PROJECT ABSTRACT
Patients receiving dialysis are one of the highest risk groups for serious illness with SARS-CoV-2 infection. In
addition to the inherent risks of travel to and dialysis within indoor facilities, patients receiving dialysis are more
likely to be older, non-white, from disadvantaged backgrounds, and have impaired immune responses to viral
infections and vaccinations. Universal testing offered at hemodialysis facilities could shield this vulnerable
population from exposure, enable early identification and treatment for those affected, and reduce transmission
to other patients and family members. In our preliminary work, we created an academic-industry partnership
with the third largest dialysis provider in the US (US Renal Care) and a central commercial laboratory (Ascend
Clinical). We evaluated SARS-CoV-2 seroprevalence, response to infection and vaccination, and vaccine
acceptability among patients receiving dialysis. We now propose to build on this partnership to implement and
compare two test-based universal screening strategies in dialysis facilities, and to assess vaccine
effectiveness. In a pragmatic cluster randomized controlled trial, we will randomize 62 US Renal Care facilities
with an estimated 2480 patients to static versus dynamic universal screening testing strategies. Static universal
screening will involve offering patients SARS-CoV-2 screening tests every two weeks; the dynamic universal
screening strategy will vary the frequency of testing from once every week to once every four weeks,
depending on community COVID-19 case rates. We hypothesize that patients dialyzing at facilities randomized
to a dynamic testing frequency responsive to community case rates will have higher test acceptability (primary
outcome), experience lower rates of COVID-19 death and hospitalization, and report better experience-of-care
metrics. Since patients receiving dialysis achieve suboptimal rates of seroconversion post influenza, hepatitis
B, and COVID-19 vaccination, we will embed an assessment of the clinical effectiveness of COVID-19
vaccination within the framework of this pragmatic intervention. We will determine rates of asymptomatic and
symptomatic SARS-CoV-2 infection in vaccinated versus unvaccinated patients, and risk factors for vaccine
breakthrough, specifically whether longer duration of ESKD and absent or diminished semi-quantitative
receptor binding domain IgG response one-year post vaccination increase risk for breakthrough infection. Our
network will be well-positioned to rapidly generate data on the acceptability and benefits of test-based
screening, and will inform policies for SARS-CoV-2 prevention including potential modification of vaccine
dosing and/or formulations. The objectives of our work align with the goals of the RADx-UP initiative. In
collaboration with a major community stakeholder serving this medically vulnerable population, we will address
two issues of utmost public health concern—universal screening strategies and vaccine assessments—and
reduce risks for SARS-CoV-2 infection, morbidity, and mortality in patients receiving dialysis.
