Clinical trial NCT04367857: ARMOR Study: COVID-19 Seroprevalence Among Healthcare Workers
Official title: SARS-CoV-2 Seroprevalence Among Healthcare Workers: ARMOR Study Demonstration Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid-19
Coronavirus Infection
Coronavirus
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Employee of NewYork-Presbyterian Hospital and its affiliates

Brief summary: The novel coronavirus (SARS-CoV-2) has spread all around the world and testing has posed a challenge globally. Health care providers are highly exposed and are an important group to test. On top of these concerns, health care workers are also stressed by the needs on responders in the COVID-19 crisis. The investigators will look at different ways to measure how common COVID-19 is among health care workers, how common is the presence of antibodies by serological tests (also known as serostatus). The investigators will describe health worker mental and emotional well-being and their coping strategies in their institutional settings. Lastly, the investigators will describe how knowing serostatus can affect individuals' mental and emotional well-being and how to cope in the midst of the COVID-19 response. This will help to how to better test and help healthcare workers in the COVID-19 pandemic and prepare for possible future outbreaks.

Detailed description: The rapid spread of the novel coronavirus SARS-CoV-2 has resulted in pandemic levels and a global challenge in diagnosing infection. Diagnosing infection, defining recovery and immunity has been challenging. Health care providers in particular are very interested in knowing their status as they are highly exposed, and if infectious, can potentially transmit infection nosocomially (in the healthcare workplace setting) and to their household. In addition to understanding their exposure risk, infectious period, and immunity status, health care workers are reporting high levels of psychosocial distress including anxiety and burnout. The investigators aim to assess the baseline and cumulative seroprevalence of SARS-CoV-2 among health care workers using both quantitative and qualitative serological assays; describe psychosocial well-being and coping strategies among health workers in their institutional settings and describe how knowledge of one's serostatus affect psychosocial well-being, and coping strategies. Findings from this study will inform; 1) use of serological assays and testing algorithms, and 2) approaches to manage psychosocial stress for healthcare workers.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* NewYork-Presbyterian (NYP) healthcare personnel employee or affiliate
* Understands and reads English

Exclusion Criteria:

* Younger than 18 years of age
* Mentally and/or physically unable to complete study requirements

Primary outcomes:
measure: Proportion seropositive
timeFrame: Up to 12 months after collection visit
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian Hosptial/Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Magdalena Sobieszczyk, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: