Evaluating a Community-Led COVID-19 Testing Intervention to Address Mistrust - Study 1

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

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

The goal of this 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 one hour over the course of 12 weeks. The online discussion groups were led by peer mentor facilitators and supported by a research team member. Discussion topics included current events, COVID-19, and other health related topics. Control group participants did not meet in weekly discussion groups. At approximately the 0 month, 3 month, and 6 month time points, all participants answered online surveys about health related topics. At the 3 month and 6 month time points, all participants were also asked to self-administer a COVID-19 test that investigators provide. Finally, around the fourth month, intervention group participants were invited to an online feedback session with the research team about participants' experiences in the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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, 3-month, and 6-month timepoints
  • Ability to read, speak, and understand English

Exclusion Criteria:

  • None

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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, 3, and 6 months 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Openness to COVID-19 testing
Time Frame: 0 months, 3 months, 6 months
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 months, 3 months, 6 months
COVID-19 Testing Efficacy
Time Frame: 0 months, 3 months, 6 months
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 months, 3 months, 6 months
Qualitative feedback
Time Frame: 4 months
Qualitative feedback will be obtained from participants in a group feedback session
4 months
COVID-19 Trust
Time Frame: 0 months, 3 months, 6 months
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 months, 3 months, 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
COVID-19 Vaccine Hesitancy
Time Frame: 0 months, 3 months, 6 months
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." Higher scores indicate greater hesitancy.
0 months, 3 months, 6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Old Dominion University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-10-FB-0215 - Study 1

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

product manufactured in and exported from the U.S.

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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