SARS-CoV2 InfectionNCT06085547
Rural Tailored COVID-19 Communication to Promote SARS-CoV-2 Antibody Testing in Saliva
A study testing General SARS-CoV-2 Communication and Rural-Targeted SARS-CoV-2 Communication in people with SARS-CoV2 Infection, run by Michigan State University at 1 site in United States.
Trial summary
This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern 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?
- General SARS-CoV-2 Communication and Rural-Targeted 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
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2023to 14 Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- White, 18 or older
Who cannot join
- All who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rural Tailored COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake
This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern Michigan. This iteration will consider individuals recruited from rural Northern Michigan and assess individuals' willingness to participate in home-based saliva sample collections.
Read the detailed description
Rural Americans are at higher risk of many severe COVID-19 related health outcomes. These disparities are likely to endure given lower vaccination uptake in many rural communities, and also the continued emergence of SARS-COV-2 variants, even as overall vaccination rates and COVID-19 treatments improve. Better understanding and addressing rural disparities in COVID-19 could be aided by SARS-CoV-2 antibody testing that can measure herd immunity, assess vaccination efficacy and uptake, and perhaps inform re-vaccination strategies. However, implementing antibody testing education and outreach in rural contexts poses unique challenges, including that many rural communities remain skeptical of COVID-19 testing and treatment. Moreover, rural communities are racially and regionally diverse, including predominantly White populations in some rural regions, but largely African American in others. Such diversity highlights that tailoring the use of specific antibody communication strategies to particular rural contexts is critical. Another challenge posed by rural contexts is in implementing biological sample collections, including effectively distributing and receiving biospecimen collection kits and ensuring proper sample collections. Taken together, there is an urgent need to develop and evaluate communication and collection strategies that can better promote SARS-CoV-2 antibody testing in diverse rural contexts. This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern Michigan. The central hypothesis is that rural Americans will be receptive to antibody testing when communication is specifically tailored, and when non-invasive home-based salivary collection is used. The rationale is that combining effective rural health communication with home-based salivary testing will reduce skepticism and mistrust, and promote uptake that can lead to better grasping and addressing rural disparities in COVID-19. The clinical trial aims for this study are to 1) develop and compare the effects of tailored rural videos about antibody testing to general antibody education videos on salivary antibody testing attitudes, intentions, and behavior among rural White Americans residing in Michigan, and rural African Americans residing in Arkansas; 2) compare effects of tailored rural videos on activation of medical mistrust among rural White Americans in Michigan and rural African Americans in Arkansas when considering antibody testing; and 3) develop, evaluate, and compare the efficacy and fidelity of a protocol for home-based salivary collection in rural contexts that includes sending, collecting, receiving and successfully assaying for SARS-CoV-2 antibodies using salivary collection kits. In this study iteration, the investigators will consider individuals recruited from rural Northern Michigan and assess individuals' willingness to participate in home-based saliva sample collections.
- Conditions
- SARS-CoV2 Infection
- Being tested
- General SARS-CoV-2 Communication, Rural-Targeted SARS-CoV-2 Communication
- Keywords
- SARS-CoV-2, COVID-19, Rural Health Disparities, Health Communication, Rural Health, 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.
General SARS-CoV-2 CommunicationBehavioural
SARS-CoV-2 video tutorial is for general consumption and does not include rural-targeted information
Rural-Targeted SARS-CoV-2 CommunicationBehavioural
SARS-CoV-2 video tutorial includes a two and a half minute video based messaging adjunct meant to enact a rural-targeted framing of health information presented to White rural individuals.
| Study group | Role | What they receive |
|---|---|---|
| White Rural: General | Active comparator | White rural participants receive "general consumption" video information about SARS-CoV-2 antibody testing. Receives: Behavioral: General SARS-CoV-2 Communication |
| White Rural: Rural-Targeted | Experimental | White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing. Receives: Behavioral: Rural-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 Home-based Saliva-based SARS-CoV-2 Antibody Testing.
Number (percentage) of participants who respond "yes" to be included in the offer to participate in no cost home-based SARS-CoV-2 salivary antibody testing.
Measured: Immediately following didactic study portion and health communication randomization on day 1.
Number (Percentage) of Participants Who Completed Home-based Salivary Antibody 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 home-based salivary-based SARS-CoV-2 antibody testing.
Theory of Planned Behavior Antibody Testing Outcomes
Self-report measures of antibody testing attitudes, norms, perceived control, and intentions to be screened are each adapted from published research (Lucas et al., 2021). These items are constructed following recommended procedures to ensure construct validity and adequate behavioral specificity (Fishbein \& Ajzen, 2011). All items use Likert-type scales that range from 1 (Strongly Agree) to 7 (Strongly Disagree).
Measured: collected immediately, up to 1 hour
Antibody Testing Rural-Adapted Anticipatory Racism
Extent to which participants believe that rural 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 posted17 Oct 2023
- Study start4 May 2023
- Primary completion14 Nov 2023
- Study completion14 Nov 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.
