SARS-CoV-2NCT04901624
Use of Behavioral Economics in Repeat SARS-CoV-2 (COVID-19) Antibody Testing in Disadvantaged Communities
A study testing Family Risk Messaging, Personal Risk Messaging and Loss Protection in people with SARS-CoV-2, run by University of Southern California at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Family Risk Messaging, Personal Risk Messaging and Loss Protection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,164 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 3 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults and children 5 years of age and older
Who cannot join
- Children under 5 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- SARS-CoV-2
- Being tested
- Family Risk Messaging, Personal Risk Messaging, Loss Protection, Lottery Incentive
- Keywords
- antibodies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Risk MessagingBehavioural
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."
Personal Risk MessagingBehavioural
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."
Loss ProtectionBehavioural
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.
Lottery IncentiveBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personal Risk + Loss Protection | Experimental | Personal Risk + Loss Protection Receives: Behavioral: Personal Risk Messaging; Behavioral: Loss Protection |
| Personal Risk + Lottery Incentive | Experimental | Personal Risk + Lottery Incentive Receives: Behavioral: Personal Risk Messaging; Behavioral: Lottery Incentive |
| Family Risk + Loss Protection | Experimental | Family Risk + Loss Protection Receives: Behavioral: Family Risk Messaging; Behavioral: Loss Protection |
| Family Risk + Lottery Incentive | Experimental | Family Risk + Lottery Incentive Receives: Behavioral: Family Risk Messaging; Behavioral: Lottery Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance Rate at Time 2 SARS-CoV-2 Antibody Test
Effectiveness of risk-based messaging and incentives to encourage attendance at Time 2 testing for SARS-CoV-2 antibodies
Measured: 6 months
Secondary outcomes (1)
Social and Behavioral Determinants of Antibody Testing
Characterize barriers to access, bias, risk attitude and incentive preferences assessed through survey responses
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start29 Jun 2021
- Primary completion3 Jun 2023
- Study completion3 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- AltaMed Health Services Corporation, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jason Doctor, University of Southern California
- Investigators
- Jason Doctor, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901624
- Sponsor's protocol ID
- HS-20-00793
- Other IDs
- 3R33AG057395-04S1
- Status last verified
- Jul 2024
- First submitted
- 29 Mar 2021
- Last updated
- 14 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Doctor JN, Berg AH, Knight TK, Kadono M, Stewart E, Sonik R, Hochman M, Sood N. Cross-sectional study examining household factors associated with SARS-CoV-2 seropositivity in low-income children in Los Angeles. BMJ Open. 2023 May 31;13(5):e070291. doi: 10.1136/bmjopen-2022-070291.
PubMed 37258079
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Behavioral Economics in Repeat SARS-CoV-2 (COVID-19) Antibody Testing in Disadvantaged Communities
- ClinicalTrials.gov ID
- NCT04901624
- Acronym / sponsor ID
- HS-20-00793
- Conditions
- SARS-CoV-2
- Keywords
- antibodies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,164 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- AltaMed Health Services Corporation, National Institute on Aging (NIA)
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 3 Jun 2023 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Posted 14 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Personal Risk + Loss Protection | Experimental | Behavioral: Personal Risk Messaging, Behavioral: Loss ProtectionPersonal Risk + Loss Protection |
| Personal Risk + Lottery Incentive | Experimental | Behavioral: Personal Risk Messaging, Behavioral: Lottery IncentivePersonal Risk + Lottery Incentive |
| Family Risk + Loss Protection | Experimental | Behavioral: Family Risk Messaging, Behavioral: Loss ProtectionFamily Risk + Loss Protection |
| Family Risk + Lottery Incentive | Experimental | Behavioral: Family Risk Messaging, Behavioral: Lottery IncentiveFamily Risk + Lottery Incentive |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults and children 5 years of age and older
Key exclusion criteria (1 listed)
- Children under 5 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Risk MessagingFamily 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." | Behavioural | Family Risk + Loss Protection, Family Risk + Lottery Incentive |
| Personal Risk MessagingPersonal 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." | Behavioural | Personal Risk + Loss Protection, Personal Risk + Lottery Incentive |
| Loss ProtectionHousehold 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. | Behavioural | Family Risk + Loss Protection, Personal Risk + Loss Protection |
| Lottery IncentiveHousehold 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. | Behavioural | Family Risk + Lottery Incentive, Personal Risk + Lottery Incentive |
Primary outcome
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
1 secondary outcome
Social and Behavioral Determinants of Antibody Testing
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37258079Doctor JN, Berg AH, Knight TK, Kadono M, Stewart E, Sonik R, Hochman M, Sood N. Cross-sectional study examining household factors associated with SARS-CoV-2 seropositivity in low-income children in Los Angeles. BMJ Open. 2023 May 31;13(5):e070291. doi: 10.1136/bmjopen-2022-070291.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Doctor, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Risk Messaging, Personal Risk Messaging and Loss Protection in people with SARS-CoV-2, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance Rate at Time 2 SARS-CoV-2 Antibody Test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04901624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.