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

Primary Purpose

SARS-CoV2 Infection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
General SARS-CoV-2 Communication
Rural-Targeted SARS-CoV-2 Communication
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for SARS-CoV2 Infection focused on measuring SARS-CoV-2, COVID-19, Rural Health Disparities, Health Communication, Rural Health, Antibodies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: White, 18 or older Exclusion Criteria: All who do not meet inclusion criteria

Sites / Locations

  • Flint Journal BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

White Rural: General

White Rural: Rural-Targeted

Arm Description

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

White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing.

Outcomes

Primary Outcome Measures

Home-Based Salivary Kit Request
Does participant request to receive a home-based salivary test kit from the study team? (yes-no)
Home-Based Salivary Test Kit Completion
Do participants who request home-based salivary test kits use/return them? (yes-no)
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).
Group-Based Medical Mistrust Outcomes
Self-report measures of general feelings about the health care system are adapted from published research (Thompson et al., 2004). All items on the Group-Based Medical Mistrust measure use Likert-type scales that range from 1 (Strongly Disagree) to 5 (Strongly Agree).

Secondary Outcome Measures

Full Information

First Posted
October 10, 2023
Last Updated
October 10, 2023
Sponsor
Michigan State University
Collaborators
National Cancer Institute (NCI), Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT06085547
Brief Title
Rural Tailored Communication to Promote SARS-CoV-2 Antibody Testing in Saliva
Official Title
Rural Tailored COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
National Cancer Institute (NCI), Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 their 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 to them, and when non-invasive home-based salivary collection is used. Our 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. Our clinical trial aims 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, we will consider individuals recruited from rural Northern Michigan and assess their willingness to participate in home-based saliva sample collections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV2 Infection
Keywords
SARS-CoV-2, COVID-19, Rural Health Disparities, Health Communication, Rural Health, Antibodies

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Participant
Masking Description
Participants will be unaware of their assignment to a general versus rural-targeted condition.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
White Rural: General
Arm Type
Active Comparator
Arm Description
White rural participants receive "general consumption" video information about SARS-CoV-2 antibody testing.
Arm Title
White Rural: Rural-Targeted
Arm Type
Experimental
Arm Description
White rural participants receive rural-targeted video information about SARS-CoV-2 antibody testing.
Intervention Type
Behavioral
Intervention Name(s)
General SARS-CoV-2 Communication
Intervention Description
SARS-CoV-2 video tutorial is for general consumption and does not include rural-targeted information
Intervention Type
Behavioral
Intervention Name(s)
Rural-Targeted SARS-CoV-2 Communication
Intervention Description
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 Outcome Measure Information:
Title
Home-Based Salivary Kit Request
Description
Does participant request to receive a home-based salivary test kit from the study team? (yes-no)
Time Frame
up to 2 weeks
Title
Home-Based Salivary Test Kit Completion
Description
Do participants who request home-based salivary test kits use/return them? (yes-no)
Time Frame
up to 8 weeks
Title
Theory of Planned Behavior Antibody Testing Outcomes
Description
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
Title
Group-Based Medical Mistrust Outcomes
Description
Self-report measures of general feelings about the health care system are adapted from published research (Thompson et al., 2004). All items on the Group-Based Medical Mistrust measure use Likert-type scales that range from 1 (Strongly Disagree) to 5 (Strongly Agree).
Time Frame
collected immediately, up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: White, 18 or older Exclusion Criteria: All who do not meet inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Lucas, PhH
Phone
810-600-5629
Email
lucastod@msu.edu
Facility Information:
Facility Name
Flint Journal Building
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Lucas
Phone
810-600-5629
Email
lucastod@msu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available per requirements and sharing structures established by NCI "SeroNet" initiative.
IPD Sharing Time Frame
Upon Study Completion

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

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