COVID-19 SAFE Enrollment
COVID SAFE
Opt-In Versus Opt-Out for COVID Screening Assessment for Exposure
1 other identifier
interventional
412
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Sep 2020
Shorter than P25 for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2020
CompletedFirst Posted
Study publicly available on registry
August 10, 2020
CompletedStudy Start
First participant enrolled
September 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2020
CompletedMarch 11, 2021
March 1, 2021
2 months
August 7, 2020
March 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion Enrolled
The proportion of those invited that enroll in the study
4 weeks
Secondary Outcomes (6)
Participant Age
4 weeks
Participant Sex
4 weeks
Participant Race/Ethnicity
4 weeks
Participant Income
4 weeks
Participant Education
4 weeks
- +1 more secondary outcomes
Study Arms (2)
Opt-in Recruitment Email
EXPERIMENTALParticipants will receive a recruitment email that describes the objectives of a new COVID-19 voluntary screening program, and invites them to enroll.
Opt-out Recruitment Email
EXPERIMENTALParticipants 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.
Interventions
Behaviorally informed, opt-out framed recruitment email
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Participants will not be eligible for the study if they identify any reason they are unable to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn Medicine
Philadelphia, Pennsylvania, 19103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitesh S Patel, MD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2020
First Posted
August 10, 2020
Study Start
September 9, 2020
Primary Completion
October 30, 2020
Study Completion
October 30, 2020
Last Updated
March 11, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share