Community-Led COVID-19 Testing Intervention to Address Mistrust

February 25, 2026 updated by: Kelli J. England, Old Dominion University

Evaluating a Community-Led COVID-19 Testing Intervention to Address Mistrust - Study 2

The goal of this adapted intervention study is to assess how community-led group discussions about health-related topics may alter beliefs and intentions regarding healthcare recommendations, such as COVID-19 testing and vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible participants were randomized to intervention or control group. Intervention group participants met virtually with other community member participants in small discussion groups once a week for 75 minutes over the course of 14 weeks. The online discussion groups were led by peer mentor facilitators and supported by a research team member. Discussion topics included current events and other health related topics. Control group participants did not meet in weekly discussion groups. At approximately the 0 weeks, 14 weeks, and 18 weeks time points, all participants answered online surveys about health related topics. At the 14 weeks and 18 weeks time points, all participants were asked to self-administer a COVID-19 test that investigators provide.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Macon & Joan Brock Virginia Health Institute at Old Dominion University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years or older
  • Resident of one of the 9 housing authority agencies
  • Willing to participate in Zoom meetings and complete online assessments at baseline, 14-week, and 18-week timepoints
  • Ability to read, speak, and understand English

Exclusion Criteria:

  • May not have participated in Study 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
non-intervention control (participants complete surveys only)
Experimental: Intervention
Participants engage in weekly community-led small group discussions about health-related topics and answer surveys at 0, 14, and 18 week time points
Behavioral: Community-led discussion
Participants engage in weekly community-led small group discussions about health related topics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Openness to COVID-19 Testing
Time Frame: 0 weeks, 14 weeks, 18 weeks
The COVID-19 Testing Openness Questionnaire is an 7-item self-report measure designed to assess participants' openness to getting tested for COVID-19. Each item is rated on a 5-point scale, from 1 "Strongly Disagree" to 5 "Strongly Agree," with the sum of scores ranging from 7 to 35. Higher scores indicate greater openness to COVID-19 testing.
0 weeks, 14 weeks, 18 weeks
COVID-19 Testing Efficacy
Time Frame: 0 weeks, 14 weeks, 18 weeks
The COVID-19 Testing Efficacy Scale is a 6-item self-report measure that will assess participants' perceived self- and response-efficacy related to COVID-19 testing. Each item is rated on a 5-point scale ranging from 1 "Strongly Disagree" to 5 "Strongly Agree," with the sum of scores ranging between 6 and 30. Higher scores indicate greater efficacy.
0 weeks, 14 weeks, 18 weeks
COVID-19 Trust
Time Frame: 0 weeks, 14 weeks, 18 weeks
Two items assessing (1) trust in the safety of the COVID-19 vaccine, and (2) trust in the efficacy of the COVID-19 vaccine were used to assess participants' trust relating to COVID-19. Each item is rated on a 5-point Likert scale. Higher scores indicate greater trust.
0 weeks, 14 weeks, 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Connectedness
Time Frame: 0 weeks, 14 weeks, 18 weeks
The Social Connectedness Scale Revised is a 20-item scale that measures a participant's feeling of connection with other people and their community. Each item is rated on a 6-point scale ranging from 1 "Strongly Disagree" to 6 "Strongly Agree," with the sum of scores ranging between 20 and 120. Higher scores indicate greater connectedness.
0 weeks, 14 weeks, 18 weeks
Health Literacy
Time Frame: 0 weeks, 14 weeks, 18 weeks
The Health Literacy Scale (HLS-14) for Adults is a 14-item scale adapted for use in the US that measures an individual's ability to understand, access, and apply health-related information. Each item is rated on a 5-point scale ranging from 1 "Strongly Disagree" to 5 "Strongly Agree," with the sum of scores ranging between 14 and 70. Higher scores indicate greater health literacy.
0 weeks, 14 weeks, 18 weeks
COVID-19 Vaccine Hesitancy
Time Frame: 0 weeks, 14 weeks, 18 weeks
Vaccine Hesitancy was assessed by an item that asked, "Overall, how hesitant about the COVID-19 vaccine would you consider yourself to be?." This question was adapted from the Parent Attitudes about Childhood Vaccines (PACV) survey. The item is scored on a 5-point Likert scale, ranging from "1 - not at all hesitant" to "5 = very hesitant" with higher scores indicating greater hesitancy.
0 weeks, 14 weeks, 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Old Dominion University

Investigators

  • Principal Investigator: Kelli J England, PhD, Old Dominion University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Actual)

January 27, 2026

Study Completion (Actual)

January 27, 2026

Study Registration Dates

First Submitted

September 5, 2025

First Submitted That Met QC Criteria

September 5, 2025

First Posted (Actual)

September 10, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-10-FB-0215 - Study 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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