dbGaP Study Accession: phs003083

NIH Institute/Center: NIAID

RADx Data Program: RADx-UP

DOI: 10.60773/0h5r-v081

Release Date: 08/29/2023

Updated Date: 04/17/2024

Study Description: This study planned to offer SARS-CoV-2 screening tests at selected dialysis facilities in order to: reduce transmission, and detect early cases and prevent serious illness among patients receiving dialysis. Patients receiving dialysis have an 8-fold higher risk for hospitalization and 15-fold higher risk for death from COVID-19 compared with the general population. Patients receiving dialysis also disproportionately belong to racial/ethnic minority and economically disadvantaged groups. Thus, the goals of this project were to increase availability of highly sensitive and specific testing for SARS-CoV-2 infection in a medically vulnerable and disadvantaged population. The study planned to perform a pragmatic cluster (facility-level) randomized study to test the patient level acceptability of two strategies for offering test-based screening offered at the dialysis facility. This study offered anterior nares, rtPCR tests at a static frequency (aim 1) versus a dynamic frequency anchored to county COVID-19 spread (aim 2). After a pilot in four facilities, this study planned to scale up the study to 62 dialysis facilities within US Renal Care. After a 3-month period of testing, the study assessed the following outcomes: Patient level test acceptability (primary outcome), Facility level Deaths, and Facility level Hospitalization. The overall goal was to identify a highly acceptable universal testing strategy for patients receiving dialysis, and prevent serious complications from SARS-CoV-2 by identifying cases early.

Principal Investigator: Anand, Shuchi

Has Data Files: Yes

Study Domain: Testing Rate/Uptake; Social Determinants of Health; Screening Testing

Data Collection Method: Molecular (Nucleic Acid/PCR) Testing Device; Survey

Keywords: COVID-related Hospitalizations; COVID-related Deaths

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

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

Study Start Date: 01/01/2022

Study End Date: 12/31/2023

Species: Human Data

Estimated Cohort Size: 2480

Study Population Focus: Lower Socioeconomic Status (SES) Population; Adults; Older Adults or Elderly; Racial and Ethnic Minorities; Dialysis Patients; Underserved/Vulnerable Population

Study Website URL: https://clinicaltrials.stanford.edu/trials/s/NCT05225298.html

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05225298

Acknowledgement Statement: This study was supported through funding, 5U01AI169477-02, for the National Institute of Allergy and Infectious Diseases (NIAID) as part of the RADx-UP program. We would like to thank the research and clinical teams at US Renal Care, Ascend Clinical Laboratory, and Stanford University. Abbott Laboratory funded the acute testing performed for this project. We are grateful for the participants who shared their time and experiences with us. Approved users should acknowledge the provision of data access by dbGaP for accession phs003083.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: RFA-OD-21-008

NIH Grant or Contract Number(s): 5U01AI169477-02

Consent/Data Use Limitations: General Research Use