- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06650462
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
Completed
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 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
Interventional
Enrollment (Actual)
57
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
-
-
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, 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 |
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, 3, and 6 months time points
|
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 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
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
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 2, 2024
Primary Completion (Actual)
April 1, 2025
Study Completion (Actual)
April 1, 2025
Study Registration Dates
First Submitted
October 16, 2024
First Submitted That Met QC Criteria
October 17, 2024
First Posted (Actual)
October 21, 2024
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
Additional Relevant MeSH Terms
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Treatment Refusal
- Vaccination Refusal
- COVID-19
- Vaccination Hesitancy
Other Study ID 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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