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COVID-19 SAFE Enrollment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04506268
Acronym
COVID SAFE
Enrollment
412
Registered
2020-08-10
Start date
2020-09-09
Completion date
2020-10-30
Last updated
2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COVID-19, Coronavirus, opt-in, opt-out, behavioral science

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.

Interventions

BEHAVIORALOpt-in Recruitment Email

Standard, opt-in framed recruitment email

BEHAVIORALOpt-out Recruitment Email

Behaviorally informed, opt-out framed recruitment email

Sponsors

University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion Enrolled4 weeksThe proportion of those invited that enroll in the study

Secondary

MeasureTime frameDescription
Participant Sex4 weeksThe proportion of females enrolled in the study
Participant Race/Ethnicity4 weeksThe 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 Age4 weeksThe average age of participants enrolled in the study
Participant Education4 weeksThe 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 Completion8 weeksThe proportion of enrolled participants that submit a saliva sample
Participant Income4 weeksThe proportion of enrolled participants belonging to specified categories of income (e.g., Less than $10000, $10000 to $19999, $20000 to $29999, $150000 or more)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026