Culturally-Targeted COVID-19 Communication and SARS-CoV-2 Antibody Testing Evaluation and Uptake

Sponsor
Michigan State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04957082
Collaborator
National Cancer Institute (NCI) (NIH), Johns Hopkins University (Other)
500
1
3
21.9
22.9

Study Details

Study Description

Brief Summary

This disparities-focused study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing among African Americans residing in Flint, Michigan. This iteration will consider individuals recruited from the Flint Registry and assess willingness to participate in a drive-up saliva sample collection taking place at a central location in Flint, Michigan.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Culturally Targeted SARS-CoV-2 Communication
  • Behavioral: General SARS-CoV-2 Communication
N/A

Detailed Description

African Americans develop and die from SARS-CoV-2 infection more than any other racial group in the United States, including in majority African American cities such as Flint, Michigan. Addressing these disparities may be aided by SARS-CoV-2 antibody testing. However, African Americans may be reluctant to partake in conventional antibody testing programs due to medical mistrust and experiences with racism. This study seeks to evaluate communication strategies for better encouraging understanding and uptake of salivary SARS-CoV-2 antibody testing. The central hypothesis is that African-Americans will be more receptive to antibody testing when benefits and limitations are communicated in a culturally effective manner. Our clinical trial aims are to 1) develop and compare effects of a general versus culturally-targeted video about antibody testing on African American and White Flint residents' antibody testing attitudes and uptake; 2) identify and compare effects of a general versus culturally-targeted video on activation of medical mistrust and racism-related cognition among African Americans when considering antibody testing. In collaboration with clinical and community partners, we have prepared and will evaluate general and culturally-targeted video tutorials about SARS-CoV-2 antibody testing. These brief videos will be distributed to the Flint community through the Flint Registry - a highly visible local health resource exchange. We will furnish an opportunity to engage salivary antibody screening and measure willingness to participate. In this study iteration, we will consider willingness to participate in a drive-up saliva sample collection that is taking place at a central location in Flint, Michigan.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Design is partial factorial. All white participants and half of African American participants will receive general video education/messaging. Half of African American participants will be assigned to an intervention condition that includes culturally-targeted information about SARS-CoV-2 antibody testing.Design is partial factorial. All white participants and half of African American participants will receive general video education/messaging. Half of African American participants will be assigned to an intervention condition that includes culturally-targeted information about SARS-CoV-2 antibody testing.
Masking:
Single (Participant)
Masking Description:
Participants will be unaware of their assignment to a general versus culturally targeted condition.
Primary Purpose:
Screening
Official Title:
Culturally-targeted Communication to Promote SARS-CoV-2 Antibody Testing in Saliva: Enabling Evaluation of Inflammatory Pathways in COVID-19 Racial Disparities
Actual Study Start Date :
Aug 4, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: White Flint Registry: General

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

Behavioral: General SARS-CoV-2 Communication
SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information

Active Comparator: African American Registry: General

African American participants receive "general consumption" video information about SARS-CoV-2 antibody testing.

Behavioral: General SARS-CoV-2 Communication
SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information

Experimental: African American Registry: Culturally Targeted

African American participants receive culturally targeted video information about SARS-CoV-2 antibody testing.

Behavioral: Culturally Targeted SARS-CoV-2 Communication
SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.

Outcome Measures

Primary Outcome Measures

  1. Salivary Kit Request [up to 2 weeks]

    Does participant request to receive a salivary kit from the study team? (yes-no)

  2. Salivary Kit Completion [up to 8 weeks]

    Do participants who request salivary kits use/return them? (yes-no)

  3. Theory of Planned Behavior Antibody Testing Outcomes [collected immediately, up to 1 hour]

    Self-report measures of antibody testing attitudes, norms, perceived control, 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).

  4. Anticipatory Racism [collected immediately, up to 1 hour]

    Adapted from published research (Lucas et al., 2021), all participants respond to questions that asked whether they believe racism would impact the benefits they could experience from obtaining antibody testing. Participants will then respond to three questions that ask, "In some way, my obtaining CRC screening would be impacted by racism," "Racism would undermine the value of CRC screening for me." and "Racism would negatively impact the accuracy of my CRC screening. Responses are collected using a 7-point Likert-type scale that ranged from 1 (strongly agree) to 7 (strongly disagree).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • African American or White, 18 or older, and enrolled in the Flint Registry
Exclusion Criteria:
  • All who do not meet inclusion criteria.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Flint Journal Building Flint Michigan United States 48502

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Todd Lucas, Principal Investigator, Michigan State University
ClinicalTrials.gov Identifier:
NCT04957082
Other Study ID Numbers:
  • MSUSeronet1
  • U01CA260469
First Posted:
Jul 12, 2021
Last Update Posted:
Dec 6, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Todd Lucas, Principal Investigator, Michigan State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2021