COVID-19NCT06650462
Evaluating a Community-Led COVID-19 Testing Intervention to Address Mistrust - Study 1
A study testing Community-led discussion in people with COVID-19 and Trust, run by Old Dominion University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Community-led discussion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Macon & Joan Brock Virginia Health Institute at Old Dominion University
Norfolk, Virginia, 23507
About this study
Official title: 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.
Read the 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.
- Being tested
- Community-led discussion
- Keywords
- community-led, COVID-19, trust, vaccine hesitancy, peer mentor, community advisory board
- Medical subject headings
- COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-led discussionBehavioural
Participants engage in weekly community-led small group discussions about health related topics
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | non-intervention control (participants complete surveys only) |
| Intervention | Experimental | Participants engage in weekly community-led small group discussions about health-related topics and answer surveys at 0, 3, and 6 months time points Receives: Behavioral: Community-led discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Openness to COVID-19 testing
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.
Measured: 0 months, 3 months, 6 months
COVID-19 Testing Efficacy
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.
Measured: 0 months, 3 months, 6 months
COVID-19 Trust
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.
Measured: 0 months, 3 months, 6 months
Qualitative feedback
Qualitative feedback will be obtained from participants in a group feedback session
Measured: 4 months
Secondary outcomes (1)
COVID-19 Vaccine Hesitancy
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.
Measured: 0 months, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start2 Jul 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomly assigned to intervention or control group; repeated measure assessments at 0 months, 3 months, 6 months
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Old Dominion University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelli J. England, Old Dominion University
- Investigators
- Kelli J England, PhD, Principal investigator, Old Dominion University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650462
- Sponsor's protocol ID
- 22-10-FB-0215 - Study 1
- Status last verified
- Feb 2026
- First submitted
- 16 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Community-Led COVID-19 Testing Intervention to Address Mistrust
- ClinicalTrials.gov ID
- NCT06650462
- Acronym / sponsor ID
- 22-10-FB-0215 - Study 1
- Keywords
- community-led, COVID-19, trust, vaccine hesitancy, peer mentor, community advisory board
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants randomly assigned to intervention or control group; repeated measure assessments at 0 months, 3 months, 6 months
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –non-intervention control (participants complete surveys only) |
| Intervention | Experimental | Behavioral: Community-led discussionParticipants engage in weekly community-led small group discussions about health-related topics and answer surveys at 0, 3, and 6 months time points |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-led discussionParticipants engage in weekly community-led small group discussions about health related topics | Behavioural | Intervention |
Primary outcome
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.
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.
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.
Qualitative feedback
Time frame: 4 months
Qualitative feedback will be obtained from participants in a group feedback session
1 secondary outcome
COVID-19 Vaccine Hesitancy
Time frame: 0 months, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelli J England, PhD principal investigator
Old Dominion University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-led discussion in people with COVID-19 and Trust, run by Old Dominion University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Openness to COVID-19 testing (time frame: 0 months, 3 months, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.