- 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
- Parallel groups
- Model description
- This study will use a two-group design (Video tutorial: general versus rural-targeted). Half of White rural participants will receive general video education/messaging and half of White rural participants will be assigned to an intervention condition that includes rural-targeted information about SARS-CoV-2 antibody testing.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Todd Lucas, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085547
- Sponsor's protocol ID
- 00005016
- Other IDs
- U01CA260469
- Status last verified
- Jan 2025
- First submitted
- 10 Oct 2023
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural Tailored COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake
- ClinicalTrials.gov ID
- NCT06085547
- Acronym / sponsor ID
- 00005016
- Conditions
- SARS-CoV2 Infection
- Keywords
- SARS-CoV-2, COVID-19, Rural Health Disparities, Health Communication, Rural Health, Antibodies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Cancer Institute (NCI)
- Study start
- 4 May 2023 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Posted 17 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern Michigan. This iteration will consider individuals recruited from rural Northern Michigan and assess individuals' willingness to participate in home-based saliva sample collections.
Detailed description
Rural Americans are at higher risk of many severe COVID-19 related health outcomes. These disparities are likely to endure given lower vaccination uptake in many rural communities, and also the continued emergence of SARS-COV-2 variants, even as overall vaccination rates and COVID-19 treatments improve. Better understanding and addressing rural disparities in COVID-19 could be aided by SARS-CoV-2 antibody testing that can measure herd immunity, assess vaccination efficacy and uptake, and perhaps inform re-vaccination strategies. However, implementing antibody testing education and outreach in rural contexts poses unique challenges, including that many rural communities remain skeptical of COVID-19 testing and treatment. Moreover, rural communities are racially and regionally diverse, including predominantly White populations in some rural regions, but largely African American in others. Such diversity highlights that tailoring the use of specific antibody communication strategies to particular rural contexts is critical. Another challenge posed by rural contexts is in implementing biological sample collections, including effectively distributing and receiving biospecimen collection kits and ensuring proper sample collections. Taken together, there is an urgent need to develop and evaluate communication and collection strategies that can better promote SARS-CoV-2 antibody testing in diverse rural contexts. This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among individuals residing in rural Northern Michigan. The central hypothesis is that rural Americans will be receptive to antibody testing when communication is specifically tailored, and when non-invasive home-based salivary collection is used. The rationale is that combining effective rural health communication with home-based salivary testing will reduce skepticism and mistrust, and promote uptake that can lead to better grasping and addressing rural disparities in COVID-19. The clinical trial aims for this study are to 1) develop and compare the effects of tailored rural videos about antibody testing to general antibody education videos on salivary antibody testing attitudes, intentions, and behavior among rural White Americans residing in Michigan, and rural African Americans residing in Arkansas; 2) compare effects of tailored rural videos on activation of medical mistrust among rural White Americans in Michigan and rural African Americans in Arkansas when considering antibody testing; and 3) develop, evaluate, and compare the efficacy and fidelity of a protocol for home-based salivary collection in rural contexts that includes sending, collecting, receiving and successfully assaying for SARS-CoV-2 antibodies using salivary collection kits. In this study iteration, the investigators will consider individuals recruited from rural Northern Michigan and assess individuals' willingness to participate in home-based saliva sample collections.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will use a two-group design (Video tutorial: general versus rural-targeted). Half of White rural participants will receive general video education/messaging and half of White rural participants will be assigned to an intervention condition that includes rural-targeted information about SARS-CoV-2 antibody testing.
| Arm | Type | Receives |
|---|---|---|
| White Rural: General | Active comparator | Behavioral: General SARS-CoV-2 CommunicationWhite rural participants receive "general consumption" video information about SARS-CoV-2 antibody testing. |
| White Rural: Rural-Targeted | Experimental | Behavioral: Rural-Targeted SARS-CoV-2 CommunicationWhite rural participants receive rural-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)
- White, 18 or older
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 |
|---|---|---|
| General SARS-CoV-2 CommunicationSARS-CoV-2 video tutorial is for general consumption and does not include rural-targeted information | Behavioural | White Rural: General |
| Rural-Targeted SARS-CoV-2 CommunicationSARS-CoV-2 video tutorial includes a two and a half minute video based messaging adjunct meant to enact a rural-targeted framing of health information presented to White rural individuals. | Behavioural | White Rural: Rural-Targeted |
Primary outcome
Number (Percentage) of Participants Requested to Participate in Home-based 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 the offer to participate in no cost home-based SARS-CoV-2 salivary antibody testing.
Number (Percentage) of Participants Who Completed Home-based Salivary Antibody Testing.
Time frame: 8 weeks from the day of consenting to participate in the home-based salivary-based SARS-CoV-2 antibody testing.
Number (Percentage) of participants that requested to participate in antibody testing who actually complete antibody testing.
Theory of Planned Behavior Antibody Testing Outcomes
Time frame: collected immediately, up to 1 hour
Self-report measures of antibody testing attitudes, norms, perceived control, and intentions to be screened are each adapted from published research (Lucas et al., 2021). These items are constructed following recommended procedures to ensure construct validity and adequate behavioral specificity (Fishbein \& Ajzen, 2011). All items use Likert-type scales that range from 1 (Strongly Agree) to 7 (Strongly Disagree).
Antibody Testing Rural-Adapted Anticipatory Racism
Time frame: Immediately following didactic study portion and health communication randomization on day 1.
Extent to which participants believe that rural 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 17 Jan 2025.
- 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 General SARS-CoV-2 Communication and Rural-Targeted 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 17 Jan 2025. 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 17 Jan 2025). 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 Home-based Saliva-based SARS-CoV-2 Antibody Testing. (time frame: Immediately following didactic study portion and health communication randomization on day 1.). The study lists 4 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 17 Jan 2025.