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CompletedNCT04506268COVID SAFEUpdated Mar 11, 2021

COVID-19 SAFE Enrollment

An interventional study of Opt-out Recruitment Email and Opt-in Recruitment Email in Covid19, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-11.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
412
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Covid19

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Keywords

  • COVID-19
  • Coronavirus
  • opt-in
  • opt-out
  • behavioral science
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 412 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
412 participants (actual)

Study arms

  • Experimental
    Opt-in Recruitment Email

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

    Behavioral: Opt-in Recruitment Email

  • Experimental
    Opt-out Recruitment Email

    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.

    Behavioral: Opt-out Recruitment Email

Interventions

  • BehavioralOpt-out Recruitment Email

    Behaviorally informed, opt-out framed recruitment email

  • BehavioralOpt-in Recruitment Email

    Standard, opt-in framed recruitment email

06

What researchers measure

Primary outcomes

  1. Proportion Enrolled

    The proportion of those invited that enroll in the study

    Time frame: 4 weeks

Secondary outcomes

  1. Participant Age

    The average age of participants enrolled in the study

    Time frame: 4 weeks

  2. Participant Sex

    The proportion of females enrolled in the study

    Time frame: 4 weeks

  3. 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)

    Time frame: 4 weeks

  4. 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)

    Time frame: 4 weeks

  5. 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)

    Time frame: 4 weeks

  6. Test Completion

    The proportion of enrolled participants that submit a saliva sample

    Time frame: 8 weeks

07

Study locations

1 site
  • Penn Medicine
    Philadelphia, Pennsylvania 19103, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04506268
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Aug 10, 2020
Start date
Sep 9, 2020
Primary completion
Oct 30, 2020
Completion
Oct 30, 2020
Last update
Mar 11, 2021

Study contacts

Mitesh S Patel, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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