search
Back to results

COVID-19 SAFE Enrollment (COVID SAFE)

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opt-out Recruitment Email
Opt-in Recruitment Email
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Covid19 focused on measuring COVID-19, Coronavirus, opt-in, opt-out, behavioral science

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

•University of Pennsylvania staff, faculty, and trainees that have returned to work on campus who have been identified by leadership at the University of Pennsylvania Perelman School of Medicine.

Exclusion Criteria:

•Participants will not be eligible for the study if they identify any reason they are unable to participate in the study.

Sites / Locations

  • Penn Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Opt-in Recruitment Email

Opt-out Recruitment Email

Arm Description

Participants will receive a recruitment email that describes the objectives of a new COVID-19 voluntary screening program, and invites them to enroll.

Participants will receive a recruitment email that describes the objectives of a new COVID-19 voluntary screening program, and informs them that they have been conditionally enrolled.

Outcomes

Primary Outcome Measures

Proportion Enrolled
The proportion of those invited that enroll in the study

Secondary Outcome Measures

Participant Age
The average age of participants enrolled in the study
Participant Sex
The proportion of females enrolled in the study
Participant Race/Ethnicity
The proportion of enrolled participants belonging to specified categories of race (e.g., Alaska Native, Asian, Black or African American, Native Hawaiian or other Pacific Islander, White or Caucasian) and ethnicity (i.e., Hispanic or Latino, Non-Hispanic or Latino)
Participant Income
The proportion of enrolled participants belonging to specified categories of income (e.g., Less than $10000, $10000 to $19999, $20000 to $29999, $150000 or more)
Participant Education
The proportion of enrolled participants belonging to specified categories of education (e.g., less than high school, some high school, high school grad, college: 4 year degree, post-college education)
Test Completion
The proportion of enrolled participants that submit a saliva sample

Full Information

First Posted
August 7, 2020
Last Updated
March 10, 2021
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT04506268
Brief Title
COVID-19 SAFE Enrollment
Acronym
COVID SAFE
Official Title
Opt-In Versus Opt-Out for COVID Screening Assessment for Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In order to safely and effectively reopen businesses and universities across the US, institutions will need to develop approaches to rapidly identify COVID-19 cases and manage their spread while balancing program effectiveness, feasibility, costs, and scalability. The investigators will evaluate the implementation of a COVID-19 screening program that coordinates several existing systems at the University of Pennsylvania including saliva-based viral testing and test different outreach strategies (opt-in vs opt-out) to improve program enrollment.
Detailed Description
The coronavirus disease 2019 (COVID-19) pandemic has resulted in close to 10,000,000 reported cases worldwide, including more than 2,000,000 aggregated reported cases and 120,000 deaths in the United States. Initial efforts to address the COVID-19 pandemic were aimed at testing symptomatic individuals, implementing stay-in-place orders, and at increasing hospital capacity to meet surge demands. While the US continues to confront the current crisis, we must plan for the future by putting in place tools to enhance our ability to conduct effective screening, containment, and case management. Widespread COVID-19 testing is needed to safely and effectively reopen schools and businesses across the US. However, currently approved testing options require reagents that are limited in supply, severely hindering scalability. Emerging evidence indicates that saliva testing with the option of at-home sample collection can accurately identify COVID-19 viral infection. Additional diagnostic testing options will continue to increase patient access. Moreover, this approach provides an option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor's office, hospital, or testing site. Collection by the patient also reduces exposure of health care workers to the virus and preserves limited personal protective equipment. With access to expanded testing, health systems and universities will need to test alternative methods to manage COVID-19 spread while balancing program effectiveness, feasibility, costs, and scalability. Insights from the field of behavioral economics offer promise for designing and sustaining these kinds of policies. Specifically, research has demonstrated that an opt-out framed recruitment strategy compared to a conventional opt-in strategy can improve enrollment and adherence to behavioral interventions. For these reasons, the investigators propose to evaluate the implementation of a COVID-19 screening program that uses saliva-based testing and to test approaches to improve program enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, Coronavirus, opt-in, opt-out, behavioral science

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
412 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Opt-in Recruitment Email
Arm Type
Experimental
Arm Description
Participants will receive a recruitment email that describes the objectives of a new COVID-19 voluntary screening program, and invites them to enroll.
Arm Title
Opt-out Recruitment Email
Arm Type
Experimental
Arm Description
Participants will receive a recruitment email that describes the objectives of a new COVID-19 voluntary screening program, and informs them that they have been conditionally enrolled.
Intervention Type
Behavioral
Intervention Name(s)
Opt-out Recruitment Email
Intervention Description
Behaviorally informed, opt-out framed recruitment email
Intervention Type
Behavioral
Intervention Name(s)
Opt-in Recruitment Email
Intervention Description
Standard, opt-in framed recruitment email
Primary Outcome Measure Information:
Title
Proportion Enrolled
Description
The proportion of those invited that enroll in the study
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Participant Age
Description
The average age of participants enrolled in the study
Time Frame
4 weeks
Title
Participant Sex
Description
The proportion of females enrolled in the study
Time Frame
4 weeks
Title
Participant Race/Ethnicity
Description
The proportion of enrolled participants belonging to specified categories of race (e.g., Alaska Native, Asian, Black or African American, Native Hawaiian or other Pacific Islander, White or Caucasian) and ethnicity (i.e., Hispanic or Latino, Non-Hispanic or Latino)
Time Frame
4 weeks
Title
Participant Income
Description
The proportion of enrolled participants belonging to specified categories of income (e.g., Less than $10000, $10000 to $19999, $20000 to $29999, $150000 or more)
Time Frame
4 weeks
Title
Participant Education
Description
The proportion of enrolled participants belonging to specified categories of education (e.g., less than high school, some high school, high school grad, college: 4 year degree, post-college education)
Time Frame
4 weeks
Title
Test Completion
Description
The proportion of enrolled participants that submit a saliva sample
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: •University of Pennsylvania staff, faculty, and trainees that have returned to work on campus who have been identified by leadership at the University of Pennsylvania Perelman School of Medicine. Exclusion Criteria: •Participants will not be eligible for the study if they identify any reason they are unable to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitesh S Patel, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

COVID-19 SAFE Enrollment

We'll reach out to this number within 24 hrs