Use of Behavioral Economics in Repeat SARS-CoV-2 (COVID-19) Antibody Testing in Disadvantaged Communities

July 22, 2024 updated by: Jason Doctor, University of Southern California
Repeat testing for SARS-CoV-2 antibodies in disadvantaged communities will help identify active and recovered infections over time, and as more is understood about antibody protection, it may help identify persons who have immunity. Many questions about social barriers and behavioral facilitators remain unanswered. This project aims to evaluate the effectiveness of risk-based messaging and incentives that promote repeated testing for SARS-CoV-2 antibodies, as well as to understand social and behavioral determinants of COVID-19 testing and variations within sub-groups of this population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The rapid spread of the SARS-CoV-2 virus has greatly impacted underserved populations. This project aims to understand social and behavioral determinants of COVID-19 testing and variations within sub-groups of this population. In partnership with the largest federally qualified health center in the United States, investigators will collect survey data and conduct a randomized experiment on 2,160 individuals (540 families) to evaluate the effectiveness of risk-based messaging and incentives that promote repeated testing for SARS-CoV-2 antibodies. In a 2 x 2 (Messaging x Incentive) factorial experiment, participants complete a comprehensive set of social and behavioral surveys to identify determinants of commitment to testing. Participants are then randomized to receive customized messaging promoting repeated testing. Messaging will focus upon either (1a) household risk or (1b) personal risk of COVID-19. Participants are also randomly assigned to an incentive condition that either (2a) insures against losing baseline rewards for initial testing, or (2b) entry into a lottery with a small chance to win $150 if both tests are completed. Both the loss protection and lottery conditions carry the same incentive costs. Previous work in similar populations demonstrates that adherence to planned health behaviors is higher with insurance-based incentives than cash payments of equal value. This experiment compares insurance-based incentives to lottery incentives that have been shown to be effective in multiple contexts. Finally, the investigators evaluate if social and behavioral determinants of health result in heterogeneous treatment effects that can inform customization of incentive offerings in future programs devoted to increasing uptake of testing or vaccinations among underserved populations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2164

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90022
        • AltaMed Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults and children 5 years of age and older

Exclusion Criteria:

  • Children under 5 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Personal Risk + Loss Protection
Behavioral: Personal Risk Messaging
Personal risk framing may engender concern for oneself. Households randomized to personal risk messaging will receive the following message: "Antibody testing will help you understand your risk of getting COVID-19."
Behavioral: Loss Protection
Household members are offered a baseline incentive with a 90% (9 in 10) chance of $60 and receive insurance on winning the baseline incentive for repeat antibody testing.
Experimental: Personal Risk + Lottery Incentive
Behavioral: Personal Risk Messaging
Personal risk framing may engender concern for oneself. Households randomized to personal risk messaging will receive the following message: "Antibody testing will help you understand your risk of getting COVID-19."
Behavioral: Lottery Incentive
Household members are offered a baseline incentive with a 90% (9 in 10) chance of $60 and receive a bonus lottery incentive with a 4 small (1 in 25) chance of winning $150 for repeat antibody testing.
Experimental: Family Risk + Loss Protection
Behavioral: Loss Protection
Household members are offered a baseline incentive with a 90% (9 in 10) chance of $60 and receive insurance on winning the baseline incentive for repeat antibody testing.
Behavioral: Family Risk Messaging
Family risk framing may engender concern for loved ones. It may also make it easier to mentally simulate family burdens with COVID-19 such as knowing how several people in the family becoming sick could adversely affect the lives of everyone in the family. Households randomized to family risk messaging will receive the following message: "Antibody testing will help you understand your family's risk of getting COVID-19."
Experimental: Family Risk + Lottery Incentive
Behavioral: Lottery Incentive
Household members are offered a baseline incentive with a 90% (9 in 10) chance of $60 and receive a bonus lottery incentive with a 4 small (1 in 25) chance of winning $150 for repeat antibody testing.
Behavioral: Family Risk Messaging
Family risk framing may engender concern for loved ones. It may also make it easier to mentally simulate family burdens with COVID-19 such as knowing how several people in the family becoming sick could adversely affect the lives of everyone in the family. Households randomized to family risk messaging will receive the following message: "Antibody testing will help you understand your family's risk of getting COVID-19."

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attendance Rate at Time 2 SARS-CoV-2 Antibody Test
Time Frame: 6 months
Effectiveness of risk-based messaging and incentives to encourage attendance at Time 2 testing for SARS-CoV-2 antibodies
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Social and Behavioral Determinants of Antibody Testing
Time Frame: 6 months
Characterize barriers to access, bias, risk attitude and incentive preferences assessed through survey responses
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)
AltaMed Health Services Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jason Doctor, PhD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-20-00793
  • 3R33AG057395-04S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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