH Grant or Contract Number(s): 3U54MD010711-05S1

Consent/Data Use Limitations: General Research Use