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OpenTrials
Completed

NCT Number: NCT04506268

COVID-19 SAFE Enrollment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine

Philadelphia, Pennsylvania, 19103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Opt-out Recruitment Email

Behavioral

Behaviorally informed, opt-out framed recruitment email

Opt-in Recruitment Email

Behavioral

Standard, opt-in framed recruitment email

Primary outcomes

  1. Proportion Enrolled

    Time frame: 4 weeks

    The proportion of those invited that enroll in the study

Secondary outcomes

  1. Participant Age

    Time frame: 4 weeks

    The average age of participants enrolled in the study

  2. Participant Sex

    Time frame: 4 weeks

    The proportion of females enrolled in the study

  3. Participant Race/Ethnicity

    Time frame: 4 weeks

    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)

  4. Participant Income

    Time frame: 4 weeks

    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)

  5. Participant Education

    Time frame: 4 weeks

    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)

  6. Test Completion

    Time frame: 8 weeks

    The proportion of enrolled participants that submit a saliva sample

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Opt-In Versus Opt-Out for COVID Screening Assessment for Exposure

Acronym: COVID SAFE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2020
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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