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

NCT ID: NCT06085547

Last Updated: 2025-01-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-04

Study Completion Date

2023-11-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV2 Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

White Rural: General

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

Group Type ACTIVE_COMPARATOR

General SARS-CoV-2 Communication

Intervention Type BEHAVIORAL

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

White Rural: Rural-Targeted

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

Group Type EXPERIMENTAL

Rural-Targeted SARS-CoV-2 Communication

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

General SARS-CoV-2 Communication

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* White, 18 or older
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johns Hopkins University

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Todd Lucas

C.S. Mott Endowed Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Flint Journal Building

Flint, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U01CA260469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00005016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Getting to Yes, Michigan! (G2YMI)
NCT05096260 ACTIVE_NOT_RECRUITING NA
CommunityRx-Cardiovascular Disease
NCT06264726 ACTIVE_NOT_RECRUITING NA