COVID-19NCT07166770
Community-Led COVID-19 Testing Intervention to Address Mistrust
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 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. 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
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 27 Jan 2026
- 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, 14-week, and 18-week timepoints
- Ability to read, speak, and understand English
Who cannot join
- May not have participated in Study 1
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 - 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.
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 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.
- 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, 14, and 18 week 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 weeks, 14 weeks, 18 weeks
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 weeks, 14 weeks, 18 weeks
Trust in the Safety of the COVID-19 Vaccine
Trust in the safety of the COVID-19 vaccine was measured with one item which assessed participants' trust in the safety of the COVID-19 vaccine. The item is rated on a 5-point Likert scale. Higher scores indicate greater trust.
Measured: 0 weeks, 14 weeks, 18 weeks
Trust in Efficacy of the COVID-19 Vaccine
Trust in the efficacy of the COVID-19 vaccine was measured with one item which assessed participants' perceptions of efficacy related to the COVID-19 vaccine, or trust that it works as intended. The item is rated on a 5-point Likert scale. Higher scores indicate greater trust.
Measured: 0 weeks, 14 weeks, 18 weeks
Secondary outcomes (3)
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" with higher scores indicating greater hesitancy.
Measured: 0 weeks, 14 weeks, 18 weeks
Social Connectedness
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.
Measured: 0 weeks, 14 weeks, 18 weeks
Health Literacy
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.
Measured: 0 weeks, 14 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Jul 2025
- Primary completion27 Jan 2026
- Study completion27 Jan 2026
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 weeks, 14 weeks, and 18 weeks
- Masking
- None (open label)
- Enrolment
- 49 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
- NCT07166770
- Sponsor's protocol ID
- 22-10-FB-0215 - Study 2
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2025
- Last updated
- 11 Sep 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 11 Sep 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 - Study 2
- ClinicalTrials.gov ID
- NCT07166770
- Acronym / sponsor ID
- 22-10-FB-0215 - Study 2
- Keywords
- community-led, COVID-19, trust, vaccine hesitancy, peer mentor, community advisory board
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Old Dominion UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 10 Sep 2025 (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 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.
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 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 weeks, 14 weeks, and 18 weeks
| 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, 14, and 18 week 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, 14-week, and 18-week timepoints
- Ability to read, speak, and understand English
Key exclusion criteria (1 listed)
- May not have participated in Study 1
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 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.
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.
Trust in the Safety of the COVID-19 Vaccine
Time frame: 0 weeks, 14 weeks, 18 weeks
Trust in the safety of the COVID-19 vaccine was measured with one item which assessed participants' trust in the safety of the COVID-19 vaccine. The item is rated on a 5-point Likert scale. Higher scores indicate greater trust.
Trust in Efficacy of the COVID-19 Vaccine
Time frame: 0 weeks, 14 weeks, 18 weeks
Trust in the efficacy of the COVID-19 vaccine was measured with one item which assessed participants' perceptions of efficacy related to the COVID-19 vaccine, or trust that it works as intended. The item is rated on a 5-point Likert scale. Higher scores indicate greater trust.
3 secondary outcomes
COVID-19 Vaccine Hesitancy
Time frame: 0 weeks, 14 weeks, 18 weeks
Social Connectedness
Time frame: 0 weeks, 14 weeks, 18 weeks
Health Literacy
Time frame: 0 weeks, 14 weeks, 18 weeks
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 11 Sep 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 11 Sep 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 weeks, 14 weeks, 18 weeks). 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 11 Sep 2026.