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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA260469 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| White Rural: General | Active Comparator | White rural participants receive "general consumption" video information about SARS-CoV-2 antibody testing. |
|
| White Rural: Rural-Targeted | Experimental | White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General SARS-CoV-2 Communication | Behavioral | SARS-CoV-2 video tutorial is for general consumption and does not include rural-targeted information |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | 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). | Immediately following didactic study portion and health communication randomization on day 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flint Journal Building | Flint | Michigan | 48502 | United States |
Data will be made available per requirements and sharing structures established by NCI "SeroNet" initiative.
Upon Study Completion
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Of 264 enrolled participants, 207 met inclusion criteria and were randomized to a video group. Of the 207 participants who participated in the survey, 13 participants were filtered out for inattentiveness.
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| ID | Title | Description |
|---|---|---|
| FG000 | White Rural: General | White rural participants receive "general consumption" video information about SARS-CoV-2 antibody testing. General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include rural-targeted information |
| FG001 | White Rural: Rural-Targeted | White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing. Rural-Targeted SARS-CoV-2 Communication: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | White Rural: General | White rural participants receive "general consumption" video information about SARS-CoV-2 antibody testing. General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include rural-targeted information |
| BG001 | White Rural: Rural-Targeted |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Immediately following didactic study portion and health communication randomization on day 1. |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | White Rural: General | White rural participants receive "general consumption" video information about SARS-CoV-2 antibody testing. General SARS-CoV-2 Communication: SARS-CoV-2 video tutorial is for general consumption and does not include rural-targeted information |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Todd Lucas | Michigan State University | 810-600-5629 | lucastod@msu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 24, 2023 | Dec 12, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2024 | Dec 19, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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Participants will be unaware of their assignment to a general versus rural-targeted condition.
| Rural-Targeted SARS-CoV-2 Communication | Behavioral | 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. |
|
White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing. Rural-Targeted SARS-CoV-2 Communication: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing.
Rural-Targeted SARS-CoV-2 Communication: 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.
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 8 weeks from the day of consenting to participate in the home-based salivary-based SARS-CoV-2 antibody testing. |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | Units on a Scale (Minimum:1, Maximum:7) | collected immediately, up to 1 hour |
|
|
|
| Primary | 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). | All participants for whom Rural-adapted Anticipatory Racism measure was successfully recorded immediately following messaging randomization. | Posted | Mean | Standard Deviation | Units on a Scale (Minimum:1, Maximum:7) | Immediately following didactic study portion and health communication randomization on day 1. |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | White Rural: Rural-Targeted | White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing. Rural-Targeted SARS-CoV-2 Communication: 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. | 0 | 94 | 0 | 94 | 0 | 94 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Antibody Testing Perceived Behavioral Control |
|
| Antibody Testing Intentions |
|