SARS-CoV2 InfectionNCT04957082
Culturally-Targeted COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake
A study testing Culturally Targeted SARS-CoV-2 Communication and General SARS-CoV-2 Communication in people with SARS-CoV2 Infection, run by Michigan State University at 1 site in United States.
Trial summary
This disparities-focused study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among African Americans residing in Flint, Michigan. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- Culturally Targeted SARS-CoV-2 Communication and General SARS-CoV-2 Communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 19 Dec 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American or White, 18 or older, and enrolled in the Flint Registry
Who cannot join
- All who do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culturally-targeted Communication to Promote SARS-CoV-2 Antibody Testing in Saliva: Enabling Evaluation of Inflammatory Pathways in COVID-19 Racial Disparities
This disparities-focused study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among African Americans residing in Flint, Michigan. This iteration will consider individuals recruited from the Flint Registry and assess willingness to participate in a drive-up saliva sample collection taking place at a central location in Flint, Michigan.
Read the detailed description
African Americans develop and die from SARS-CoV-2 infection more than any other racial group in the United States, including in majority African American cities such as Flint, Michigan. Addressing these disparities may be aided by SARS-CoV-2 antibody testing. However, African Americans may be reluctant to partake in conventional antibody testing programs due to medical mistrust and experiences with racism. This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing. The central hypothesis is that African-Americans will be more receptive to antibody testing when benefits and limitations are communicated in a culturally effective manner. Our clinical trial aims are to 1) develop and compare effects of a general versus culturally-targeted video about antibody testing on African American and White Flint residents' antibody testing attitudes and uptake; 2) identify and compare effects of a general versus culturally-targeted video on activation of medical mistrust and racism-related cognition among African Americans when considering antibody testing. In collaboration with clinical and community partners, we have prepared and will evaluate general and culturally-targeted video tutorials about SARS-CoV-2 antibody testing. These brief videos will be distributed to the Flint community through the Flint Registry - a highly visible local health resource exchange. We will furnish an opportunity to engage salivary antibody screening and measure willingness to participate. In this study iteration, we will consider willingness to participate in a drive-up saliva sample collection that is taking place at a central location in Flint, Michigan.
- Conditions
- SARS-CoV2 Infection
- Being tested
- Culturally Targeted SARS-CoV-2 Communication, General SARS-CoV-2 Communication
- Keywords
- SARS-CoV-2, COVID-19, Health Disparities, Health Communication, Antibodies
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Targeted SARS-CoV-2 CommunicationBehavioural
SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.
General SARS-CoV-2 CommunicationBehavioural
SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
| Study group | Role | What they receive |
|---|---|---|
| White Flint Registry: General | Active comparator | White participants receive "general consumption" video information about SARS-CoV-2 antibody testing. Receives: Behavioral: General SARS-CoV-2 Communication |
| African American Registry: General | Active comparator | African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing. Receives: Behavioral: General SARS-CoV-2 Communication |
| African American Registry: Culturally Targeted | Experimental | African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing. Receives: Behavioral: Culturally Targeted SARS-CoV-2 Communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (Percentage) of Participants Requested to Participate in Saliva-based SARS-CoV-2 Antibody Testing
Number (Percentage) of participants who respond "yes" to be included in offer to participate in no cost SAR-CoV-2 salivary antibody test.
Measured: Immediately following didactic study portion and health communication randomization on day 1.
Number (Percentage) of Participants Who Requested Saliva-based SARS-CoV-2 Antibody Testing Participated in the Testing.
Number (Percentage) of participants that requested to participate in antibody testing who actually complete antibody testing.
Measured: 8 weeks from the day of consenting to participate in the salivary-based SARS-CoV-2 antibody testing
SARS-CoV-2 Antibody Testing Attitudes
Submeasure of Theory of Planned Behavior Indicating extent of a favorable attitude SARS-CoV-2 towards antibody testing (Seven point Likert Rating, with higher scores indicating more favorable Attitudes).
Measured: Immediately following didactic study portion and health communication randomization on day 1.
SARS-CoV-2 Antibody Testing Normative Beliefs
Sub-measure of Theory of Planned Behavior Indicating extent to which believes other people are favorable towards SARS-CoV-2 towards antibody testing (Seven point Likert Rating, with higher scores indicating stronger Normative Beliefs).
Measured: Immediately following didactic study portion and health communication randomization on day 1.
Antibody Testing Perceived Behavioral Control
Sub-measure of Theory of Planned Behavior Indicating Self Efficacy to Complete Antibody Testing (Seven point Likert Rating, with higher scores indicating greater Perceived Behavioral Control).
Measured: Immediately following didactic study portion and health communication randomization on day 1.
Antibody Testing Intentions
Sub-measure of Theory of Planned Behavior indicating Intentions to Complete Antibody Testing (Seven point Likert Rating, with higher scores indicating stronger screening Intentions).
Measured: Immediately following didactic study portion and health communication randomization on day 1.
Antibody Testing Anticipatory Racism
Extent to which participants believe that racism-related factors would diminish the value of SARS-CoV-2 antibody testing for self (Seven-point Likert rating, with higher scores indicating greater Anticipatory Racism).
Measured: Immediately following didactic study portion and health communication randomization on day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start4 Aug 2021
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
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.
