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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-led discussion | Behavioral | Participants engage in weekly community-led small group discussions about health related topics |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 0 weeks, 14 weeks, 18 weeks |
| 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. | 0 weeks, 14 weeks, 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelli J England, PhD | Old Dominion University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macon & Joan Brock Virginia Health Institute at Old Dominion University | Norfolk | Virginia | 23507 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2025 | Feb 25, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Participants randomly assigned to intervention or control group; repeated measure assessments at 0 weeks, 14 weeks, and 18 weeks
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| 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. | 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. | 0 weeks, 14 weeks, 18 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |