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

NCT06085547 | Completed Results DMC

• 2 other identifiers: 00005016U01CA260469
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

White Rural: General

ACTIVE COMPARATOR

White rural participants receive "general consumption" video information about SARS-CoV-2 antibody testing.

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.

Behavioral: Rural-Targeted SARS-CoV-2 Communication

Interventions

General SARS-CoV-2 Communication BEHAVIORAL

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

White Rural: General

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: Rural-Targeted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• White, 18 or older

Sponsors & Collaborators

• Michigan State University: lead
• Johns Hopkins University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Flint Journal Building

Flint, Michigan, 48502, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Todd Lucas
• Organization: Michigan State University

lucastod@msu.edu

810-600-5629

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of their assignment to a general versus rural-targeted condition.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: C.S. Mott Endowed Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: May 4, 2023
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Upon Study Completion

Locations

US (1)