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Rural Tailored COVID-19 Communication to Promote SARS-CoV-2 Antibody Testing in Saliva

Rural Tailored COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06085547
Enrollment
264
Registered
2023-10-17
Start date
2023-05-04
Completion date
2023-11-14
Last updated
2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV2 Infection

Keywords

SARS-CoV-2, COVID-19, Rural Health Disparities, Health Communication, Rural Health, Antibodies

Brief 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. 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.

Interventions

SARS-CoV-2 video tutorial is for general consumption and does not include rural-targeted information

BEHAVIORALRural-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.

Sponsors

Johns Hopkins University
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
Michigan State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)

Masking description

Participants will be unaware of their assignment to a general versus rural-targeted condition.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* White, 18 or older

Exclusion criteria

* All who do not meet inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Number (Percentage) of Participants Requested to Participate in Home-based Saliva-based SARS-CoV-2 Antibody Testing.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.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 Outcomescollected immediately, up to 1 hourSelf-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 RacismImmediately 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).

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
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
100
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.
94
Total194

Baseline characteristics

CharacteristicWhite Rural: GeneralWhite Rural: Rural-TargetedTotal
Age, Customized
18-21 years
0 Participants0 Participants0 Participants
Age, Customized
22-40 years
47 Participants43 Participants90 Participants
Age, Customized
>= 41
53 Participants51 Participants104 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
100 Participants94 Participants194 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
100 Participants94 Participants194 Participants
Sex: Female, Male
Female
74 Participants73 Participants147 Participants
Sex: Female, Male
Male
26 Participants21 Participants47 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1000 / 94
other
Total, other adverse events
0 / 1000 / 94
serious
Total, serious adverse events
0 / 1000 / 94

Outcome results

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).

Time frame: Immediately following didactic study portion and health communication randomization on day 1.

Population: All participants for whom Rural-adapted Anticipatory Racism measure was successfully recorded immediately following messaging randomization.

ArmMeasureValue (MEAN)Dispersion
White Rural: GeneralAntibody Testing Rural-Adapted Anticipatory Racism1.63 Units on a Scale (Minimum:1, Maximum:7)Standard Deviation 0.885
White Rural: Rural-TargetedAntibody Testing Rural-Adapted Anticipatory Racism2.18 Units on a Scale (Minimum:1, Maximum:7)Standard Deviation 1.166
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.

Time frame: Immediately following didactic study portion and health communication randomization on day 1.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
White Rural: GeneralNumber (Percentage) of Participants Requested to Participate in Home-based Saliva-based SARS-CoV-2 Antibody Testing.91 Participants
White Rural: Rural-TargetedNumber (Percentage) of Participants Requested to Participate in Home-based Saliva-based SARS-CoV-2 Antibody Testing.88 Participants
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.

Time frame: 8 weeks from the day of consenting to participate in the home-based salivary-based SARS-CoV-2 antibody testing.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
White Rural: GeneralNumber (Percentage) of Participants Who Completed Home-based Salivary Antibody Testing.77 Participants
White Rural: Rural-TargetedNumber (Percentage) of Participants Who Completed Home-based Salivary Antibody Testing.70 Participants
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).

Time frame: collected immediately, up to 1 hour

ArmMeasureGroupValue (MEAN)Dispersion
White Rural: GeneralTheory of Planned Behavior Antibody Testing OutcomesSARS-CoV-2 Antibody Testing Attitudes5.97 Units on a Scale (Minimum:1, Maximum:7)Standard Deviation 0.966
White Rural: GeneralTheory of Planned Behavior Antibody Testing OutcomesSARS-CoV-2 Antibody Testing Normative Beliefs4.01 Units on a Scale (Minimum:1, Maximum:7)Standard Deviation 1.244
White Rural: GeneralTheory of Planned Behavior Antibody Testing OutcomesAntibody Testing Perceived Behavioral Control6.06 Units on a Scale (Minimum:1, Maximum:7)Standard Deviation 1.026
White Rural: GeneralTheory of Planned Behavior Antibody Testing OutcomesAntibody Testing Intentions4.80 Units on a Scale (Minimum:1, Maximum:7)Standard Deviation 1.487
White Rural: Rural-TargetedTheory of Planned Behavior Antibody Testing OutcomesSARS-CoV-2 Antibody Testing Normative Beliefs3.85 Units on a Scale (Minimum:1, Maximum:7)Standard Deviation 1.158
White Rural: Rural-TargetedTheory of Planned Behavior Antibody Testing OutcomesAntibody Testing Intentions4.92 Units on a Scale (Minimum:1, Maximum:7)Standard Deviation 1.455
White Rural: Rural-TargetedTheory of Planned Behavior Antibody Testing OutcomesSARS-CoV-2 Antibody Testing Attitudes5.97 Units on a Scale (Minimum:1, Maximum:7)Standard Deviation 0.91
White Rural: Rural-TargetedTheory of Planned Behavior Antibody Testing OutcomesAntibody Testing Perceived Behavioral Control6.02 Units on a Scale (Minimum:1, Maximum:7)Standard Deviation 1.092

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026