- Other trials for SARS-CoV2 InfectionStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Design is partial factorial. All white participants and half of African American participants will receive general video education/messaging. Half of African American participants will be assigned to an intervention condition that includes culturally-targeted information about SARS-CoV-2 antibody testing.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Johns Hopkins University
- Responsible party
- Principal investigator, Todd Lucas, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957082
- Sponsor's protocol ID
- MSUSeronet1
- Other IDs
- U01CA260469
- Status last verified
- Jun 2024
- First submitted
- 6 Jul 2021
- Last updated
- 28 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available per requirements and sharing structures established by NCI "SeroNet" initiative.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally-targeted Communication to Promote SARS-CoV-2 Antibody Testing in Saliva: Enabling Evaluation of Inflammatory Pathways in COVID-19 Racial Disparities
- ClinicalTrials.gov ID
- NCT04957082
- Acronym / sponsor ID
- MSUSeronet1
- Conditions
- SARS-CoV2 Infection
- Keywords
- SARS-CoV-2, COVID-19, Health Disparities, Health Communication, Antibodies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 666 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Johns Hopkins University
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 28 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This disparities-focused study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among African Americans residing in Flint, Michigan. This iteration will consider individuals recruited from the Flint Registry and assess willingness to participate in a drive-up saliva sample collection taking place at a central location in Flint, Michigan.
Detailed description
African Americans develop and die from SARS-CoV-2 infection more than any other racial group in the United States, including in majority African American cities such as Flint, Michigan. Addressing these disparities may be aided by SARS-CoV-2 antibody testing. However, African Americans may be reluctant to partake in conventional antibody testing programs due to medical mistrust and experiences with racism. This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing. The central hypothesis is that African-Americans will be more receptive to antibody testing when benefits and limitations are communicated in a culturally effective manner. Our clinical trial aims are to 1) develop and compare effects of a general versus culturally-targeted video about antibody testing on African American and White Flint residents' antibody testing attitudes and uptake; 2) identify and compare effects of a general versus culturally-targeted video on activation of medical mistrust and racism-related cognition among African Americans when considering antibody testing. In collaboration with clinical and community partners, we have prepared and will evaluate general and culturally-targeted video tutorials about SARS-CoV-2 antibody testing. These brief videos will be distributed to the Flint community through the Flint Registry - a highly visible local health resource exchange. We will furnish an opportunity to engage salivary antibody screening and measure willingness to participate. In this study iteration, we will consider willingness to participate in a drive-up saliva sample collection that is taking place at a central location in Flint, Michigan.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Design is partial factorial. All white participants and half of African American participants will receive general video education/messaging. Half of African American participants will be assigned to an intervention condition that includes culturally-targeted information about SARS-CoV-2 antibody testing.
| Arm | Type | Receives |
|---|---|---|
| White Flint Registry: General | Active comparator | Behavioral: General SARS-CoV-2 CommunicationWhite participants receive "general consumption" video information about SARS-CoV-2 antibody testing. |
| African American Registry: General | Active comparator | Behavioral: General SARS-CoV-2 CommunicationAfrican American participants receive "general consumption" video information about SARS-CoV-2 antibody testing. |
| African American Registry: Culturally Targeted | Experimental | Behavioral: Culturally Targeted SARS-CoV-2 CommunicationAfrican American participants receive culturally targeted video information about SARS-CoV-2 antibody testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- African American or White, 18 or older, and enrolled in the Flint Registry
Key exclusion criteria (1 listed)
- All who do not meet inclusion criteria.
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 |
|---|---|---|
| Culturally Targeted SARS-CoV-2 CommunicationSARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans. | Behavioural | African American Registry: Culturally Targeted |
| General SARS-CoV-2 CommunicationSARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information | Behavioural | African American Registry: General, White Flint Registry: General |
Primary outcome
Number (Percentage) of Participants Requested to Participate in Saliva-based SARS-CoV-2 Antibody Testing
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Number (Percentage) of participants who respond "yes" to be included in offer to participate in no cost SAR-CoV-2 salivary antibody test.
Number (Percentage) of Participants Who Requested Saliva-based SARS-CoV-2 Antibody Testing Participated in the Testing.
Time frame: 8 weeks from the day of consenting to participate in the salivary-based SARS-CoV-2 antibody testing
Number (Percentage) of participants that requested to participate in antibody testing who actually complete antibody testing.
SARS-CoV-2 Antibody Testing Attitudes
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Submeasure of Theory of Planned Behavior Indicating extent of a favorable attitude SARS-CoV-2 towards antibody testing (Seven point Likert Rating, with higher scores indicating more favorable Attitudes).
SARS-CoV-2 Antibody Testing Normative Beliefs
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Sub-measure of Theory of Planned Behavior Indicating extent to which believes other people are favorable towards SARS-CoV-2 towards antibody testing (Seven point Likert Rating, with higher scores indicating stronger Normative Beliefs).
Antibody Testing Perceived Behavioral Control
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Sub-measure of Theory of Planned Behavior Indicating Self Efficacy to Complete Antibody Testing (Seven point Likert Rating, with higher scores indicating greater Perceived Behavioral Control).
Antibody Testing Intentions
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Sub-measure of Theory of Planned Behavior indicating Intentions to Complete Antibody Testing (Seven point Likert Rating, with higher scores indicating stronger screening Intentions).
Antibody Testing Anticipatory Racism
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Extent to which participants believe that racism-related factors would diminish the value of SARS-CoV-2 antibody testing for self (Seven-point Likert rating, with higher scores indicating greater Anticipatory Racism).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be made available per requirements and sharing structures established by NCI "SeroNet" initiative.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Targeted SARS-CoV-2 Communication and General SARS-CoV-2 Communication in people with SARS-CoV2 Infection, run by Michigan State University 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 28 Jun 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 28 Jun 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?
Number (Percentage) of Participants Requested to Participate in Saliva-based SARS-CoV-2 Antibody Testing (time frame: Immediately following didactic study portion and health communication randomization on day 1.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2024.